Novelos Therapeutics Announces Continued Encouraging Results in Ongoing Phase 2 Ovarian Cancer Trial at Dana-Farber/Harvard Cancer CenterNEWTON, Mass.--(BUSINESS WIRE)--March 31, 2008 - Novelos Therapeutics, Inc. (OTCBB: NVLT), a biopharmaceutical company focused on the development of therapeutics to treat cancer and hepatitis, today announced continued encouraging results in an ongoing Massachusetts General Hospital Cancer Center and Dana-Farber/Harvard Cancer Center (DF/HCC) Phase 2 trial of NOV-002 in combination with carboplatin in platinum-resistant ovarian cancer patients. Fifteen patients have now been enrolled and, to date, 60% (9) have had slower than expected disease progression. NOV-002 was well-tolerated, further extending the excellent safety profile NOV-002 has demonstrated in previous studies.
Detailed results of this trial will be presented as a poster at the 2008 annual meeting of the American Society of Clinical Oncology (ASCO) taking place May 30 - June 3 in Chicago, Illinois.
"I am encouraged by these results in platinum-resistant ovarian cancer, with NOV-002 (in combination with carboplatin) apparently slowing disease progression in over half of the treated patients. Most women who have failed three lines of chemotherapy would be expected to progress in about eight weeks. I am excited to present the trial results at ASCO," said Dr. Carolyn Krasner, medical oncologist at the Massachusetts General Hospital Cancer Center and the Principal Investigator.
"We look forward to working closely with Dr. Krasner, the Massachusetts General Hospital Cancer Center, Dana-Farber/Harvard and other institutions on designing and implementing a larger NOV-002 trial for this indication," said Harry Palmin, President and CEO of Novelos. "Our objective is to commence the next Phase 2 trial in platinum-resistant ovarian cancer in early 2009."
According to the American Cancer Society, in 2007 approximately 22,000 U.S. women were diagnosed with ovarian cancer and 15,000 women were 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% and only 10-20% with other available agents. Thus, there is a major unmet medical need for this indication.
About Massachusetts General Hospital Cancer Center
An integral part of one of the world's most distinguished medical centers, the Massachusetts General Hospital Cancer Center is chosen by more cancer patients than any other hospital in New England. Its commitment to eradicating cancer is fueled by scientific investigation conducted as part of the largest hospital-based research program in the United States. The Cancer Center fosters innovation in basic, translational and clinical research. It is a founding member of the DF/HCC, a Harvard Medical School consortium designated by the National Cancer Institute as a comprehensive cancer center. This prestigious seven-member center comprises the largest research collaboration in the country. Also, through the DF/HCC partnership, the Cancer Center and Dana-Farber/Brigham & Women's Cancer Center collaborate on joint clinical trials, education, training programs and quality of care improvements.
About Dana-Farber/Harvard Cancer Center (DF/HCC)
DF/HCC is a joint venture non-profit consortium established by Dana-Farber Cancer Institute, the Harvard Medical School and Harvard School of Medicine and Public Health, and the Beth Israel Deaconess, Brigham and Women's, Children's, and Massachusetts General hospitals. 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 biopharmaceutical 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 and Fast Track, acts together with chemotherapy as a chemoprotectant and an immunomodulator. NOV-002 is also in Phase 2 development for chemotherapy-resistant ovarian cancer and early-stage breast cancer. NOV-205 acts as a hepatoprotective agent with immunomodulating and anti-inflammatory properties. NOV-205 is in Phase 1b development for chronic hepatitis C non-responders. 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.
Posted: March 2008