SuperGen has discontinued clinical development of its Phase 1 PIM kinase drug candidate, SGI-1776, while continuing development of the PIM inhibitor program.
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SuperGen said that the dose limiting toxicity of cardiac QTc prolongation was identified previously in the Phase 1 study in patients with refractory prostate and lymphoma.
Additional detailed cardiac and pharmacokinetic data evaluation of SGI-1776 in this trial has failed to demonstrate a safe therapeutic window to prudently continue clinical development of this molecule.
SuperGen stated that its discovery and development teams are still committed to pursue PIM kinase inhibition as a highly attractive cancer treatment target by continuing to evaluate back-up drug candidates that may exhibit a more favorable safety profile.
SuperGen president and CEO James Manuso said that while they were disappointed with the toxicity seen in patients receiving SGI-1776 and the discontinuation of the development of the specific compound, PIM kinase continues to be an important target for oncology drug development.
"The discovery team has identified backup candidates that initially appear to lack some of the liabilities seen in SGI-1776," Manuso said.
"We continue to pursue inhibitors of PIM that might exhibit a more favorable therapeutic profile."
SuperGen chief medical officer Mohammad Azab said that they continue to believe that PIM inhibition is an important new approach to the treatment of cancer, including patients with refractory acute myeloid leukemia.
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