Alfacell Corp. said Tuesday that it was given approval to start aPhase III trial of Onconase, which is being tested in combinationwith tamoxifen for pancreatic cancer.
Alfacell, of Bloomfield, N.J., plans a 200-patient randomized trialcomparing that combination against another chemotherapy regimen.The endpoint in the 10- to 16-center trial will be survival, GailFraser, the company's chief financial officer, told BioWorld.
Fraser said Onconase, isolated and purified by the company in 1988,is recognized as the smallest known member of the super-family ofpancreatic ribonucleases (RNases). She said it is the only RNase inclinical trials.
Alfacell's stock (OTC:ACEL) was up 33 percent, or $1 per shareTuesday, closing at $4 per share, Fraser said.
"This is a whole new way to treat cancer," she said. "You'redegrading ribosomal RNA in the cancer cell, which inhibits proteinsynthesis, which in turn may eventually lead to cell death.
"What's interesting about this drug is it's very well tolerated forbeing a chemotherapeutic. Some of our patients have been treated ona weekly basis for as long as three years. The biggest benefit isthere's no myelosuppression; it doesn't knock out your immunesystem. Our patients don't even lose their hair."
The most prevalent side effect involves build-up in the kidney, shesaid, but only 10 of 245 patients have been terminated from studiesbecause of renal toxicities.
Treatment involves weekly intravenous infusions. Fraser saidAlfacell is starting immediately in getting various institutions toapprove the protocol, and that the first patient could be treated in twoto three months.
The company also said it is looking for a marketing partner forOnconase, which is being tested in other cancer indications, and isbeing studied in collaboration with the National Institutes of Healthagainst HIV.
Fraser said, of the 245 patients treated to date, only 51 have been incombination with tamoxifen for pancreatic cancer. In other studiesOnconase has been used as a single agent primarily against non-small cell lung, mesothelioma (lining of the lungs), colorectal andmetastatic breast cancers.
She said in vitro tests of Onconase showed it inhibited HIV by 99percent.
"This is phenomenal," Fraser said of the drug's progress. "Themeeting down at the FDA was excellent. We showed them the[Phase II] data, and they're trying their best to help us design a goodPhase III study. It's like they want to see something approved."n
-- Jim Shrine
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