
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, and is in addition being developed for acute radiation injury. 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.
Interim Efficacy Target Achieved Earlier Than Expected - Trial Moving into Stage 2
Novelos Therapeutics, Inc. (OTCBB: NVLT - News), a biopharmaceutical company focused on the development of therapeutics to treat cancer and hepatitis, today announced positive interim results in an ongoing Medical University of South Carolina (MUSC) Hollings Cancer Center Phase 2 trial of neoadjuvant treatment with NOV-002 in combination with chemotherapy in patients with stage II-IIIC HER-2/neu negative invasive breast cancer. Alberto Montero, MD, Assistant Professor of Medicine, Division of Hematology-Oncology, is the Principal Investigator.
"NOV-002, a Glutathione Disulfide Mimetic, as a Modulator of Cellular Redox Balance"
Novelos Therapeutics, Inc. (OTCBB: NVLT - News), a biopharmaceutical company focused on the development of therapeutics to treat cancer and hepatitis, today announced that Novelos’ peer reviewed article, based on the collaboration with Dr. Kenneth Tew and Dr. Danyelle Townsend of the Medical University of South Carolina (MUSC), has been published in Cancer Research 68: (8) April 15, 2008. This article describes findings in cellular and animal model systems that demonstrate the ability of NOV-002 to influence redox balance in and around cells, resulting in a constellation of effects on redox-sensitive cell processes and functions. NOV-002 is the subject of an ongoing pivotal Phase 3 trial for non-small cell lung cancer under a Special Protocol Assessment (SPA) and Fast Track, and is in Phase 2 trials for other oncology indications.
"NOV-002, a Glutathione Disulfide Mimetic, is a Pleiotropic Modulator of Cellular Redox Balance"
Novelos Therapeutics, Inc. (OTCBB: NVLT - News), a biopharmaceutical company focused on the development of therapeutics to treat cancer and hepatitis, announced that today Novelos is presenting a scientific poster, based on the collaboration with Dr. Kenneth Tew and Dr. Danyelle Townsend of the Medical University of South Carolina (MUSC), at the ongoing American Association for Cancer Research (AACR) annual meeting in San Diego, CA. This presentation will describe findings in cellular and animal model systems that demonstrate the ability of NOV-002 to influence redox balance in and around cells, resulting in a constellation of effects on redox-sensitive cell processes and functions.
Novelos Therapeutics, Inc. (OTCBB: NVLT - News), a biopharmaceutical company focused on the development of therapeutics to treat cancer and hepatitis, today announced that it closed its previously announced private placement with existing institutional investors resulting in approximately $5.7 million in gross proceeds through the sale of shares of a new series of its convertible preferred stock and warrants to purchase its common stock. Novelos sold 113.5 shares of Series D convertible preferred stock, having a stated value equal to $50,000 per share, a cumulative annual dividend of 9% of stated value and a conversion price of $0.65 per share of common stock. The investors also received warrants, callable in certain circumstances, expiring in five years to purchase an aggregate of 4,365,381 shares of common stock at an exercise price of $0.65 per share.
Data Accepted for Poster Presentation at ASCO 2008
Novelos Therapeutics, Inc. (OTCBB: NVLT - News), 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.
Novelos Therapeutics, Inc. (OTCBB: NVLT - News), a biopharmaceutical company focused on the development of therapeutics to treat cancer and hepatitis, today announced that it has entered into a definitive agreement with existing institutional investors to raise $5 million in gross proceeds through the sale of shares of a new series of its convertible preferred stock and warrants to purchase its common stock. Novelos has agreed to sell 100 shares of Series D convertible preferred stock, having a stated value equal to $50,000 per share, a cumulative annual dividend of 9% of stated value and a conversion price of $0.65 per share of common stock. The investors will also receive warrants, callable in certain circumstances, expiring in five years to purchase an aggregate of 3,846,151 shares of common stock at an exercise price of $0.65 per share. The transaction is expected to close within two weeks, subject to the satisfaction of certain closing conditions.
Zangani interviews Harry S. Palmin, President and Chief Executive Officer of Novelos Therapeutics, Inc.
Mr. Palmin discusses Novelos' recent accomplishment of reaching the target enrollment of 840 patients in the pivotal Phase 3 trial in advanced non-small cell lung cancer (NSCLC) for its lead product NOV-002 in combination with first-line chemotherapy.
Trial Conclusion is Expected mid-2009
Novelos Therapeutics, Inc. (OTCBB: NVLT - News), a biopharmaceutical company focused on the development of therapeutics to treat cancer and hepatitis, today announced that Novelos has reached the target enrollment of 840 patients in the pivotal Phase 3 trial in advanced non-small cell lung cancer (NSCLC) for its lead product NOV-002 in combination with first-line chemotherapy. Thomas Lynch, M.D. and Panos Fidias, M.D., recognized experts in treating lung cancer from the Massachusetts General Hospital Cancer Center, are the trial co-Chairs. Dr. Lynch is Director of the Center for Thoracic Cancers and Dr. Fidias is Clinical Director for the Cancer Center.
Novelos Therapeutics, Inc. (OTCBB: NVLT - News), a biopharmaceutical company focused on the development of therapeutics to treat cancer and hepatitis, today announced that Harry S. Palmin, President and CEO of Novelos, will present at the Roth Capital Partners 20th Annual OC Conference on Tuesday, February 19, 2008. Mr. Palmin is scheduled to present at 8:30am PST (11:30am EST) at the Promenade. The event will be held at the Ritz Carlton, Laguna Niguel, CA.
NOV-002, a Glutathione Disulfide Mimetic, is a Pleiotropic Modulator of Cellular Redox Balance
Novelos Therapeutics, Inc. (OTCBB: NVLT - News), a biopharmaceutical company focused on the development of therapeutics to treat cancer and hepatitis, today announced that Novelos’ scientific abstract, based on the collaboration with Dr. Kenneth Tew and Dr. Danyelle Townsend of the Medical University of South Carolina (MUSC), has been accepted for a poster presentation at the American Association for Cancer Research (AACR) annual meeting in April 2008 in San Diego, CA, and will be published in the 2008 Proceedings of the AACR. This presentation will describe findings in cellular and animal model systems that demonstrate the ability of NOV-002 to influence redox balance in and around cells, resulting in a constellation of effects on redox-sensitive cell processes and functions.
Novelos Therapeutics, Inc. (OTCBB: NVLT - News), a biopharmaceutical company focused on the development of therapeutics to treat cancer and hepatitis, today announced that Harry Palmin, President and CEO of Novelos, purchased 150,000 shares of the Company’s common stock on December 19, 2007, in open market transactions. In total, Mr. Palmin purchased 300,000 shares of common stock in open market transactions over the past thirteen months.
Novelos Therapeutics, Inc. (OTCBB: NVLT - News), a biopharmaceutical company focused on the development of therapeutics to treat cancer and hepatitis, today announced that Novelos signed an exclusive license agreement with Lee’s Pharmaceutical (HK) Ltd (which is 30% owned by Sigma-Tau Group through Defiante Farmaceutica Lda) to develop and commercialize in China, including Hong Kong and Macau, as well as in Taiwan, two of Novelos’ compounds: NOV-002 for cancer and NOV-205 for hepatitis. NOV-002 is Novelos’ lead compound in pivotal Phase 3 trial for non-small cell lung cancer under a Special Protocol Assessment (SPA) and Fast Track.
Plans to Initiate a Longer Proof-of-Concept Trial in 2nd Half of 2008
Novelos Therapeutics, Inc. (OTCBB: NVLT - News), a biopharmaceutical company focused on the development of therapeutics to treat cancer and hepatitis, today announced that it has concluded the initial U.S.-based double-blind, placebo-controlled Phase 1b trial evaluating NOV-205 as monotherapy in chronic hepatitis C genotype 1 patients who previously failed treatment with pegylated interferon plus ribavirin. Based on favorable safety data in this 14-dose trial with 18 subjects (12 treated with NOV-205 and 6 with placebo), Novelos plans to initiate a longer proof-of-concept trial in hepatitis C non-responders in the second half of 2008.
Novelos Therapeutics, Inc. (OTCBB: NVLT - News), a biopharmaceutical company focused on the development of therapeutics to treat cancer and hepatitis, today announced that Novelos will host and webcast presentations to institutional investors and analysts on Tuesday, November 27, 2007, 8-11am EST. The event will be held at The Cornell Club, 6 East 44th Street, New York, NY.
Scientific Mini-Symposium on NOV-002, a Phase 3 Oncology Drug
Novelos Therapeutics, Inc. (OTCBB: NVLT - News), a biopharmaceutical company focused on the development of therapeutics to treat cancer and hepatitis, today announced that Novelos will host and webcast presentations to institutional investors and analysts on Tuesday, November 27, 2007, 8-11am EST. The event will be held at The Cornell Club, 6 East 44th Street, New York, NY.
Presentations will highlight molecular, cellular and animal findings with NOV-002 (Novelos’ lead compound currently in a pivotal Phase 3 trial for non-small cell lung cancer under a Special Protocol Assessment and Fast Track). The current understanding of its mechanisms of action will be discussed, particularly in relation to the unique clinical profile of NOV-002 when administered to cancer patients in combination with standard chemotherapy – improved toleration and increased efficacy.
Novelos Therapeutics, Inc. (OTCBB: NVLT - News), a biopharmaceutical company focused on the development of therapeutics to treat cancer and hepatitis, today announced that Harry S. Palmin, President and CEO of Novelos, will present at the Acumen BioFin Rodman & Renshaw 9th Annual Healthcare Conference on Monday, November 5, 2007. Mr. Palmin is scheduled to present at 12:20 pm EST in Kennedy I, 4th floor. The event will be held at the New York Palace Hotel, 455 Madison Avenue, New York, NY.
Novelos Therapeutics, Inc. (OTCBB: NVLT - News), a biopharmaceutical company focused on the development of therapeutics to treat cancer and hepatitis, today announced that Novelos, in collaboration with the Medical University of South Carolina (MUSC), was awarded a $150,000 competitive grant by the National Institutes of Health (NIH) under Phase I of the Small Business Technology Transfer (STTR) program. This grant will support further scientific development of NOV-002, Novelos' lead compound in pivotal Phase 3 trial for non-small cell lung cancer under a Special Protocol Assessment (SPA) and Fast Track.
Kenneth D. Tew, Ph.D., D.Sc, is the principal investigator of the grant. Tew is chairman of Novelos' Scientific Advisory Board, professor and chair of the MUSC Department of Cell and Molecular Pharmacology & Experimental Therapeutics and John C. West Endowed Chair in Cancer Research.
Novelos Therapeutics, Inc. (OTCBB: NVLT - News), a biopharmaceutical company focused on the development of therapeutics to treat cancer and hepatitis, today announced the election of Stephen A. Hill, B.M. B.Ch., M.A., F.R.C.S. to serve as non-executive chairman of Novelos' board of directors. Dr. Hill, President and CEO of ArQule, Inc. (NASDAQ: ARQL - News), has over 25 years of expertise in biopharmaceutical senior management, product development, commercialization and partnering. His election increases the number of directors to eight, six of whom are independent directors.
Novelos Therapeutics, Inc. (OTCBB: NVLT - News), a biopharmaceutical company focused on the development of therapeutics to treat cancer and hepatitis, today announced that Novelos was issued U.S. Pat. No. 7,169,412 by the U.S. Patent and Trademark Office extending the composition and method of use claims relating to NOV-002, Novelos' lead compound in pivotal Phase 3 trial for non-small cell lung cancer under a Special Protocol Assessment (SPA) and Fast Track.