Orchestra Therapeutics Inc. has decided to discontinue its HIV vaccine development program after data from a year-long trial failed to produce desired results.
An analysis of data from 70 patients who completed a 52-week Phase II trial in Europe and Canada did not show a clear advantage of its second-generation HIV vaccine, IR103, over its original whole-killed HIV vaccine, Remune. While an interim 36-week analysis of patients suggested a trend toward stabilization of CD4+ counts in HAART-naive patients vaccinated with Remune or IR103, that 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," Joseph F. O'Neill, president and CEO of Carlsbad, Calif.-based Orchestra, said in a news release. To reduce its burn rate, O'Neill said Orchestra has contracted with PharmaBioSource Realty LLC to act as a broker to sell its HIV vaccine production facility located in King of Prussia, Pa. It also is exploring options for disposal of other HIV assets, including sale or donation of its HIV-related intellectual property.
Formerly known as The Immune Response Corp., Orchestra's only other product candidate in the clinic is NeuroVax, a T-Cell Receptor peptide in relapsing-remitting multiple sclerosis. In June it presented data from a Phase II open-label study showing it increased levels of TCR-specific T cells and expanded the capacity of the T cells to recognize TCRs expressed by potentially pathogenic T cells.
Orchestra's shares (OTC BB:OCHT) gained 1 cent Wednesday, closing at 52 cents.