Oncolytics Biotech presented on their lead product REOLYSIN, a proprietary reovirus being studied for cancer treatment. Key points included:
1) REOLYSIN is in a Phase 3 trial in combination with paclitaxel/carboplatin for platinum-refractory head and neck cancer patients.
2) The program is expanding to include studies of REOLYSIN in NSCLC, melanoma, and squamous cell lung cancer.
3) The company has a large intellectual property portfolio covering REOLYSIN and a commercial-scale cGMP manufacturing process.
This is NHL clinical update on 57th ASH Annual Meeting and Exposition (December 5-8, 2015).
It includes only clinical aspects include both chemotherapy and antibody therapy.
This is NHL clinical update on 57th ASH Annual Meeting and Exposition (December 5-8, 2015).
It includes only clinical aspects include both chemotherapy and antibody therapy.
Recurrent/Metastatic HNSCC: Harnessing Immunotherapy in Comprehensive Carei3 Health
i3 Health is pleased to make this slide deck from this activity available for use as a non-accredited self-study or teaching resource.
This slide deck, presented by Glenn J. Hanna, MD, Director, Center for Cancer Therapeutic Innovation (Early Drug Development Program)
Medical Oncologist, Center for Head & Neck Oncology
Dana-Farber Cancer Institute, and Deborah Wong, MD, PhD, Associate Clinical Professor of Medicine, Division of Hematology-Oncology, UCLA Medical Center, was presented at a live educational event at the 2024 Multidisciplinary Head and Neck Cancers Symposium. It will provide expert perspectives on harnessing immunotherapy in recurrent/metastatic HNSCC to provide comprehensive care.
Tonight’s speakers: Dr. Dan Sargent and Kim Ryan
Disclaimer: “This Report is not an official event of the 2012 Gastrointestinal Cancers Symposium. Not sponsored or endorsed by any of the cosponsoring organizations of the 2012 Gastrointestinal Cancers Symposium.”
Dr. Olwen Hahn, medical oncologist at the University of Chicago Department of Medicine, discusses recent developments in MBC research and treatment. Joining her is Dionna Koval, a metastatic breast cancer patient advocate.
Jorge A. Marrero, MD, MS, Anthony El-Khoueiry, MD, Richard S. Finn, MD, and Laura M. Kulik, MD, prepared useful practice aids pertaining to HCC management for this CME activity titled "Surveying the View From the Driver’s Seat in Hepatocellular Carcinoma: Bringing Into Focus Hepatology’s Key Role in Guiding HCC Care Down the Path to Improved Outcomes." For the full presentation, monograph, complete CME information, and to apply for credit, please visit us at http://bit.ly/2Pj9wM8. CME credit will be available until December 20, 2019.
Chair and Moderator, Petros Grivas, MD, PhD, Shilpa Gupta, MD, and Gary D. Steinberg, MD, prepared useful Practice Aids pertaining to bladder cancer for this CME/MOC activity titled “Breaking Down the Evidence in Bladder Cancer: Expert Perspectives and Practical Strategies on Immune, Targeted, and Antibody-Based Therapies.” For the full presentation, downloadable Practice Aids, and complete CME/MOC information, and to apply for credit, please visit us at https://bit.ly/2WcJp3n. CME/MOC credit will be available until December 31, 2022.
New post-chemotherapy maintenance treatment options for ovarian cancer have emerged in recent years. Dr. Maurie Markman explains and takes questions on maintenance therapies for ovarian cancer in our 4th annual Joan Sommer Educational Program.
Richard S. Finn, MD, Anthony El-Khoueiry, MD, and Josep M. Llovet, MD, PhD, prepared useful practice aids pertaining to hepatocellular carcinoma for this CME activity titled "Breaking the Paradox: Expanding Options and New Questions in HCC Management: Mapping the Pathways to Better Patient Outcomes." For the full presentation, monograph, complete CME information, and to apply for credit, please visit us at http://bit.ly/2HU6L5K. CME credit will be available until February 14, 2020.
Chair and Presenter Neal D. Shore, MD, FACS, Sia Daneshmand, MD, and Guru P. Sonpavde, MD, prepared useful Practice Aids pertaining to bladder cancer for this CME/MOC/AAPA activity titled “Pioneering Precision Medicine in Bladder Cancer: Multidisciplinary Perspectives on Personalizing Patient Care.” For the full presentation, downloadable Practice Aids, and complete CME/MOC/AAPA information, and to apply for credit, please visit us at https://bit.ly/40qGkJH. CME/MOC/AAPA credit will be available until December 28, 2024.
Flu Vaccine Alert in Bangalore Karnatakaaddon Scans
As flu season approaches, health officials in Bangalore, Karnataka, are urging residents to get their flu vaccinations. The seasonal flu, while common, can lead to severe health complications, particularly for vulnerable populations such as young children, the elderly, and those with underlying health conditions.
Dr. Vidisha Kumari, a leading epidemiologist in Bangalore, emphasizes the importance of getting vaccinated. "The flu vaccine is our best defense against the influenza virus. It not only protects individuals but also helps prevent the spread of the virus in our communities," he says.
This year, the flu season is expected to coincide with a potential increase in other respiratory illnesses. The Karnataka Health Department has launched an awareness campaign highlighting the significance of flu vaccinations. They have set up multiple vaccination centers across Bangalore, making it convenient for residents to receive their shots.
To encourage widespread vaccination, the government is also collaborating with local schools, workplaces, and community centers to facilitate vaccination drives. Special attention is being given to ensuring that the vaccine is accessible to all, including marginalized communities who may have limited access to healthcare.
Residents are reminded that the flu vaccine is safe and effective. Common side effects are mild and may include soreness at the injection site, mild fever, or muscle aches. These side effects are generally short-lived and far less severe than the flu itself.
Healthcare providers are also stressing the importance of continuing COVID-19 precautions. Wearing masks, practicing good hand hygiene, and maintaining social distancing are still crucial, especially in crowded places.
Protect yourself and your loved ones by getting vaccinated. Together, we can help keep Bangalore healthy and safe this flu season. For more information on vaccination centers and schedules, residents can visit the Karnataka Health Department’s official website or follow their social media pages.
Stay informed, stay safe, and get your flu shot today!
ARTIFICIAL INTELLIGENCE IN HEALTHCARE.pdfAnujkumaranit
Artificial intelligence (AI) refers to the simulation of human intelligence processes by machines, especially computer systems. It encompasses tasks such as learning, reasoning, problem-solving, perception, and language understanding. AI technologies are revolutionizing various fields, from healthcare to finance, by enabling machines to perform tasks that typically require human intelligence.
These lecture slides, by Dr Sidra Arshad, offer a quick overview of physiological basis of a normal electrocardiogram.
Learning objectives:
1. Define an electrocardiogram (ECG) and electrocardiography
2. Describe how dipoles generated by the heart produce the waveforms of the ECG
3. Describe the components of a normal electrocardiogram of a typical bipolar leads (limb II)
4. Differentiate between intervals and segments
5. Enlist some common indications for obtaining an ECG
Study Resources:
1. Chapter 11, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 9, Human Physiology - From Cells to Systems, Lauralee Sherwood, 9th edition
3. Chapter 29, Ganong’s Review of Medical Physiology, 26th edition
4. Electrocardiogram, StatPearls - https://www.ncbi.nlm.nih.gov/books/NBK549803/
5. ECG in Medical Practice by ABM Abdullah, 4th edition
6. ECG Basics, http://www.nataliescasebook.com/tag/e-c-g-basics
NVBDCP.pptx Nation vector borne disease control programSapna Thakur
NVBDCP was launched in 2003-2004 . Vector-Borne Disease: Disease that results from an infection transmitted to humans and other animals by blood-feeding arthropods, such as mosquitoes, ticks, and fleas. Examples of vector-borne diseases include Dengue fever, West Nile Virus, Lyme disease, and malaria.
The prostate is an exocrine gland of the male mammalian reproductive system
It is a walnut-sized gland that forms part of the male reproductive system and is located in front of the rectum and just below the urinary bladder
Function is to store and secrete a clear, slightly alkaline fluid that constitutes 10-30% of the volume of the seminal fluid that along with the spermatozoa, constitutes semen
A healthy human prostate measures (4cm-vertical, by 3cm-horizontal, 2cm ant-post ).
It surrounds the urethra just below the urinary bladder. It has anterior, median, posterior and two lateral lobes
It’s work is regulated by androgens which are responsible for male sex characteristics
Generalised disease of the prostate due to hormonal derangement which leads to non malignant enlargement of the gland (increase in the number of epithelial cells and stromal tissue)to cause compression of the urethra leading to symptoms (LUTS
Couples presenting to the infertility clinic- Do they really have infertility...Sujoy Dasgupta
Dr Sujoy Dasgupta presented the study on "Couples presenting to the infertility clinic- Do they really have infertility? – The unexplored stories of non-consummation" in the 13th Congress of the Asia Pacific Initiative on Reproduction (ASPIRE 2024) at Manila on 24 May, 2024.
Tom Selleck Health: A Comprehensive Look at the Iconic Actor’s Wellness Journeygreendigital
Tom Selleck, an enduring figure in Hollywood. has captivated audiences for decades with his rugged charm, iconic moustache. and memorable roles in television and film. From his breakout role as Thomas Magnum in Magnum P.I. to his current portrayal of Frank Reagan in Blue Bloods. Selleck's career has spanned over 50 years. But beyond his professional achievements. fans have often been curious about Tom Selleck Health. especially as he has aged in the public eye.
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Introduction
Many have been interested in Tom Selleck health. not only because of his enduring presence on screen but also because of the challenges. and lifestyle choices he has faced and made over the years. This article delves into the various aspects of Tom Selleck health. exploring his fitness regimen, diet, mental health. and the challenges he has encountered as he ages. We'll look at how he maintains his well-being. the health issues he has faced, and his approach to ageing .
Early Life and Career
Childhood and Athletic Beginnings
Tom Selleck was born on January 29, 1945, in Detroit, Michigan, and grew up in Sherman Oaks, California. From an early age, he was involved in sports, particularly basketball. which played a significant role in his physical development. His athletic pursuits continued into college. where he attended the University of Southern California (USC) on a basketball scholarship. This early involvement in sports laid a strong foundation for his physical health and disciplined lifestyle.
Transition to Acting
Selleck's transition from an athlete to an actor came with its physical demands. His first significant role in "Magnum P.I." required him to perform various stunts and maintain a fit appearance. This role, which he played from 1980 to 1988. necessitated a rigorous fitness routine to meet the show's demands. setting the stage for his long-term commitment to health and wellness.
Fitness Regimen
Workout Routine
Tom Selleck health and fitness regimen has evolved. adapting to his changing roles and age. During his "Magnum, P.I." days. Selleck's workouts were intense and focused on building and maintaining muscle mass. His routine included weightlifting, cardiovascular exercises. and specific training for the stunts he performed on the show.
Selleck adjusted his fitness routine as he aged to suit his body's needs. Today, his workouts focus on maintaining flexibility, strength, and cardiovascular health. He incorporates low-impact exercises such as swimming, walking, and light weightlifting. This balanced approach helps him stay fit without putting undue strain on his joints and muscles.
Importance of Flexibility and Mobility
In recent years, Selleck has emphasized the importance of flexibility and mobility in his fitness regimen. Understanding the natural decline in muscle mass and joint flexibility with age. he includes stretching and yoga in his routine. These practices help prevent injuries, improve posture, and maintain mobilit
Prix Galien International 2024 Forum ProgramLevi Shapiro
June 20, 2024, Prix Galien International and Jerusalem Ethics Forum in ROME. Detailed agenda including panels:
- ADVANCES IN CARDIOLOGY: A NEW PARADIGM IS COMING
- WOMEN’S HEALTH: FERTILITY PRESERVATION
- WHAT’S NEW IN THE TREATMENT OF INFECTIOUS,
ONCOLOGICAL AND INFLAMMATORY SKIN DISEASES?
- ARTIFICIAL INTELLIGENCE AND ETHICS
- GENE THERAPY
- BEYOND BORDERS: GLOBAL INITIATIVES FOR DEMOCRATIZING LIFE SCIENCE TECHNOLOGIES AND PROMOTING ACCESS TO HEALTHCARE
- ETHICAL CHALLENGES IN LIFE SCIENCES
- Prix Galien International Awards Ceremony
Lung Cancer: Artificial Intelligence, Synergetics, Complex System Analysis, S...Oleg Kshivets
RESULTS: Overall life span (LS) was 2252.1±1742.5 days and cumulative 5-year survival (5YS) reached 73.2%, 10 years – 64.8%, 20 years – 42.5%. 513 LCP lived more than 5 years (LS=3124.6±1525.6 days), 148 LCP – more than 10 years (LS=5054.4±1504.1 days).199 LCP died because of LC (LS=562.7±374.5 days). 5YS of LCP after bi/lobectomies was significantly superior in comparison with LCP after pneumonectomies (78.1% vs.63.7%, P=0.00001 by log-rank test). AT significantly improved 5YS (66.3% vs. 34.8%) (P=0.00000 by log-rank test) only for LCP with N1-2. Cox modeling displayed that 5YS of LCP significantly depended on: phase transition (PT) early-invasive LC in terms of synergetics, PT N0—N12, cell ratio factors (ratio between cancer cells- CC and blood cells subpopulations), G1-3, histology, glucose, AT, blood cell circuit, prothrombin index, heparin tolerance, recalcification time (P=0.000-0.038). Neural networks, genetic algorithm selection and bootstrap simulation revealed relationships between 5YS and PT early-invasive LC (rank=1), PT N0—N12 (rank=2), thrombocytes/CC (3), erythrocytes/CC (4), eosinophils/CC (5), healthy cells/CC (6), lymphocytes/CC (7), segmented neutrophils/CC (8), stick neutrophils/CC (9), monocytes/CC (10); leucocytes/CC (11). Correct prediction of 5YS was 100% by neural networks computing (area under ROC curve=1.0; error=0.0).
CONCLUSIONS: 5YS of LCP after radical procedures significantly depended on: 1) PT early-invasive cancer; 2) PT N0--N12; 3) cell ratio factors; 4) blood cell circuit; 5) biochemical factors; 6) hemostasis system; 7) AT; 8) LC characteristics; 9) LC cell dynamics; 10) surgery type: lobectomy/pneumonectomy; 11) anthropometric data. Optimal diagnosis and treatment strategies for LC are: 1) screening and early detection of LC; 2) availability of experienced thoracic surgeons because of complexity of radical procedures; 3) aggressive en block surgery and adequate lymph node dissection for completeness; 4) precise prediction; 5) adjuvant chemoimmunoradiotherapy for LCP with unfavorable prognosis.
New Directions in Targeted Therapeutic Approaches for Older Adults With Mantl...i3 Health
i3 Health is pleased to make the speaker slides from this activity available for use as a non-accredited self-study or teaching resource.
This slide deck presented by Dr. Kami Maddocks, Professor-Clinical in the Division of Hematology and
Associate Division Director for Ambulatory Operations
The Ohio State University Comprehensive Cancer Center, will provide insight into new directions in targeted therapeutic approaches for older adults with mantle cell lymphoma.
STATEMENT OF NEED
Mantle cell lymphoma (MCL) is a rare, aggressive B-cell non-Hodgkin lymphoma (NHL) accounting for 5% to 7% of all lymphomas. Its prognosis ranges from indolent disease that does not require treatment for years to very aggressive disease, which is associated with poor survival (Silkenstedt et al, 2021). Typically, MCL is diagnosed at advanced stage and in older patients who cannot tolerate intensive therapy (NCCN, 2022). Although recent advances have slightly increased remission rates, recurrence and relapse remain very common, leading to a median overall survival between 3 and 6 years (LLS, 2021). Though there are several effective options, progress is still needed towards establishing an accepted frontline approach for MCL (Castellino et al, 2022). Treatment selection and management of MCL are complicated by the heterogeneity of prognosis, advanced age and comorbidities of patients, and lack of an established standard approach for treatment, making it vital that clinicians be familiar with the latest research and advances in this area. In this activity chaired by Michael Wang, MD, Professor in the Department of Lymphoma & Myeloma at MD Anderson Cancer Center, expert faculty will discuss prognostic factors informing treatment, the promising results of recent trials in new therapeutic approaches, and the implications of treatment resistance in therapeutic selection for MCL.
Target Audience
Hematology/oncology fellows, attending faculty, and other health care professionals involved in the treatment of patients with mantle cell lymphoma (MCL).
Learning Objectives
1.) Identify clinical and biological prognostic factors that can guide treatment decision making for older adults with MCL
2.) Evaluate emerging data on targeted therapeutic approaches for treatment-naive and relapsed/refractory MCL and their applicability to older adults
3.) Assess mechanisms of resistance to targeted therapies for MCL and their implications for treatment selection
New Drug Discovery and Development .....NEHA GUPTA
The "New Drug Discovery and Development" process involves the identification, design, testing, and manufacturing of novel pharmaceutical compounds with the aim of introducing new and improved treatments for various medical conditions. This comprehensive endeavor encompasses various stages, including target identification, preclinical studies, clinical trials, regulatory approval, and post-market surveillance. It involves multidisciplinary collaboration among scientists, researchers, clinicians, regulatory experts, and pharmaceutical companies to bring innovative therapies to market and address unmet medical needs.
Report Back from SGO 2024: What’s the Latest in Cervical Cancer?bkling
Are you curious about what’s new in cervical cancer research or unsure what the findings mean? Join Dr. Emily Ko, a gynecologic oncologist at Penn Medicine, to learn about the latest updates from the Society of Gynecologic Oncology (SGO) 2024 Annual Meeting on Women’s Cancer. Dr. Ko will discuss what the research presented at the conference means for you and answer your questions about the new developments.
Knee anatomy and clinical tests 2024.pdfvimalpl1234
This includes all relevant anatomy and clinical tests compiled from standard textbooks, Campbell,netter etc..It is comprehensive and best suited for orthopaedicians and orthopaedic residents.
263778731218 Abortion Clinic /Pills In Harare ,sisternakatoto
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2. Forward Looking Statements
Today’s 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.
3. Summary
REOLYSIN - A Broadly Active Novel Cancer Therapy
Focused Clinical Program
• lead product is REOLYSIN®
• SPA agreed with the FDA for first pivotal program –
Phase III REOLYSIN and paclitaxel/carboplatin in platinum-refractory
head and neck cancer patients
• this drug platform expanding to include NSCLC, melanoma and
squamous cell lung cancer
Growing Intellectual Property Portfolio
• broad patent coverage in US, Europe and Canada
Manufacturing at Commercial Scale
• 100L cGMP completed
4. Mode of Action
• REOLYSIN is a proprietary
isolate of the reovirus, a
replication competent virus
• asymptomatic in humans (does
not cause disease)
• replicates in Ras-activated
cancers
• at least 2/3 of carcinomas and
more than 90% of metastatic
disease has Ras involvement
• at least 5M new patients per
year are predicted to develop
cancers with Ras involvement
5. REOLYSIN Pipeline
Indication Preclinical Phase 1 Phase 2 Phase 3
Head & neck (REO 018)
in combination with carboplatin + paclitaxel
NSCLC (KRAS screened) (REO 016)
in combination with carboplatin + paclitaxel
Melanoma (REO 020)
in combination with carboplatin + paclitaxel
as monotherapy
Squamous cell carcinoma lung (REO 021)
in combination with carboplatin + paclitaxel
Pancreatic (REO 017)
in combination with gemcitabine
Sarcoma metastatic to lung (REO 014)
as monotherapy
Ovarian
as monotherapy
with carboplatin + paclitaxel
Colorectal (KRAS screened) (REO 022)
in combination with irinotecan
6. Pivotal (Phase III) Program for REOLYSIN
• Phase III trial examining REOLYSIN in combination with
paclitaxel/carboplatin in patients with platinum-refractory head and
neck cancers
• randomized, two-arm, double-blind, multicentre, two-stage, adaptive
trial
• first company to have an intravenously administered oncolytic virus
approved under the SPA program
• primary endpoint: overall survival
secondary endpoint: progression-free survival
pharmacodynamic endpoints: tumour Ras pathway status and
HPV status
• two-stage Phase III trial
- 80 patients in first stage
- adaptive design in second stage allows for detection of a range of
increases in overall survival by enrolling from 100 to 400 patients, with
the most probable being ~200
7. REOLYSIN clinical overview – Phase I/II
Combination Program
Phase I/II carboplatin/paclitaxel/REOLYSIN
Drug • REOLYSIN, d1-5, iv carboplatin (AUC5), d1, and paclitaxel (175mg/m2), d1,
Combination qw3. REOLYSIN was administered at a starting dose of 3x109 TCID50 and then
Program increased to 1x1010 and 3x1010 TCID50 in cohorts of 3 patients
(UK)
• there were no DLTs in the dose escalation. Toxicities were mainly grade 1 and 2
and included: nausea, fatigue, vomiting, myalgia, fever, neutropenia,
lymphopenia, thrombocytopenia and hypotension
• this combination resulted in a blunting of antiviral immune response as
compared to monotherapy virus
• response rates in 19 evaluable patients were partial response (PR) (5 pts),
stable disease (SD) (8 pts) and progressive disease (PD) (6 pts). Of note, all
PRs and 4/8 SDs were in H&N disease
• a total disease control rate (CR+PR+SD) of 68% was achieved to date
• positive results in head and neck disease led to the filing of two single arm
Phase II studies in refractory head and neck disease (US & UK)
8. Interim Results Compared to Historical Controls
Second-Line Other Therapies in Platinum Refractory Patients
Study Reference Response Rate Median TTP Median Survival
or PFS (months)
(months)
Various treatments or Léon et al., 2005 2.6% No Data 3
Best Supportive care
Various Vermorken, 2009 No data 1.9 4.5
Carboplatin/paclitaxel Vermorken’s 10% 2.0 4.5 (refractory)
Estimate for 6.5 (pt failed)
control
arm in REO 018
Personal
communication
REOLYSIN + RR 42% (8 PRs), N/A N/A
carboplatin/paclitaxel CBR 74%
H&N patients (N=19) (8 PRs, 6 SDs)
November 17, 2009
9. Phase I REOLYSIN/Paclitaxel/Carboplatin – Lung and Head &
Neck Tumours – Response Maintained for 8 Cycles
Pre-treatment Pre-treatment
Post 6 Cycles Post 6 Cycles
Prior treatment: radiotherapy; cisplatin/fluorouracil – 6 cycles
10. Phase II REOLYSIN/Paclitaxel/Carboplatin
Combination Metastatic Nasopharyngeal
Pre-treatment Post cycle 3
prior treatment results
• radiation - 2 cycles •target lesion - liver metastases
• cisplatin, gemcitabine/carboplatin, baseline - 59.4 mm
carboplatin/5-FU - 6 cycles •post cycle 3-19 mm
• docetaxel - 3 cycles •response maintained through 8 cycles
11. UK Phase II REOLYSIN/Carbo/Taxol Combination
Partial Response in Poorly Differentiated SCC H&N
Pre-treatment
Post Cycle 3
Treatment history:
palliative RT
cisplatin + 5FU
carboplatin + 5FU
12. UK Phase II REOLYSIN/Carbo/Taxol Combination
Partial Response in SCC H&N
Pre-treatment
Rapid After 3 cycles
progression
in <3 weeks
before Study
Treatment history: cisplatin + 5 FU; RT/cisplatin;
13. REOLYSIN: A Broader Market Opportunity
EGFR Inhibitors
contra-indicated: Tumors with Ras pathway
KRas mutated
activation
- NSCLC
- Colorectal
cancer
2008 Sales
Tumors with Tumors with Erbitux - $1.7B
Ras Mutation EGFR
Tarceva - $457M
Overexpressed
No Approved or Vectibix - $153 M
Therapies Mutated
REOLYSIN is effective in both situations
14. Phase II NSCLC and Kras/EGFR
U.S. Phase II
• for NSCLC prescreened for Kras and EGFR mutation status
• 15 to 20% of NSCLC is Kras mutated and up to 50% is EGFR
mutated or over expressed
• first line therapy study i.e. patients will be offered
REOLYSIN/paclitaxel/carboplatin instead of standard of care
if they are Kras or EGFR mutated or EGFR over expressed,
all of which cause Ras pathway activation
• current standard of care includes EGFR inhibitors which have
been shown to be ineffective in Kras mutated patients
15. Colorectal Cancer and Kras
• current standard of care for second-line patients also includes
EGFR inhibitors
• 45% of second-line colorectal patients have Kras mutations
• preclinical work completed using reovirus in combination with
irinotecan
16. Increasing Vascular Efflux Through
Manipulation of VEGF Signalling
Sunitinib
B-16 Melanoma Mouse Model
• transient destabilization and
permeabilization of tumor vasculature
enhances localization of circulating
REOLYSIN
• therapy is associated with increased
vascular permeability to circulating
virus and increased virus recovery from
Avastin tumors
17. Safety
• >285 patients treated, >200 intravenously at doses up to 3x1010
TCID50 daily
• no maximum tolerated dose (MTD) reached to date
• toxicities have been generally mild (grade 1 or 2) and included
chills, fever, headache, cough, myalgia, runny nose, sore throat
and 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
18. Intellectual Property
• more than 200 patents issued worldwide including
33 U.S. and 11 CDN
• reovirus issued patent claims cover
- 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
• more than 180 pending applications worldwide
19. Manufacturing
• successful development of a proprietary cell growth medium
• commercial cGMP process established
• cGMP now produced at 100L
21. Summary
REOLYSIN - A Broadly Active Novel Cancer Therapy
Focused Clinical Program
• lead product is REOLYSIN®
• SPA agreed with the FDA for first pivotal program - Phase III
REOLYSIN and paclitaxel/carboplatin in platinum-refractory head and
neck cancer patients
• this drug platform expanding to include NSCLC, melanoma and
squamous cell lung cancer
Growing Intellectual Property Portfolio
• broad patent coverage in US, Europe and Canada
Manufacturing at Commercial Scale
• 100L cGMP completed