Cel-Sci gets manufacturing go-ahead at Maryland, US facility

Cel-Sci Corporation is moving ahead with clinical testing of its investigational cancer drug after gaining approval to start production at its plant in Maryland, US.

The Vienna-based late-stage oncology company and a developer of vaccines and drugs for the prevention and treatment of infectious diseases, said this "very important milestone" would enable it to progress drug manufacturing plans for Multikine for a Phase III clinical trial with head and neck cancer patients.

The facility will also offer contract manufacturing services after starting production of Multikine.

"We believe that having our own facility gives us greater control over the Multikine manufacturing process and helps increase the probability of Multikine becoming an approved drug," said Geert Kersten, ceo of Cel-Sci.

The company will recruit approximately 800 patients in 11 countries around the world to the Phase III clinical trial. In Phase II trials Multikine was shown to be safe and well tolerated and to improve a patient's survival by 33%, compared with what can be achieved with standard treatment alone.

Head and neck cancer represents about 6% of all of the world's cancer.

The US Food and Drug Administration (FDA) gave the go-ahead for this Phase III clinical trial and granted orphan drug status to Multikine in the neoadjuvant therapy of patients having squamous cell carcinoma of the head and neck.

Cel-Sci reported a US$41.4m loss for fiscal 2009. Its share price jumped from 14 cents to more than US$2 a share last year after the FDA approved research into its immunotherapy technology to treat the H1N1 swine flu virus, which is taking place at John Hopkins University, Baltimore.

The company has increased its r&d spending from US$4.1m to US$6m as it prepares for the Phase III clinical trial of Multikine. It says it has more than US$33.5m in cash, allowing it to fund the trial.