This corporate presentation provides an overview of Oncolytics Biotech and their lead product REOLYSIN. Key points include:
- REOLYSIN is a proprietary reovirus being tested in combination with chemotherapy in seven randomized clinical trials for various cancers. Completed trials show signs of efficacy and a favorable safety profile.
- Preclinical evidence suggests REOLYSIN selectively replicates in Ras-activated cancer cells. Ongoing trials are exploring this mechanism of action and correlating outcomes with Ras pathway biomarkers.
- A randomized Phase 3 trial in head and neck cancer showed increased progression-free and overall survival for patients receiving REOLYSIN plus chemotherapy compared to chemotherapy alone.
This corporate presentation provides an overview of Oncolytics Biotech and its lead product REOLYSIN. Key points include:
- REOLYSIN is a proprietary reovirus being tested in combination with chemotherapy in multiple randomized phase 2 clinical trials for various cancers.
- Completed phase 2 trial REO 018 in head and neck cancer showed increased progression-free and overall survival when combined with chemotherapy.
- Ongoing trials include studies sponsored by the NCI in pancreatic, ovarian, lung, and breast cancers.
- REOLYSIN works by selectively replicating in Ras-activated cancer cells and is believed to have a favorable safety profile.
This presentation provides an overview of Oncolytics Biotech and its lead product REOLYSIN®, a proprietary reovirus for the treatment of cancers. Key points include:
- REOLYSIN® shows efficacy in Ras-activated cancers and has a favorable safety profile. It is being studied in 7 randomized clinical trials in various cancer types.
- Data from a randomized phase 2 trial in head and neck cancer (REO 018) showed improved progression-free survival and tumor responses with the combination of REOLYSIN®, carboplatin and paclitaxel.
- Additional phase 2 studies in lung, prostate, colorectal and other cancers are ongoing to further evaluate REOLYS
The corporate presentation summarizes Oncolytics Biotech's lead product REOLYSIN, a therapeutic reovirus being studied in multiple clinical trials. Key points include:
- REOLYSIN has been administered to over 1,000 patients safely and shows efficacy against Ras-activated cancers.
- A randomized Phase II trial of REOLYSIN in head and neck cancer, REO 018, showed improved tumor stabilization and shrinkage for those receiving REOLYSIN compared to the control arm.
- Oncolytics intends for REO 018 to support a planned Phase III registration trial of REOLYSIN in head and neck cancer.
Oncolytics Biotech presented their investor presentation which included the following key points:
1) Oncolytics is developing REOLYSIN, a novel immuno-oncology viral agent for systemic administration that exploits cancer cell lysis and anti-tumor immunity.
2) Additional randomized phase 2 clinical trials in 2017 are expected to generate overall survival data in breast cancer, ovarian cancer, non-small cell lung cancer, and colorectal cancer.
3) The clinical development plan focuses on combining REOLYSIN with chemotherapy for late-stage development and establishing it as a backbone agent combined with immunotherapy.
4) Over 900 patients have been treated with REOLYSIN intravenously with no drug
The document discusses Cancer Genetics' focus on personalized cancer treatment through genomics. It provides an overview of Cancer Genetics' business model, which utilizes molecular diagnostic testing to support the cancer care continuum and improve outcomes. Key acquisitions are highlighted that expand Cancer Genetics' capabilities in clinical services, research, and pharmacogenomics.
This company presentation provides an overview of NeoGenomics and their cancer genetic testing services. Some key points:
- NeoGenomics is a fast-growing cancer genetics lab that services oncologists, pathologists, and hospitals through strategic partnerships and a tech-only model.
- They have an experienced management team with experience at large cap labs and offer the most comprehensive cancer testing menu in the industry.
- NeoGenomics has demonstrated a proven track record of consistent growth over the last 10 years with 65% CAGR in revenue and test volume.
- Their focus for 2015 includes expanding next generation sequencing, developing a prostate cancer liquid biopsy test, launching new products, and growing their clinical trials business
This document discusses Biocept, Inc., a commercial-stage cancer diagnostics company. It provides an overview of Biocept's liquid biopsy platform and tests, including OncoCEE-BR, their first commercialized test for breast cancer. The document also summarizes Biocept's growth strategy, which includes expanding their test menu, improving operational efficiency, and increasing market penetration. It introduces Biocept's executive team and describes their extensive experience in cancer diagnostics, genomics, and life sciences.
This corporate presentation provides an overview of Oncolytics Biotech and its lead product REOLYSIN. Key points include:
- REOLYSIN is a proprietary reovirus being tested in combination with chemotherapy in multiple randomized phase 2 clinical trials for various cancers.
- Completed phase 2 trial REO 018 in head and neck cancer showed increased progression-free and overall survival when combined with chemotherapy.
- Ongoing trials include studies sponsored by the NCI in pancreatic, ovarian, lung, and breast cancers.
- REOLYSIN works by selectively replicating in Ras-activated cancer cells and is believed to have a favorable safety profile.
This presentation provides an overview of Oncolytics Biotech and its lead product REOLYSIN®, a proprietary reovirus for the treatment of cancers. Key points include:
- REOLYSIN® shows efficacy in Ras-activated cancers and has a favorable safety profile. It is being studied in 7 randomized clinical trials in various cancer types.
- Data from a randomized phase 2 trial in head and neck cancer (REO 018) showed improved progression-free survival and tumor responses with the combination of REOLYSIN®, carboplatin and paclitaxel.
- Additional phase 2 studies in lung, prostate, colorectal and other cancers are ongoing to further evaluate REOLYS
The corporate presentation summarizes Oncolytics Biotech's lead product REOLYSIN, a therapeutic reovirus being studied in multiple clinical trials. Key points include:
- REOLYSIN has been administered to over 1,000 patients safely and shows efficacy against Ras-activated cancers.
- A randomized Phase II trial of REOLYSIN in head and neck cancer, REO 018, showed improved tumor stabilization and shrinkage for those receiving REOLYSIN compared to the control arm.
- Oncolytics intends for REO 018 to support a planned Phase III registration trial of REOLYSIN in head and neck cancer.
Oncolytics Biotech presented their investor presentation which included the following key points:
1) Oncolytics is developing REOLYSIN, a novel immuno-oncology viral agent for systemic administration that exploits cancer cell lysis and anti-tumor immunity.
2) Additional randomized phase 2 clinical trials in 2017 are expected to generate overall survival data in breast cancer, ovarian cancer, non-small cell lung cancer, and colorectal cancer.
3) The clinical development plan focuses on combining REOLYSIN with chemotherapy for late-stage development and establishing it as a backbone agent combined with immunotherapy.
4) Over 900 patients have been treated with REOLYSIN intravenously with no drug
The document discusses Cancer Genetics' focus on personalized cancer treatment through genomics. It provides an overview of Cancer Genetics' business model, which utilizes molecular diagnostic testing to support the cancer care continuum and improve outcomes. Key acquisitions are highlighted that expand Cancer Genetics' capabilities in clinical services, research, and pharmacogenomics.
This company presentation provides an overview of NeoGenomics and their cancer genetic testing services. Some key points:
- NeoGenomics is a fast-growing cancer genetics lab that services oncologists, pathologists, and hospitals through strategic partnerships and a tech-only model.
- They have an experienced management team with experience at large cap labs and offer the most comprehensive cancer testing menu in the industry.
- NeoGenomics has demonstrated a proven track record of consistent growth over the last 10 years with 65% CAGR in revenue and test volume.
- Their focus for 2015 includes expanding next generation sequencing, developing a prostate cancer liquid biopsy test, launching new products, and growing their clinical trials business
This document discusses Biocept, Inc., a commercial-stage cancer diagnostics company. It provides an overview of Biocept's liquid biopsy platform and tests, including OncoCEE-BR, their first commercialized test for breast cancer. The document also summarizes Biocept's growth strategy, which includes expanding their test menu, improving operational efficiency, and increasing market penetration. It introduces Biocept's executive team and describes their extensive experience in cancer diagnostics, genomics, and life sciences.
Oncotype DX is a 21-gene diagnostic test developed by Genomic Health to analyze gene expression in breast cancer tumors. It provides a Recurrence Score that quantitatively estimates the likelihood of cancer recurrence and predicts whether chemotherapy will provide benefit. The test analyzes the expression of 16 cancer-related genes and 5 reference genes using RT-qPCR. Validation studies have shown the Recurrence Score strongly correlates with actual cancer recurrence. While approved through CLIA, Genomic Health is also pursuing FDA approval and expanding the test to other cancers.
Cancer Genetics provides personalized cancer treatment through molecular diagnostic testing. They have launched 6 proprietary diagnostic products targeting hematological and urogenital cancers. Their tests help determine cancer type and prognosis, guiding treatment selection. Recent acquisitions expand their capabilities and access to new markets in India. Their business model provides clinical testing services to oncologists and biopharma partnerships to support drug development.
This document discusses Oncotype DX, a 21-gene diagnostic test for breast cancer recurrence developed by Genomic Health. It measures gene expression from tumor samples using RT-qPCR to determine a Recurrence Score predicting recurrence risk and chemotherapy benefit. Oncotype DX was validated using large clinical trials and provides a quantitative recurrence risk assessment to guide treatment decisions. Though regulated under CLIA, Oncotype DX avoids the lengthy FDA approval process required for diagnostic tests. Genomic Health continues developing additional cancer diagnostic tests.
Speaker: Lisette Stork-Sloots, Sr Program Director at Agendia, discusses how their technology, MammaPrint was commercialized.
Part of Dx2010, a workshop at MaRS focused on best practices and regulatory considerations for developing gene-based diagnostic and prognostic tests.
The document discusses the use of genomics in early stage breast cancer treatment. It describes how genomics can provide personalized treatment by understanding each tumor's biology and risk of recurrence. Two multi-gene assays, Mammaprint and Oncotype DX, are discussed. Oncotype DX has been clinically validated to predict recurrence risk and chemotherapy benefit in node-negative patients. Studies also show it can predict outcomes for node-positive patients treated with tamoxifen. The results from these assays often change treatment decisions by identifying patients unlikely to benefit from chemotherapy.
Our vision is enabling effective cancer treatment sooner. BIOARRAY's approach is to confront "cancer in reverse" by focusing on healthy cell organization, not limited to specific patients or treatments. BIOARRAY has developed a proprietary discovery platform leveraging normal cell biology and math to identify novel cancer genes. Markers of healthy cell organization stratify cancer patients by prognosis in independent datasets totaling 699 patients. BIOARRAY's discovery approach can be applied to multiple cancer types including breast, prostate, and pancreatic.
Liquid Biopsy: From Isolation to Downstream Applications 2018 Report by Yole ...Yole Developpement
How will liquid biopsy change cancer care?
More information on: https://www.i-micronews.com/category-listing/product/liquid-biopsy-from-isolation-to-downstream-applications-2018.html
Specialized oncology reference laboratory providing the latest testing technologies, global/tech-only options, and interactive education to the pathology community
Offer the complete spectrum of diagnostic services through nationwide network of laboratories
Dedicated to providing superior service, faster turn-around times, and complete attention to the needs of our clients and their patients
This corporate presentation discusses the company's mission to help eradicate colon cancer. It summarizes the challenges of colon cancer as the second deadliest cancer in the U.S. and highlights Cologuard, the company's non-invasive stool DNA test, as a way to address low screening rates and detect precancerous polyps. Data shows Cologuard has strong performance in detecting cancer and precancer, and its inclusion in guidelines is expected to help make it the standard of care for colon cancer screening.
1. Genomic predictors like Oncotype DX and Mammaprint provide prognostic information about the risk of cancer recurrence in early-stage breast cancer patients. They have been validated in multiple retrospective studies but need further prospective validation.
2. These genomic predictors provide additional information beyond standard clinical parameters like ER and PR status. However, they do not perfectly correlate with these parameters and may capture different biological information.
3. Improving genomic predictors may involve developing them within specific molecular subclasses of breast cancer and using larger datasets to train them. Whole genome analyses could provide more detailed biological insights to guide treatment decisions.
Future Of Cancer Diagnostics Conference 8 21 08sanglorikian
The document discusses how molecular diagnostics (MDx) are influencing cancer care. MDx are having a large impact by assisting with early detection, prognosis, and theranostics. MDx help personalize treatment and provide effective solutions by determining predisposition, predicting aggressiveness, and indicating response to therapies. MDx are also helping to monitor cancer management and patient surveillance.
Marketplace positioning and preliminary Market forecast Gabrielle Forman
The document provides an overview of TARIS's market research on bladder cancer and overactive bladder syndrome (OAB). Key points include:
1) Bladder cancer represents a large underserved market opportunity with increasing development activity in recent years. The market research validated the potential for TARIS's sustained drug delivery approach to transform bladder cancer treatment.
2) The research estimated the peak US market opportunity for successful bladder cancer treatment to be over $1 billion based on incidence rates and treatment costs.
3) Research also found the economic burden of OAB to be high, around $36.5 billion annually in the US. TARIS's non-invasive treatment approach could address unmet needs and target
- The company provides an overview presentation of its business operations, growth strategy, and recent acquisition of Clarient, which is expected to more than double its revenue and more than triple its adjusted EBITDA in 2016.
- Key highlights include its focus on cancer genetics testing, strategic partnerships with pathologists and oncologists, a comprehensive testing menu, and experienced management team.
- Financial projections estimate combined pro forma revenue of $242-252 million and adjusted EBITDA of $35-40 million in 2016 following the acquisition of Clarient. Synergies from the acquisition are expected to provide $20-30 million in annual cost savings.
- The company provides an overview presentation of its business operations, growth strategy, and recent acquisition of Clarient, which is expected to more than double its revenue and more than triple its adjusted EBITDA in 2016.
- Key highlights include its focus on being a leading cancer genetics testing provider, experience in consolidating the industry, a comprehensive testing menu, and strategic partnerships with pathologists and oncologists.
- Financial projections estimate the combined company will generate around $247 million in revenue and $35-40 million in adjusted EBITDA in 2016 following the acquisition.
New science is redefining cancer as a large number of narrowly defined diseases and bringing therapeutic options to an expanded number of patients. With the rapid growth in the oncology treatment landscape, health systems are struggling to adapt and embrace the evolution—including regulatory systems, diagnostic infrastructure, treatment providers and financing mechanisms. These challenges will require urgent attention in light of the strong near-term pipeline of clinically distinctive therapies and new programs that are galvanizing research efforts to change the trajectory for cancer.
Read the full report >> http://imsh.co/2axszmt
This Presentation provides information about the segmentation of oncology market worldwide, Global Oncology market analysis along with Indian Oncology market.
This presentation covers the following information - Indian Government initiatives,Market Challenges,Market Drivers and SWOT Analysis.
The document discusses several gene expression profiling tests for early breast cancer, including OncotypeDX, MammaPrint, and TAILORx. OncotypeDX analyzes the expression of 21 genes to calculate a recurrence score that predicts the likelihood of distant recurrence within 10 years for tamoxifen-treated patients. MammaPrint analyzes 70 genes to classify patients into low or high risk groups. The TAILORx clinical trial aims to determine which patients with early breast cancer and OncotypeDX scores of 11-25 benefit from chemotherapy using a randomized design.
This document provides information about the Sub-betic Mountain range in Spain. It notes that the distance from Valdepeñas to the Sub-betic Range is 209km and that the autonomous community is Andalusia. It also lists the peak of La Sagra at 2,381 meters and names the most important areas as Sierra Cazorla, Sierra Magina and Sierra Segura.
Tutorial pembuatan sop dengan menggunakan moscrosoft visiooliviadia
Dokumen ini memberikan tutorial singkat tentang pembuatan Standar Operasional Prosedur (SOP) menggunakan Microsoft Visio. SOP digunakan untuk mendokumentasikan alur proses kerja secara tertulis dan sistematis guna memudahkan pelaksanaan dan konsistensi hasil kerja. Tutorial menjelaskan tiga langkah utama pembuatan SOP menggunakan Visio yaitu: 1) menyiapkan data, 2) membuka halaman Visio, 3) membuat kolom fungsi dan alur
Oncotype DX is a 21-gene diagnostic test developed by Genomic Health to analyze gene expression in breast cancer tumors. It provides a Recurrence Score that quantitatively estimates the likelihood of cancer recurrence and predicts whether chemotherapy will provide benefit. The test analyzes the expression of 16 cancer-related genes and 5 reference genes using RT-qPCR. Validation studies have shown the Recurrence Score strongly correlates with actual cancer recurrence. While approved through CLIA, Genomic Health is also pursuing FDA approval and expanding the test to other cancers.
Cancer Genetics provides personalized cancer treatment through molecular diagnostic testing. They have launched 6 proprietary diagnostic products targeting hematological and urogenital cancers. Their tests help determine cancer type and prognosis, guiding treatment selection. Recent acquisitions expand their capabilities and access to new markets in India. Their business model provides clinical testing services to oncologists and biopharma partnerships to support drug development.
This document discusses Oncotype DX, a 21-gene diagnostic test for breast cancer recurrence developed by Genomic Health. It measures gene expression from tumor samples using RT-qPCR to determine a Recurrence Score predicting recurrence risk and chemotherapy benefit. Oncotype DX was validated using large clinical trials and provides a quantitative recurrence risk assessment to guide treatment decisions. Though regulated under CLIA, Oncotype DX avoids the lengthy FDA approval process required for diagnostic tests. Genomic Health continues developing additional cancer diagnostic tests.
Speaker: Lisette Stork-Sloots, Sr Program Director at Agendia, discusses how their technology, MammaPrint was commercialized.
Part of Dx2010, a workshop at MaRS focused on best practices and regulatory considerations for developing gene-based diagnostic and prognostic tests.
The document discusses the use of genomics in early stage breast cancer treatment. It describes how genomics can provide personalized treatment by understanding each tumor's biology and risk of recurrence. Two multi-gene assays, Mammaprint and Oncotype DX, are discussed. Oncotype DX has been clinically validated to predict recurrence risk and chemotherapy benefit in node-negative patients. Studies also show it can predict outcomes for node-positive patients treated with tamoxifen. The results from these assays often change treatment decisions by identifying patients unlikely to benefit from chemotherapy.
Our vision is enabling effective cancer treatment sooner. BIOARRAY's approach is to confront "cancer in reverse" by focusing on healthy cell organization, not limited to specific patients or treatments. BIOARRAY has developed a proprietary discovery platform leveraging normal cell biology and math to identify novel cancer genes. Markers of healthy cell organization stratify cancer patients by prognosis in independent datasets totaling 699 patients. BIOARRAY's discovery approach can be applied to multiple cancer types including breast, prostate, and pancreatic.
Liquid Biopsy: From Isolation to Downstream Applications 2018 Report by Yole ...Yole Developpement
How will liquid biopsy change cancer care?
More information on: https://www.i-micronews.com/category-listing/product/liquid-biopsy-from-isolation-to-downstream-applications-2018.html
Specialized oncology reference laboratory providing the latest testing technologies, global/tech-only options, and interactive education to the pathology community
Offer the complete spectrum of diagnostic services through nationwide network of laboratories
Dedicated to providing superior service, faster turn-around times, and complete attention to the needs of our clients and their patients
This corporate presentation discusses the company's mission to help eradicate colon cancer. It summarizes the challenges of colon cancer as the second deadliest cancer in the U.S. and highlights Cologuard, the company's non-invasive stool DNA test, as a way to address low screening rates and detect precancerous polyps. Data shows Cologuard has strong performance in detecting cancer and precancer, and its inclusion in guidelines is expected to help make it the standard of care for colon cancer screening.
1. Genomic predictors like Oncotype DX and Mammaprint provide prognostic information about the risk of cancer recurrence in early-stage breast cancer patients. They have been validated in multiple retrospective studies but need further prospective validation.
2. These genomic predictors provide additional information beyond standard clinical parameters like ER and PR status. However, they do not perfectly correlate with these parameters and may capture different biological information.
3. Improving genomic predictors may involve developing them within specific molecular subclasses of breast cancer and using larger datasets to train them. Whole genome analyses could provide more detailed biological insights to guide treatment decisions.
Future Of Cancer Diagnostics Conference 8 21 08sanglorikian
The document discusses how molecular diagnostics (MDx) are influencing cancer care. MDx are having a large impact by assisting with early detection, prognosis, and theranostics. MDx help personalize treatment and provide effective solutions by determining predisposition, predicting aggressiveness, and indicating response to therapies. MDx are also helping to monitor cancer management and patient surveillance.
Marketplace positioning and preliminary Market forecast Gabrielle Forman
The document provides an overview of TARIS's market research on bladder cancer and overactive bladder syndrome (OAB). Key points include:
1) Bladder cancer represents a large underserved market opportunity with increasing development activity in recent years. The market research validated the potential for TARIS's sustained drug delivery approach to transform bladder cancer treatment.
2) The research estimated the peak US market opportunity for successful bladder cancer treatment to be over $1 billion based on incidence rates and treatment costs.
3) Research also found the economic burden of OAB to be high, around $36.5 billion annually in the US. TARIS's non-invasive treatment approach could address unmet needs and target
- The company provides an overview presentation of its business operations, growth strategy, and recent acquisition of Clarient, which is expected to more than double its revenue and more than triple its adjusted EBITDA in 2016.
- Key highlights include its focus on cancer genetics testing, strategic partnerships with pathologists and oncologists, a comprehensive testing menu, and experienced management team.
- Financial projections estimate combined pro forma revenue of $242-252 million and adjusted EBITDA of $35-40 million in 2016 following the acquisition of Clarient. Synergies from the acquisition are expected to provide $20-30 million in annual cost savings.
- The company provides an overview presentation of its business operations, growth strategy, and recent acquisition of Clarient, which is expected to more than double its revenue and more than triple its adjusted EBITDA in 2016.
- Key highlights include its focus on being a leading cancer genetics testing provider, experience in consolidating the industry, a comprehensive testing menu, and strategic partnerships with pathologists and oncologists.
- Financial projections estimate the combined company will generate around $247 million in revenue and $35-40 million in adjusted EBITDA in 2016 following the acquisition.
New science is redefining cancer as a large number of narrowly defined diseases and bringing therapeutic options to an expanded number of patients. With the rapid growth in the oncology treatment landscape, health systems are struggling to adapt and embrace the evolution—including regulatory systems, diagnostic infrastructure, treatment providers and financing mechanisms. These challenges will require urgent attention in light of the strong near-term pipeline of clinically distinctive therapies and new programs that are galvanizing research efforts to change the trajectory for cancer.
Read the full report >> http://imsh.co/2axszmt
This Presentation provides information about the segmentation of oncology market worldwide, Global Oncology market analysis along with Indian Oncology market.
This presentation covers the following information - Indian Government initiatives,Market Challenges,Market Drivers and SWOT Analysis.
The document discusses several gene expression profiling tests for early breast cancer, including OncotypeDX, MammaPrint, and TAILORx. OncotypeDX analyzes the expression of 21 genes to calculate a recurrence score that predicts the likelihood of distant recurrence within 10 years for tamoxifen-treated patients. MammaPrint analyzes 70 genes to classify patients into low or high risk groups. The TAILORx clinical trial aims to determine which patients with early breast cancer and OncotypeDX scores of 11-25 benefit from chemotherapy using a randomized design.
This document provides information about the Sub-betic Mountain range in Spain. It notes that the distance from Valdepeñas to the Sub-betic Range is 209km and that the autonomous community is Andalusia. It also lists the peak of La Sagra at 2,381 meters and names the most important areas as Sierra Cazorla, Sierra Magina and Sierra Segura.
Tutorial pembuatan sop dengan menggunakan moscrosoft visiooliviadia
Dokumen ini memberikan tutorial singkat tentang pembuatan Standar Operasional Prosedur (SOP) menggunakan Microsoft Visio. SOP digunakan untuk mendokumentasikan alur proses kerja secara tertulis dan sistematis guna memudahkan pelaksanaan dan konsistensi hasil kerja. Tutorial menjelaskan tiga langkah utama pembuatan SOP menggunakan Visio yaitu: 1) menyiapkan data, 2) membuka halaman Visio, 3) membuat kolom fungsi dan alur
How a Credit Union Can Stay Off the CFPB's RadarSilver cloud
Learn what it takes to align consumer expectations, CFPB expectations and your business. SilverCloud, Inc. will take you through the evolving consumer behaviors, the current regulatory landscape and where you want to be to stay off the radar. Learn what your financial institution needs to be doing to have happier consumers, drive more revenue, lower costs, and stay compliant.
This document summarizes a student presentation on NoSQL databases given at the Web Data Management, Search and Retrieval course at Birzeit University in Palestine. The presentation introduces document-oriented databases and compares their structure and querying to relational databases. It also covers concepts like joins, constraints, transactions, embedding documents, and indexing arrays. Benefits of NoSQL databases discussed include scalability, performance, and flexibility in schema design. Specific examples are provided for one-to-many and many-to-many relationships using embedding and references. The presentation concludes with sections on data replication and sharding in MongoDB.
The document summarizes renovations to the library space at St. Mary of the Purification Montessori School. Photos show the cluttered office space being reorganized with desks removed to open up more work space. The main library was brightened up by adding colorful walls, chairs and lighter shelves to make it more inviting. Bathrooms were uncovered by removing tall bookcases. The preschool area was updated by removing obstructive shelves to add seating and create more space for children. New steel shelves provided more storage capacity so old shelves could be replaced with palms to flank windows. A custom stage was added per request. Renovations transformed tight, dark spaces into brighter, more functional areas for students and staff.
REOLYSIN is an oncolytic virus being developed as a cancer therapeutic. It selectively replicates in and kills Ras activated tumor cells. Over 1,100 patients have been treated with REOLYSIN which has shown a good safety profile and evidence of tumor reduction. Clinical trials are ongoing in various cancer types, both as a monotherapy and in combination with chemotherapy and immunotherapy. The goal is to demonstrate tumor reduction and improved overall survival to support regulatory approval. Oncolytics Biotech has a strong patent portfolio and manufactures REOLYSIN at commercial scale.
Taman Sriwedari merupakan taman yang dibangun oleh Paku Buwono X di Solo. Saat ini kepemilikan taman ini sedang dalam sengketa antara pemerintah kota Solo dengan ahli waris keluarga KRMH Wirjodiningrat. Taman ini terletak di Jalan Brigjen Slamet Riyadi 275, Penumping, Laweyan, Solo dan memiliki fasilitas seperti gedung pertunjukan wayang orang, toko buku, serta dijadikan tempat berbagai acara.
El documento describe los fundamentos de la planeación para las organizaciones. Explica que la planeación implica definir objetivos, establecer estrategias para lograrlos, y desarrollar planes para coordinar las actividades. También señala que la planeación proporciona dirección a los gerentes y empleados, reduce la incertidumbre, y minimiza el desperdicio. Finalmente, destaca que la planeación es importante para los gerentes porque les enseña a establecer objetivos y planear con flexibilidad ante cambios.
Product Placement - An Innocent Mistake(罪美麗) sallyshiu
This document lists 5 product placements seen in the film "An Innocent Mistake": 1) Formosa Eyeglasses, 2) Jack Daniel's Tennessee whiskey, 3) Taiwan Beer, 4) Apple Sidra, and 5) FUJUYA Peko Candy. The film is analyzed by UE3A 1100200018 Sally Shiu for instances of product placement.
This document provides an overview of mobile marketing services offered by Mobile Marketing Pro LLC. It discusses how mobile strategies can increase customer awareness, engagement, and purchases. Key services highlighted include premium responsive websites, mobile apps, QR codes, text messaging, geo-location tools, and social media integration. Statistics are presented showing the growth of mobile internet and coupon usage. The benefits of different mobile tactics like websites, apps, and beacons are compared. Sample mobile applications like loyalty programs and mobile commerce are also described.
10 tips To Boost Your Search Visibility in 2017NetscapeIndia
This document provides 10 tips for boosting search engine optimization (SEO) in 2017, including analyzing competitor SEO strategies, including keywords in content such as the first paragraph and image alt tags, using keywords in URLs and meta tags, focusing on local SEO, and being published by Netscape India Pvt. Ltd.
This presentation provides an overview of Oncolytics Biotech and their lead product REOLYSIN®, a therapeutic reovirus being studied for various cancer indications. Key points include:
- REOLYSIN® has shown selective cytotoxicity against cancer cells with Ras pathway activation and is currently in six phase II randomized clinical trials in cancers like breast, lung, colorectal, prostate, pancreatic, and ovarian.
- Early clinical data shows REOLYSIN® may have immune-mediated anti-tumor activity in addition to direct cytotoxic effects. Combinations with immunotherapy agents are being explored.
- Over 1,000 patients have been treated with REOLYSIN® which has shown a good safety profile with mostly
This presentation provides an overview of Oncolytics Biotech and its lead product REOLYSIN®, a proprietary reovirus for the treatment of cancers. Key points include:
- REOLYSIN® selectively replicates in and kills Ras-activated cancer cells through a mechanism of action that deactivates the cellular defense protein PKR.
- Oncolytics has an expanding clinical program testing REOLYSIN® across several cancer types both as a monotherapy and in combination with chemotherapy.
- A randomized Phase II head and neck cancer study (REO 018) showed increased progression-free and overall survival for patients receiving REOLYSIN® plus chemotherapy compared to chemotherapy alone.
This corporate presentation provides an overview of Oncolytics Biotech and their lead product REOLYSIN. Key points include:
- REOLYSIN is a proprietary reovirus being studied in five randomized phase 2 clinical trials for various cancers.
- Preclinical research shows REOLYSIN selectively replicates in cancer cells with Ras pathway activation. Over 1,000 patients have been treated safely.
- The company has a strong patent portfolio with over 370 patents worldwide and manufacturing capacity at commercial scale.
- Ongoing studies are evaluating REOLYSIN alone or in combination with chemotherapy to show improved survival outcomes and tumor response rates.
This corporate presentation provides an overview of Oncolytics Biotech Inc. and its lead product REOLYSIN®, a cancer therapy. It discusses ongoing randomized phase II clinical trials in ovarian, colorectal, lung, prostate and breast cancers. Previous clinical trials have shown REOLYSIN® to be generally safe and well-tolerated, with the potential to reduce tumour burden and improve survival. The company has a strong intellectual property portfolio with over 370 patents worldwide and manufacturing capacity at commercial scale. Top-line data readouts from the ongoing randomized studies are anticipated in 2015 which could support preparation for a registration study.
REOLYSIN® shows promise as a cancer therapeutic through two mechanisms of action. It acts as a directed cytotoxin against cancer cells with Ras pathway mutations, reducing tumor burden in clinical trials. It also stimulates anti-tumor immune responses, improving overall survival in some studies compared to chemotherapy alone. Oncolytic Biotech is conducting additional registration trials with tumor reduction and overall survival endpoints to confirm these findings and seek approvals.
- The presentation provides an overview of Oncolytics Biotech Inc. and its lead product candidate REOLYSIN®, an oncolytic virus being developed as a cancer therapeutic.
- Data is presented showing REOLYSIN®'s ability to reduce tumor burden through direct cytotoxic effects and stimulate anti-tumor immune responses, improving overall survival in clinical trials.
- Oncolytics has conducted over 30 clinical trials across many cancer types and is preparing registration trials in indications like pancreatic cancer based on favorable results. Manufacturing and a strong patent portfolio were also summarized.
This presentation provides an overview of Oncolytics Biotech Inc. and its lead product REOLYSIN®, a novel cancer therapy. Key points include:
- REOLYSIN® is a proprietary reovirus being studied in five randomized Phase II clinical trials for various cancer indications. Interim data has shown increased progression-free and overall survival compared to controls.
- Preclinical research demonstrates REOLYSIN®'s ability to directly kill tumor cells and stimulate anti-tumor immune responses. Combinations with immunotherapies are being explored.
- Over 1,100 patients have been treated with REOLYSIN® to date, which has shown a favorable safety profile both as monotherapy and in
This investor presentation summarizes Oncolytics Biotech's clinical development plan for REOLYSIN, a viral immunotherapy for cancer. It discusses three pathways: 1) chemotherapy combinations, which are the basis for the first registration pathway in pancreatic cancer. Survival data from several phase 2 studies is expected in 2017. 2) Immunotherapy combinations, including an ongoing study of REOLYSIN with pembrolizumab. 3) Targeted agent/IMiD combinations, such as a collaboration using REOLYSIN with pomalidomide in multiple myeloma. The presentation outlines the mechanism of action of REOLYSIN and how combinations can enhance innate and adaptive immune responses against cancer.
1. The presentation discusses a corporate overview of Oncolytics Biotech including their clinical programs investigating REOLYSIN, a proprietary reovirus, as a cancer therapeutic.
2. Data is presented showing REOLYSIN can reduce tumor burden through direct cytotoxic effects and enhance long-term immune responses. Studies also indicate it may improve overall survival.
3. Oncolytics is developing REOLYSIN for registration in muscle invasive bladder cancer based on ability to show histopathological response. They are also investigating its use in gliomas and other cancers.
1) The document contains forward-looking statements about Oncolytics Biotech's financial results, business prospects, and the development of REOLYSIN, noting inherent risks and uncertainties.
2) REOLYSIN is a proprietary reovirus isolate that selectively replicates in and lyses tumor cells with an activated Ras pathway. Over 1,100 patients have been treated with REOLYSIN, demonstrating a strong safety profile and evidence of anti-tumor activity.
3) Clinical studies show REOLYSIN can reduce tumor burden, improve overall survival rates compared to standard therapies, and enhance long-term immune responses against residual tumor cells through viral replication and immune-mediated effects.
This presentation provides an overview of Oncolytics Biotech and its lead product candidate REOLYSIN. Key points include:
- REOLYSIN is a first-in-class immuno-oncolytic virus being developed for solid tumors and blood cancers. It has a dual mechanism of action selectively killing cancer cells while activating the immune system.
- In a phase 2 trial in metastatic breast cancer, REOLYSIN combined with paclitaxel more than doubled overall survival compared to paclitaxel alone in ER+/PR+/HER2- patients.
- The clinical development plan is pursuing combinations with chemotherapy, immunotherapy agents like Keytruda, and targeted therapies. This includes an ongoing myel
- The document outlines Oncolytics Biotech's corporate presentation from September 2016. It discusses the company's oncolytic virus REOLYSIN, its two mechanisms of action, positive clinical trial data showing increased progression-free and overall survival for certain patient groups, evidence of tumor responses including reductions in liver metastases, an upcoming colorectal cancer study, potential in multiple myeloma based on preclinical data, commercial-scale manufacturing, and a strong intellectual property portfolio with over 400 issued patents worldwide. The presentation positions REOLYSIN as a promising cancer therapeutic prepared for late-stage clinical trials.
This document provides an overview of Oncolytics Biotech and their lead product, REOLYSIN.
It discusses three clinical development pathways for REOLYSIN: 1) Combinations with chemotherapy to directly lyse tumor cells, 2) Combinations with immunotherapy to activate immune responses, and 3) Combinations with targeted therapies to modulate innate immunity.
For pathway 1, a phase 2 trial showed REOLYSIN in combination with paclitaxel significantly improved overall survival over paclitaxel alone in metastatic breast cancer patients. This provides the basis for a planned 400-patient phase 3 registration study in this indication.
Corporate Presentation August 24, 2015
1) Oncolytics Biotech is developing the oncolytic virus REOLYSIN® as a cancer therapeutic. REOLYSIN® has shown to selectively replicate in and kill Ras-activated tumor cells while sparing normal cells.
2) Clinical trials involving over 1,100 patients have demonstrated REOLYSIN®'s favorable safety profile and ability to reduce tumor burden and improve overall survival rates.
3) Ongoing randomized phase 2 studies in ovarian, colorectal, breast, lung, and prostate cancers are evaluating REOLYSIN®'s ability to enhance immune responses and improve long-term clinical outcomes.
This investor presentation summarizes the development of Oncolytics Biotech's lead product REOLYSIN, a therapeutic reovirus. Key points include:
1) REOLYSIN has demonstrated statistically significant improvements in overall survival for metastatic breast cancer and doubled two-year survival for metastatic pancreatic cancer.
2) The clinical development plan focuses on combination therapies with chemotherapy, immunotherapy agents like pembrolizumab, and targeted therapies/IMiDs to boost REOLYSIN's mechanism of action.
3) Over 1,100 patients have been treated with REOLYSIN which has shown a good safety profile with no maximum tolerated dose reached and mostly mild side effects.
Oncolytics Biotech presented an investor presentation that summarized their progress with REOLYSIN, a therapeutic reovirus for treating cancer. Key points included:
- REOLYSIN showed statistically significant increased overall survival in a phase 2 trial for metastatic breast cancer.
- The FDA granted REOLYSIN Fast Track designation and the clinical development plan focuses on combinations with chemotherapy, immunotherapy, and targeted therapies.
- Safety data has shown REOLYSIN to be well-tolerated with no maximum tolerated dose reached. Manufacturing is established at commercial scale.
- The patent portfolio and leadership team provide a strong foundation to further develop REOLYSIN as a potential treatment for multiple cancer types.
This investor presentation summarizes Oncolytics Biotech's REOLYSIN viral therapy program. It highlights statistically significant increases in overall survival seen in phase 2 trials in metastatic breast cancer and pancreatic cancer. The clinical development plan focuses on three pathways: chemotherapy combinations as the first registration pathway, immunotherapy combinations with agents like pembrolizumab, and targeted therapy combinations using agents like pomalidomide. Safety data from over 1,100 patients shows a good toxicity profile. Manufacturing is established at commercial scale and the company has a strong patent portfolio. The leadership team has extensive experience in oncology drug development.
This investor presentation summarizes Oncolytics Biotech's progress developing its lead product REOLYSIN, a proprietary reovirus for treating cancer. Key points include:
- REOLYSIN showed statistically significant increased overall survival in a phase 2 trial combining it with paclitaxel for metastatic breast cancer.
- The company is preparing for regulatory meetings to discuss a potential registration pathway in breast cancer based on these results.
- Additional clinical studies are investigating REOLYSIN in combination with chemotherapy for pancreatic cancer, immunotherapy with pembrolizumab, and targeted therapies from Celgene.
- REOLYSIN's mechanism of action involves direct killing of cancer cells, stimulation of innate and
This document summarizes an investor presentation by Oncolytics Biotech regarding their immuno-oncology agent REOLYSIN. It discusses 3 key points:
1. REOLYSIN's dual mechanism of action turns "cold" tumors "hot" by selectively lysing cancer cells and activating the innate and adaptive immune system.
2. Clinical trials showed REOLYSIN in combination with chemotherapy significantly improved overall survival in patients with metastatic breast cancer and doubled 2-year survival in pancreatic cancer.
3. The company's development plan focuses on combination trials with chemotherapy, immunotherapy agents like Keytruda, and targeted therapies through collaborations with Celgene to advance their lead program in registration trials for metastatic breast cancer
This presentation provides an overview of Oncolytics Biotech Inc. and its lead product REOLYSIN®. REOLYSIN® is a first-in-class immuno-oncology viral therapy for solid tumors and blood cancers. Recent clinical trials showed REOLYSIN® statistically significantly increased overall survival when combined with chemotherapy for metastatic breast cancer. The company has defined a clinical development plan targeting registration in metastatic breast cancer and is pursuing combination trials to further develop REOLYSIN®'s mechanism of action. Oncolytics Biotech has strengthened its leadership team and secured manufacturing agreements to support late-stage trials and early commercialization.
This presentation provides an overview of Oncolytics Biotech and its lead product candidate REOLYSIN. Key points include:
- REOLYSIN is an immuno-oncolytic virus that has demonstrated a statistically significant improvement in overall survival for patients with metastatic breast cancer.
- The clinical development plan focuses on combining REOLYSIN with chemotherapy or immunotherapy agents to boost its dual mechanism of action. This includes an ongoing phase 3 study in metastatic breast cancer.
- If approved, REOLYSIN would address a large market as the first systemically delivered oncolytic virus for solid tumors. Oncolytics is preparing for commercial-scale manufacturing.
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2. Forward Looking Statements
This presentation contains certain forward looking statements relating to the
company’s financial results, business prospects and the development and
commercialization of REOLYSIN®, a therapeutic reovirus. These statements are
based on management’s current expectations and beliefs and are subject to a
number of factors which involve known and unknown risks, delays, uncertainties
and other factors not under the company’s control which may cause actual results,
performance or achievements of the company to be materially different from the
results, performance or other expectations implied by these forward looking
statements.
In any forward looking statement in which Oncolytics Biotech® Inc. expresses an
expectation or belief as to future results, such expectations or beliefs are expressed
in good faith and are believed to have a reasonable basis, but there can be no
assurance that the statement or expectation or belief will be achieved. These
factors include results of current or pending clinical trials, risks associated with
intellectual property protection, financial projections, market projections, actions
by the FDA/HPB/MHRA and those other factors detailed in the company’s filings
with SEDAR and the Securities and Exchange Commission. Oncolytics does not
undertake an obligation to update the forward looking statements, except as
required by applicable laws.
2
3. Oncolytics Overview
o
o
o
Expanding Clinical Program
o Lead product is REOLYSIN®, a broadly active novel cancer therapy
o Ongoing clinical trials include seven randomized studies:
o Enrollment complete randomized international study (REO 018) of
REOLYSIN® in combination with carboplatin and paclitaxel in platinumrefractory recurrent head and neck cancer patients – the supportive
study to a planned Phase III registration study in this indication
o Six sponsored Phase II studies announced or ongoing in the US and
Canada – breast, non-small cell lung, colorectal, prostate, pancreatic
and ovarian cancers
Strong Intellectual Property Portfolio
o More than 370 patents issued worldwide
Manufacturing at Commercial Scale
o 100L cGMP completed, commercial manufacturing agreement in place
3
4. REOLYSIN® Overview
REOLYSIN® is a proprietary isolate of the reovirus
o
o
Reovirus is a replication competent virus and is considered safe to humans
REOLYSIN® has been safely administered to patients via intravenous,
intratumoral and intrathecal injection
Mechanism of Action:
o
o
o
o
o
In Ras-activated cells, one of the key cellular defence mechanisms against
double-stranded RNA viral infection, Protein Kinase-R (PKR), is deactivated
This specific vulnerability of constitutive Ras-activated cancer cells to the
reovirus is the basis of REOLYSIN®’s activity and specificity
Reovirus oncolysis is seen in cancer cells with constitute Ras pathway
activation; susceptible cancer cells therefore include those with either:
o
o
o
1
2
EGFR overexpression or mutation1; or
Ras mutation, which includes Kras mutation2
Both of these mutations lead to activation of the Ras pathway
Evidence that the epidemal growth factor receptor on host cells confers reovirus infection efficiency. Strong et al. Virology 1993; 197(1): 405
The molecular basis of viral oncolysis: usurpation of the Ras signalling pathway by reovirus. Strong et al. EMBO J 1998; 17(12): 3351
4
5. REOLYSIN® Mechanism of Action
Normal Cells
REOLYSIN®
administered to
patients via IV
REOLYSIN®
infects both tumor
cells and normal,
healthy cells
REOLYSIN®
Healthy cell
is a virus whose
remains
replication is
undamaged
stopped in a nonRas-activated cell
Ras-Activated Cells
REOLYSIN®
infects both tumor
cells and normal,
healthy cells
REOLYSIN®
replicates in Rasactivated tumor
cells
5
Replicated viruses
Tumor cells
rupture to release repeat cell lysis cycle
in nearby tumor cells
progeny virus
6. REO 013: REOLYSIN® Induced Tumour Response
o
o
o
o
Image shows positive (red
staining) for reovirus in the
metastatic lesions (blue arrow)
and negative for reovirus in the
normal cells (red arrow)
Nine out of ten patients showed
the same pattern, i.e. targeted
delivery to metastatic tumor
lesions of the liver
In addition, two of the ten
patients had complete tumor
necrosis
This demonstrates that
REOLYSIN® specifically accesses
and replicates in metastatic
colorectal cancer when delivered
as a monotherapy
6
7. Market for Ras Pathway Mediated Cancers
o
o
o
Estimated global cancer market was $77 billion in 2011; this is
expected to rise to $105 billion in 2016
At least five million new patients per year are expected to
develop cancers with a Ras pathway involvement
In the developed world alone, at least 2.6 million patients per
year die of cancers that have metastasized
7
8. REOLYSIN® Clinical Program Overview
REOLYSIN® has been utilized in studies in over 1,000 patients
In total, nearly thirty ongoing or completed clinical trials including:
o Seven randomized Phase II and Phase III clinical trials, including Phase III
head and neck cancer and Phase II trials for ovarian, pancreatic, prostate,
colorectal, non-small cell lung and breast cancers
o Nine single arm studies in the following indications:
o Phase II trials:
o
o
Company sponsored: pancreatic cancer, non-small cell lung cancer, head and neck carcinoma,
metastatic melanoma and squamous cell carcinoma
Phase I trials:
o
o
Company sponsored: colorectal cancer and advanced malignancies
Investigator sponsored: multiple myeloma and relapsed or refractory solid tumors
8
9. REOLYSIN®: Randomized Pipeline
Indication
Combination
Therapy
n
REO 018: Head & Neck Cancer
Carboplatin +
paclitaxel
167
n/a
GOG-0186H: Ovarian, Fallopian Tube
& Primary Peritoneal Cancers
Paclitaxel
110
NCI/
GOG
OSU-10045: Pancreatic Cancer
Carboplatin +
paclitaxel
70
NCI
IND 209: Prostate Cancer
Docetaxel
80
NCIC
IND 210: Colorectal Cancer
FOLFOX-6 +
Avastin®
100
NCIC
IND 211: Non-Small Cell Lung Cancer
Docetaxel or
pemetrexed
150
NCIC
IND 213: Breast Cancer
Paclitaxel
100
NCIC
Preclinical
9
Phase I
Phase II
Phase III
Sponsor
10. Phase III (Pivotal) Program for REOLYSIN®
in Squamous Cell Head & Neck Cancers
o
In Q3 2012, Oncolytics completed enrollment in REO 018, a randomized, two stage, two-arm,
double-blind, multi-center trial examining REOLYSIN® in combination with carboplatin and
paclitaxel in taxane-naïve patients with platinum-refractory recurrent head and neck cancers
o
o
The study was approved and run in fourteen countries in North America and Europe
Patients in the REO 018 study were stratified for:
o
ECOG performance status (0-1 versus 2)
o
Time of progression/relapse after prior platinum-based chemotherapy
o
o
Disease location (patients with locally recurrent disease, with or without distal metastases, versus patients
with metastatic disease only)
REO 018 Endpoints:
o
o
Secondary Endpoints: Progression-Free Survival (PFS), best response and tumour-specific response
o
o
Primary Endpoint: Overall Survival (OS)
Pharmacodynamic Endpoints: Tumour Ras pathway status and HPV status
The Company intends to treat REO 018 as a separate supportive study to a planned randomized,
follow-on international Phase III head and neck registration study in patients with loco-regional
head and neck cancer
10
11. REO 018: Tumor Specific Response Data
o
o
Data announced December 13, 2012
Endpoint examines initial percentage tumor changes between
baseline and first post treatment scans in all patients,
differentiating between loco-regional tumours and metastatic
tumours
o
o
o
This is a measure of rate or velocity of response, not magnitude of
response
The endpoint was introduced to determine if REOLYSIN® adds
tumor specific differential activity in metastatic and loco-regional
disease in a randomized setting
Of the total 105 patients with evaluable metastatic tumors, 86%
(n=50) of those in the test, and 67% (n=55) in the control arm, arm
had tumor stabilization (0% growth) or shrinkage
o
This is a statistically significant difference, with a p-value of 0.025
11
12. REO 018: Percentage Change in Metastatic Lesions at
First Post-Treatment Scan (Control vs. Test)
100.00%
Percent Change (Target Lesions)
80.00%
60.00%
40.00%
20.00%
Control
0.00%
0
0.1
0.2
0.3
0.4
0.5
0.6
-20.00%
-40.00%
-60.00%
-80.00%
-100.00%
p=0.03
12
0.7
0.8
0.9
1
Test
13. REO 018: Top-Line Efficacy Data
o
o
Data announced November 21, 2013
An analysis was performed on an intent-to-treat basis of the 118
patients with loco-regional disease, with or without metastases
o
o
Patients in the test arm (n=62) showed a median PFS of 94 days
(13.4 weeks), versus 50 days (7.1 weeks) in the control arm (n=56)
o
o
At the time of reporting, there had not been a sufficient number of
events to conduct a survival analysis of patients in the metastatic-only
group
Patients who received REOLYSIN® had increased benefit through five
cycles of therapy
Of 88 patients who did not receive additional therapy following
discontinuation of study treatment, those in the test arm (n=50)
showed a median OS of 150 days (21.4 weeks), versus 115 days
(16.4 weeks) in the control arm (n=38)
13
14. REO 018: Top-Line Safety Data
o
o
o
Data announced November 21, 2013 for all 167 patients enrolled
REOLYSIN® was safe and well-tolerated by patients
Patients on the test arm of the study experienced a higher
incidence of flu-like symptoms consistent with earlier clinical trials
of REOLYSIN® and treatment with a virus
o
o
Most commonly mild fever, chills, nausea and diarrhea
Fewer patients required dose reductions of paclitaxel due to
neuropathy or neurotoxicity on the test arm than the control arm
(zero in the test arm versus six in the control; p=0.028)
o
On this basis, Oncolytics intends to explore the potential
chemoprotective and neuroprotective properties of REOLYSIN® in
future clinical studies
14
15. REO 016: Non-Small Cell Lung Cancer
o
o
Single-arm (up to 36 patients), open-label, two-stage US
Phase II study of intravenously-administered REOLYSIN® in
combination with carboplatin and paclitaxel
For non-small cell lung cancer (NSCLC) patients who have
been pre-screened for Kras and EGFR mutation status
o
o
15-20% of NSCLC is Kras mutated, while up to 50% is EGFR mutated or
overexpressed, all of which cause Ras pathway activation
First-line therapy study, i.e. patients will be offered REOLYSIN® /
carboplatin / paclitaxel instead of standard of care if they are Kras or
EGFR mutated or EGFR overexpressed
15
16. REO 016: Biomarker Correlations with
REOLYSIN® Efficacy
o
o
o
o
o
Of 36 evaluable patients, all of whom were Stage IV on
entry, 89% exhibited SD or better (11 PR, 21 SD and 4 PD by
RECIST)
20 of these 36 patients (56%) had one year or more of
survival
Of 24 patients with at least an EGFR mutation or
amplification, 16 (66.7%) had one year or more of survival
Of 13 patients with only an EGFR mutation or amplification,
9 (69.2%) had one year or more of survival
Of 4 patients with BRAF and EGFR amplifications, 4 (100%)
had one year or more of survival
16
18. REO 021: Squamous Cell Carcinoma of
the Lungs
o
o
o
Single-arm (up to 36 patients), open-label US Phase II
study of intravenously-administered REOLYSIN® in
combination with carboplatin and paclitaxel
Final results in 25 evaluable patients (all with
metastatic disease) demonstrated that 92% (23
patients) exhibited overall tumour shrinkage, with
mean shrinkage of 32.7%
Of the 25 evaluable patients who received more than
one cycle of therapy, 10 (40%) showed partial
responses by RECIST, and a further 12 (48%) showed
stable disease by RECIST, for a disease control rate (CR
+ PR + SD) of 92%
18
20. REO 021: Partial Response in Lung
Right Upper Lung Mass (8.3 cm)
Right Upper Lung Mass (4.1 cm)
Right Upper Lung Mass (3.6 cm)
Right Pleural Met (2.2 cm)
Right Pleural Met (0.8 cm)
Right Pleural Met (0.4 cm)
Pre-Treatment
Post-Cycle 2
20
Post-Cycle 4
21. Randomized Canadian Studies of REOLYSIN®
o
Patients are currently being enrolled in four randomized Phase II
studies in Canada:
o
o
o
o
o
IND 209: Intravenous Administration of REOLYSIN® in Combination
with Docetaxel for Patients with Recurrent or Metastatic Castration
Resistant Prostate Cancer
IND 210: Intravenous Administration of REOLYSIN® in Combination
with FOLFOX-6 Plus Avastin® versus FOLFOX-6 Plus Avastin® Alone in
Patients with Advanced or Metastatic Colorectal Cancer
IND 211: Intravenous Administration of REOLYSIN® in Combination
with Docetaxel or Pemetrexed for Patients with Previously-Treated
Advanced or Metastatic Non-Small Cell Lung Cancer
IND 213: Intravenous Administration of REOLYSIN® in Combination
with Paclitaxel for Patients with Advanced or Metastatic Breast Cancer
All four studies are sponsored by the National Cancer Institute of
Canada’s Clinical Trials Group (NCIC CTG)
21
22. Randomized U.S. Studies of REOLYSIN®
o
Patients are currently being enrolled in two
randomized Phase II studies in the United States:
o
o
o
OSU-10045: Intravenous Administration of REOLYSIN® in
Combination with Paclitaxel and Carboplatin for Patients
with Metastatic Pancreatic Cancer
GOG-0186H: Intravenous Administration of REOLYSIN® in
Combination with Paclitaxel for Patients with Persistent or
Recurrent Ovarian, Fallopian Tube or Primary Peritoneal
Cancer
Both studies are sponsored by the U.S. National Cancer
Institute (NCI), with GOG-0186H being conducted by
the Gynecologic Oncology Group (GOG)
22
23. REOLYSIN® and Safety
o
o
o
o
o
More than 1,000 patients treated, more than 900 intravenously at
doses up to 3x1010 TCID50 daily
No maximum tolerated dose (MTD) reached to date
Monotherapy toxicities have generally been mild (grade 1 or 2) and
included chills, fever, headache, cough, myalgia, runny nose, sore
throat, fatigue and grade 1 or 2 lymphopenia and neutropenia
Transient grade 3 and 4 toxicities included lymphopenia and
neutropenia
These symptoms were more frequently observed from day 2 of
treatment and usually lasted less than 6 hours
23
24. Intellectual Property
o
o
More than 370 patents issued worldwide, including 51 US
and 16 Canadian
Reovirus issue patent claims cover:
o
o
o
o
o
o
Compositions of matter comprising reovirus
Pharmaceutical use of reoviruses to treat neoplasia and cellular
proliferative diseases
Combination therapy with radiation, chemotherapy and/or
immune suppressants
Methods for manufacturing reovirus and screening for
susceptibility to reovirus
Pharmaceutical use of reoviruses in transplantation procedures
Approximately 235 pending applications worldwide
24
27. Oncolytics Summary
o
o
o
Expanding Clinical Program
o Lead product is REOLYSIN®, a broadly active novel cancer therapy
o Ongoing clinical trials include seven randomized studies:
o Enrollment complete randomized international study (REO 018) of
REOLYSIN® in combination with carboplatin and paclitaxel in platinumrefractory recurrent head and neck cancer patients – the supportive
study to a planned Phase III registration study in this indication
o Six sponsored Phase II studies announced or ongoing in the US and
Canada – breast, non-small cell lung, colorectal, prostate, pancreatic
and ovarian cancers
Strong Intellectual Property Portfolio
o More than 370 patents issued worldwide
Manufacturing at Commercial Scale
o 100L cGMP completed, commercial manufacturing agreement in place
27