Partner to Make Direct Investment in CEL-SCI
VIENNA, Va., Nov. 3 /PRNewswire-FirstCall/ -- CEL-SCI Corporation (NYSE: CVM) announced today that it has expanded its exclusive licensing agreement for Multikine(R) with Orient Europharma Co., Ltd. ("Orient Europharma"), a leading pharmaceutical company from Taiwan. The new agreement extends the Multikine collaboration to also cover South Korea, the Philippines, Australia and New Zealand. The licensing agreement initially focuses on the areas of head and neck cancer, nasopharyngeal cancer and potentially cervical cancer.
As part of this new agreement, Orient Europharma will invest $500,000 in CEL-SCI and fund a portion of the Company's global Phase III clinical trial for Multikine due to start in 2009. Orient Europharma's clinical group will conduct part of the clinical study in its territory. In addition to making a direct investment in the Company and funding a portion of the clinical trials, Orient Europharma will also be responsible for registering the product in the Territory. Once Multikine has been approved, CEL-SCI will be responsible for manufacturing the product, while Orient Europharma will be responsible for sales in the Territory. Revenues will be split between CEL-SCI and Orient Europharma.
"We are pleased that Orient Europharma has recognized the potential for Multikine and has extended its license into more countries," said Geert Kersten, Chief Executive Officer of CEL-SCI. "We expect enrollment in Taiwan to be very speedy, particularly with Orient Europharma running that part of the Phase III study. Orient Europharma proved that it is capable of running part of an international Phase III cancer trial when it successfully executed its part in the Phase III clinical trial that led to the approval of Navelbine(R)."
CEL-SCI has also licensed certain rights related to Multikine to Teva Pharmaceuticals in Israel and Turkey.
CEL-SCI is developing Multikine for approval as a first line indication in head and neck cancer. To that end, the Company's upcoming Phase III clinical trial is an 800 patient clinical study designed to demonstrate that administration of its cancer drug Multikine to head and neck cancer patients before they receive any conventional cancer treatment will increase their survival. Head and neck cancer is one of the world's biggest cancers affecting about 600,000 people per annum worldwide.
About CEL-SCI's Phase III Cancer Drug Multikine:
In Phase II clinical trials Multikine was shown to be safe and well-tolerated, and to improve the patients' overall survival by 33% at a median of three and a half years following surgery. The U.S. Food and Drug Administration (FDA) gave the go-ahead for a Phase III clinical trial with Multikine and granted orphan drug status to Multikine in the neoadjuvant therapy of squamous cell carcinoma (cancer) of the head and neck. Multikine is also the first immunotherapeutic agent being developed as a first-line standard of care treatment for cancer. It is administered prior to any other cancer therapy because that is the period when the anti-tumor immune response can still be fully activated. Once the patient has advanced disease, or had surgery or has received radiation and/or chemotherapy, the immune system is severely weakened and is less able to mount an effective anti-tumor immune response. Other immunotherapies are administered after the patient has received chemotherapy and/or radiation therapy, which can limit their effectiveness.
CEL-SCI has operations in Vienna, Virginia and Baltimore, Maryland. CEL-SCI's other products, which are currently in pre-clinical stage, have shown protection against a number of diseases in animal tests and are being tested against diseases associated with bio-defense. Most recently CEL-SCI announced that its newly discovered rheumatoid arthritis vaccine showed excellent results in animal tests.
SOURCE CEL-SCI Corporation