Oncolytics Biotech® Inc. Announces 2009 Year End Results

Oncolytics Biotech Inc. (TSX:ONC, NASDAQ:ONCY) ("Oncolytics" or the "Company") today announced its financial results and operational highlights for the year ended December 31, 2009.

"In 2009, we executed on our business plan focused on preparing the Company for late stage clinical testing and ultimately commercial launch by making substantial clinical progress, strengthening our intellectual property position and balance sheet, and scaling up manufacturing to near commercial levels," said Dr. Brad Thompson, President and CEO of Oncolytics. "Our focus in the year ahead will be on advancing our first Phase 3 trial, which we expect to begin in the second quarter."

Selected Highlights
In the last 14 months the Company:

Clinical Trial Results

• Announced positive updated results from a U.K. Phase 1/2 combination REOLYSIN® and paclitaxel/carboplatin trial for patients with advanced head and neck cancers (REO 011). Of 19 evaluable patients with head and neck cancer, mostly squamous cell carcinoma of the head and neck refractory to prior platinum-based chemotherapy for recurrent/metastatic disease, eight experienced partial responses (PR) and six had stable disease (SD), for a clinical benefit rate (complete response (CR) + PR + SD) of 74%;
• Presented updated U.S. Phase 2 sarcoma trial (REO 014) data at the 15th Annual Connective Tissue Oncology Society Meeting demonstrating that 19 of 44 evaluable patients experienced stable disease ranging from two to 20 months, resulting in a total clinical benefit rate of 43%;
• Announced positive results from a U.K. combination REOLYSIN and docetaxel trial for patients with a variety of advanced cancers (REO 010). Fifteen of the 17 evaluable patients experienced SD or better, including two PR, three minor responses and 10 SD, giving a clinical benefit rate of 88%;
• Announced positive results of a U.K. Phase 2 REOLYSIN and radiation combination clinical trial (REO 008). Of 14 evaluable patients, 13 patients had SD or better in the treated target lesions, including four PRs and two minor responses, for a clinical benefit rate of 93% in the treated lesions;
• Presented a poster at ASCO demonstrating that the combination of REOLYSIN and gemcitabine in a U.K. Phase 1 trial (RE0 009) was well tolerated, and resulted in disease control for a majority of the patients. Of the ten patients evaluable for response, two patients (breast and nasopharyngeal) had partial responses and/or clinical responses and five patients had SD for 4-8 cycles, for a total disease control rate (CR+PR+SD) of 70%;

Clinical Program

• Completed an agreement with the U.S. Food and Drug Administration (FDA) under the Special Protocol Assessment (SPA) process for the design of a Phase 3 trial examining REOLYSIN in combination with paclitaxel and carboplatin in patients with platinum refractory head and neck cancers;
• Received a letter of approval from the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) to conduct its Phase 3 trial examining REOLYSIN in combination with paclitaxel and carboplatin in patients with platinum-refractory head and neck cancers. Started patient enrolment in a U.S. Phase 2 Combination REOLYSIN and paclitaxel/carboplatin clinical trial (REO 016) for patients with non-small cell lung cancer with Kras or EGFR-activated tumours. Eligible patients include those who have not received chemotherapy treatment for their metastatic or recurrent disease;Started patient enrolment in a U.K. translational clinical trial (REO 013) investigating REOLYSIN in patients with metastatic colorectal cancer;
• Announced multi-trial clinical research collaboration with the Cancer Therapy & Research Center (CTRC) at the University of Texas Health Science Center involving up to five, open-label, Phase 2 studies exploring the use of REOLYSIN in combination with chemotherapy for various cancer indications. These indications are expected to include melanoma, pancreatic cancer, squamous cell lung, liver and Kras mutated colorectal cancers in combination with standard chemotherapeutics;
• Started enrollment in a U.S. Phase 2 clinical trial using intravenous administration of REOLYSIN in combination with paclitaxel and carboplatin in patients with metastatic melanoma being conducted at CTRC;

Financial

• Announced the results of two warrant expiry date acceleration programs for warrants generating proceeds of approximately $14.9 million;
• Completed a public offering consisting of 3.45 million units at $2.00 per unit, for gross proceeds of $6.9 million;
• Completed a public offering consisting of 4,887,500 units at US$3.00 per unit, for gross proceeds of US$14.7 million;
• Completed the acquisition of an inactive private company with net cash of $2.1 million by issuing 1,875,121 common shares;

Intellectual Property

• Announced the grant of the Company's 32nd U.S. Patent, # 7,582,289, entitled "Viruses for the Treatment of Cellular Proliferative Disorders" with the claims covering methods of using modified parapoxvirus orf virus to treat Ras-mediated cancers;
•  Announced the grant of the Company's 33rd U.S. Patent, # 7,608,257 entitled "Sensitization of Chemotherapeutic Agent Resistant Neoplastic Cells with a Virus." The patent claims cover methods of using reovirus in combination with currently approved chemotherapeutic agents to treat patients that are refractory to those chemotherapeutic agents alone;

Manufacturing

•  Completed of the lyophilized (freeze-dried) formulation development program for REOLYSIN;
•  Completed an initial 100-litre production run of REOLYSIN under cGMP conditions; and

Management Team
    -   Appointed Dr. Alan Warrander to the role of Senior Vice President,
        Global Licensing and Business Development.

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Source: PRNewswire/Yahoo Finance