Lpath, Inc. has been advised by Merck Serono, a division of Merck KGaA, (Darmstadt, Germany) that Merck Serono has exercised its right to extend the "initial development period," the period during which Lpath is responsible, in close collaboration with Merck Serono, for development of Asonep.
While the Asonep license agreement provided Merck Serono the right to extend this period to April 28, 2010, the parties agreed upon a revised date of June 27, 2010 in order to complete the phase 1 study and various non-clinical studies undertaken to further the development of Asonep as contemplated in the License Agreement. Lpath will continue to receive the previously agreed upon monthly research and development funding from Merck Serono until April 28, 2010. In addition, Lpath remains eligible to earn development milestone payments during the extension period.
Lpath is nearing completion of its Asonep phase 1 clinical trial in cancer patients. The drug candidate was well tolerated at all tested dose levels, and there have been no drug-related Serious Adverse Events reported. Lpath expects to complete enrolment in its phase 1 trial within a few weeks, but dosing of these patients may continue for several months.
Scott Pancoast, Lpath's CEO, commented: "We expect the additional insights gleaned from the remaining phase 1 patients and the extended collaboration will be extremely valuable in designing phase 2 clinical trials for Asonep. We continue to work hand-in-hand with Merck Serono in a collaborative effort to advance the Asonep program to the next level."
San Diego-based Lpath, Inc. is the category leader in lipidomics-based therapeutics, an emerging field of medicine that targets bioactive signalling lipids for treating a wide range of human disease.