ARTICLE | Clinical News

Neumedicines preclinical data

January 13, 2014 8:00 AM UTC

In non-human primates, a single low-dose subcutaneous injection of HemaMax significantly improved the survival rate at 60 days after exposure to lethal radiation vs. placebo (56% vs. 36%, p<0.05). In a comparator arm, 18 consecutive days of treatment with Neupogen filgrastim, a human G-CSF, did not improve the 60-day survival rate vs. placebo (31% vs. 36%). Additionally, a single dose of HemaMax plus 18 consecutive days of Neupogen non-significantly improved the survival rate vs. HemaMax alone (58% vs. 56%). Furthermore, HemaMax alone significantly reduced the frequency of severe neutropenia (<100 cells/µL, p<0.006) and severe thrombocytopenia (<10,000 cells/µL, p<0.0001) vs. placebo or Neupogen. Neumedicines also said HemaMax plus Neupogen augmented the rate and extent of hematopoietic recovery in all lineages relative to that achieved with HemaMax alone. Neumedicines said HemaMax was given at a dose equivalent to a human dose of 12 µg, which was established to be well tolerated in a Phase Ib trial in healthy volunteers. The company said it plans seek pre-emergency use authorization for HemaMax, which would allow U.S. government stockpiling of the product for use in patients in the event of exposure to lethal doses of radiation. HemaMax is a recombinant human IL-12.

Neumedicines also plans to conduct additional safety trials in humans and a confirmatory efficacy study in non-human primates to provide sufficient data required to support a BLA submission for HemaMax. Last May, the company said a BLA submission for the compound is expected by year end 2016, but that emergency use authorization "could come sooner" (see BioCentury, May 20, 2013 & June 17, 2013). ...