Orchestra Therapeutics discontinues HIV vaccine program

October 04, 2015

Analysis of data from 70 patients who completed a 52 weeks clinical trial in Europe and Canada did not show a clear advantage of Orchestra Therapeutics' second generation HIV vaccine, IR103, over its original whole-killed HIV vaccine, REMUNE(R). Furthermore, although interim analysis of patients in this trial at 36 weeks suggested a trend toward stabilization of CD4+ counts in HAART naive patients vaccinated with REMUNE(R) or IR103, this trend was not observed at week 52.

"While recognizing that the sample size is too small to achieve statistical significance, these results are, nonetheless, less than we had expected," said Joseph F. O'Neill, MD MPH President and CEO of Orchestra Therapeutics. "We are deeply appreciative of the support that our investors, clinical researchers, and patients have given to development of this approach to an HIV vaccine and know that knowledge gained through our efforts will contribute to the eventual discovery of an immune therapy for HIV/AIDS. Our company, however, does not have the resources to move this program forward at this time."

Dr. O'Neill also announced that Orchestra has contracted with PharmaBioSource Realty, LLC to act as a broker to sell its HIV vaccine production facility located in King of Prussia, Pennsylvania. "Selling the assets of this facility will bring new capital into the company, help us to further reduce our burn rate, and thereby strengthen Orchestra's potential to emerge as the world's leading autoimmune immunotherapy company in the months and years ahead."

Orchestra Therapeutics is exploring a number of strategic options for disposition of its other HIV assets. These include sale or donation of its HIV related intellectual property to an entity interested in pursuit of whole killed HIV vaccine technology. Dr. Peter Salk, a member of Orchestra's HIV Scientific Advisory Committee, commented that "The rationale for investigation of a whole killed virus approach to an HIV/AIDS vaccine remains strong. I trust that the effort that Orchestra Therapeutics has made will stimulate other researchers' interest and effort in this field. The HIV/AIDS epidemic is far too devastating to leave any stone unturned in the quest for an effective vaccine."

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According to Dr. Morse, it is likely that the emergence of ,novel, infections such as SARS, H5NI influenza and HIV/AIDS will continue and possibly even increase in the future, making early warning increasingly critical. "Unfortunately the outlook for global surveillance capabilities is variable in most of the world and varies from weak to virtually nonexistent." He attributes the limited global capabilities to a combination of factors including health's low priority on government agendas and the delayed reporting of disease information. "Governments are often reluctant to report disease information for fear of political embarrassment, economic repercussions, or concern that it may make the government look ineffectual," noted Dr. Morse. He also suggests that infectious disease activities may fall victim to overall competition for limited public health resources.

Despite some progress many more improvements are needed, believes Dr. Morse. He outlines the following recommendations: Coordinating reporting systems worldwide to ensure compatible standards for aggregating and sharing data. The new WHO International Health regulations may provide an opportunity to develop a consistent worldwide system; Encourage improvements by providing additional resources; Further encourage clinicians and health officials to report by providing useful feedback; Train local people to recognize and report outbreaks where clinicians are in short supply; and Educate policymakers to consider disease surveillance a priority.

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