VIENNA, Va., Jan. 22 /PRNewswire-FirstCall/ -- CEL-SCI Corporation (Amex: CVM - News) has signed a letter of intent with BioProperties, Inc., a privately held real estate firm specialized in the biomedical sector, to acquire and build out to CEL-SCI’s specifications a turn-key CGMP drug manufacturing facility for CEL-SCI’s cancer product Multikine®. CEL-SCI was recently given the green light by the FDA to start a Phase III clinical trial of head & neck cancer patients with Multikine.
This manufacturing facility is an integral part of moving Multikine into the Phase III clinical trial and later commercialization. The commitment, subject to a final contract, is for $15 million. The facility is expected to cost about $12 - 14 million, to be paid through a long-term lease agreement.
According to Stan Wendzel, Managing Director of BioProperties, Inc., “CEL- SCI has made tremendous progress advancing their Multikine product candidate towards FDA approval. We are very excited to be providing a facility to CEL- SCI that will allow them to complete the Phase III trials for Multikine and ultimately bring this important product to market.”
Geert Kersten, Chief Executive Officer of CEL-SCI said, “This facility represents a huge step forward for our Company. We will be able to produce our drug Multikine in our own CGMP facility for Phase III trials as well as for sale once marketing approval is granted. From a regulatory perspective and for the control of the manufacturing process this is the most prudent way for the Company to proceed. An additional benefit of having this facility is that, during the Phase III study, it may also be used for contract manufacturing work with other biotech companies and/or the U.S. government since it will contain a clean cold-fill suite. The ability to aseptically fill in the cold is rapidly becoming very important for many bio-defense and other biologic drugs, and is aimed at avoiding the large biological activity losses seen in these products when cold aseptic fill is not available.”
The CGMP drug manufacturing facility design and use plan have been reviewed by the appropriate regulatory bodies and all recommendations received were incorporated.
CEL-SCI Corporation is developing new immune system based treatments for cancer and infectious diseases. 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, inability to get American Stock exchange approval for any transaction 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 thereof or to reflect the occurrence of unanticipated events.
CONTACT: Gavin de Windt of CEL-SCI Corporation, +1-703-506-9460
Source: CEL-SCI Corporation
