Another set of positive trial results. These look good to me. Any other opinions?
PLYMOUTH MEETING, Pa., March 18 /PRNewswire/ -- Magainin Pharmaceuticals
Inc. (NASDAQ:MAGN) today announced the successful results of its second,
pivotal Phase III clinical trial of Cytolex(TM) 1% topical antibiotic cream
(MSI-78) for the treatment of infection in diabetic foot ulcers. The
Company's analysis of the study showed statistical equivalence between MSI-78
and orally administered ofloxacin, with respect to the study's primary
endpoint of clinical response of infection at day 10 of treatment, and at
subsequent time points through day 28, and at follow-up. Floxin(R)
(ofloxacin) is a quinolone antibiotic indicated for the treatment of skin and
soft tissue infections. The study enrolled 342 patients.
As a secondary endpoint, MSI-78 and ofloxacin were comparable with respect
to overall assessments of microbiological improvement.
Preliminary analyses of adverse events in the study suggest a favorable
profile for MSI-78. Both drugs were well tolerated, however, treatment with
ofloxacin was associated with a significant excess of adverse events related
to the central nervous system, particularly as it relates to insomnia.
Magainin previously announced successful results of its initial, pivotal
trial of MSI-78 for the treatment of infection in diabetic foot ulcers in
September 1996. In February 1997, Magainin and SmithKline Beecham ("SB")
entered into a development, supply and distribution agreement pursuant to
which SB will market and sell MSI-78 in North America.
"This is a strong confirmation of the efficacy and safety results observed
in our initial pivotal study," said Jay Moorin, Chairman, President and Chief
Executive Officer of Magainin. "Our two studies represent, to our knowledge,
the largest database of clinical data for infected diabetic foot ulcers that
has been assembled. If approved for marketing by the U.S. Food and Drug
Administration ("FDA"), we expect that MSI-78 will be the first antibiotic
specifically labeled for the treatment of infection in diabetic foot ulcers,
and will provide physicians an important alternative to systemic therapy. Our
efforts continue on the completion of the manufacturing and other activities
that will be required for the submission of a New Drug Application for MSI-78
to the FDA."
"This positive trial further demonstrates the promise of MSI-78 in the
treatment of diabetic foot infections," said Dr. Jerry Karabelas, Executive
Vice President, SmithKline Beecham Pharmaceuticals. "We are committed to
collaborating with Magainin to make this innovative treatment option available
to physicians and their patients."
Magainin Pharmaceuticals Inc. is a biopharmaceutical company engaged in
the development of breakthrough medicines for serious diseases. The Company
isolates and develops compounds from the host-defense systems of animals and
uses molecular techniques such as gene identification to understand the
pathogenesis of disease. The Company's development efforts are focused on
anti-infectives, oncology and, pulmonary and allergic disorders.
This announcement contains certain forward looking statements that are
subject to risks and uncertainties. Such statements reflect management's
current views and are based on certain assumptions. Actual results could
differ materially from those currently anticipated as a result of a number of
factors, including, but not limited to, the risks and uncertainties discussed
under "Management's Discussion and Analysis of Financial Condition and Results
of Operations" in the Company's Quarterly Report on Form 10-Q for the quarter
ended September 30, 1996 as filed with the Securities and Exchange Commission
and the following sections of Item 1 of the Company's Annual Report on Form
10-K for the fiscal year ended December 31, 1995 as filed with the Securities
and Exchange Commission: "Synthesis Technology; Manufacturing;" "Product
Development and Research Programs;" "Government Regulation;" "Additional
Regulatory Issues;" "Patents and Proprietary Rights; Licensed Technology;"
"Competition" and "Product Liability and Insurance." The Company disclaims
any intent or obligation to update these forward looking statements.
Upon applicable regulatory approvals, MSI-78 is expected to be marketed
under the trade name Cytolex.
SOURCE Magainin Pharmaceuticals
-0- 3/18/97
/CONTACT: Michael R. Dougherty, Chief Financial Officer of Magainin |
