CEL-SCI's Cancer Drug Gets Orphan Status
VIENNA, Va., June 12 -- CEL-SCI Corporation announced today that its cancer drug Multikine® has been granted orphan-drug designation as neoadjuvant therapy in patients with squamous cell carcinoma of the head and neck (head and neck cancer) by the United States Food and Drug Administration (FDA). An orphan drug is any drug developed under the Orphan Drug Act of January 1983 ("ODA"), a federal law concerning rare diseases (orphan diseases"), defined as diseases affecting fewer than 200,000 people in the United States. In 2003, the leading orphan drug by worldwide sales revenue was Amgen's Erythropeietin (Epogen®), with sales of $2.4bn.
Geert Kersten, CEO of CEL-SCI said, "Receiving orphan-drug designation for Multikine is yet another major achievement for CEL-SCI, following the go-ahead from the FDA earlier this year for the Company's Phase III study in advanced primary head and neck cancer patients and the subsequent raising of substantial funds in April, 2007. We are putting in place all of the pieces required to make this company very successful."
Receipt of the US FDA orphan-drug designation for Multikine qualifies CEL- SCI for a number of very significant incentives, including:
1. Seven years marketing exclusivity from the date the designated product is approved or licensed.
2. Approval time for the designated product may be quicker - Orphan products may receive expedited or accelerated approval.
3. Companies may apply for Orphan Grants for clinical studies for the designated indication. These grants can provide up to $350 thousand per year for up to 3 years.
4. Tax incentives for the company which can amount to up to 50% of clinical investigation costs associated with the designated product's development.
The science behind Multikine is based on the premise that a healthy immune system can cure cancer. When the immune system is imbalanced or weakened, diseases like cancer occur. Multikine is a mixture of naturally occurring cytokines, substances that regulate the immune system. The Multikine mixture is representative of the mixture of cytokines produced by a healthy immune system.
Multikine is the first cancer immunotherapy being developed as a first line treatment. This means it is administered prior to any other cancer therapy (e.g. surgery, radiation and/or chemotherapy) because that is the period when the immune system can still be fully activated. Once the patient has had surgery or has received radiation and/or chemotherapy, the immune system is severely weakened and less able to mount an effective immune response.
Multikine works in two ways:
1. It signals the immune system to mount an effective immune response. Multikine changes the type of immune cell that attacks the tumor from a CD-8 cell to a CD-4 cell. The CD-4 cell breaks what is referred to as "tumor tolerance," allowing the immune system to see and attack the tumor.
2. Multikine has been shown to render cancer cells much more susceptible to radiation and chemotherapy treatments, thereby making these treatments much more effective.
Multikine is currently cleared for a Phase III clinical trial in the US and Canada in advanced primary head and neck cancer patients. These are recently diagnosed, not yet treated patients. Head and neck cancer is an aggressive cancer that accounts for about 500 - 600,000 new annual cases of cancer world wide.
Advanced primary head and neck cancer patients typically have a 50% chance of survival three years following the first treatment. The Phase III study, which is designed to prove that Multikine works, is expected to enroll about 800 advanced primary head and neck cancer patients worldwide. In its last Phase II clinical trial Multikine increased overall survival by 33%. This Phase III study will need to show a 10% increase in overall survival to be successful. For more detailed information, go to http://www.cel-sci.com .
CEL-SCI Corporation is developing new immune system based treatments for cancer and infectious diseases. CEL-SCI's other products, which are currently in pre-clinical stage and have been funded with U.S. government support, have shown protection against a number of diseases in animal tests and are currently being tested against diseases associated with bio-defense and avian flu. The Company has operations in Vienna, Virginia and Baltimore, Maryland. When used in this report, the words "intends," "believes," "anticipated" and "expects" and similar expressions are intended to identify forward-looking statements. Such statements are subject to risks and uncertainties which could cause actual results to differ materially from those projected. Factors that could cause or contribute to such differences include, an inability to duplicate the clinical results demonstrated in clinical studies, timely development of any potential products that can be shown to be safe and effective, receiving necessary regulatory approvals, difficulties in manufacturing any of the Company's potential products, inability to raise the necessary capital and the risk factors set forth from time to time in CEL-SCI Corporation's SEC filings, including but not limited to its report on Form 10- K for the year ended September 30, 2006. The Company undertakes no obligation to publicly release the result of any revision to these forward-looking statements which may be made to reflect the events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.