West Coast Editor

Gaining more ground in its bid to win FDA approval for lead product Multikine, Cel-Sci Corp. reported positive data from a long-term follow-up study showing increased survival in head and neck cancer patients treated during a Phase II trial.

The company’s stock (AMEX:CVM) closed Tuesday at 67 cents, up 7 cents.

"There hasn’t really been any improvement [treating head and neck cancer] in decades," said Vienna, Va.-based Cel-Sci’s CEO Geert Kersten, noting that Multikine, given before standard therapy, works by copying a healthy person’s immune system.

Patients in the Phase II study included those with advanced primary head and neck cancer who were scheduled for their first treatment, and they were given Multikine for three weeks before the standard course, which is surgery or surgery plus radiation and chemotherapy. Results from the study were published in the May 2005 edition of the Journal of Clinical Oncology.

"The way to intervene is by increasing the success rate of the first therapy," Kersten said. "Our whole goal is to decrease the number of recurrent patients, because recurrence generally translates to death."

The median follow-up period for the patients was 3.2 years. Survival and two-year local regional control beat the rates reported in scientific literature from 39 trials between 1987 and 2004.

Results of Cel-Sci’s study are being prepared for publication, so the company is not disclosing details, but it did say Multikine - a mix of cytokines, including interleukins, interferons, chemokines and colony-stimulating factors - also improved local regional control of tumors in the study, which used the same protocol as the proposed Phase III trial.

"It’s like a football team," Kersten said. "You don’t put a bunch of quarterbacks out there. You need a bunch of players with different abilities, and that’s what Multikine is about."

Cel-Sci is awaiting word from the FDA on the planned Phase III study, the design of which was approved in August by Canadian drug regulatory authorities.

Head and neck cancer strikes about 500,000 people annually worldwide. The causal factors are smoking, drinking and chewing tobacco or betel nuts. Most cases are diagnosed outside the U.S., and about two-thirds of patients appear with advanced disease.

"About 50 percent are alive after three years," Kersten said. "If you can make that 60 percent or even 65 percent, it’s a huge improvement. If you follow the dollar, [the Multikine approach, which attacks early in the condition] is the only way to go. Big pharma says cancer is a chronic disease. First of all, I think that’s nonsense, but who’s going to pay for it?"

Firms working in the same area - though both, unlike Cel-Sci, take aim at recurrent disease - include New York-based ImClone Inc. and Introgen Therapeutics Inc., of Austin, Texas. Last week, ImClone completed patient enrollment in a Phase III trial called EXTREME, sponsored by Darmstadt, Germany-based Merck KGaA, testing Erbitux (cetuximab) as a first-line treatment for patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck. Erbitux is approved for colorectal cancer.

Introgen also has a compound in the works. In January, the firm asked the FDA for permission to accelerate an interim analysis of its Phase III Advexin trial data ahead of schedule, before the protocol-specified number of survival events has occurred. The trial is investigating Advexin as a monotherapy to control recurrent squamous cell carcinoma of the head and neck.

Although Multikine is Cel-Sci’s lead candidate, the firm also has an anti-infective that might work against the bird flu. In December, Cel-Sci signed a cooperative agreement with the National Institute of Allergy and Infectious Diseases to test CEL-1000 against the H5N1 virus in animal models.

Previous animal challenge studies proved the compound works against herpes simplex virus, viral encephalitis, malaria and others, as well as enhances survival in animal cancer models. (See BioWorld Today, Dec. 6, 2005.)

No Comments