Important note: Information in this article was accurate in 2003. The state of the art may have changed since the publication date.
PRNewswire - December 23, 2003
The new HIV vaccine incorporates proprietary technology exclusively licensed to CytRx by the University of Massachusetts Medical School (UMMS) and ABL. The HIV Vaccine project has been funded to date in whole by federal funds from the National Institute of Allergy and Infectious Diseases, National Institutes of Health. The funds under this program, totaling approximately $15 million, are expected to provide all of the needed funding for the Phase I trial, and UMMS will be primarily responsible for conducting this trial under a subcontract arrangement.
An IND for the Phase I trial is expected to be filed with the FDA by January 31, 2004, and CytRx and ABL expect the Phase I trial to begin within 30 days after obtaining IND clearance from the FDA. The Phase I trial is projected to take approximately 12-18 months to complete.
"There is a worldwide urgent need for an effective HIV vaccine, said Steven A. Kriegsman, Chief Executive Officer of CytRx. "With the anticipated launch of the Phase I trial for this vaccine utilizing our licensed UMMS technology, we will take a major step forward in efforts to create such a vaccine. ABL is a well-recognized leader in the fields of HIV research and vaccine technology and CytRx looks forward to working together with ABL to develop and bring this exciting new product to the market."
Under the terms of CytRx's new collaboration agreement with ABL, CytRx will assume ownership of and responsibility for the HIV vaccine FDA registration following completion of the Phase I trial. ABL will have an option to acquire the commercial manufacturing rights for the vaccine if the FDA approves it for use.
ABL and UMMS have also filed a joint patent application in the U.S. and other countries covering the combination of the HIV vaccine technology owned by UMMS and licensed exclusively to CytRx and covered by a pending patent application and a UMMS-developed HIV protein boost technology for which ABL has previously filed a patent application. CytRx and ABL said that the combined patent application will supercede the earlier, separate patent applications and should increase the strength of the patent claims for both technologies, and help to secure protection of valuable intellectual property.
The HIV protein boost technology has been added to CytRx's exclusive license, under which it will make milestone development and royalty payments to UMMS and ABL for the current HIV vaccine that is being developed and any future HIV vaccines utilizing these technologies.
In addition to the HIV vaccine technology, CytRx also has exclusive technology licenses from UMMS for RNAi-based therapies for amyotrophic lateral sclerosis (ALS, also known as Lou Gehrig's Disease) and for obesity and type 2 diabetes.
About CytRx Corporation
CytRx Corporation is a biopharmaceutical company engaged in the development and commercialization of large-market opportunity products in a variety of therapeutic categories. The company formed a broad-based strategic alliance with the University of Massachusetts Medical School to develop novel compounds for obesity, type 2 diabetes and ALS, including using a promising new technology known as RNA interference (RNAi). CytRx licensed from UMMS the exclusive worldwide rights to a DNA-based HIV vaccine technology. The company also has a research program with Massachusetts General Hospital, Harvard University's teaching hospital, to use RNAi technology to develop a drug for the prevention, treatment or cure for ALS. The company has licensed its TranzFect delivery technology for DNA-based vaccines for certain diseases. A CytRx subsidiary also holds interests in two development stage genomics-based healthcare companies. For more information, visit CytRx's website at http://www.cytrx.com .
About Advanced BioScience Laboratories
Advanced BioScience Laboratories, Inc. (ABL) is a biomedical research, development and manufacturing company focusing on human retroviral diseases. ABL is located in Kensington, Maryland. For more information visit ABL's website at http://www.ablinc.com .
This press release contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, that involve risks and uncertainties that could cause actual events or results to differ materially from the events or results described in the forward-looking statements, including risks or uncertainties related to the risk that ABL may encounter delays in filing the IND or in having the IND cleared by the FDA or in starting the Phase I vaccine trial due to delays in obtaining clinical supplies of the vaccine or for other reasons, the risk of delays in completing and the uncertainty of the results of the Phase I trial or future trials, the risk of the NIH grant being cancelled or providing insufficient funds to complete the Phase I trial, the risk of obtaining adequate or any patent coverage for the HIV vaccine, and the need to obtain substantial funding to carry out subsequent clinical trials for the HIV vaccine. Additional uncertainties and risks are described in CytRx's most recently filed SEC documents, such as its most recent annual report on Form 10-K, all quarterly reports on Form 10-Q and any current reports on Form 8-K filed since the date of the last Form 10-K. All forward-looking statements are based upon information available to CytRx on the date the statements are first published. CytRx undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
SOURCE CytRx Corporation
Web Site: http://www.cytrx.com
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