NEW
AIDS STUDY SUGGESTS T-20-CONTAINING REGIMENS REDUCES HIV IN HEAVILY PRE-TREATED PATIENTS16-Week
Phase II Clinical Results Presented at ICAAC
SAN FRANCISCO, CA, September 27, 1999 -- Trimeris, Inc. (Nasdaq: TRMS) and
Roche announced today 16-week results from a Phase II clinical trial (T20-205) evaluating
the safety and antiviral activity of T-20, a member of a new class of anti-HIV compounds
known as fusion inhibitors. Unlike other anti-HIV medications, fusion inhibitors attack
and block the HIV virus before it enters the host cell. Results at 16 weeks showed that 33
of 55 (60%) of heavily pre-treated patients who were given T-20 in combination with oral
antiretroviral agents responded with a clinically significant reduction of HIV in the
blood. Indeed, 20 of the 55 (36%) had virus levels below the level of quantification (400
copies/mL). The study is being presented today at a late-breaking session of the
Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC).
"There is currently an unmet need for new treatment options that are effective in
the ever-growing number of HIV-infected patients who have cycled through available drugs.
The study results are exciting because the response rates exceeded what is normally
observed in this advanced patient population. We achieved these results by combining a
fusion inhibitor with traditional AIDS drugs," commented lead study investigator Jay
Lalezari, MD, of Quest Clinical Research in San Francisco, CA.
"This trial answered two major questions not addressed in previous trials. The
first was that T-20 provides a virologic benefit through week 16 and the second was that
the drug was well tolerated through week 16. No patients discontinued the trial due to
T-20-related adverse events or intolerance of the twice-daily subcutaneous
injection," said Sam Hopkins, senior vice president of medical affairs at Trimeris.
"The results of this study now gives us the confidence to continue planning for our
phase III pivotal trials. These trials, which are scheduled to begin next year, will
evaluate T-20 in patients who are extensively pre-treated as well as in those with less
treatment experience."
T20-205 -- Trial Design and Results
In this Phase II clinical trial, T-20 was given in combination with oral
antiretrovirals to 55 HIV-1 positive adults who had previously received T-20 during
earlier trials. At entry, patients had previously been treated with a median of 11
antiretrovirals and 93% had a clinical history of triple class exposure. Ninety-three
percent of patients demonstrated genotypic evidence associated with resistance to protease
inhibitors (median of five mutations per patient) and 87% demonstrated mutations
associated with resistance to reverse transcriptase inhibitors (median of four mutations
per patient).
In this protocol, patients received T-20 (50 mg/twice daily via sub-cutaneous
injection) in combination with a median of four oral antiretrovirals. Combinations were
individualized to each patient and were chosen based on genotypic analysis evaluating
patients resistance to anti-HIV medications. The median baseline viral load was
79,400 copies/mL (4.9 log10 copies/mL) and median CD4+ count was 70 cells/mm3.
At sixteen weeks, 33 of55 (60%) of heavily pretreated patients who were given T-20 in
combination with oral anti-retrovirals responded with a clinically significant reduction
of HIV in the blood (viral suppression greater than 1.0 log10 from baseline or
below the level of quantification of 400 copies/mL, using the Roche Amplicor assay)
Furthermore, 20 of 55 or 36% had virus levels below the level of quantification. The
average decrease in viral load for all patients was greater than 90% over the 16 week
period
In all clinical studies to date, most adverse events reported on T-20 were mild or
moderate in severity. The most frequent adverse events included fever, headache and lymph
node abnormalities, in addition to local irritation resulting from the subcutaneous
injection.
"Because T-20 attacks the HIV virus before it enters the cell it works differently
than currently approved anti-HIV drugs. It therefore has the potential to combat strains
of the virus that have become resistant to these treatments," said Michael Saag,
M.D., director of HIV outpatient care at the University of Alabama at Birmingham.
"These exciting results confirm observations from prior short-term T-20 studies where
a greater than 98% reduction was seen when T-20 was given alone. This current trial goes
one step further in validating the T-20 proof of concept."
This past July, Trimeris and Roche signed an agreement for the full-scale clinical
testing and development of Trimeris two novel anti-HIV fusion inhibitors, T-20 and
T-1249.
Hoffmann-La Roche Inc. is a leading research-intensive pharmaceutical company that
discovers, develops, manufactures and markets numerous important prescription drugs that
improve, prolong and save the lives of patients with serious illnesses. Among the
companys areas of therapeutic interest are: Virology, including HIV/AIDS and
hepatitis C; Infectious Diseases, including influenza; Cardiology; Neurology; Oncology;
Transplantation; Dermatology; and Metabolic Diseases, including obesity and diabetes.
The company provides a wide range of medications in the United States through its
marketing and sales subsidiary, Roche Laboratories Inc. Headquartered in Nutley, N.J.,
both companies are members of the Basel, Switzerland-based Roche Group, a global leader in
health care with principal businesses in pharmaceuticals, diagnostics, vitamins, and
fragrances and flavors. For more information on Roche Pharmaceuticals in the United
States, visit the companys web site at: http://www.rocheusa.com/