Looks likes the University of Havanna licensed the drug to an Indian company as well.
Biocon commences Phase II Clinical Trials for Novel Cancer Drug Company posts clinical trial data on website
Bangalore, September 28, 2004
Biocon Limited, has commenced Phase II clinical trials of its drug TheraCIM (h-R3), a humanised monoclonal antibody, for the treatment of head and neck cancers, after obtaining all the necessary approvals from the concerned authorities. This drug has already received a Fast Track approval from the National Regulatory Authority of Cuba and 'Orphan Drug' status from the EMEA (European Agency for the Evaluation of Medicinal Products) to treat cancer patients. Biocon has also announced that all clinical trial data pertaining to this drug is posted on the company website www.biocon.com Monoclonal antibodies (MAbs) are spearheading a new line of effective cancer treatments along with conventional radiotherapy and chemotherapy. These novel drugs are engineered to attack receptors responsible for the origin and growth of cancer cells. Anticipating the increasing importance of MAbs as future therapeutics, Biocon Biopharmaceuticals, Biocon's JV (Joint Venture) with the Cuban Institute CIMAB, plans to introduce TheraCIM (h-R3) in the Indian market. Ms. Kiran Mazumdar-Shaw, Chairman and Managing Director, Biocon Limited, said, "Biocon is proud to announce the commencement of Phase II clinical trials of TheraCIM (h-R3) for head and neck cancers. This marks a substantial advancement in Biocon's recombinant bio-therapeutic portfolio and brings us closer to commercializing the first such proprietary product. The data posted online is testimony to the safety and effectiveness of TheraCIM (h-R3) monoclonal antibodies to treat head and neck cancers and a reiteration of our core policy of transparency." Exploring new treatments like TheraCIM MAbs is critically important given the high incidence of head and neck cancers worldwide. There are half a million new cases annually with nearly 250,000 deaths occurring. Further it is estimated that globally about 9 million new cancer cases are diagnosed every year of which over half are fatal. In India, there are an estimated 7,00,000 new cancer patients every year and half of them do not survive. Karnataka has 150,000 cancer patients and approximately 35,000 people get the disease every year.
About the company
Established in 1978, Biocon is India's premier biotechnology company. Biocon and its three subsidiary companies, Syngene International Private Limited, Clinigene International Private Limited and Biocon Biopharmaceuticals Private Limited, form a fully integrated biotechnology enterprise specializing in biopharmaceuticals, custom research, clinical research and enzymes. With successful initiatives in drug discovery, clinical development, bioprocessing and global marketing, Biocon delivers products and solutions to partners and customers across 70 countries.
True it is a small deal but we did find someone to study this drug for gastric cancers and they are footing the bill. YMI has so many other products to execute clincial trial on, I don' t think we could have afforded to take this gastric cancer study on by ourselves.
And of course your right. The one thing this company needs is exposure which I believe will only come with a good theracim deal in the US or a good Tesmilifene deal in the EU or US, or in late 2006 when tesmilifene trial results come out.
The license is almost certainly exclusive to Asia, perhaps even India. No other explanation seems possible.
In fact I read somewhere that Asians have a large incidence of certain cancers, contrary to common lore, their incidence of head-neck types - particularly those with tumors in the ear/nose areas - is much higher than the rest of the world. Whether this is due to genetic or environmental factors, I don't know, and maybe no-one does.
I looked at that biocon site, and there is nothing more about it - certainly it is their first attempt at a cancer clinical trial of any kind. Plus contrary to their news release, I don't see how to access any past clinical data on Theracim.
The neck cancer is more common in orientals. Indians tend to suffer cancer far less than Europeans or Orientals. Anyways the drug is not really being "developed" rather its being tested and approved. What we are really doing is trying to convince the FDA.