Triangle Pharmaceuticals Reports Preliminary Clinical Results for Anti-HIV Drug MKC-442
PR Newswire, Friday, January 17, 1997 at 09:09
DURHAM, N.C., Jan. 17 /PRNewswire/ -- Triangle Pharmaceuticals, Inc.
(Nasdaq: VIRS) confirmed today that preliminary clinical data on one of its
anti-HIV drugs, MKC-442, will be presented at the Fourth Conference on
Retroviruses and Opportunistic Infections in Washington, D.C. next week.
The preliminary data are from an ongoing Phase Ib/IIa double-blind,
placebo-controlled trial designed to evaluate the safety and efficacy of
repeated multiple oral doses of MKC-442 in HIV-infected patients. A total of
26 patients were treated for up to two months. Doses ranging from 100 mg twice
a day to 350 mg twice a day were given to groups of six patients at each
dosage level and additional patients are currently entering the trial to
receive higher doses. MKC-442 produced a significant reduction in the amount
of HIV in the blood. The degree of this viral load reduction varied depending
on dosage, with over a 90% reduction seen during the first week of therapy at
the highest dose studied to date. This was followed by varying increases from
this nadir over the following three week observation period for which viral
load data are available. Genetic mutations that may be associated with
resistance were found in the virus obtained from some patients after one month
of therapy, consistent with observations obtained from patients on other
monotherapy regimens. During the course of over 210 patient-weeks of active
drug exposure, the only significant adverse reaction observed was a rash in
one patient receiving the lowest dose.
The preliminary trial is continuing, and conclusions about the efficacy and
safety profile of MKC-442 when used alone will not be possible until more
extensive dose escalation has occurred. "While we are pleased with the
decreases in viral load and the paucity of adverse reactions seen with dosages
tested to date, the full therapeutic index of this drug will not be known
until higher dosages have been tested and further trials have taken place,"
said David W. Barry, M.D., Chairman and Chief Executive Officer of Triangle
Pharmaceuticals. "A number of additional issues including drug metabolism,
viral resistance and synergy with other HIV drugs will need to be more
completely explored before definitive efficacy studies of MKC-442 in
combination therapy can begin," he said. The Company currently intends to
initiate such studies later this year.
MKC-442 is a non-nucleoside reverse transcriptase inhibitor for the
treatment of HIV infection and AIDS. Triangle has obtained an option to
acquire a license to this compound from Mitsubishi Chemical Corporation. If
Triangle exercises its option, it will obtain rights to MKC-442 worldwide
except in certain East Asian countries, including Japan, China and Taiwan.
Triangle Pharmaceuticals, Inc., based in Durham, North Carolina, is
engaged in the development of new drug candidates primarily in the antiviral
area, with a particular focus on therapies for the human immunodeficiency
virus, the acquired immunodeficiency syndrome, and hepatitis B virus. Prior
to their employment with the Company, members of the Company's management team
played instrumental roles in the identification, clinical development and
commercialization of several leading antiviral therapies.
Statements in this press release regarding the development of the
Company's drug candidates constitute forward-looking statements and are
subject to numerous risks and uncertainties, including the failure to
successfully complete pivotal clinical trials, the Company's ability to obtain
additional funding and required regulatory approvals, the development of
competitive products by others and other risks detailed from time to time in
the Company's filings with the Securities and Exchange Commission. The actual
results may differ materially from those projected in the forward-looking
statements. The Company disclaims any obligation to update these forward-
looking statements.
SOURCE Triangle Pharmaceuticals, Inc.
-0- 01/17/97
/CONTACT: Carolyn Underwood, Vice President, Marketing & Investor
Relations of Triangle Pharmaceuticals, Inc., 919-493-5980 or Douglas
MacDougall or Betsy Godshalk of Feinstein Partners Inc., 617-577-8110/ |
