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Look To CEL-SCI To Deliver Phase III Results In 2018 For Worldwide Approval Of Head & Neck Cancer Immunotherapy

|About: Cel-Sci Corporation (CVM)

Summary

Multi-billion dollar head & neck cancer treatment market represents 6% of all cancers with 600,000 people worldwide.

Dire need for new treatment as FDA has not approved a new drug for head and neck cancer in 60 years.

CEL-SCI's immunotherapy works by boosting immune system before surgery, chemo and radiation.

Top line results may soon be in at CEL-SCI (CVM), which concluded patient enrollment and dosing in the world’s largest Phase III trial in the treatment of head and neck cancer. Between 2011 and 2016, 928 patients were enrolled and treated. According to the study’s protocol, the effectiveness of CEL-SCI’s drug in prolonging life can only be judged after 298 of the enrolled patients have died, since the FDA wants to see survival benefit. The number of deaths, or ‘events’, as they are termed in clinical trials, is unfortunately how and when the primary endpoint of most cancer studies are determined.

A quick look at the enrollment numbers and simple math using published survival data reveal that a total of 298 events may happen by 2018. In the table I’ve put together below, the number of patients enrolled each year is based on a recent company press release. The number of deaths is an estimate based on CEL-SCI’s assumption that overall survival will be 55% for standard of care 3 years after diagnosis, with 45% unfortunately succumbing to the disease.

Year(S) Enrolled

# of patients enrolled

Estimated # of deaths after 3 years

2011 - 2013

135

61

2014

195

87

2015

340

153

2016

260

117

Total

~928

~418

669 patients were enrolled by the end of 2015. Fast forward 3 years to 2018 and 301 of those people will have died if treated only with the current standard of care, based on survival rates for this disease. However, we assume approximately half of those 669 patients had the benefit of being treated with Multikine before they received standard of care. We all hope those people benefited from Multikine and will have a longer survival.


CEO Geert Kersten with Ray Dirks

The magic number in terms of the study’s protocol is a 10% improvement in overall survival in the patient group treated with Multikine plus standard of care vs. standard of care alone. All primary and secondary outcome measures of the study have a timeframe of 3 year or less. If this 10% improvement is achieved, the study will be a success and Multikine will be eligible for regulatory approval worldwide.

CEL-SCI’s success bringing Multikine to market would have a huge impact on the head and neck cancer treatment market which has not seen a new FDA approved drug in over 60 years.

600,000 people who currently have head and cancer worldwide, and the 50,000 Americans diagnosed each year, desperately need a better alternative than the current standard of care. Accounting for 6% of all cancer, the head and neck cancer treatment market is worth billions of dollars.

Immunotherapy, now acknowledged as one of the most promising paradigms to treat cancer, was heralded early on by the visionary scientists at CEL-SCI who developed Multikine. The idea is to treat newly diagnosed cancer patients with Multikine, prior to standard of care, which involves surgery, chemotherapy and radiation, all of which are proven to weaken the immune system. By boosting the body’s natural ability to heal itself, Multikine can give patients a huge advantage before they receive the standard of care treatment.

For investors, CEL-SCI is a bargain and great bet. At only $23 million in market cap, this company is right around the corner from Phase III results that can transform its valuation. For a little investment risk, at approximately $2.00 per share, the rewards could be big.

RAY DIRKS Research suggests that Readers/Investors place no more than 1% of the funds they devote to common stocks in any one issue. It's best to diversify.

Disclosure: I am/we are long CVM.