SuperGen, Inc. announced that it has discontinued clinical development of its phase 1 PIM kinase drug candidate, SGI-1776, while continuing development of the PIM inhibitor programme.
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. SGI-1776 was not associated with any other clinically significant adverse effects. SuperGen 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 favourable safety profile.
"While we are disappointed with the toxicity seen in patients receiving SGI-1776 and the discontinuation of the development of this specific compound, PIM kinase continues to be an important target for oncology drug development," said James S.J. Manuso, Ph.D., president and chief executive officer. "The discovery team has identified backup candidates that initially appear to lack some of the liabilities seen in SGI-1776. We continue to pursue inhibitors of PIM that might exhibit a more favourable therapeutic profile."
"We continue to believe that PIM inhibition is an important new approach to the treatment of cancer, including patients with refractory acute myeloid leukaemia," said Mohammad Azab, M.D., chief medical officer. "Given a significant, unmet need for effective therapies for these patients, SuperGen will continue to research drug candidates that might serve as an effective and safe treatment in this, and other, cancers."
SuperGen is a pharmaceutical company dedicated to the discovery and development of novel cancer therapeutics in epigenetic and cell signalling modulation. The company develops products through biochemical and clinical proof of concept to partner for further development and commercialization.