CEL-SCI Corporation CVM announced today the Institutional Review
Board (IRB) of the U.S. Navy's Naval Medical Center San Diego (NMCSD), has
approved the start of a Phase I dose escalation study of the Company's
investigational immunotherapy Multikine* (Leukocyte Interleukin, Injection) in
HIV/HPV co-infected men and women with peri-anal warts. This approval marks
the third indication for which Multikine is being investigated in clinical
trials. Multikine is currently being investigated in the largest Phase III
trial in the world for the treatment of head and neck cancer. It has
previously been evaluated as a potential treatment for cervical dysplasia in
HIV/HPV co-infected women and a Phase II study to further investigate this
indication is currently in the planning stages.
The Phase I dose escalation study is being funded and conducted through a
Cooperative Research and Development Agreement (CRADA) between the U.S. Navy
and CEL-SCI. CEL-SCI will contribute the investigational immunotherapy drug
Multikine, will retain all rights to any currently owned technology and will
have the right to exclusively license any new technology developed from the
collaboration. By entering into this CRADA, NMCSD does not directly or
indirectly endorse any product or service provided, or to be provided, by
CEL-SCI, its successors, assignees, or licensees.
Anal and genital warts are commonly associated with the Human Papilloma Virus
(HPV), the most common sexually transmitted disease. The U.S. Center for
Disease Control and Prevention (CDC) has named HPV the 4th largest health
threat the U.S. will face in 2014. According to the CDC, 360,000 people in the
U.S. get genital warts each year. Persistent HPV infection in the anal region
is thought to be responsible for up to 80% of anal cancers. HPV is an even
more significant health problem in the HIV infected population as individuals
are living longer as a result of greatly improved HIV medications, but are
mostly unable to clear HPV due to their weakened immune system.
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