Paris, France, June 30th, 2009 - Hybrigenics (ALHYG), a bio-pharmaceutical company listed on Alternext (NYSE-Euronext) in Paris with a focus on the research and development of new cancer treatments and specialized in protein interactions, today reports the highlights of its general meeting held on June 29th, 2009.
Inecalcitol on its way to efficacy Phase IIb clinical trial
The results of the ongoing clinical tolerance Phase IIa study in hormone-refractory prostate cancer patients demonstrate that daily oral doses up to 1,000 microgram, i.e. 1 milligram (mg) of inecalcitol per day, are very well tolerated in combination with intravenous Taxotere chemotherapy. Out of 38 evaluable patients having completed their treatment, 33 had a significant decline of Prostate Specific Antigen (PSA) within 3 months. This finding confirms the 87 percent response rate reported previously on 31 evaluable patients at doses up to 600 microgram/day of inecalcitol.
Efficacy Phase IIb clinical trial is currently being designed in agreement with the outcome of the pre-IND meeting held with the United States Food and Drug Administration earlier this year. Scientific advice will also be sought from the European Medicines Agency now that Hybrigenics has been granted the small and medium-sized enterprise status allowing reduced advisory fees. Inecalcitol will be tested at a dose which will be set in milligrams, a high dose range which has just been protected by a new patent application.
Sustained growth of the fee-for-service activities
Total revenues from Pharma research collaboration with Servier and from Services related to Hybrigenics’ expertise in protein interactions should exceed EUR 2 million for the first half of 2009, up more than 60 percent as compared to the EUR 1.24 million revenues of the first half of 2008. Precise audited figures will be released soon.
Renewed confidence of the shareholders
All Board members have been re-elected for 2 years and the full year 2008 accounts approved. Delegations to the Board of Directors to decide on raising money through secondary offering, subscription rights, private placement or equity-linked loan instruments have been voted, including authorization for over-allocation, for a period of 18 months and for a maximum total amount equivalent to the doubling the social capital or for a maximum of EUR 20 million in equity-linked loans.
“It is good to see that the positive developments at Hybrigenics translate into renewed confidence of our shareholders as well as they are reflected in the recent spectacular increase in liquidity with an upward trend of our share price,” concluded Daan Ellens, Chairman of Hybrigenics’ Board of Directors, who chaired the General Meeting.
About Hybrigenics (ISIN: FR0004153930, Mnemo: ALHYG)
Hybrigenics (www.hybrigenics.com) is a bio-pharmaceutical company listed (ALHYG) on Alternext (NYSE-Euronext) in Paris, focusing its internal R&D programs on innovative targets and therapies for the treatment of cancer. Hybrigenics’ development program is based on inecalcitol, a vitamin D analogue, for the treatment of hormone-refractory prostate cancer in combination with Sanofi-Aventis’ Taxotere(R), which is the current gold-standard chemotherapeutic treatment for this indication. Hybrigenics’ research program explores the role of enzymes known as ubiquitin-specific proteases (USP) in the degradation of onco-proteins, and the effectiveness of proprietary USP inhibitors in treating various types of cancer.
Hybrigenics is also the market leader in Yeast-Two Hybrid (Y2H) and related services to identify, validate and inhibit protein interactions for researchers in all areas of life sciences, using its ISO 9001-certified high-throughput Y2H screening platform, its sophisticated bioinformatics tools and extensive database, along with its chemical library and chemical screening platform.
