Posted on RB by Billycal:
Here is a part of a correspondence between myself and someone who is familiar with FDA/Govt. proceedures.
Bill,
..."DNAG is in the process of developing a biological drug product that is in a class of products called "super-EPO". EPO is the acronym for erythropoeitin, a biological drug that aids in the transport of oxygen in the blood. It is used to support patients who are receiving chemotherapy who have developed low red blood cell counts and for other medical uses (also used by athletes in a "doping" way to increase their blood oxygen content which gives a competitive advantage). Super-EPO is a far more potent version of the old EPO and I believe that a number of companies, including DNAG have some sort of super-EPO in development. According to the press releases, DNAG is making consistent forward progress in developing its super-EPO, which has potentially a huge market once approved. DNAG has set up a relationship with a separate (wholly owned?) company to manufacture the product according to "good manufacturing practices" (GMPs) which is required by the FDA. One of the early steps in eventually securing a new drug approval (NDA) is demonstrating to the FDA that the company can produce the product with reliable potency and free of contamination (a particular concern with biological products). DNAG has done this already or at least demonstrated the contaminants-free bit. DNAG also is working with Beth Israel Deaconness to perform some of the pre-clinical (i.e. lab or animal model) tests on the product. The data from these studies, along with compliance with GMPs, will eventually be submitted to the FDA to request an investigational new drug (IND) license. Then the company can begin the three-stage clinical trial process to test the product in humans. From the press releases, and this is only a guess, it looks like the company might be positioned to request an IND in 12 to 18 months. I don't know how long the FDA takes these days to review and grant an IND request, but it would probably be multiple months, perhaps longer. The clinical trials phases I, II, and III can take multiple years depending on how many people are enrolled and how complicated the study design is and what the company thinks the FDA will want in terms of human data. They will have to test for safety, determine appropriate dosing, and of course test for efficacy. This is also a guess, but it would appear that, even if everything goes well, the company is still several years away from bringing the super-EPO product to market (but this is typical for new drug development). They do seem to be making good progress and the partnership with Beth Israel Deaconness (and Harvard Medical School) certainly suggests that people who really know about this product have some confidence in it. Let me know if you have any questions."
Ann
AI
