суббота, 28 мая 2011 г.

Merrimack Pharmaceuticals Initiates Enrollment In A Phase 2 Study Of MM-093 In Patients With Rheumatoid Arthritis

Merrimack Pharmaceuticals,
Inc. today announced the initiation of a Phase 2 study to evaluate the
safety and efficacy of its immunomodulator, MM-093, in patients suffering
from rheumatoid arthritis (RA). MM-093, Merrimack's lead product, is a
recombinant version of human alpha-fetoprotein (AFP).



The randomized, double-blind, placebo-controlled, Phase 2 study is
being conducted at 15 centers throughout the United States. The objective
of this study is to examine the safety and efficacy of MM-093 in
approximately 90-100 patients with moderate to severe, active RA despite
stable doses of methotrexate. Each patient will receive 60mg of MM-093 per
week or placebo for 12 weeks and will then be followed for an additional 4
weeks. In addition to evaluating the safety of MM-093, patients will be
assessed for changes in the signs and symptoms of their disease using
standard clinical outcome measurements for RA, such as ACR20 and DAS28
scores.



"MM-093 has been well-tolerated in studies to date and we believe its
unique profile will differentiate it from other therapies and allow it to
make a significant difference in the highly competitive RA market," said
Robert Mulroy, President & CEO of Merrimack. "Despite the advances that
have been made in treating the signs and symptoms of RA, there remains a
significant need for safer, more effective therapies."



This study follows an exploratory Phase 2, dose-ranging study of MM-093
in patients with RA completed in 2006. Merrimack is presenting results from
that trial at the European League Against Rheumatism (EULAR) conference in
Barcelona this spring. MM-093 has also completed both a Phase 1 study in
healthy volunteers and a pilot study in RA patients that demonstrated it
was well tolerated and bioactive in addressing the signs and symptoms of
RA.



Merrimack controls a strong intellectual property estate around MM-093
including 14 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 merrimackpharma.


Merrimack Pharmaceuticals, Inc.

merrimackpharma

Комментариев нет:

Отправить комментарий