Investigative cancer treatment undergoes two phase I trials.

2003 OCT 2 - (NewsRx.com & NewsRx.net) -- Pharmacyclics, Inc., (PCYC) has opened two new phase I trials of its investigative drug Xcytrin (motexafin gadolinium) Injection in combination with Taxotere (docetaxel) for the treatment of advanced solid tumors.

These studies are based upon promising results of this combination therapy in animal models of cancer where the two drugs were shown to have a synergistic anticancer effect.

"Preclinical animal model studies have provided evidence that Xcytrin improves the anticancer effects of several commonly used chemotherapy drugs," said Nithya Ramnath, MD, principal investigator at Roswell Park Cancer Institute in Buffalo, New York.

"These clinical studies are designed to evaluate the safety and benefit of Xcytrin in combination with docetaxel in treating patients with common solid tumors that have failed prior therapies - a situation where currently available treatments are inadequate."

The phase I trials will each recruit approximately 25 patients with relapsed prostate, breast, lung, or ovarian cancers that have failed initial chemotherapy. Each of the protocols is designed to evaluate Xcytrin in combination with different, but commonly used, docetaxel dosing regimens.

One study will evaluate Xcytrin in combination with docetaxel given every 3 weeks. This study will be conducted at the James P. Wilcot Cancer Center of the University of Rochester Medical Center in Rochester, New York . The other protocol is designed to examine Xcytrin with docetaxel given weekly and will be conducted at the Roswell Park Cancer Institute in Dallas, Texas .

"Xcytrin's unique mechanism of action and tumor selectivity provide the rationale for examining its activity with a variety of chemotherapy agents," said Richard A. Miller, MD, president and chief executive officer of Pharmacyclics.