>>LOS ANGELES, Sept. 20 /PRNewswire-FirstCall/ -- CytRx Corporation (Nasdaq: CYTR - News), Advanced BioScience Laboratories (ABL) and the University of Massachusetts Medical School (UMMS) announced today that enrollment in the ongoing Phase I HIV vaccine clinical trial at UMMS is proceeding to the final cohort of participants.
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"We are grateful for the enthusiastic responses from the participants. Recruitment to date has allowed us to quickly enroll the first two groups for the trial," said Jeff Kennedy, M.D., assistant professor of medicine at UMMS and principal investigator of the clinical trial. "Interim safety and tolerability data from these groups are currently being reviewed; and we are optimistic that we will get permission from our Institutional Review Board to recruit for the remaining 12 slots for the escalated DNA dose beginning in late September through October."
The clinical trial's primary objective is to determine the safety and tolerability of different dosages of the novel HIV DNA vaccine and a fixed dosage of the HIV protein boost. The HIV vaccine formulation created by researchers at UMMS and ABL is a polyvalent vaccine based on multiple strains of HIV collected directly from infected people living in five locations around the globe, representing five different strains of the virus. The approach uses elements of HIV's DNA to induce an immune response to the virus. The DNA is then boosted by an injection of recombinant HIV proteins that in animal models have been shown to enhance the immune response to the DNA elements of the vaccine. The vaccine contains elements from the HIV genome, not the live virus and, therefore, individuals receiving inoculations cannot get HIV from the vaccine.
The ongoing clinical trial will eventually enroll a total of 36 people who are not infected with HIV. Over the course of the trial, each participant will receive three doses of the DNA element of the vaccine and two doses of the protein boost element of the vaccine. The participants will be monitored at regular intervals, and researchers will look for any adverse events as well as for antibody responses and cell-mediated immune responses, which is the ability of the vaccine to cause the host to produce T-cells that kill HIV-infected cells.
The HIV vaccine is exclusively licensed to CytRx by UMMS and ABL. To date, the HIV vaccine project has been funded under a 5-year HIV Vaccine Design and Development Team contract from the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health. The funds under this program, totaling approximately $16 million, are expected to provide all of the needed funding for the Phase I trial.
"We are extremely pleased with the progress of enrollment to date," said Steven Kriegsman, President and CEO of CytRx. "Our goal is to develop a successful vaccine to prevent this worldwide epidemic of HIV/AIDS."<<
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Regarding BofA report for ALNY . . . George sometimes can get that stuff:
Member 7629647
Cheers, Tuck |
