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Print Edition StoriesThursday, September 10, 2009
Generex diabetes drug gets FDA approval
By Mass High Tech staff
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The U.S. Food and Drug Administration has granted approval to Worcester-based Generex Biotechnology Corp. for its Oral-lyn treatment of Type 1 or Type 2 diabetes mellitus for patients with facing serious or life-threatening conditions that have no alternative treatment options.
Oral-lyn oral insulin spray is currently in Phase 3 clinical trials and can be used for treatment under the FDA’s Treatment Investigational New Drug (IND) program, which allows treatment for people who otherwise don’t meet the criteria for participating in the trial. The drug is being sold now in India and Ecuador. As of a June announcement, Generex has raised more than $15 million total, which it said could be applied to the Phase 3 trials.
Worcester-based Generex (Nasdaq: GNBT) researches, develops and markets drug delivery systems. The company announced also in June that it has completed a registered direct offering of 17.2 million shares of common stock at 64 cents per share to certain investors, resulting with net proceeds of $10.8 million.
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