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news.Ambrilia Biopharma has initiated a Phase I/II clinical development program of its proprietary, novel three-month formulation of goserelin, in hormone-sensitive prostate cancer patients.
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The study is designed to assess the hormonal efficacy, pharmacokinetic and safety of its formulation of goserelin (Zoladex) in prostate cancer patients.
The goserelin formulation is manufactured by Ambrilia at its good manufacturing practice facilities in Montreal, and the company aims to divest this product by the end of 2008.
Ambrilia’s strategy is to capitalize on its broad product portfolio and original expertise in virology. During the course of 2008, execution of the strategy aims to monetize the non-virology assets through third parties agreements, in turn strengthening the company’s financial position to continue building its novel pipeline of antivirals.
Philippe Calais, president and CEO of Ambrilia, said: “We are now moving forward with the clinical development of this potentially first-to-market generic of Zoladex 10.8mg, one of the top luteinizing hormone-releasing hormone analogues in Europe.”