Biotech group GTX Inc. said early Friday that data from a late-stage clinical trial for its proposed treatment Acapodene show the drug can mitigate two serious side effects associated with the prostate cancer therapy ADT.
GTX said the results were from interim analyses of an ongoing Phase III clinical study of 1,400 men with advanced prostate cancer who were on androgen deprivation therapy, or ADT, a drug combination used to keep prostate cancer tumors in remission. Patients on ADT generally stay on the therapy, which blocks the production of testosterone, for life.
However, one common side effect of ADT therapy is a decrease in bone density, which can lead to bone fractures. Another side effect can be an increase of certain fats in the blood, such as cholesterol and triglycerides, which can lead to cardiovascular disease and even diabetes.
The Phase III data unveiled Friday showed that Acapodene, also known as toremifene, was effective in both increasing bone density and improving levels of cholesterol and triglycerides.
"In previous studies, other agents -- including bisphosphonates -- have also been associated with significant improvements in bone mineral density in men receiving androgen deprivation therapy for prostate cancer," said Dr. Matthew Smith, an oncologist at the Massachusetts General Hospital Cancer Center who authored Friday's presentation, in a statement. See more health-care coverage.
"However, these results suggest that toremifene has the potential not only to reduce the risk of fractures in men with advanced prostate cancer, but also to improve lipid levels, addressing another significant side effect of the standard treatment for this disease," Smith added.
Examples of bisphosphonate drugs include Merck's Fosamax, Novartis' Zometa, Roche's Boniva, and Procter & Gamble and Sanofi-Aventis' Actonel, according to WedMD.
Smith presented the results at the American Society for Clinical Oncology's annual prostate cancer symposium, currently being held in Orlando, Fla.
In an interview with MarketWatch, Smith said the results indicate Acapodene could improve the long-term health and quality of life of ADT patients by making them less prone to bone fractures and cardiovascular disease as they age. He noted that because ADT blocks the production of testosterone, which feeds prostate cancer tumors, men often quickly become obese, a condition that predisposes them to diabetes.
Currently, there are about 1 million men on ADT therapy, with an additional 100,000 put on it every year, according to analysts.
Hopes grow for swing to profitability
GTX Chief Executive Officer Dr. Mitchell Steiner told MarketWatch the company hopes to have final results from the study during the fourth quarter of 2007 or early 2008. It was "shooting for" filing for U.S. regulatory approval during the first half of 2008, he said.
GTX is pursuing having Acapodene approved for the prevention of osteoporosis and other side effects in ADT patients.
The company is also conducting Phase III trials for the drug in the prevention of prostate cancer in men who already have precancerous lesions. Final results from the trials are expected during the first quarter of 2008. Steiner said if the results are positive, the company would file for U.S. approval for that indication in the latter half of 2008.
In a recent note, Cowen & Co. analysts said that each indication represents a potential sales opportunity in excess of $500 million.
Founded in 1997, GTX has yet to turn a profit. However, Steiner said that approval for Acapodene for either indication "would put us on solid footing to profitability."
GTX already markets toremifene under the brand name Fareston for the treatment of advanced breast cancer. According to a note by analysts at Leerink Swan & Co., the patent on toremifene for use in breast cancer is slated to run out in 2009. However, the patents for use in the prevention of prostate cancer and with ADT do not expire until 2019 and 2023, respectively.
he company is also developing a drug called Ostarine to treat the muscle wasting associated with kidney disease and cancer. The drug is currently in Phase II clinical trials.
GTX is up 3 cents per share at $20.80 in light trading this afternoon.
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