CEL-SCI Expands Licensing Agreement for Multikine
CEL-SCI has expanded its exclusive licensing agreement for cancer drug Multikine with Orient Europharma Co., Ltd., 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 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 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. “We expect enrollment in Taiwan to be very speedy, particularly with Orient Europharma running that part of the Phase III study.†said Geert Kersten, CEO of CEL-SCI. “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.â€, he continued.
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.
CEL-SCI is developing Multikine for approval as a first line indication in head and neck cancer. To that end, the upcoming Phase III trial is an 800 patient clinical study designed to demonstrate that administration of Multikine in 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.
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 FDA gave the go-ahead for a Phase III clinical trial and gave orphan drug status to Multikine in the neoadjuvant therapy of squamous cell carcinoma of the head and neck.
