The Commitment of CytoDyn to a New Approach to Treating HIV-AIDS
CytoDyn has been meeting with Principle Investigator Dr. Jay Lalezari at Quest Clinical Research in regards to finalizing their work towards a ‘Phase 2′ trial of ‘Cytolin®’, which is an immune therapy. It works along with our human immune systems, not to cure, but to control, the HIV infection. It’s full of promise, and this is known because it was actually used about 2 full years before the ‘antiretroviral cocktails’ came out.
The main goal of this meeting is to decide on how to proceed in order to get Cytolin® approved by the FDA. Standards for AIDS treatments grow with each passing year, as new studies and new drugs evolve. It’s hoped that Cytolin® can help to control the HIV and thus delay the need for someone to begin the antiretroviral therapy.
In essence, Cytolin® is a monoclonal antibody. It’s basically antibodies from mice. Researchers believe that there’s a flaw in the human immune system. That’s because only humans get sick from the HIV virus. Animals get the virus, but we get sick, and they don’t. Thus the conclusion that our immune systems aren’t all they should be. They believe that Cytolin® will ‘correct’ the immune system flaw, which is not the same as they’ve been doing, trying to ‘reconstitute’ the immune system.
The success for Cytolin® looks good, but getting it approved is an uphill battle. The FDA requested a test from CytoDyn in which CytoDyn had to respond that the request was impossible to fulfill. But the commitment of CytoDyn has not been hampered. They have give their response to the FDA and under Section 117 (C)(3) of the Food and Drug Modernization Act of 1997, they have only 30 days upon receipt of a complete response, to act on it.
This whole process has brought the FDA under close scrutiny, giving fuel to many conspiracy theories, due to their unwillingness to approve something that is the direct opposite of something they wouldn’t approve before. Raptiva was an antibody that was supposed to do the exact opposite of what Cytolin® does, and the FDA responded the same way.
The FDA is said to be notoriously underfunded and understaffed. This brings up other questions. If the FDA is so inadequate, and its approval isn’t considered to imply that drugs are safe, then why should drug companies spend billions of dollars for that approval? Isn’t this one of the factors leading to the high cost of health care? This looks to be a real mess.
The sad part about this country is that, when a company KNOWS it has a drug that will save lives, it can still take it 20 years or more to get it approved. That’s ludicrous, and we should be ashamed. An example is in the case of a couple of oncology drugs – Avastin and Erbitux.
CytoDyn has been a part of a documentary about the company, but it hasn’t been released yet either. CytoDyn is to be applauded for the work they do, not only with Cytolin® and Aids, but other areas as well.
Do you want to learn more about CytoDyn and the progress being made with it? Go to http://supportcytolin.com to learn more.
