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Innovative melanoma therapy that 'turns cancer on itself' gets $18 million

by Gus Iversen, Editor in Chief | May 28, 2015
Business Affairs Rad Oncology
Since May is Melanoma Awareness month, it seems fitting to take a look at new advancements taking place in the fight against skin cancer. The U.S. melanoma market is approximately $1 billion per year, which is money predominantly spent to treat metastatic melanoma.

A publicly traded company called NeoStem recently received an $18 million dollar grant from the California Institute for Regenerative Medicine for a new therapy being developed to help curb the damage done by melanoma. The injectable treatment, called NBS20, fights the disease by turning cancer cells against themselves. DOTmed News spoke to Dr. David J. Mazzo, the CEO of NeoStem, about the significance of the company's work.

DOTmed News: Can you tell us a bit about the development process for how this therapy came to be?

David J. Mazzo:
NeoStem’s product candidate, NBS20, was developed initially by Dr. Robert Dillman, who was then with Hoag Cancer Center of Hoag Memorial Hospital Presbyterian in Newport Beach, California. Dr. Dillman is currently NeoStem’s Vice President of Oncology and the clinical lead on the NBS20 program.

In 2011, the technology platform that became NBS20 was acquired by California Stem Cell, Inc., which was subsequently acquired by NeoStem in 2014. In early 2015, NeoStem initiated the Phase 3 Intus Study (based on a Special Protocol Assessment from FDA) to investigate the therapy for the treatment of stage III recurrent and stage IV metastatic melanoma. That trial is now enrolling and randomizing patients.

The Intus trial is based on consistent, compelling results from two Phase 2 trials in identical patient populations evaluating the therapeutic vaccine that has become NBS20. The more recent of the two trials was a randomized trial comparing NBS20 to injections of autologous irradiated (inactivated) tumor cells in 42 patients. At two years, survival was 72 percent compared to 31 percent for control patients (p=0.007), which was consistent with the previous Phase 2 trial's findings in which NBS20 demonstrated 73 percent two-year survival in 54 patients, with a median survival of five years. Toxicity was minimal and consisted of mild to moderate local injection site reactions of the type normally associated with injections of GM-CSF (a protein secreted by immune cells that helps stimulate other immune cells to promote immune defenses against disease).

DOTmed News: What will the funding you've gotten allow you to do?

DJM:
The funding from the California Institute for Regenerative Medicine serves two important purposes for NeoStem:

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