Peptimmune Completes Phase Ib Study of PI-2301 in Multiple Sclerosis Patients, and Presentation at ECTRIMS 2009
CAMBRIDGE, Mass., Aug. 25 /PRNewswire/ -- Peptimmune, Inc., a
privately held biotechnology company, announced the completion of a
clinical trial to evaluate the safety, tolerability,
pharmacokinetics, and pharmacodynamics of PI-2301 in subjects with
Secondary Progressive Multiple Sclerosis (SP-MS). PI-2301 is a
novel peptide copolymer for the treatment of multiple sclerosis and
other autoimmune diseases.
The Phase Ib multiple-ascending dose, double-blind,
placebo-controlled, randomized study enrolled 50 subjects with
SP-MS. A total of 36 subjects received PI-2301 once weekly for 8
weeks followed by an open label extension of an additional 4 weeks.
The doses ranged from 1 to 60 mg. Safety at all doses, including
potentially therapeutic doses, was established. The most frequent
adverse events (AEs) were dose-dependent site reactions which were
mild to moderate, transient, and resolved without specific therapy.
Dose-dependent increases in serum levels of anti-inflammatory
markers were consistent with PI-2301 exposure as measured using the
Company's proprietary pharmacokinetic assay. The Company plans to
continue developing this promising compound by initiating a Phase
II study in multiple sclerosis patients later this year.
"PI-2301 has now shown safety and pharmacologic activity in two
clinical studies, the first in healthy volunteers, and this second
in patients with multiple sclerosis. As we look forward to the
Phase II, we are excited about the observed pharmacologic effects
of PI-2301 in patients suffering from secondary progressive MS,"
stated Thomas P. Mathers, President and CEO of Peptimmune.
Data from this Phase Ib study will be presented at the Congress
of the European Committee for Treatment and Research in Multiple
Sclerosis (ECTRIMS). Dr. Eric Zanelli will make a poster
presentation titled "Clinical and biological results of a 12-week,
double-blind, multiple ascending dose study evaluating the safety
and tolerability of peptide copolymer PI-2301 in patients with the
secondary progressive form of multiple sclerosis." The poster
(P-422) will be presented within Topic 15 - Immunomodulation - 1
during the Poster Session I taking place on Thursday, September 10,
2009, between 2:30 and 5:00 p.m.
About PI-2301
PI-2301 is a second-generation peptide copolymer from a similar
compound class as Copaxone (Teva Pharmaceuticals). PI-2301 works
through immune modulation by enhancing the regulatory response of
the immune system and thereby controlling the pathogenic autoimmune
response observed in autoimmune diseases such as multiple
sclerosis. PI-2301 has been optimized using Peptimmune's novel
platform peptide chemistry and, in preclinical studies, has shown
to be more potent and effective than Copaxone in treating disease
models for multiple sclerosis and other autoimmune diseases where
immune modulation may be effective, such as Crohn's disease,
rheumatoid arthritis, and autoimmune uveitis. Peptimmune has
high-quality synthesis and analytical methods that provide a
superior level of batch-to-batch reproducibility in the
manufacturing of PI-2301.
In January 2009 Peptimmune granted Novartis (NYSE:NVS) an exclusive option to obtain
exclusive worldwide rights to develop and commercialize
PI-2301.
About Multiple Sclerosis
Over 400,000 Americans have multiple sclerosis (MS), and MS may
affect over 2.5 million individuals worldwide. MS is an autoimmune
disease in which the individuals' immune system attacks components
of nerves. The effects of these immune-mediated attacks often
progress to a chronic disabling disease, as communication between
the brain and other parts of the body is disrupted.
About Peptimmune (www.peptimmune.com)
Peptimmune, Inc. is a privately held biotechnology company
clinically focused on the development of peptide therapies to
improve the management of chronic autoimmune and inflammatory
disorders. Founded in 2002 and located in Cambridge, MA USA, the
Company is led by an experienced management team and exploits its
proprietary DEEP(TM) Technology to design peptide copolymers for
the diagnosis and treatment of infectious diseases, autoimmune
disorders, and the generation of novel antibodies. Current
investors include New Enterprise Associates, MPM Capital, Hunt
Ventures, Boston Medical Investors, Silicon Valley Bank Capital,
and Genzyme Corporation.
Source: Peptimmune, Inc.
CONTACT: Tom Mathers of Peptimmune, Inc., +1-617-715-8000,
tom.mathers@peptimmune.com
Web Site: http://www.peptimmune.com
Posted: August 2009
