Protox Therapeutics Investor Fact Sheet September 2009

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    Protox Therapeutics Investor Fact Sheet September 2009 - Presentation Transcript

    1. Protox Facts Passion to care. Power to cure.™ Cancer and prostatic disease kill millions of people every year and devastate the quality of TSX: PRX life for countless millions more. The future of treatment depends on developing more effective targeted therapies, today the fastest growing field in cancer therapeutics. With a pipeline Share performance of clinical stage products in development for BPH (enlarged prostate), prostate cancer and Protox is listed on the Toronto Stock Exchange, symbol: PRX brain cancer, Protox is at the forefront of developing novel treatments in the emerging field • 52-week range: of targeted fusion protein therapeutics to improve the health and survival of patients who $0.17 - $0.69 look to companies like ours for hope. • Shares Outstanding: 84.5 million • Fully Diluted: profile mileStoneS 90.4 million • Three technology platforms: INxin™, PRX302: Initiate Phase 2 BPH trial Q2-08 • Market Capitalization: PORxin™ and HUMxin™ PRX302: Report long-Term $42.3 million • Three clinical programs: BPH Results Q2-08 - Phase 2a trials of PRX302 (PORxin) completed PRX302: Complete enrollment As at September 2, 2009 for benign prostatic hyperplasia (BPH) and of Phase 2 BPH trial Q3-08 ongoing for localized recurrent prostate PRX302: Report 1 year Phase 1 cancer (PC) BPH Results Q4-08 - Phase 2b program in development with PRX321 (INxin) for brain cancer PRX302: Report Phase 2 BPH Results Q4-08 • Cost-effective manufacturing: four grams PRX302: Initiate Phase 2b BPH trial Q1-09 can treat 40,000 patients • PRX302: Complete enrollment 1210 - 885 west georgia Street • Targeted potency: a single molecule can of Phase 2b BPH trial Q3-09 Vancouver, BC Canada V6C 3E8 destroy an entire cancer cell • PRX302: 12-month Phase 2a T. 604.688.0199 • Fast Track Designation and Orphan Drug BPH results Q3-09 F. 604.688.0173 Designation (PRX321) • PRX302: Top-line Phase 2b BPH www.protoxtherapeutics.com • Billion-dollar markets with vast unmet needs Results Q4-09 • Strong intellectual property portfolio inveStor relationS • Management with proven track record James Beesley, BSc, DC 604.484.0975 jbeesley@protoxtherapeutics.com FORwARD lOOkINg STATEMENT pipeline Certain statements in this fact sheet constitute “forward-looking statements” within the meaning of the private securities litigation reform act of 1995. Forward-looking statements are statements about the future and are inherently uncertain and can be identified by forward looking terminology such as “will”, “expected”, “planned”, “intended to”, “is being designed”, “potentially”, “anticipates”, and similar expressions or variations thereon, by reference to future dates or events, or that events or conditions “will,” “may,” “could” or “should” occur. These statements are based on management’s current expectations and beliefs and actual events or results may differ materially. There are many important facts that could cause actual events or results to differ materially from those suggested by such forward-looking statements. we encourage you to read our annual report for a more detailed discussion of risk factors which affect our business. Protox does not assume an obligation to update forward-looking statements in respect of subsequent events except as required by law.
    2. inDication factS technology • Approximately 60 million men porxin ™ worldwide suffer from BPH • Over 50% of men will have symptomatic BPH by age 60; over 90% after age 70 • Over $12 billion is spent each year on treatments for BPH 1. Binding site. 3. PRX302 binds 4. PSA cuts off tail activating 5. PRX302 assembles into structure 6. Cell contents and prostate cancer. 2. Activation tail to a receptor on PRX302. that punches a hole in the cell leak out caus- engineered for cell surface. membrane. ing cell death. prostate specific • In 2006 approximately 250,000 antigen (PSA). men in North America were PORxin drugs are inactive prodrugs, activated by score is measured on a scale from 0-6 with 0 defined as diagnosed with prostate cancer, disease-specific proteases to become potent agents that “delighted” and 6 defined as “terrible” with respect to the second leading cause of form pores on the cell surfaces which cause cell death. patient quality of life due to BPH. The mean pre-treatment cancer death among men PRX302, the lead PORxin drug, contains two important Qol score of subjects in the study was 4.5. regions that allow it to exert its effect. The first is a Subjects who received an optimal dose of PRX302 {1.0ml or • Nearly 47,000* new cases binding site that allows the molecule to attach to the greater volume per deposit (n=13)} showed a statistically surface of a cell. The second is an “activation tail” that significant IPSS improvement of 11.2 points (p<0.0001) of primary brain cancer are must be removed before it is able to form a pore and kill diagnosed each year (*France, and a statistically significant Qol improvement of 2.5 a cell. PRX302 has been engineered so that its tail can be points (p<0.0001) at day 90 post-treatment. These results germany, Italy, Japan, Spain, cut off and activated by prostate specific antigen (PSA), are very encouraging and are approximately double the Uk, US) an enzyme that is produced at high levels in patients improvement reported for currently approved BPH drugs with prostate cancer and BPH. and comparable to many of the successful surgical results • The average survival rate The Phase 2a clinical trial for the treatment of BPH has that are published. for recurrent brain cancer been completed and is ongoing for the treatment of Top-line results from the Phase 1 trial for localized recurrent prostate cancer. (glioblastoma multiforme) is localized prostate cancer have shown that PRX302 less than six months Top-line results from the Phase 2a trial for BPH is safe and well tolerated while demonstrating demonstrated that PRX302 provided significant encouraging signs of therapeutic activity. Despite a symptomatic relief while maintaining an excellent safety 100-fold escalation in dose the maximum tolerated profile in men with moderate to severe BPH. Therapeutic dose was not reached in this study. In 18 of the 24 activity of PRX302 was evaluated in this study using patients tested in this trial a decrease in the percentage standardized symptom indices, namely International of cancer-positive biopsies was observed. Three of the Prostate Symptom Score (IPSS) and Quality of life Score patients showed a complete absence of cancer in their (Qol). IPSS is the most well defined clinical end-point day 30 biopsy. In 21 of 24 patients PSA levels were below that is used to assess therapeutic activity in BPH clinical baseline during one of the follow up periods compared to studies. This symptom index consists of seven categories screening levels. In 15 of 24 patients PSA levels were including weak urinary stream, straining, intermittence, below screening levels or stable at 90 days post-treatment. management nocturia (or how many times one gets up to urinate at PRX302 is injected locally into the prostate to shrink night), incomplete emptying, urgency and frequency. This the prostate gland (for BPH) or destroy the tumor (for fahar merchant, PhD index is measured on a 0-35 scale with 0 defined as having prostate cancer) and is considerably less invasive and President & CEO no problems and 35 defined as the high end of severe safer with fewer side effects compared to surgery and symptoms. The mean pre-treatment IPSS of subjects in other treatments. Samuel Denmeade, MD the Phase 2a study was 20.2 (severe symptoms). The Qol Chief Scientific Officer John parkinson, CA inxin ™ Chief Financial Officer PE Il-4 tom D’orazio, MBA VP, Business Development and Strategy nina merchant, MESc VP, Development and Regulatory Affairs 1. PRX321 (Il-4 4-5. PRX321 binds to Il-4 receptor and 6-8. Toxin component inhibits protein synthesis causing protein linked enters cell. cell death. BoarD of DirectorS to Pseudomonas exotoxin). frank holler, MBA, Chairman 2. Il-4 receptor. avtar Dhillon, MD 3. Cancer cell Jim heppell INxin drugs target cancer cells that produce tumor- PRX321 has been studied in 72 patients in Phase 1 alex giaquinto, PhD specific receptors on their surfaces. The lead INxin drug, and 2a trials for glioblastoma multiforme (gBM) and PRX321, is a novel protein comprised of an engineered anaplastic astrocytoma. Over 70% of gBM patients saw fahar merchant, PhD version of interleukin-4 (Il-4) linked to an engineered their tumours shrink by 50% or more, while median James miller, PhD version of Pseudomonas exotoxin, a potent toxin that survival times increased by some 80% from six to nearly Jack geltosky, PhD destroys cells. The Il-4 portion of the compound has been 11 months. PRX321 has also been studied in a Phase 1 designed so it can bind with a high level of affinity to Il-4 trial among 14 patients with end-stage metastatic renal receptors found on the cell surfaces of numerous cancers. stage carcinoma and non-small-cell lung cancer, resulting The drug then enters the cell where the toxin component in stable disease for 64% of evaluable patients. induces cell death by inhibiting protein synthesis.
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