-- Plasma HCV RNA levels are less than 10 IU/mL in 12 of 12 patients after 28
days of dosing with VX-950/peg-IFN/RBV in Phase II study --
CAMBRIDGE, Mass., Feb. 7 /PRNewswire-FirstCall/ -- Vertex Pharmaceuticals
Incorporated (Nasdaq: VRTX) today announced that it has completed dosing with
VX-950 in a Phase II, 28-day clinical study in hepatitis C virus (HCV)
infected patients. In addition, the Company announced that it has completed
three-month animal toxicology studies that will support clinical studies of
VX-950 of up to three months duration. Initiation of additional Phase II
clinical studies in the U.S. in patients with HCV is planned following
required Food and Drug Administration (FDA) review of these latest non-
clinical and clinical results, and FDA review of a proposed clinical study
protocol. This information will be submitted to the FDA within the first
quarter of 2006.
Clinical Study Design and Results
The 28-day, Phase II clinical study enrolled 12 treatment-naive patients
with genotype 1 HCV. Patients received VX-950 in a tablet formulation at a
dose of 750 mg every eight hours (q8h) for 28 days in combination with
standard doses of pegylated interferon alfa-2a (Pegasys(R); peg-IFN) and
ribavirin (Copegus(R); RBV). At the end of 28 days, patients completed dosing
with VX-950 and per study protocol were required to continue treatment with
peg-IFN and RBV. This 28-day, Phase II study was not designed to evaluate
sustained viral responses (SVR) in patients receiving VX-950.
There were no treatment discontinuations and no serious adverse events
reported. A detailed safety analysis is ongoing.
For patients entering the study, the distribution of baseline plasma HCV
RNA values was typical for a treatment-naive patient population. At the end
of week 1 (day 8 of VX-950 dosing), plasma HCV RNA was below the limit of
quantitation (30 IU/mL; Roche Taqman(R) assay) in six of the 12 patients; and
undetectable (less than 10 IU/mL; Roche Taqman(R) assay) in two of 12
patients. Preliminary HCV RNA results in patients for weeks 2-4 are as
follows:
* At the end of week 2, plasma HCV RNA was below the limit of quantitation
(30 IU/mL) in 11 of the 12 patients; and undetectable (less than 10
IU/mL) in three of 12 patients.
* At the end of week 3, plasma HCV RNA was below the limit of quantitation
(30 IU/mL) in 12 of the 12 patients; and undetectable (less than 10
IU/mL) in nine of 12 patients.
* At the end of VX-950 dosing (end of week 4; day 28), plasma HCV RNA was
undetectable (less than 10 IU/mL) in all 12 patients.
* No patients showed evidence of viral breakthrough while on treatment.
The Phase II study reported today is the third in a series of clinical
trials of VX-950 in patients with HCV designed to evaluate safety,
pharmacokinetics and antiviral activity, in order to guide the design of
larger, longer duration Phase II studies. The Company plans to present the
full data set from the 28-day, Phase II study at a medical conference later
this year.
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 co-promotes
the HIV protease inhibitor, Lexiva, with GlaxoSmithKline.
Safe Harbor Statement
This press release may contain forward-looking statements, including
statements that (i) Vertex will submit data from the toxicology and clinical
studies to the FDA within the first quarter; (ii) the Company's three-month
animal toxicology data support clinical studies of VX-950 of up to three
months duration; and (iii) additional Phase II clinical studies in the U.S.
are planned following FDA review of data from Vertex studies and the Company's
proposed clinical study protocols. 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 Vertex's actual results to vary
materially. These risks and uncertainties include, among other things, the
risks that full analysis of the data, including an ongoing detailed safety
analysis, or further testing, will not reflect the interim results reported in
this press release, or support any or all of the conclusions provided in this
press release; the FDA will not agree to a clinical trial designed to
determine SVR after three months of combination treatment; clinical trials for
VX-950 may not proceed as planned due to technical, scientific, or patient
enrollment issues; expected regulatory filings or clinical trial starts may
not occur or may be delayed due to adverse clinical or non-clinical trial
developments or FDA action, any one or more of which events could delay the
start of Phase III clinical trials and planned filings for regulatory
approval; and other risks listed under Risk Factors in Vertex's Form 10-K
filed with the Securities and Exchange Commission on March 16, 2005.
Lexiva is a registered trademark of the GlaxoSmithKline group of
companies, and Pegasys is a registered trademark of Hoffman-La Roche Inc.
Vertex's press releases are available at http://www.vrtx.com.
Vertex Contacts:
Lynne H. Brum, Vice President, Strategic Communications, (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
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, Vice President, Strategic
Communications, +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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