|BioMed News Bytes: GeoVax (OTC: GOVX.OB), Nutra Pharma (OTC: NPHC.OB)|
|Monday, 21 September 2009 10:54|
GeoVax stated that the FDA has 60 days (i.e. 11/20/09) from its submission to review the proposal and respond with questions or comments.
The proposed human clinical trial is based on the achievement of excellent post vaccine viral control in animal trials conducted in recently infected non-human primates at the Yerkes National Primate Research Center, affiliated with Emory University and follows the precedents set in preclinical animal trials. Submission of a request to the FDA for a pre-IND meeting is the first step in a process that is expected to take a number of months to complete with commencement of the trial targeted for 1Q10.
On 9/21/09, Nutra Pharma (OTC: NPHC.OB) ($0.60, +29%, heavy volume) announced that it plans to begin the drug registration process in Canada and Europe for its over-the-counter (OTC) pain reliever. The Company is currently marketing a similar drug in the U.S. under the brand name Cobroxin for the treatment of moderate to severe (Stage 2) chronic pain. Nutra Pharma stated that it is confident that its pain reliever can be successfully registered in the near term based on the regulatory requirements in Canada and Europe, with estimated populations exceeding 33 million and 830 million, respectively.
In August, Nutra Pharma introduced Cobroxin as the first OTC pain reliever clinically proven to treat moderate to severe (Stage 2) chronic pain. The drug, which was developed by Nutra Pharma’s wholly-owned drug discovery subsidiary, ReceptoPharm, will be available in October as an oral spray for treating lower back pain, migraines, neck aches, shoulder pain, cramps and neuralgia and as a topical gel for treating joint pain and pain associated with repetitive stress and arthritis. In addition, the Company recently completed a licensing agreement that grants XenaCare (OTCBB: XCHO.OB) with the exclusive marketing and distribution rights to Cobroxin within the U.S.
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