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.

View full article here: http://www.drugs.com/clinical_trials/peptimmune-completes-phase-ib-study-pi-2301-multiple-sclerosis-patients-presentation-ectrims-2009-7950.html

Dirucotide (formally named MBP8298) is a synthetic peptide that consists of 17 amino acids linked in a sequence identical to that of a portion of human myelin basic protein (MBP). Dirucotide has been developed for the treatment of multiple sclerosis (specifically secondary progressive MS) and is based on over 26 years of research.

MS is generally considered an autoimmune disease, caused by immune attack against normal components of the central nervous system. The specificity of the immune attack at the molecular level is determined in each case by the HLA type of the individual patient, and HLA type is known to be one factor that contributes to susceptibility to MS. The dirucotide synthetic peptide is a molecular replicate of the site of attack that is dominant in MS patients with HLA haplotypes DR-2 or DR-4. These HLA types are found in 65-75% of all MS patients.

The proposed mechanism of action of dirucotide is the induction or restoration of immunological tolerance with respect to ongoing immune attack at this molecular site. High doses of antigen delivered periodically by the intravenous route are expected to suppress immune responses to the administered substance. The potential benefit of dirucotide for any individual patient is therefore expected to be related to the extent to which his or her disease process is dominated by autoimmune attack at the site represented by this synthetic peptide.

The results of phase II and long-term follow-up treatment of MS patients with dirucotide, published in the European Journal of Neurology (EJN), showed that dirucotide safely delayed median time to disease progression for five years in progressive MS patients with HLA-DR2 or HLA-DR4 immune response genes.
Read more: Multiple Sclerosis (MS) Treatment | Dirucotide MBP8298 | BioMS Medical – http://www.biomsmedical.com/mbp8298-dirucotide-overview.php#ixzz0CfKgUGG9

Edmonton, Alberta, March 17, 2009 – BioMS Medical Corp. (TSX: MS), a leading developer in the treatment of multiple sclerosis (MS), today announced financial and operational results for the year ended December 31, 2008.

“Dirucotide has demonstrated the ability to safely affect MS progression in previous studies and we look forward to the results of the Canadian/European trial (MAESTRO-01) in the second half of this year,” said Kevin Giese, President and CEO of BioMS Medical. “Our hope is that the results of this trial will confirm that dirucotide is able to significantly slow the progression of MS, specifically in patients with secondary progressive multiple sclerosis.”

Currently, BioMS is conducting two clinical trials and one open-label follow-on trial of dirucotide for the treatment of secondary progressive MS (SPMS):

• MAESTRO-01: On January 22, 2007, BioMS announced that this pivotal phase III trial, being conducted in Canada and Western Europe, had completed full recruitment of 611 SPMS patients at 47 trial sites in ten countries. To date, there have been nine positive safety reviews from the Data Safety Monitoring Board (DSMB). The primary clinical endpoint for MAESTRO-01 (and MAESTRO-03) is defined as a statistically and clinically significant increase in the time to progression of the disease as measured by the Expanded Disability Status Scale (EDSS), in patients with HLA-DR2 and/or HLA-DR4 immune response genes.

On August 13, 2008, the DSMB conducted a scheduled interim analysis of efficacy and safety and recommended that the trial continue to completion. The interim analysis evaluated the first 200 patients to complete MAESTRO-01 and assessed the likelihood of the study reaching its primary endpoint at the end of the trial. Based on the DSMB decision, Eli Lilly and Company (Lilly) provided a US $10 million milestone payment to BioMS as part of the terms of the licensing and collaboration agreement.

BioMS anticipates MAESTRO-01 will be completed in 2009 with results from the trial expected in the second half of this year.

• MAESTRO-02: Eligible patients who have successfully completed MAESTRO-01 may choose to receive dirucotide on an un-blinded basis in this open-label follow-on study. To date, approximately 95% of the eligible patients who have successfully completed the MAESTRO-01 trial have enrolled in this follow-on study.

• MAESTRO-03: Enrollment was initiated in June, 2007 and completed on August 1, 2008 for this pivotal U.S. phase III trial of approximately 510 SPMS patients at 67 sites across the U.S. To date, the DSMB has conducted three reviews of the data from this trial and recommended it continue. The next DSMB review is expected to take place in the second quarter of fiscal 2009.

• MINDSET-01: MINDSET-01 was a randomized, double-blind study that recruited 218 relapsing-remitting MS patients at 24 trial sites in six countries across Europe. BioMS recently announced that the top line results of this exploratory study did not meet its primary endpoint of effecting annualized relapse rate or associated secondary magnetic resonance imaging (MRI) endpoints. Dirucotide did meet certain secondary endpoints related to the progression of the disease, including mean change from baseline in the EDSS and the MS Functional Composite (MSFC) score. Changes in EDSS and MSFC are primary and secondary outcomes in the ongoing phase III SPMS trials.

The data also showed that dirucotide was generally well tolerated. The most common side effects reported were redness and burning sensation at the injection site. No patients withdrew due to adverse events.

Eligible patients in this trial are now receiving dirucotide on an un-blinded basis to the end of their 27th month in the trial.

Licensing and Development Agreement with Lilly
On December 17, 2007, BioMS entered into a licensing and development agreement (the “Agreement”) granting Lilly exclusive worldwide rights to dirucotide. The transaction closed on January 25, 2008 and BioMS received an upfront payment of US $87 million. In September 2008, BioMS received a development milestone payment of US $10 million as a result of the positive interim analysis from the DSMB for MASESTRO-01. BioMS has the potential to receive future development and sales milestones up to US $400 million and escalating royalties on sales if dirucotide is commercialized.

Not later than sixty (60) days following receipt of the final written report of the results of the MAESTRO-01 trial, Lilly shall notify BioMS in writing whether Lilly will terminate the Agreement or alternatively Lilly shall bear 100% of any and all continuing development costs incurred by Lilly or BioMS for dirucotide.

HYC750 and BioCyDex
On May 9, 2008, BioMS entered into a Royalty and Assignment Agreement with Orcrist Bio. Inc. for HYC750, a technology based on hyaluronic acid that has a number of potential therapeutic uses and is being developed as a treatment for the side effects of chemotherapy. BioMS held an exclusive worldwide license to HYC750 from the University of Alberta. As a result of the Royalty and Assignment Agreement, BioMS terminated its license with the University of Alberta and the University entered into a direct license with Orcrist. BioMS assigned all BioMS owned patents relating to HYC750 and transfered all HYC750 assets to Orcrist. Under the terms of the agreement, BioMS will receive certain milestone payments in addition to a royalty on net sales of products which otherwise would have infringed on patents related to the HYC750 technology.

BioMS also ceased all development activities with respect to BioCyDex. Future development or licensing activities will be the responsibility of BioCyDex.

Financial Results
The consolidated net loss for the year ended December 31, 2008 was $0.5 million or ($0.01) per share compared with a consolidated net loss of $47.2 million or ($0.56) per share for the previous year. The consolidated net income for the three months ended December 31, 2008 was $0.3 million or $0.01 per share compared with a net loss of ($11.7) million or ($0.13) per share for the previous year.

Revenue of $52.6 million was recorded for the year ended December 31, 2008 compared to $Nil for the year ended December 31, 2007. The revenue is the result of the amortization of the upfront payment and development milestone received from the Agreement with Lilly. Investment income earned on funds invested for the year ended December 31, 2008 increased to $2.4 million from $1.6 million for 2007 due to the increase in cash and cash equivalents as a result of the Agreement with Lilly. The increase was partially offset by a general reduction in interest rates experienced in the market. The investment income is earned from the short-term investment of cash reserves in low risk term deposits and bankers acceptance notes.

Total consolidated expenses for the year ended December 31, 2008 were $61.9 million compared with $48.0 million for 2007. Total consolidated expenses for the three months ended December 31, 2008 totaled $16.5 million as compared to $12.1 million in the same quarter the previous year.

Research and development expenses for the year ended December 31, 2008 totaled $46.5 million compared with $38.9 million in 2007. Research and development expenses were $13.9 million for the three months ended December 31, 2008 compared to $9.3 million for the same quarter the previous year. The increase in expenses was the net result of: achieving full enrolment of clinical sites and patients in the MAESTRO-03 trial; increased costs for the MAESTRO-02 trial as patients enter the trial; reduced costs of the MAESTRO-01 and MINDSET-01 trials as more patients complete these trials; a decrease in drug manufacturing expenses as the manufacture of validation batches is completed; a licensing bonus payment related to the Agreement with Lilly, and; additional expenses related to alliance management and support.

About BioMS Medical Corp.
BioMS Medical is a biotechnology company engaged in the development and commercialization of novel therapeutic technologies. BioMS Medical’s lead technology, dirucotide, is for the treatment of multiple sclerosis and is being evaluated in two pivotal phase III clinical trials for Secondary Progressive MS patients, MAESTRO-01 in Canada and Europe and MAESTRO-03 in the United States. In December 2007, BioMS entered into a licensing and development agreement granting Eli Lilly and Company exclusive worldwide rights to dirucotide in exchange for an $87 million upfront payment, milestone payments and escalating royalties on sales. For further information please visit our website at http://www.biomsmedical.com