• E-mail
• Print
• Comment
• Font Size
• Digg
• del.icio.us
• Discuss article

Avantogen Oncology Inc. Announces Preliminary Results of a Dose Ranging Study of RP101 in Combination With Gemcitabine Chemotherapy in Patients With Advanced Pancreatic Cancer

Posted on: Thursday, 17 August 2006, 06:00 CDT

Avantogen Oncology, Inc. (OTCBB:AVTO) today announced preliminary results from a phase I dose ranging study evaluating different doses of RP101 in combination with gemcitabine chemotherapy in patients with advanced pancreatic cancer.

The open label study evaluated oral RP101 therapy in combination with intravenous gemcitabine chemotherapy. Gemcitabine was administered at a dose of 1000mg/m2 on days 1, 8 and 15 every 28 days and RP101 was taken for four consecutive days starting on the day of each gemcitabine administration. Five dose levels of RP101 were evaluated (500, 625, 750, 875 or 1000mg/day).

Of the 22 patients enrolled in the study, 68% were male (n=15), 32% were female (n=7) and the mean age was 61. The protocol allowed baseline ECOG scores of 0-2 and the majority of patients (73%) had an ECOG baseline score of 1, 18% with 0 and 9% a baseline score of 2.

Adverse events were generally consistent with those experienced by patients with advanced pancreatic cancer undergoing gemcitabine chemotherapy. Neutropenia, nausea, vomiting, loss of appetite, fatigue and fever being those most commonly observed.

Based on the safety profile and the ability to deliver planned doses of gemcitabine in combination with RP101, an RP101 dose of 750mg/day has been selected to be taken into the planned randomized, placebo controlled, phase 2 study.

A preliminary analysis of the survival data from all 22 subjects followed for a median 12 months, indicated a 6-month survival rate of 68% and a 12-month survival rate of 39%. An estimated median survival of 9.3 months was observed (95% confidence interval: 5.9 to 13.3) and this compares favorably to a median survival of approximately 6 months seen in several recent large randomized studies evaluating gemcitabine monotherapy and gemcitabine in combination with erlotinib or oxaliplatin. There was no apparent difference in survival between the various dose groups of RP101, however there were only 4 to 5 patients in each dose cohort.

This study is the second open label evaluation of the treatment of patients with advanced pancreatic cancer with RP101 in combination with chemotherapy. Both studies have produced a median survival that is markedly longer when compared to that typically expected in patients treated with chemotherapy alone. In the first such study that evaluated RP101 administered with gemcitabine and cisplatin combination chemotherapy, a median survival of approximately 14 months was reported (Fahrig et al. Journal of Clinical Oncology, 2006 ASCO Annual Meeting Proceedings Part 1. Vol 24, No 18s, 2006: 14000).

Avantogen Oncology Inc. now plans to file an IND in the US and a CTA in a number of countries in Europe in Q4 2006 and to begin a randomized, placebo controlled, phase 2 study comparing gemcitabine plus placebo with gemcitabine combined with RP101. The study is targeted to start early in 2007.

About Avantogen Oncology, Inc.

Avantogen Oncology is an international biotechnology company developing a focused oncology product portfolio, including the clinical evaluation of RP101, for patients with advanced pancreatic cancer and the pre-clinical evaluation of two further candidates, capridine beta in the setting of prostate cancer and an oral formulation of paclitaxel. Avantogen Oncology, Inc. is traded on the OTC Bulletin Board under the symbol AVTO.

For further information, visit www.avantogenoncology.com or contact; Chris Nowers, Chief Executive Officer, Avantogen Oncology, Inc. 2121 Avenue of the Stars, Suite 2550, Los Angeles, CA 90067, USA Tel: +1 310 279 2932 Email: cnowers@avantogenoncology.com

Forward-Looking Statements

Statements contained in this press release that are not historical information are forward-looking within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements are subject to risks and uncertainties that may cause the company's actual results to differ materially from stated expectations. Such potential risks and uncertainties include, among others, the results of clinical trials, access to capital, the effectiveness and pace of current and future product development efforts, regulatory approvals, product demand and market acceptance, the impact of competitive products and other factors which may be identified from time to time in the company's SEC filings and other public announcements.

Source: Business Wire

More News in this Category