Genetic wins initial OK on 3 treatments U.S. panel backs anti-cancer efforts

September 11, 1993|By Kim Clark | Kim Clark,Staff Writer

Genetic Therapy Inc. said yesterday that it had won initial federal approval for clinical trials of three experimental anti-cancer treatments, including a second round of tests of genetically altered mouse cells used to fight brain tumors.

The Recombinant DNA Advisory Committee of the National Institutes of Health said the Gaithersburg-based biotechnology company could now test its brain cancer therapy on children.

The committee, which rules on all genetic testing, said the company also could start trials injecting genetically altered viruses into patients undergoing bone marrow transplants for the treatment of breast cancer.

And the panel approved the company's use of Interleukin-2, an immune cell growth factor, in the treatment of a deadly form of skin cancer.

The company must receive approval from the U.S. Food and Drug Administration before beginning any of the trials.

The next round of brain cancer trials would be conducted on 10 children and directed by researchers at St. Jude Children's Research Hospital in Memphis. The breast cancer trials would be directed by the NIH, while the skin cancer tests would be directed by researchers at the University of California at Los Angeles.

Jeffrey Swarz, an industry analyst for First Boston in New York, said the committee approvals were simply the first, and some of the easiest, steps on the path to making the treatments a commercial success.

Genetic Therapy would need to conduct even more tests and win further federal approval before it could begin selling its treatments.

But, Mr. Swarz said, the company was a leader in the biotechnology field and was far ahead of competitors in developing a treatment for brain cancer.

M. James Barrett, chairman of the company, said yesterday that he hoped to begin the final round of brain cancer therapy tests by next year.

Yesterday's news capped a good week for the company, which saw its stock rise from $15.25 a share at the end of Tuesday to close at $21 yesterday, up $1.25.

On Wednesday, Genetic Therapy announced its first trials of the brain cancer treatment had shown some signs of success, pushing the stock up $2 a share to $17.25.

The company announced at a conference in Norway that tumors in three of eight patients shrank, and tumors in two others changed consistency. A change in consistency was viewed by researchers as a positive reaction and, none of the patients showed ill effects from the treatment.

Although the therapy is uniquely designed for the brain -- the only area in the body without dividing cells -- the company said it is experimenting with a similar therapy for other kinds of cancer.

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