Category Archives: Business of Biotech

Oncolytics enters into agreement with FDA for Phase 3 trial of REOLYSIN®

Oncolytics Biotech Inc. (“Oncolytics”) (TSX:ONC, NASDAQ:ONCY) has reached an agreement with the 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. The SPA is an agreement between Oncolytics and the FDA that the design and planned analyses of the Phase 3 study is adequately designed to provide the necessary data, that depending Read More >

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WILEX receives approval for Phase I trial

WILEX AG (ISIN DE0006614720 / Frankfurt Stock Exchange / Prime Standard) announced that the German Federal Institute for Drugs and Medical Devices approved the Phase I trial with the MEK inhibitor WX-554. The trial is a first-in-man-trial in healthy volunteers and will be conducted at a single site in Germany. With the first dose in man, the second milestone payment of EUR 5 million agreed in the strategic alliance with UCB Pharma S.A. will become Read More >

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Medicago begins human testing of flu vaccine

Medicago Inc. (TSX-V: MDG) announced a Phase I trial for its H5N1 Avian Influenza vaccine. The Phase I study will evaluate safety, tolerability and the immune response of the Company’s H5N1 vaccine candidate in 48 healthy volunteers between the ages 18 to 60. Results of the study are expected during the fourth quarter of 2009. Read the release.

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Provectus starts Phase 1 trial for liver cancer treatment

Provectus Pharmaceuticals, Inc. (OTCBB: PVCT) has initiated a Phase 1 study of PV-10 for liver cancer that will enroll up to six subjects with cancer metastatic to the liver or with recurrent liver cancer. PV-10 is the company’s lead oncology drug candidate that is also currently undergoing Phase 2 study for metastatic melanoma. The primary objective of the study is to determine the safety and tolerability of a single intralesional injection of PV-10 in patients Read More >

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XOMA to initiate Phase 2 program for Type 2 Diabetes and Cardiovascular Disease

XOMA Ltd. (Nasdaq:XOMA) announced plans for the Phase 2 clinical development of its anti-inflammatory drug candidate to interleukin-1 beta (IL-1 beta), XOMA 052, designed for the treatment of the inflammatory cause of cardiovascular, diabetes, autoimmune and other diseases. The clinical trials are designed to further evaluate the use of multiple dose regimens on the safety, pharmacodynamics and efficacy of XOMA 052 in cardiometabolic and other diseases, and based on positive results, select doses for pivotal Read More >

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