Lpath reported positive summary results of its dose-escalation Phase I trial of Asonep in cancer patients with a wide variety of solid tumors. Study results included demonstration that lymphocyte counts in the vascular space were reduced in a dose-related fashion. As such, Lpath achieved an objective established by Merck KGaA and received a $2 million payment according to the terms of Lpath’s license agreement with Merck KGaA.
Concurrently, Lpath reported that Merck had proposed moving forward with the partnership via an extension of the opt-in deadline. The extension proposal from Merck, however, included terms that were rejected by Lpath’s board as not being in the best interest of Lpath or its stockholders. Consequently, the license agreement between the two firms has been terminated effective April 24, at which time Merck will relinquish all rights to the Asonep program.
"Lpath will aggressively seek to re-partner its Asonep program," said Scott R. Pancoast, Lpath’s president and CEO," and based on the program’s many successes thus far, we’re confident we will do so on terms that are more favorable to our stockholders than those offered by Merck KGaA. These compelling factors include strong efficacy signals from a wide spectrum of preclinical studies in animal models involving renal cell carcinoma, prostate cancer, neuroblastoma, ovarian cancer, and lung cancer, and now the successful completion of the Phase I trial that demonstrated an excellent safety profile and produced evidence of pharmacological activity in cancer patients."
The summary results show that the Phase I trial met its primary endpoint of identifying safe dose levels for investigation in the Phase II setting. Asonep was reportedly well tolerated at all the dose levels studied, which ranged from 1 mg/kg to 24 mg/kg. More than half the patients that completed the initial four-treatment evaluation period showed stable disease. Durable stable disease was observed in several patients.