Important note: Information in this article was accurate in 1999. The state of the art may have changed since the publication date.
Important note: Information in this article was accurate in 1999. The state of the art may have changed since the publication date.
Reuters NewMedia - Monday September 27, 1999
David Brinkerhoff
The company, which has been developing drugs that are part of a new class of HIV medicines, released a study on its lead experimental treatment for HIV, T-20, which showed results "exciting" enough to give the drug maker confidence to keep planning more advanced tests, it said.
Those results, from a 16-week trial on 55 patients, showed that 60 percent of the patients experienced a "clinically significant" drop of HIV in their bloodstreams, when the peptide drug was taken in combination with drugs already on the market. Trimeris also said that 20 of the 55 (36 percent) had virus levels below the level of quantification.
The company said none of the patients who were treated with the twice-daily injections dropped out of the trial because adverse events or intolerance. The patients had also been previously treated with other HIV drugs.
In all T-20 studies to date, the company said the most frequent adverse events included fever, headache, and lymph node abnormalities, along with irritation at the site of injection.
Carl Gordon, analyst with OrbiMed Advisors Inc., said some investors may have expected more significant data from the Phase II study, announced at a drug conference in San Francisco on Monday.
"It's hard to know the extent to which the effects are Trimeris' drug versus (the combination)," with other drugs, Gordon said. He said that investors' hopes may have been disappointed because they were unclear about the study's goals.
T-20 is one of a new class of so-called fusion inhibitors, which are different from current HIV medicines because they block and attack the HIV virus before it enters the host cell.
"(The data) don't prove that this drug works or how well it works, Gordon said. However, Trimeris Chief Executive Dani Bolognesi told Reuters the data had "promise" and was certain the drug would enter Phase III trials, the final stage before a company asks regulators to clear a drug for sale.
While unsure why his company's stock price had dropped, Bolognesi speculated that the price may have been weighed down by a grim outlook for AIDS drugs presented by some experts at Monday's conference for anti-viral and anti-AIDS medicines.
While deaths from AIDS are falling, researchers said, the rate of decline is slowing at the same time as reports are emerging that drug-resistant strains are on the rise.
"Despite the promise of this one little drug, that could have been washed away," by the gloomier big picture, Bolognesi said.
The stock may also have been hurt by concerns that the company would fail to produce enough of the drug to meet demand, he said. But he discounted that concern, saying the company would have dropped the program if they didn't think they could make enough.
The company has already partnered with Swiss drug giant Roche to help with production, he said.
"We are early in development and it's going to take an enormous amount of work to get it to the goal line," he said.
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