CytoDyn commences enrollment in Cytolin clinical trial

Following approval of the Institutional Review Board, CytoDyn, Inc. (Pink Sheets: CYDY) has discharged its duty to register a clinical trial of Cytolin®, the Company’s lead product, with the government’s website at www.clinicaltrials.gov, ID NCT01048372. The public has online access to this federal database, which describes the key elements of clinical trials and their status. To peruse the continually updated public record for the study of Cytolin® on the government’s website, enter “HIV AND Boston AND Cytolin” as search terms (case sensitive).

Human subjects are now being recruited for the study from the clinic of the Principal Investigator. The study protocol calls for 10 adults with early HIV infection and 10 healthy control subjects. According to the study protocol, it could take up to one year to fill these 20 slots. Although the Company expects enrollment to be completed in a shorter period of time, there can be no guarantee that enrollment will be completed in less time than is permitted by the study protocol.

The Current Standard for Treating HIV/AIDS

During the past decade, significant improvements in the antiviral “cocktails” used to treat HIV/AIDS have transformed this once fatal disease into a chronic, manageable condition. Many such antiviral drugs are available, including Atripla®, which combines drugs from Bristol-Myers Squibb (NYSE: BMY) and Gilead Sciences (NasdaqGS: GILD); Viracept® from Pfizer (NYSE: PFE); and Norvir® from Abbott Laboratories (NYSE: ABT), to name but a few. These drugs are the ingredients of Highly Active Antiretroviral Therapy (HAART), which has saved countless lives and is well tolerated by most patients, although all drugs have side effects.

The current standard of treatment recommends withholding antiviral drugs until the disease has progressed to the point where the drugs are required to maintain a patient’s health, typically a period of about five years from initial infection. A chief reason for withholding treatment during the early years of HIV infection is that antiviral drugs attack the virus directly. As a result, natural selection promotes the evolution of HIV into species that are resistant to those drugs. If antiviral drugs were prescribed too early, then the virus might become resistant to those drugs, rendering them ineffective, by the time they were necessary to maintain a patient’s health.

SOURCE CytoDyn, Inc.