GTC Biotherapeutics (fka GTCB)

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Merrimack Pharmaceuticals Initiates Enrollment in a Phase 2 Pilot Study of MM-093 in Patients with Autoimmune Uveitis

[The start of this trial was noted previously on this board (#msg-17784735) but it hadn’t been formally announced by Merrimack.]

http://biz.yahoo.com/prnews/070404/new007.html?.v=1

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Wednesday April 4, 8:30 am ET

CAMBRIDGE, Mass., April 4 /PRNewswire/ -- Merrimack Pharmaceuticals, Inc. today announced the initiation of a Phase 2 pilot study to determine the safety and efficacy of its immunomodulator MM-093 in patients suffering from autoimmune uveitis. MM-093, Merrimack's lead product, is a recombinant version of human alpha-fetoprotein (AFP).

Uveitis is an autoimmune inflammatory disease that produces eye pain, light sensitivity, and diminished vision, including blindness. Sarcoid and birdshot are rare uveitis subtypes, which could be classified as Orphan indications due to their small patient size.

The randomized, double-blind, placebo-controlled, Phase 2 study is being conducted at the Massachusetts Eye Research and Surgery Institute in Cambridge, Massachusetts under the direction of C. Stephen Foster, MD, a world-renowned expert in uveitis and Clinical Professor of Ophthalmology at Harvard Medical School. The objective of this study is to examine the safety and efficacy of MM-093 in approximately 20 patients with either sarcoid or birdshot uveitis. Patients will discontinue their current therapy for uveitis and be treated with MM-093 or placebo for up to 36 weeks. This study is a flare design where the number of patients whose uveitis relapses after discontinuing the use of their background therapy will be assessed at the end of the study. Patients who experience a flare of uveitis during the study will be retreated with their original therapy.

"Uveitis remains a significant cause of blindness in developed countries, and immunosuppressive chemotherapy and systemic corticosteroid therapy continue to form the backbone for ocular immunologists trying to preserve the vision of patients who are going blind from uveitis. However, such therapies can cause significant, potentially serious side effects," said Dr. Foster, principal investigator for the study. "MM-093 is a particularly promising immunomodulatory molecule from a risk/benefit standpoint, with very little likelihood of exposing patients to the side effects of corticosteroid or of immunosuppressive therapy."

Merrimack controls a strong intellectual property estate around MM-093 including fourteen issued patents and a number of pending applications, both in the U.S. and internationally, which cover composition of matter, production methods and therapeutic uses of the drug.

Merrimack Pharmaceuticals, Inc. is a biotechnology company focused on the discovery and development of novel treatments for diseases in the areas of autoimmune disease and cancer. Its lead compound, MM-093, is currently in clinical development to treat patients with rheumatoid arthritis, psoriasis or with autoimmune uveitis. MM-093 is an investigational drug and has not been approved by the U.S. Food and Drug Administration or any international regulatory agency. The company's proprietary Network Biology discovery platform, developed with the help of leading scientists from MIT and Harvard, enables the high throughput profiling of protein networks as a basis for improved validation, lead identification and speed in the development of innovative, effective and safe therapeutics. Merrimack is a privately held company based in Cambridge, Massachusetts. For additional information, please visit http://www.merrimackpharma.com.
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