Navigation Links
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(R) (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 (

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.
Copyright©2009 PR Newswire.
All rights reserved

Related biology technology :

1. Peptimmune Presentations at Upcoming Events
2. Peptimmune Presentation at Upcoming World Congress on Treatment and Research in Multiple Sclerosis
3. Peptimmune Announces First Close of Series D Private Financing
4. Cephalon Completes Acquisition of Arana Therapeutics
5. Cardinal Health Completes Biotech Acquisition
6. Beckman Coulter Completes Acquisition of Olympus Lab-Based Diagnostics Business
7. Oncolytics Biotech Inc. Successfully Completes 100-Litre cGMP Production of REOLYSIN(R)
8. OncoGenex Pharmaceuticals Completes $9.5 Million Registered Direct Offering
9. GlaxoSmithKline Completes Acquisition of Stiefel
10. Oncolytics Biotech(R) Inc. Completes Lyophilization Process for REOLYSIN(R)
11. Encorium Group Completes Sale of its U.S. Business to Pierrel Research USA; Announces Management Changes
Post Your Comments:
(Date:11/27/2015)... /PRNewswire/--  Mallinckrodt plc (NYSE: MNK ), a ... closed the sale of its global contrast media and ... in a transaction valued at approximately $270 million. The ... total of approximately 1,000 employees spread across the globe, ... area. This entire workforce and the manufacturing ...
(Date:11/25/2015)... 26, 2015 --> ... 2016 - 2020 report analyzes that automating biobanking ... quality in long-term samples, minimizing manual errors, improving ... minimizes manual errors such as mislabeling or inaccurate ... it plays a vital role in blood fractionation, ...
(Date:11/25/2015)... 25, 2015  Neurocrine Biosciences, Inc. (Nasdaq: NBIX ... and CEO of Neurocrine Biosciences, will be presenting at ... New York . .   ... approximately 5 minutes prior to the presentation to download ... presentation will be available on the website approximately one ...
(Date:11/25/2015)... ... November 25, 2015 , ... Jessica Richman ... AngelList early in their initial angel funding process. Now, they are paying it ... to make early stage investments in the microbiome space. In this, they ...
Breaking Biology Technology:
(Date:11/9/2015)... , Nov. 9, 2015  Synaptics Inc. (NASDAQ: ... today announced broader entry into the automotive market with ... match the pace of consumer electronics human interface innovation. ... are ideal for the automotive industry and will be ... Europe , Japan ...
(Date:11/2/2015)... , Nov. 2, 2015  SRI International has ... to provide preclinical development services to the National Cancer ... SRI will provide scientific expertise, modern testing and support ... of preclinical pharmacology and toxicology studies to evaluate potential ... --> The PREVENT Cancer Drug Development Program is ...
(Date:10/29/2015)... 2015  The J. Craig Venter Institute (JCVI) policy ... and Biosecurity: Lessons Learned and Options for the Future," ... Human Services guidance for synthetic biology providers has worked ... --> --> Synthetic biology promises ... to pose unique biosecurity threats. It now is easier ...
Breaking Biology News(10 mins):