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In unprecedented numbers, clinical centers overseas are rallying to bring to medicine's attention one of most innovative therapies for cancer in many years. The compound is Multikine, made by Cel-Sci Corp. (CVM), a first-in-class cancer drug using as the basis of treatment the body's own white blood cells to shore up the immune system to fight disease in an ingenuous and effective way before surgery, radiation and chemotherapy.
Several days ago, more than 100 cancer investigators covering nearly 60 research sites clambered for the opportunity to investigate Multikine in its Phase III trial in head and neck cancer, expected to enroll 880 patients. Administration of Multikine is designed to be given early, when the immune system has not been weakened by currently-available methods of cancer treatment and thus able to overcome metastases. A recent study from Genentech shows that disease progression must be halted from the site of the tumor, supporting Cel-Sci's underlying premise.
Cel-Sci's Multikine has gotten the attention of privately-held Ergomed, a clinical research organization that partners with drug companies to fund clinical studies. Ergomed will spend up to $3 million for Cel-Sci's research into using Multikine for human papilloma virus (HPV), a pervasive sexually-transmitted disease (STD) that has become an epidemic, particularly among HIV patients that are living longer due to better medication. This commitment is behind another, earlier one where Ergomed agreed to pay $10 million for aid in funding Phase III trials in head and neck cancer discussed above, taking only a modest single-digit percentage return in net income derived from future sales of the drug when and if approved.
This late-stage trial, propelled by Ergomed, lends impetus to Cel-Sci's efforts with Multikine addressing HPV in AIDS patients, where much work needs to be done. Genital HPV infection is the most prevalent sexually transmitted diseases in both genders and does not always manifest, except in anal warts. People without a robust immune system or with a particularly virulent strain of HPV are subject to cancer of the cervix and anus, and may develop malignant skin lesions of the vagina or penis.
It has been reported that up to half of the men in the US, Mexico and Brazil carry HPV, and that the virus affects men as well as women. In the same study, a strong correlation was made between anal warts, genital cancer, and head and neck cancer. No viable treatment is in sight, although Merck & Co. (MRK) maintains that its vaccine Gardasil, recommended for late adolescents, is a prevention for HPV when in fact, it's only mildly effective in four out the possible 40 strains of the virus.
Diagnostic testing of STDs is exploding at a growth rate of over 8% compounded annually, expected to reach $108 billion in the near term. Globally, there are 500 million new cases per year, in a generally young population between 15-44 years old. This is the reason Europe looks to Multikine as a cure.
European regulators recognize that successful Phase III studies of Multikine in head and neck cancer, with implications from HPV, could make the drug a standard of care. Particularly attractive are results from prior studies that show a small fraction of patients have evidence of tumor tissue after only three weeks of treatment, an astounding 33% survival rate pursuant to 3 ½ years after treatment with Multikine, and no significant adverse effects.
The importance of Cel-Sci's budding cancer breakthrough has also come to the attention of the Cooperative Research and Development Agreement (CRADA), a government contract intended to speed commercialization of new technology. Clinical trials testing the effectiveness of Multikine in AIDS patients with anal warts will now receive a fast track, funded at US Navy hospitals, and also supply Cel-Sci with information to bring to regulatory bodies to hasten approval of the drug. CRADA has a long history of providing federal resources to the biotechnology community, giving companies access to laboratories that enhance their own capabilities and providing innovation to meet medical needs that would not be possible otherwise.
Risks with investment in Cel-Sci include any delays in enrollment for ongoing studies that would impact time to approval of Multikine; however, with a large and growing population of diseased individuals potentially treated by the drug, this threat is diminished and studies should fill quickly. Multikine as an immunotherapy for head and neck cancer also runs the risk of added FDA scrutiny because the agency is inexperienced with such drugs, having only approved a compound for the disorder by a division of Merck & Co. many years ago.
There is a strong relationship among HIV, HPV, anal warts, cervical dysplasia, and head and neck cancer. Regulators, doctors and patients need something new, that works. I believe the medical community is waking up to this fact, and will soon embrace Multikine as a cancer immunotherapy directed to reducing tumor recurrence and increasing survival.