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Novelos Therapeutics Announces Enrollment of 1st Patient in Phase 2 Ovarian Cancer Trial at Dana-Farber/Partners; Interim Results Expected in Early 2007

Posted on: Tuesday, 18 July 2006, 09:00 CDT

Novelos Therapeutics, Inc. (OTCBB: NVLT), a biotechnology company focused on the development of therapeutics to treat cancer and hepatitis, today announced that Dana-Farber/Partners Cancer Care (DFPCC) has enrolled the first patient in a Phase 2 trial of NOV-002 in combination with carboplatin in platinum-resistant ovarian cancer patients. Michael Seiden, MD, PhD is the Principal Investigator. Dr. Seiden is an Associate Physician in Medicine at Massachusetts General Hospital, Associate Professor of Medicine at Harvard University and oversees the clinical research program and Research Committee for the Gynecologic Cancer Program at the Dana Farber Harvard Cancer Center.

The primary objective of this open-label single-arm Phase 2 trial will be to determine the tumor response rate in a cohort of women with platinum-resistant ovarian cancer after treatment with NOV-002 and carboplatin. Up to 25 women will be enrolled in the trial, and may receive up to six cycles of NOV-002 and carboplatin. Interim results are expected in early 2007. A link to the trial description and contact information is available at www.novelos.com under 'Clinical Trials' section.

"I am very pleased to be collaborating with such excellent institutions as Dana-Farber/Partners, and with Dr. Seiden who is a recognized expert in treating ovarian cancer," said Harry Palmin, President and CEO of Novelos. "In addition to being in Phase 3 development with NOV-002 for lung cancer, we have now initiated a Phase 2 trial in platinum-resistant ovarian cancer, for which there is a major unmet medical need."

According to the American Cancer Society, in 2006 approximately 20,000 U.S. women are expected to be diagnosed with ovarian cancer and 15,000 women are expected to die from it. There is a lack of effective treatment, particularly in the case of platinum-resistant patients. Once a woman's ovarian cancer is defined as platinum-resistant the chance of having a partial or complete response to further platinum therapy is typically less than 10%.

"Ovarian cancer patients who do not respond to therapy with platinum-based drugs or who relapse soon after a response are in need of new, more effective therapies," said Dr. Seiden. "Based on overseas clinical data, NOV-002 added to the treatment regimen holds promise for these women."

About Dana-Farber/Partners CancerCare (DFPCC)

DFPCC is a joint venture non-profit consortium established by Massachusetts General Hospital, The Brigham and Women's Hospital, Inc. and Dana-Farber Cancer Institute. The clinical research efforts of this consortium are organized through Disease Programs. The Gynecologic Cancer Program focuses on the evaluation of novel therapeutic strategies in the treatment of women with gynecologic malignancies and in particular ovarian cancer.

About Novelos Therapeutics, Inc.

Novelos Therapeutics, Inc. is a biotechnology company commercializing oxidized glutathione-based compounds for the treatment of cancer and hepatitis. NOV-002, the lead compound currently in Phase 3 development for lung cancer under a SPA, is designed to act together with chemotherapy as a chemoprotectant and an immunomodulator. NOV-002 is in Phase 2 development for chemotherapy-resistant ovarian cancer and is also being developed for acute radiation injury. NOV-205, a second compound, is designed to act as a hepatoprotective agent with immunomodulating and anti-inflammatory properties. Novelos plans to initiate a U.S.-based NOV-205 clinical trial, under an IND, for chronic hepatitis C mid-2006. Both compounds have completed clinical trials in humans and have been approved for use in the Russian Federation where they were originally developed. For additional information about Novelos please visit www.novelos.com

This news release contains forward-looking statements. Such statements are valid only as of today, and we disclaim any obligation to update this information. These statements are subject to known and unknown risks and uncertainties that may cause actual future experience and results to differ materially from the statements made. These statements are based on our current beliefs and expectations as to such future outcomes. Drug discovery and development involve a high degree of risk. Factors that might cause such a material difference include, among others, uncertainties related to the ability to attract and retain partners for our technologies, the identification of lead compounds, the successful preclinical development thereof, the completion of clinical trials, the FDA review process and other government regulation, our pharmaceutical collaborators' ability to successfully develop and commercialize drug candidates, competition from other pharmaceutical companies, product pricing and third-party reimbursement.

Source: Business Wire

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