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Drug to Minimize Nerve Damage (Neuropathy) from Taxol, Cisplatin Now in Trials

April 6 2000 - A troublesome side effect of some chemotherapies that are quite effective for advanced prostate cancer is neuropathy, or numbness. Mostly this affects hands and feet.

Neuropathy is a real nuisance as a dose-limiting toxicity. Initially felt as tingling sensation then as numbness, damage to nerves calls a halt to the treatment, even if the treatment is holding the cancer in check. If neuropathy is missed or ignored, patients may end up unable use fingers or having difficulty balancing and walking, unable to feel their feet. Nerve damage can also affect hearing and cause deafness.

Now a computer-engineered drug designed to help minimize neuropathy is being tested in clinicaltrials. BioNumerik Pharmaceuticals, Inc. presented data about this drug at the Annual Meeting of the American Association of Cancer Research (AACR) in San Francisco.

BioNumerik says that BNP7787 is a chemoprotectant "to prevent the common and often severe toxicities associated with platinum and taxane administration without inhibiting the antitumor activity of these agents."

Data from animal and laboratory studies was presented at AACR to show that BNP7787 does protect against platinum and taxane induced toxicities. The researchers say that they have established that BNP7787 and its metabolites "selectively conjugate with monohydrated platinum species which is thought to be the overriding mechanism for platinum toxicity."

In an ongoing Phase 1 study of BNP7787 at doses of 41g/m2 in Europe and 27.6g/m2 in the U.S., "only 3 out of 46 patients treated with standard doses of cisplatin +/- paclitaxel" experienced clinically significant grade 2 nerve damage (neurotoxicity). "This number is substantially less than the expected number of patients with grade 2 nerve damage," the company says, "based on historical studies of patients who were treated with the same chemotherapy drugs without BNP7787."

These results also appear to indicate that while the toxic side effects of cisplatin and paclitaxel are alleviated , the tumor specific programmed cell death (apoptosis) associated with this therapy remains intact.

The Company plans to initiate Phase 3 trials later this year for BNP7787 which has been granted U.S. Food and Drug Administration "Fast Track" designation for the prevention or reduction of the nerve damage associated with paclitaxel.

BioNumerik Pharmaceuticals, headquartered in San Antonio, Texas, specializins in "mechanism based" drug discovery.

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The Neuropathy Trust: Peripheral Nerve, a Closer Look Supporting people affected by the neurological condition - PERIPHERAL NEUROPATHY

An interesting account of neuropathy and why it is a typical dose-limiting toxicity of chemotherapy came up during hearings about re-use of Thalidomide: Thalidomide Neuropathy National Institutes of Health (NIH) Thalidomide Meeting 9/9/97

Herceptin Plus Taxol Looks promising, Trials Underway (Medical Pike, November 3 1999)

Taxol Combines With Drug from Brazilian Tree, Trial Planned (Medical Pike, November 1999)
Neuropathy as a side-effect of Thalidomide:
Thalidomide in Trials for Treatment of Prostate and Other Cancers

Thalidomide: From Dangerous Sedative to Anti-Cancer Drug


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