Excellent, excellent news! Compare to any other treatment for brain cancer. Thank you Melanie Trottman, Dow Jones News Service and the Wall Street Journal interactive edition.
<August 27, 1998
After Face Lift, Techniclone Nears Phase II Cancer Trials
By MELANIE TROTTMAN
Dow Jones Newswires
NEW YORK -- Healing from a much-needed face lift, Techniclone Corp. (TCLN) said interim results of a Phase I study of its tumor necrosis therapy, or TNT, should allow it to file with the Food and Drug Administration soon for Phase II testing.
"We believe TNT has both therapeutic and broad market application," President and Chief Executive Larry Bymaster told Dow Jones. "As a company, we're committed to moving this forward in clinical trials."
The company, which in March underwent a restructuring program to become an integrated biopharmaceutical firm, said its Phase I TNT clinical trial for treating brain cancer showed the drug is safe. Although Phase I studies are designed only to demonstrate drug safety, Techniclone said the interim results also showed TNT stabilizes brain tumor progression.
"In these patients, being able to stabilize this disease is the best that can be hoped for," said Dr. Sunil Patel, assistant professor of neurological surgery at the Medical University of South Carolina, where the studies are being conducted.
The form of brain cancer Techniclone is treating is known as malignant glioma, a rapidly progressive disease with a median survival of nine to 12 months from diagnosis, Patel said. Between 10,000 and 15,000 new cases of the disease are diagnosed annually in the U.S., he said.
Of the six patients whose interim data were analyzed, five stabilized the progression of their cancer and three had primary tumors that shrank at 60 days. Patients received only about one-third to one-half of what the company considers to be an effective dose to treat the disease. A Phase II study would assess the effects of a higher dosage.
Upon completion of the Phase I study, expected by the end of September, 12 patients will have been treated.
The standard treatment for this kind of brain tumor has been surgery and radiation, Patel said. But getting radiation inside a tumor without killing healthy cells isn't achievable with conventional external radiation, said Techniclone Vice President of Clinical and Regulatory Affairs Jamie Oliver.
What makes TNT unique from other treatments is that it appears to bind only to the tumor, killing all of the tumor that is reached by radiation from the inside out, Oliver said.
With conventional therapy, brain tumors always recur, but it is too early to determine what the long-term effect of TNT would have on this population, Oliver added.
TNT is administered by inserting a catheter into the skull so the catheter tip is in the center of the tumor. The catheter remains in place for 24 hours while the drug is infused, and is removed in the same way as an IV, professor Patel said.
Techniclone Chief Executive Bymaster said the results of the study tie nicely into the company's recent efforts to reshift its focus.
"It's all part of the effort to better take us down the commercial pipeline of our products," he said. Clinical trials are the first step of that process, he said.
Techniclone's board began to decide last year that the company needed revamping, Bymaster said. There was concern about the ability of the management, particularly former CEO Lon Stone, to take the company to the next step of becoming an integrated biopharmaceutical firm. Also, the company had "very little presence" on Wall Street, Bymaster said.
In March, Techniclone announced a restructuring plan. It has since undergone some sweeping changes, including an expansion of the board, a series of senior management changes, a work-force reduction, the retention of an investment banker and a new round of financing.
The refocus also meant Techniclone, which had been manufacturing antibodies and licensing them out, would start to internalize the clinical development of its technology.
The company hired Oliver as vice president of clinical and regulatory affairs in August 1997 to establish a clinical trials program. In May, it appointed Bymaster president and chief executive.
Since Oliver's appointment, the company has bought back a license to Oncolym - a technology it developed - and reinstituted a revised Phase II/III clinical program of the antibody in April. Oncolym is a radiolabeled murine monoclonal antibody being studied for the treatment of intermediate- and high-grade relapsed or refractory B-cell non-Hodgkin's lymphoma.
Oncolym could become Techniclone's first product to market; the company expects to make a biologics license application to the FDA in 1999. Because cancer drugs receive fast-track status from the FDA, Oncolym would probably be on the market in 2000 if it gained approval.
Besides TNT and Oncolym, Techniclone is developing additional product candidates in preclinical stages for solid tumor therapy. The collateral targeting agents being studied are Vascular Targeting Agents, or VTAs, and Vasopermeation Enhancement Agents, or VEAs.
Techniclone has about $5 million or $6 million in the bank and a credit line of $20 million. The company's monthly spending is just under $1 million.
For the fiscal year ended April 30, the company posted a loss of $11.8 million, or 49 cents a share, on revenue of $534,313.
Bymaster said Techniclone is becoming more visible and aggressive in its licensing and is in discussions with potential companies in this area.
"Strategically," he said, "our entrance to the market will be through partners.">
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