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CytoDyn Begins GMP Manufacturing of Its First-In-Class AIDS Drug

Posted on: Wednesday, 2 July 2008, 09:01 CDT

CytoDyn, Inc. (Pink Sheets: CYDY) has begun GMP manufacturing and humanization of Cytolin(C), a monoclonal antibody that uses the human immune system to control HIV infection. The murine version of this product, for which there is already considerable human experience, will be used for a fast, randomized, double-blind, placebo-controlled clinical trial to supplement the data from a previous Phase Ib/IIa study. Ordinarily, pristine proof-of-principle requires a Phase III study. However, in the case of HIV/AIDS, a significant reduction in viral burden is universally accepted as a surrogate marker that reliably predicts reduced morbidity and increased life expectancy.

The human subjects who will be enrolled in the Company's upcoming clinical trial will be adults with HIV infection who have significant viral burdens because they are not yet candidates for, or have declined, antiretroviral drugs. This eliminates the confounding factor of having patients who are taking a variety of other drugs. Jacob Lalezari, MD, a prominent clinical researcher, will be the principal investigator for the study to be conducted in San Francisco, California. The Company will be making every effort to have the study completed before the end of 2008, although such timelines can never be guaranteed.

About Cytolin(C)

HIV infects other species, such as chimpanzees. But only humans get sick from HIV infection. In the early 1990s, several teams of university-based scientists reported in the peer-review literature that this unique response of humans to HIV infection is because of a flaw in the human immune system. Cytolin(R) is designed to correct that flaw. This is different from "reconstituting" the immune system, which can make patients sick ("immune reconstitution syndrome"). With the human immune system working better, we would expect it to do a better job of controlling HIV infection, as it does for several years following acquisition of the infection. Preliminary empirical evidence illustrating this benefit appeared in earlier clinical trials, and in the original pilot study summarized by the graphic on our home page at www.cytodyn.com.

The Need for Cytolin(C) (Indications)

The advent of the antiretroviral drugs and the concomitant use of three for Highly Affective Antiretroviral Therapy (HAART) has transformed HIV/AIDS from a death sentence into a serious but manageable chronic illness. The most recent and most effective of these drugs are the non-nucleoside reverse transcript inhibitors (NNRTI). Several have been recently approved, including Sustiva(C) (efavirenz) from Bristol-Meyers Squibb (NYSE: BMY), and Rescriptor(C) (delavirdine) from Pfizer (NYSE: PFE). Bristol-Meyers Squibb and Gilead (NasdaqGS: GILD) are now marketing a convenient three-in-one drug Atripla(C), which consists of efavirenz, tenofovir, and emtricitabine. The two drugs in addition to efavirenz belong to the older class of nucleoside reverse transcript inhibitors (NRTI). Reverse transcript inhibitors prevent retroviruses such as HIV from replicating.

One problem is that HIV can rapidly develop resistance to drugs that interrupt its life cycle due to natural selection. This has created a small but growing population of patients who have run out of treatment options and are in need of salvage therapy. Because a properly functioning immune system should control any strain of HIV, Cytolin(R) could help salvage those patients who are infected with drug-resistant strains of HIV. It might even prevent drug resistance from developing when used in combination with antiretroviral drugs by suppressing drug resistance strains as they emerge.

As another promising use for Cytolin(C), it might be given once a month or so (it is given as an intravenous infusion) in order to delay the need for antiretroviral drugs. Patients are usually advised not to start antiretroviral drugs until the disease has progressed for the following reasons: (Source: http://aidsinfo.nih.gov/contentfiles/HIVandItsTreatment_cbrochure_en. pdf)

(Due to its length, this URL may need to be copied/pasted into your Internet browser's address field. Remove the extra space if one exists.)

"Once you begin treatment, you may need to continue taking anti-HIV medications for the rest of your life. Although newer anti-HIV medications are easier to take, starting treatment usually means a significant adjustment in your lifestyle. Some anti-HIV medications need to be taken several times a day at specific times and may require a change in the foods you eat, when you eat meals, and when you take other medications.

"In addition to their desired effects, anti-HIV medications may have negative side effects, some of which are serious. If the virus is not suppressed completely, drug resistance can develop. Side effects and drug resistance may limit your future treatment options."

Disclaimer

This press release contains forward-looking statements that are not historical facts. The Company's management makes forward-looking statements concerning the Company's expected future operations, performance and other developments. These forward-looking statements are necessarily estimates based upon current information and projections and involve a number of risks and uncertainties, including but not limited to, the failure of preliminary results from scientific studies to reflect the results from more comprehensive studies. There can be no assurance that such risks and uncertainties, or other factors, will not affect the accuracy of such forward-looking statements. It is impossible to identify all factors that could cause actual results to differ materially from those estimated by the Company. They include, but are not limited to, government regulation, managing and maintaining growth, victimization by white-collar offenders, and the effects of adverse publicity, litigation, competition, and other factors that may be identified from time to time in the Company's announcements.

Source: Business Wire

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