Guilford Pharmaceuticals Inc. has released additional positive dataon a Phase III trial of its lead product for brain cancer showing that itreduces local regional recurrence of tumors, the company's presidentand CEO said Friday.
The study, published in Saturday's The Lancet, contained furtherinformation on the 222-patient trial that originally was presented lastMay at the American Society of Clinical Oncology meeting in Dallas.
The study showed six-month survival rates increased from 47 percentwith placebo to 60 percent for those treated with Gliadel, a smallwafer made of a biodegradable polymer that contains the approveddrug carmustine. In patients with glioblastoma multiforme, six-monthsurvival increased from 36 percent for those who received a placebowafer to 56 percent for those given Gliadel.
Up to eight of the wafers are implanted directly into the cavitycreated when brain cancer is removed. That method allows for higherconcentrations and extended delivery of the drug to the tumor site.
The Phase III trial was a double-blind and placebo-controlled studyat 27 centers, most of them in the U.S. It included 145 patients withglioblastoma multiforme, the most common and rapidly fatal type ofbrain cancer, and 77 patients with other types of malignant braintumors. Those in the trial had recurrence of disease after surgery andradiation therapy.
Median survival improved from 23 weeks with placebo to 31 weekswith Gliadel, and from 20 to 28 weeks in those with glioblastomamultiforme.
Craig Smith, president and CEO of Baltimore-based Guilford, saidthe company plans to submit a treatment investigational new drug(IND) application in the third quarter, and a new drug application(NDA) in the fourth quarter this year.
Guilford has completed construction of its manufacturing facility forGliadel, and Smith said product will be ready when approval isgranted. Guilford still must make submissions to the FDA regardingmanufacturing as part of the treatment IND, which would allow thecompany to make the product available and charge for it prior toformal approval.
Each year in the U.S. about 20,000 people undergo surgery forremoval of malignant brain cancer. Smith said Gliadel could be usedat the time of operation in about all cases.
"This is not a cure for brain cancer," Smith said. "However, we thinkit is an important advance." He said the company is incorporatingmore potent chemotherapeutic agents into the polymer.
"This is the first demonstration that you can use this approach toprevent local regional recurrence of a tumor," Smith said. "We thinkthis approach may be applicable to other types of tumors as well."
Guilford has all rights to the product, and is "actively discussingpotential partnerships with several companies. If we're unable toobtain favorable terms, we would certainly consider the possibility,because of the small number of physicians who operate on braincancer, of taking on this [marketing] responsibility ourselves," Smithsaid.
Guilford's stock (NASDAQ:GLFD) closed at $6 per share Friday, up38 cents. n
-- Jim Shrine
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