-- Positive Data Presented at 45th Annual ICAAC --
CAMBRIDGE, Mass., Dec. 16 /PRNewswire-FirstCall/ -- GlaxoSmithKline (GSK)
and Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) presented positive
results today from a study evaluating the safety, tolerability and antiviral
activity of the investigational HIV-1 protease inhibitor (PI), brecanavir*
(formerly known as GW640385 or VX-385)(1). These data were presented at the
45th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC)
held in Washington DC. Interim findings following 24 weeks of dosing
demonstrated potent antiviral activity for brecanavir in both PI-sensitive and
PI-resistant HIV-infected adults.
"These results support the ongoing development program for brecanavir,
which is anticipated to enter Phase III development in 2006," said Lynn Marks,
MD, Senior Vice President of the Infectious Disease Medicines Development
Centre at GSK. "If approved, brecanavir may be useful in treating patients
infected with strains of HIV that have become resistant to multiple protease
inhibitors, and its clinical advancement underscores GSK's commitment to
developing new anti-HIV drugs."
Clinical Data on Brecanavir
Brecanavir is an HIV protease inhibitor in Phase IIb clinical development.
Brecanavir has received fast track designation from the U.S. Food and Drug
Administration and is being developed by GSK as part of a collaboration with
Vertex Pharmaceuticals.
Data presented were from a planned, 24-week analysis of an open-label
study (HPR10006) of 48 weeks' duration evaluating the safety, tolerability,
antiviral activity and pharmacokinetics of ritonavir-boosted brecanavir.
Thirty-one HIV-1 infected adults received 300mg of brecanavir twice-daily
boosted with 100mg of ritonavir in combination with two nucleoside reverse
transcriptase inhibitors based on patient medical history and viral genotype.
Out of 31 patients, 81 percent had plasma HIV-1 RNA below the level of
detection of standard assays (<400 copies/mL of blood) at Week 24 (based on an
intent-to-treat, missing or discontinuation equals failure analysis), and 77
percent had viral load below the level of detection of ultrasensitive assays
(<50 copies/mL). Patients with PI-sensitive and highly PI-resistant virus had
similar response rates. Improvements in immunologic status were observed,
with a median increase in CD4+ cell count of 84 cells/mm3.
"These early data are encouraging and support the further development of
brecanavir in clinical trials in both antiretroviral treatment-naove and
experienced patients," commented lead investigator Douglas Ward, MD, FACP of
the Dupont Circle Physicians Group. "Because many HIV-infected patients
undergoing treatment develop viral resistance to those medicines already
available, a critical need for new antiretrovirals remains."
A safety assessment showed that brecanavir was well-tolerated with few
Grade 2-4 drug-related adverse events and no serious adverse events. Most
adverse events were reported as mild and did not require treatment
modification or discontinuation. Clinically relevant changes in laboratory
assessments were also infrequent.
About HIV Protease
Once inside a human immune cell, HIV uses enzymes within that cell to make
copies of itself. Protease is one such enzyme involved in HIV replication.
HIV protease inhibitors block the HIV protease enzyme, yielding copies of HIV
that cannot infect new cells.
About Vertex
Vertex Pharmaceuticals Incorporated is a global biotechnology company
committed to the discovery and development of breakthrough small molecule
drugs for serious diseases. The Company's strategy is to commercialize its
products both independently and in collaboration with major pharmaceutical
companies. Vertex's product pipeline is principally focused on viral
diseases, inflammation, autoimmune diseases and cancer.
Vertex Safe Harbor Statement
This press release may contain forward-looking statements, including that
(i) it is anticipated brecanavir will enter Phase III development in 2006; and
(ii) brecanavir may be useful in treating patients infected with resistant HIV
strains. While management makes its best efforts to be accurate in making
forward-looking statements, such statements are subject to risks and
uncertainties that could cause the actual results of studies to vary
materially, including those risks and uncertainties listed under Risk Factors
in Vertex's Form 10-K filed with the Securities and Exchange Commission on
March 16, 2005.
Vertex's press releases are available at http://www.vrtx.com.
Vertex Contacts:
Lynne H. Brum, VP, Corporate Communications and Financial Planning,
(617) 444-6614
Michael Partridge, Director, Corporate Communications, (617) 444-6108
Lora Pike, Manager, Investor Relations, (617) 444-6755
Zachry Barber, Specialist, Media Relations, (617) 444-6470
(1) D. Ward, et al. Preliminary Antiviral Activity and Safety of
640385/Ritonavir in HIV-infected Patients (Study HPR10006); an 8-Week Interim
Analysis. 45th Interscience Conference on Antimicrobial Agents and
Chemotherapy, Washington DC, Dec 2005.
*The generic name is USAN approved only.
SOURCE Vertex Pharmaceuticals Incorporated
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Related links:
http://www.vrtx.com
Company News On-Call:
http://www.prnewswire.com/comp/938395.html
CONTACT:
Lynne H. Brum, VP, Corporate Communications
and Financial Planning, +1-617-444-6614, or Michael Partridge,
Director, Corporate Communications, +1-617-444-6108, or Lora
Pike, Manager, Investor Relations, +1-617-444-6755, or Zachry
Barber, Specialist, Media Relations, +1-617-444- 6470, all of
Vertex
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