SOURCE: Novelos Therapeutics, Inc.

June 16, 2005 06:30 ET

Novelos Therapeutics Files Orphan Drug Application With FDA

NEWTON, MA -- (MARKET WIRE) -- June 16, 2005 -- Novelos Therapeutics, Inc. (OTC BB: NVLT), a biotech company focusing on oxidized glutathione for use in fighting cancer and hepatitis, today announced that it has filed an orphan drug application with the U.S. FDA for the Company's lead compound, NOV-002. The application focuses on the investigation of combination therapy of NOV-002 with standard chemotherapy for treating refractory (chemotherapy resistant) ovarian cancer. A response from the FDA is expected by mid August.

In the U.S., an orphan drug designation may be granted to drugs that treat rare life-threatening diseases that affect less than 200,000 U.S. persons. Such designation provides a company with seven years of marketing exclusivity along with regulatory assistance and reduced fees.

Refractory ovarian cancer patients -- those who do not respond to chemotherapy -- have a very poor prognosis because they are faced with inadequate therapeutic options. Response rates from second-line treatments, such as doxorubicin and topotecan, are typically less than 12%; re-exposure to cisplatin-based treatment will typically have less than 15% response rate.*

In Russian clinical studies, NOV-002 has sensitized previously resistant ovarian cancers, substantially raising the patient response rate to chemotherapy treatment.

In 2005, ovarian cancer is expected to be diagnosed in approximately 22,220 U.S. women, and be responsible for 16,210 deaths. Standard first-line treatment for ovarian cancer patients is carboplatin and paclitaxel chemotherapy combination. Doxorubicin (Doxil) and topotecan (Hycamtin) alternate as second- and third-line chemotherapy treatments.*

* www.cancer.gov

About Novelos Therapeutics, Inc.

Novelos Therapeutics, Inc. (OTC BB: NVLT) was established in 1996 to commercialize two promising oxidized glutathione based compounds, NOV-002 and NOV-205, for the treatment of cancer and hepatitis. Both compounds have completed clinical trials in humans and have been approved for use in the Russian Federation where they were developed. NOV-002, marketed in Russia by an unrelated entity under the trade name GLUTOXIM®, has been administered to over 5,000 patients, yielding excellent safety and promising efficacy data. A U.S. Phase I/II clinical trial of NOV-002 for lung cancer has been completed. The Company plans to file an IND for NOV-205 as a mono-therapy for hepatitis C and to initiate U.S. clinical trials.

About the Products

NOV-002, the lead compound, is being developed to treat non-small cell lung cancer ("NSCLC"). NOV-002 is a cytoprotectant and an immunomodulator. When used in combination with chemotherapy, NOV-002 increased the one-year survival rate from 17% to 63% in a Russian study, a result that also represents an 80% improvement above the U.S. 35% standard of care. A U.S. Phase I/II clinical study has been completed.

NOV-002 is also being developed to treat refractory (that is, not responsive to chemotherapy) ovarian cancer. Two additional opportunities for NOV-002 are under development, including radiation protection and psoriasis.

NOV-205 is being developed to treat chronic hepatitis C in the U.S. In Russian clinical studies, when used as mono-therapy for one month in hepatitis B and for two months in hepatitis C, NOV-205 has been shown to greatly reduce or eliminate viral loads and to vastly improve liver function relative to existing drugs on the market.

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.

Consulting For Strategic Growth I, Ltd. ("CFSG") has a June 1, 2005, contract to provide Novelos with consulting, business advisory, investor relations, public relations and corporate development services for a three-month period. In connection with these services, CFSG prepares press releases, corporate profiles, and other publications on behalf of the Company. Independent of CFSG's receipt of cash compensation from the Company, CFSG may choose to purchase the common stock of the Company and thereafter liquidate those securities at any time it deems appropriate to do so.

Contact Information

  • COMPANY CONTACT:
    Harry S. Palmin
    President and Acting CEO
    Novelos Therapeutics, Inc.
    One Gateway Center, Ste. 504
    Newton, MA 02458
    Ph: 617-244-1616 ext. 11
    Fax: 631-574-3130
    Email: Email Contact

    INVESTOR RELATIONS:
    Stanley Wunderlich
    CEO
    Consulting For Strategic Growth
    800 Second Avenue
    New York, NY 10017
    Ph: 800-625-2236
    Fax: 212-337-8089
    Email: Email Contact