Tuesday, June 16, 2009

Dirucotide Clinical trial. Potential Drug for Secondary Progressive MS

I alwys try to post any information that I either come across or is sent to me regarding any clinical trials related to potential new or existing MS drugs.

I recently received an email regarding a Phase III trial for Dirucotide.

For those who just want the highlights here they are (Remember the opinions are not my own, but those of BioMS www.biomsmedical.com and Eli Lilly):

1) This treatment actually delays disease progression (the first MS treatment to do so), and doesn't just treat symptoms.
2) It's the only treatment in trials specifically designed for SPMS patients - an entire subgroup of MS patients with NO treatment available to them (besides Novantrone, which elicits awful side effects and is a cancer drug.)
3) Dirucotide has no known side effects.

Frequently Asked Questions About
Dirucotide and the MAESTRO-03 Clinical Trial

What is MAESTRO-03?

MAESTRO-03 is a double-blind, placebo-controlled Phase III clinical study that is evaluating the efficacy and safety of a proprietary drug called dirucotide. Researchers hope that dirucotide could become a leading safe and effective treatment in delaying disease progression for secondary progressive multiple sclerosis (SPMS). MAESTRO-03 is evaluating the only novel agent in Phase III clinical trials anywhere in the world for SPMS.

What is SPMS?

SPMS is an advanced and especially debilitating form of MS characterized by an irreversible decline in both neurological and physical function. Of the estimated 400,000 Americans and 2.5 million people worldwide who have MS, approximately 40 – 45 percent have SPMS.

While there are numerous treatments available for MS, there currently is a lack of safe, convenient and effective drugs that are specifically indicated for the treatment of SPMS.

What is dirucotide and why is it viewed as a potential treatment for SPMS?

Dirucotide is a synthetic replica of the molecular site on Myelin Basic Protein (MBP) that is a dominant site of immune attack in MS patients with immune response genes DR2 or DR4, which are found in 65 to 75 percent of all MS patients. Periodic high dose intravenous administration of this synthetic peptide is believed to induce and maintain immune system tolerance to this normal nerve component. It is not expected to affect immune system reactions to substances unrelated to the injected peptide.

How has dirucotide performed in previous clinical trials?

In a study published in the European Journal of Neurology in August 2006, dirucotide showed a five-year delay in median time to disease progression in a subgroup of MS patients who have immune response genes HLA-DR2 and/or HLA-DR4. Dirucotide has been administered to MS patients in clinical trials for more than 14 years with more than 1000 combined patient years of treatment experience. Ongoing follow-up confirms that the side-effect profile is favorable.

How will MAESTRO-03 evaluate dirucotide’s impact on disease progression?

Patients enrolled in MAESTRO-03 are administered either dirucotide or placebo intravenously every six months for a period of two years.

Efficacy will be 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). The EDSS is a method for measuring different levels and types of disability caused by MS. The entire study period, including pre-treatment and possible follow-up visits, could be up to 44 months.

How many patients are participating in MAESTRO-03?

The study has enrolled approximately 510 male or female patients, ages 18-65, at more than 65 sites throughout the United States. Patients have a documented history of SPMS and have tested positive for immune response genes HLA DR2 or DR4. In addition, subjects have had an absence of relapse in the three months prior to their baseline visit, and have an EDSS score in the range of 3.0 - 6.5.

Are there any other studies underway for dirucotide?

An additional Phase III clinical trial evaluating dirucotide as a potential new treatment for SPMS – MAESTRO-01 – is currently underway and fully enrolled with 611 patients in Canada and Europe.

Who is developing dirucotide?

Dirucotide was discovered by two research scientists at the University of Alberta in Edmonton, Canada. The drug has been exclusively licensed by BioMS Medical Corp., a Canadian-based biotechnology company listed on the Toronto Stock Exchange (TSX: MS).

On December 17, 2007, Eli Lilly and Company (NYSE:LLY) and BioMS Medical announced a licensing and development agreement between the two companies granting Lilly exclusive worldwide rights to dirucotide. Under the terms of the agreement Lilly and BioMS Medical will collaborate on the development of dirucotide and will also share in certain development costs with Lilly being responsible for future R&D, manufacturing and marketing activities. BioMS Medical continues to oversee the current clinical trials for dirucotide.

I'll post more information as I am made aware. :)

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