Novelos Therapeutics Jumps On NOV-002 Potential
Novelos Therapeutics, Inc. [[NVLT.OB]] is one biopharmaceutical company worth watching over the next couple of months. The company, which is focused on commercializing oxidized glutathione-based compounds for the treatment of cancer and hepatitis, has a variety of compounds in Phase 1, 2 and 3 trials in the United States and abroad. Now that clinical trial results are approaching, many investors are taking an interest in the company.
Novelos lead compound, NOV-002, acts together with chemotherapy as a chemoprotectant and a chemopotentiator. Three separate Phase 2 trials demonstrated clinical activity and safety in combination with chemotherapy in non-small cell lung cancer. In May 2006, the company finalized plans with the FDA for a single pivotal Phase 3 trial, finished enrolling patients in March 2008, and expects the results to be available in late 2009.
NOV-002 has already demonstrated an excellent safety and efficacy profile in Russia where it was approved for a combination treatment with chemotherapy for many different cancers. One Russian clinical trial in 1996-1998 found that NOV-002 increased one-year survival rates from 17% to 63%, which represents an 80% improvement over the U.S. survival rate of 35% that results from the current standard of care.
In 2008, Novelos began realizing revenues from its programs abroad with $125,968 in reported revenues. However, this amount was vastly overshadowed by $14.5 million in research and development spending to develop the drugs and achieve approval in the United States. Given that the company has just $1.26 million in cash, it will likely need to raise additional debt or equity funding in order to continue operations.
In the end, Novelos remains a risky investment due to its substantial cash burn and the uncertainty of its FDA approval. However, the company’s prospects could dramatically improve with an approval from the FDA, which could become a possibility by the end of this year. As a result, many speculators are building positions now ahead of any announcement in order to take advantage of the potentially large upside.
CONTACT: Daniel Minton, Managing Director, 406-862-5400, daniel@accelerize.com