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Unlike current AIDS drugs, which attack HIV directly, Cytolin aims to correct the self-destruct mechanism of the immune system that is triggered by an HIV infection.
The progress of the new drug's development is notable in part because CytoDyn's efforts have been funded on a tight budget of $1.25 million -- a small sum by pharmaceutical standards. Most of that amount was raised from HIV-positive, gay male professionals and businessmen with a personal stake in fighting AIDS.
Cytolin is a monoclonal antibody designed to prevent one part of the immune system -- a particular type of "killer" CD8 cells -- from attacking another part -- CD4 cells, the destruction of which results in AIDS. Cytolin is designed to protect the immune system's natural defenses while antiviral drugs take the offensive against HIV.
"What distinguishes Cytolin is its apparent ability to restore the body's defenses," said David N. Hart, M.D., CytoDyn's medical director. "It works to repair a chink in the immune system's armor that HIV managed to expose."
Many experts believe that both offensive and defensive strategies will be required for the long-term control of HIV/AIDS, according to R. Scott Hitt, M.D., a Los Angeles area physician who chairs the Presidential Advisory Council on HIV/AIDS.
"Some Americans believe that the fight against AIDS is practically over, now that combination drug therapy has shown us a break in the clouds," said Hitt, "but the storm is far from over. More options as well as less-toxic treatments are needed."
"We are encouraged by the growth of knowledge about this disease and by the efforts of companies like CytoDyn to develop new therapy approaches based on this knowledge," he said. "We look forward to the evaluation of this therapy by way of FDA sanctioned clinical trials."
Cytolin is designed as an injection to be given in a doctor's office, most often as an adjunct to a combination of antiviral drugs.
Combinations, or "cocktails," of antiviral drugs have helped some patients significantly reduce the level of their HIV infection, improving their health.
However, the side effects of antiviral drugs can be so significant that at least 15 percent of patients cannot take them. Even some patients who can tolerate antiviral therapy have continued to face declining health.
The FDA's action clears the way for a Phase I/II clinical trial in which 16 AIDS patients will receive Cytolin. Dr. Victor L. Beer, a prominent Los Angeles area AIDS specialist, will conduct the trial.
Patients interested in participating in the study should call Dr. Beer's office at 213/937-5151.
This new approach to AIDS treatment was developed by Allen D. Allen, CytoDyn's chief executive officer and director of research.
"I was intrigued that several species closely related to humans can be infected by HIV, but not harmed by it," Allen said. "When we compared their immune systems with ours, we found a weakness in the human immune system. Then, we designed a large family of drugs, including Cytolin, to compensate for it."
CytoDyn secured U.S. patents for the use of antibodies directed against a specific subset of CD8 cells in the treatment of AIDS. The patents were granted partly on the evidence of an initial study of six patients with HIV disease, published in the August 1995 issue of Medical Hypotheses.
Following injection with Cytolin, the patients demonstrated significantly reduced levels of HIV infection and clinical signs of immune system recovery, including increased levels of disease fighting CD4 cells.
Subsequently, Cytolin has been used by a number of physicians under laws in a number of states that allow qualified pharmacies and laboratories to prepare small quantities for doctors to use in their own offices.
Although CytoDyn does not control this experimental use of Cytolin, medical records from four doctors shared with the company and submitted to the FDA show that at the end of 1995, they had treated 188 patients with Cytolin for a total of about 700 times for periods up to two years.
The principal side effect noted by these physicians was an allergic reaction, which occurred in about five percent of the treatments at the time of infusion, which takes about 15 minutes.
Only about one percent of treatments resulted in serious allergic reactions and these were successfully managed with standard treatments.
Allen said that additional antibodies under development by the company will be tested later, possibly in combination with Cytolin, in an effort to optimize the treatment.
CytoDyn's use of community based funding is apparently unique, according to Tom Bianchi, one of the company's founders and its vice president for public affairs. He said that hundreds of volunteer hours have also been devoted to Cytolin's development by scientists, doctors and others.
"This generous support has allowed us to move this promising therapy into clinical trials on a smaller budget and more quickly than would be possible in larger, more traditional organizations," said Bianchi.
"Today, with mounting support for our technology, we're in a much stronger position than when we started to seek additional investors, including venture capital funds, to speed our next round of testing."
"When your life and that of your friends is on the line, you don't have time to delay," said Bianchi, who is himself gay and HIV-positive. "Certainly, that is a potent motivation for my work on behalf of this company."
Allen also credits the FDA for the company's progress.
"It is within the job description of the FDA to help people do things right, and they have been diligent, gracious providers of regulatory guidance," he said. "My experience completely contradicts the perception that you need a bevy of lawyers and consultants to deal with them."
CytoDyn Inc. is a privately held company involved in the development of immunological AIDS treatments. Additional information can be accessed through the company's World Wide Web site at www.cytodyn.com.
The web site also links visitors to a collection of published scientific papers related to CytoDyn's approach. This collection of papers was compiled by PaperChase, the medical literature service offered by Beth Israel Hospital, one of the major teaching hospitals of the Harvard Medical School.
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Note to Editors: A brief teleconference scheduled for 11:00 a.m. Pacific this morning will allow questions to be directed to the individuals quoted above. To participate, call 800/720-5863 for the CytoDyn press conference.
An illustration of how Cytolin and antiviral drugs affect HIV and the immune system is being transmitted simultaneously on BusinessWire.
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CONTACT: CytoDyn Inc. Bill Haworth, 213/549-3319 Steve Bryant, 206/270-4664
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