By Lisa Seachrist
Magainin Pharmaceuticals Inc. said results from a second pivotal clinical trial of its lead topical compound, Cytolex, showed the drug was as effective as standard oral antibiotic therapy.
The data confirmed findings of a previous Phase III clinical study pitting Cytolex against oral ofloxacin — the most widely used antibiotic for treatment of infections in diabetic foot ulcers. Magainin intends to use the results of the two studies to file a new drug application (NDA) with the FDA during the fourth quarter of 1997.
"We are very excited about these results," said Michael Dougherty, chief financial officer for the Plymouth Meeting, Pa., company. "Any time you get a statistically significant result for a pivotal trial it is a milestone, and it is even more so when you get that result in a second pivotal study."
Diabetic foot ulcers afflict a large proportion of the two to five percent of the U.S. population that is diabetic. The standard of care for battling infections associated with the ulcers is oral ofloxacin, which is marketed under the brand name Floxin by Ortho-McNeil Pharmaceuticals, of Raritan, N.J. Ofloxacin is between 70 and 90 percent effective in combating the infections.
Cytolex is an antibiotic cream whose active compound, MSI-78, is a synthetic analogue of peptides that protect the skin of the African clawed frog from infection.
This most recent Phase III trial involved 342 patients with diabetic foot ulcers and compared Cytolex to ofloxacin. The primary endpoint was statistically equivalent evidence of clinical response at 10 days of treatment and at subsequent time points between the two compounds.
At all time points, Cytolex performed as well as ofloxacin therapy.
"These are extremely robust results," said Paul Litka, senior vice president of clinical research and regulatory affairs for Magainin. "At each point, Cytolex proved to be equivalent to the standard therapy. We are confident of the reliability of this data."
Litka also noted that while both Cytolex and ofloxacin were well-tolerated, ofloxacin was associated with insomnia. The company intends to present full microbiology and side effect data during several scientific meetings over the next few months.
Tim Wilson, an analyst with UBS Securities in New York, pointed out that these clinical trial data were extremely good news for the company. "What more can you ask for?" he said. "Cytolex was highly effective and equivalent to Floxin at every time point. I have no doubt that SmithKline Beecham will take the drug forward."
In February, Magainin signed an agreement worth up to $32.5 million with London-based SmithKline for the North American marketing rights. SmithKline paid $5 million up front and agreed to milestone payments. Wilson suspects that these clinical trial results will garner Magainin another $5 million as a milestone, but neither company will disclose the terms of these payments.
Magainin's stock (NASDAQ:MAGN) closed Tuesday at $9.25, down $0.375. *