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Ontogen Corporation Commences Phase I Study of OC144-093 as Treatment For Multidrug Resistance in Cancer Therapy (PR Newswire)...``P-gp``) in tumor cells.......Ontogen is also studying OC144-093 for other potential therapeutic applications including enhancement of oral bioavailability and blood brain barrier penetration....- May 03 7:03 AM ET


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Posted on: 05/03/2001

"Yahoo - Ontogen Corporation Commences Phase I Study of OC144-093 as Treatment For Multidrug Resistance in Cancer Therapy"
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Thursday May 3, 7:03 am Eastern Time

Press Release

SOURCE: Ontogen Corporation

Ontogen Corporation Commences Phase I Study of OC144-093 as Treatment For Multidrug Resistance in Cancer Therapy

SAN DIEGO, May 3 /PRNewswire/ -- Ontogen Corporation today announced the commencement of a Phase I study in cancer patients at British Columbia ("BC") Cancer Agency in Vancouver, following approval of its Canadian IND. The study is designed to evaluate the tolerability and pharmacokinetics of intravenous paclitaxel (Taxol(TM)) in combination with oral OC144-093 when given to cancer patients.

In the treatment of many cancers, chemotherapy is often complicated by clinical resistance to a broad spectrum of cytotoxic agents. Approximately 50% of cancer patients receive chemotherapy. Of those, over 75% exhibit intrinsic or develop acquired resistance to treatment. Multidrug resistance ("MDR") is now recognized as the most common cause of failure of cancer chemotherapy. A major form of MDR results from the over-expression of P-glycoprotein ("P-gp") in tumor cells. P-gp functions as an efflux pump which transports a broad range of chemotherapeutic agents out of tumor cells, significantly decreasing anti-tumor efficacy. Limited success in the reversal of MDR has been realized in the clinic to date.

In the six-cohort trial being conducted by Ontogen, each patient is initially receiving Taxol(TM) alone followed by escalating doses of both Taxol(TM) and oral OC144-093. Ontogen has previously conducted clinical trials with OC144-093 alone in healthy male and female volunteers. Those studies indicated that the drug is safe and well tolerated when given orally in doses of up to 500 mg twice a day.

"Positive results in this multi-dose Phase I trial of OC144-093 in combination with Taxol(TM) will allow us to advance the drug to a Phase II efficacy trial in patients receiving Taxol(TM) for metastatic breast cancer," said Ross Dixon, Ph.D., Ontogen's executive director, Drug Development.

Barry E. Toyonaga, Ph.D., Ontogen's president and chief executive officer noted, "Historically, the idea was that therapy in MDR would not be administered until resistance appears, due to inherent risks involved with existing MDR therapy. Beyond OC144-093's use after MDR develops, we are looking for a high safety profile with OC144-093 in combination with Taxol(TM) that should enable the administration of OC144-093 at the onset of chemotherapy in order to both treat and prevent the emergence of MDR."

Ontogen is also studying OC144-093 for other potential therapeutic applications including enhancement of oral bioavailability and blood brain barrier penetration. P-gp has been implicated in the poor oral absorption and poor CNS penetration of many drugs. Ontogen is exploring the possibility of developing OC144-093 as an adjuvant to enhance the oral bioavailability and/or CNS penetration of certain therapeutic agents.

Ontogen Corporation, founded in 1992, is a rapidly growing drug development company with vigorous research programs aimed at the development of novel small molecule therapeutics and the creation of high-throughput discovery technologies. Those technologies include proprietary and highly efficient methods of chemical synthesis, compound analysis, purification, biological screening and data analysis. With immediate projects in the area of cancer therapy, diabetes and inflammation, Ontogen is successfully applying its automated discovery technologies to achieve R&D goals of its own internal programs and its pharmaceutical partners. In its most advanced internal program, through its Toronto based Canadian subsidiary, Ontogen is conducting clinical trials of its OC144-093 drug candidate to reverse multidrug resistance during cancer chemotherapy. Currently, Ontogen collaborates on some of its programs with Novo Nordisk and Boehringer Ingelheim. For additional corporate information, visit the Ontogen website at http://www.ontogen.com.

    OntoBLOCK(TM) and OntoCHROM(TM) are trademarks of Ontogen Corporation.

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SOURCE: Ontogen Corporation

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