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Brain cancer drug in 2nd phase of tests
Birmingham´s TransMolecular Inc. said Wednesday it has launched a Phase II study on multiple doses of its experimental drug to treat a deadly form of brain cancer.
The drug - known as 131I-TM-601 - will be administered to 66 glioma patients within a year, TransMolecular Finance Director Matt D. Carrington said. About half of the patients will receive a dose a week for three weeks and the others will receive six weekly doses.
Glioma is a cancer of the brain that begins in glial cells, which surround and support nerve cells.
The first phase study on TM-601, as it´s called for short, involved single doses of the radiopharmaceutical anti-cancer drug containing chlorotoxin, a synthetic version of a substance derived from scorpion venom. TM-601 delivers chlorotoxin to the tumor, where the radioactive material attacks and kills tumor cells with minimum damage to normal cells.
UAB participating:
Expanding the clinical trials follows strong results from an initial study that showed the drug is safe for patients and that they can tolerate it, said acting Chief Executive Lyle A. Hohnke. The drug "could fill a need for safe, more effective treatment for those who suffer from this devastating disease," added Hohnke, a partner at Tullis-Dickerson & Co. Inc., an investor in the neuroscience biotechnology company.
Phase II is an open label study, meaning TransMolecular officials can view study results on the patients as data comes in from the clinical sites, said Carrington.
The University of Alabama at Birmingham´s oncology unit (MAX) is among the six current sites participating. The company plans to add a minimum of six more study centers.
Monitoring patients:
Carrington said patients will be enrolled over the next nine to 12 months. Plans are to follow their progress up to 12 months after their last dosages to evaluate safety, time to disease progression and survival rates.
"We´re observing the doses for safety reasons," Carrington said, "so we´ve kind of got a dose range to make sure there are no safety issues."
The drug will be administered through a catherer neurosurgeons will place within a cavity when they remove a portion of a tumor. After surgery, Carrington said, "the patient will go home for several days and then come back and our drug will be administered through the catherer into the cavity."
In the first of two Phase II parts, four groups of three patients each will receive escalating dose treatments until a maximum practical dose is reached or until researchers determine a maximum tolerated dose.
After that, Carrington said, the dosage will be expanded in the second sequence, which will involve 54 patients divided into two groups receiving either three or six weekly doses.
Thursday, June 02, 2005
CHARLES R. McCAULEY
The Birmingham News