West Coast Editor
Pharmacyclics Inc. is planning a new Phase III trial of its cancer cell disrupter, Xcytrin, in the sector of patients for whom the drug seems to do the most good those with lung cancer that has metastasized to the brain.
“We’re just getting the information out there [on the new trial],” said Jim Weiss, spokesman for Sunnyvale, Calif.-based Pharmacyclics. Details, such as how many patients will be tested, are “still being worked out,” he added.
“There was the potential after meeting with the FDA and discussing the data [from the original trial] that we might even file on the data we had,” Weiss told BioWorld Today, but the outcome of the FDA conference suggested otherwise.
In January, the company explained that, although Xcytrin (motexafin gadolinium) had missed its co-primary endpoints in earlier Phase III trials, the drug showed promise in the 251 patients with lung cancer (the most common cause of brain metastasis), as compared to 75 with breast cancer and 75 with other types of tumor. (See BioWorld Today, Jan. 9, 2002.)
The study was designed to compare the safety and efficacy of standard whole-brain radiation therapy to standard WBRT plus Xcytrin. Across the whole patient population, primary endpoints were missed, but the study found significant improvement in time to neurologic progression and in time to neurocognitive progression in lung cancer patients given Xcytrin.
Pharmacyclics outlined results from the Phase III trial at the JP Morgan H&Q Healthcare Conference in January, and will offer full results at the annual meeting of the American Society of Clinical Oncology in May.
Xcytrin, one of a new class of drugs called texaphyrins, works by selectively accumulating in cancer cells and shaking up their metabolism by blocking the flow of energy, thus preventing them from repairing damage caused by the effects of radiation and chemotherapy.
The company has finished Phase I and Phase II trials with Xcytrin for glioblastoma multiforme (primary brain tumors), and plans more trials for that indication. A Phase I trial is ongoing to investigate the drug’s potential for enhancing chemotherapy in advanced cancer.
Also under way are studies being done under a Cooperative Research and Development Agreement with the National Cancer Institute for the treatment of non-small-cell lung cancer, glioblastoma multiforme, childhood gliomas (life-threatening brain tumors in children) and pancreatic cancer.
More about the new Phase III trial is expected when the company finalizes protocol, Weiss said.
“I think we’ll be updating people in some other form soon, once the FDA gives its blessing,” he said.
Pharmacyclics’ stock (NASDAQ:PCYC) closed Tuesday at $7.10, down 17 cents.