Important note: Information in this article was accurate in 1998. The state of the art may have changed since the publication date.

Reuters NewMedia - Monday November 23, 1998
Elizabeth Smith

The T-20 trial results sent Trimeris's stock shooting up the day the article about T-20 was published on Nov. 3, by 120 percent to $10.75 a share. Since then however, the shares have settled back, and were trading at $6.78 Monday afternoon on the Nasdaq, reflecting in part the challenges that lie ahead for Trimeris and T-20.

Mark Markowitz, clinical director of the Aaron Diamond Institute in New York, a major AIDS research organization, explained that while the initial clinical trials on T-20 prove the way the drug works, they did not prove its long-term effectiveness. "What we are dealing with is a proof of concept study here, not a (full) clinical study," Markowitz said.

The doubts about T-20's potential, or at least its convenience, center on the fact that the 17 patients in the Phase I/II clinical trials were given the drug intravenously, rather than in pills.

"It will be a while yet before we see something in oral form," Markowitz said. The cautionary tone of Markowitz's comments underscore the difficulties that converting T-20 into a pill will involve. It may prove impossible because it is a peptide, a string of amino acids that enzymes in the stomach would break down and render ineffective as an anti-HIV agent.

Trimeris' Chief Executive Ross Johnson said the company was now seeking to come up with a drug that replicates the actions of the T-20 peptide. Johnson also stressed that even before researchers reach that stage, T-20 offers doctors a new therapy to treat HIV-infected patients, given that it attacks the virus at a much earlier stage than drugs currently available.

Known as a fusion inhibitor, T-20 prevents infection by blocking the creation of a "spring-loaded coil" in HIV that penetrates healthy human cells. The Trimeris chief added that T-20 also provided another option to patients who had become resistant to other HIV drugs.

Existing HIV drugs such as protease inhibitors and reverse transcriptase inhibitors, attack the virus after it infects the cell. Scientists familiar with T-20 echoed Johnson, saying T-20 indeed adds a new dimension to treating HIV. "What is groundbreaking here is not that we have developed a practical solution to HIV therapy, but that it is a new therapy," said Dr. Michael Kilby, assistant professor of medicine at the University of Alabama at Birmingham. Kilby is one of the investigators conducting T-20 trials for Trimeris. Kilby, like Johnson, stressed the new avenue of therapy that T-20 opens up, giving doctors more ammunition to fight a deadly, incurable disease.

Regarding the clinical trials, Kilby and other researchers involved in the first T-20 two-week trial are close to completing a 28-day clinical trial on 78 patients across the country. They expect to present the data early February. In the new trial, patients have injected T-20 or used a small pump the size of a beeper used by diabetics that dispenses the drug into the body, serving as a mobile IV.

In addition to the 28-day trial, researchers are seeking federal approval for a six-month trial on patients.

Paul Moore, another researcher at the Aaron Diamond Institute, said the drug needs to be looked at in longer trials in order to establish its long-term efficacy. Results of the two-week trial, the only one done so far, is insufficient in proving this, he said.

The one stock analyst who follows Trimeris, Scott Zacane at NationsBanc Montgomery Securities, could not immediately be reached for comment. New York newsroom 212-859-1700
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Always watch for outdated information. This article first appeared in 1998. This material is designed to support, not replace, the relationship that exists between you and your doctor.

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