Lpath announced positive summary results of its dose-escalation Phase 1 clinical trial of the investigational drug ASONEP(TM) in cancer patients with a wide variety of solid tumors
SAN DIEGO, CA, USA | March 30, 2010 | Lpath, Inc. (OTC.BB:LPTN – News), the category leader in lipidomics-based therapeutics, announced positive summary results of its dose-escalation Phase 1 clinical trial of the investigational drug ASONEP(TM) 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 (Darmstadt, Germany) and received a $2 million payment according to the terms of Lpath’s license agreement with Merck KGaA.
The summary results also show that the Phase 1 trial met its primary endpoint of identifying safe dose levels for investigation in the Phase 2 setting. ASONEP was 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.
According to Michael Gordon, M.D., the principal investigator in this Phase 1 trial, "These Phase 1 results with ASONEP are encouraging. The safety of ASONEP as demonstrated in this study allows for its evaluation as a single agent or in combination with standard therapies without expectation of significant overlapping toxicities. This safety profile, along with the observation of stable disease in several late-stage cancer patients, provides strong justification for investigation of ASONEP in Phase 2 clinical trials."
Dr. Gordon will be presenting more detailed results of the ASONEP Phase 1 trial at the annual meeting of the American Society of Clinical Oncology in Washington, D.C. on June 7, 2010.
Scott R. Pancoast, Lpath president and CEO, commented: "Our Phase 1 trial further validates our novel approach of targeting bioactive signaling lipids and underscores the potential of our ImmuneY2(TM) drug-discovery engine. Moreover, achievement of the milestone provides evidence that ASONEP is having the expected pharmacological effect in human subjects, which is important with a first-in-class drug candidate."
About Lymphocytes
A lymphocyte is a type of white blood cell that plays an integral role in the body’s defenses. The finding of a reduction in blood lymphocyte counts is consistent with the known role of S1P in stimulating the movement of lymphocytes out of lymph tissue into the blood. As such, ASONEP does not kill lymphocytes; rather, it merely results in a temporary sequestering of them in lymph tissues (e.g., lymph nodes).
About Lpath
San Diego-based Lpath, Inc., a therapeutic antibody company, is the category leader in lipidomics-based therapeutics, an emerging field of medicine that targets bioactive signaling lipids for treating a wide range of human disease. Lpath’s ImmuneY2(TM) drug-discovery engine has the unique ability to generate therapeutic antibodies that bind to and inhibit bioactive lipids that contribute to disease. The company is currently advancing three drug candidates, two of which — ASONEP(TM) for cancer and iSONEP(TM) for wet age-related macular degeneration (AMD) — have completed Phase 1 clinical trials. For more information, go to www.Lpath.com.
SOURCE: Lpath, Inc.
Post Views: 111
Lpath announced positive summary results of its dose-escalation Phase 1 clinical trial of the investigational drug ASONEP(TM) in cancer patients with a wide variety of solid tumors
SAN DIEGO, CA, USA | March 30, 2010 | Lpath, Inc. (OTC.BB:LPTN – News), the category leader in lipidomics-based therapeutics, announced positive summary results of its dose-escalation Phase 1 clinical trial of the investigational drug ASONEP(TM) 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 (Darmstadt, Germany) and received a $2 million payment according to the terms of Lpath’s license agreement with Merck KGaA.
The summary results also show that the Phase 1 trial met its primary endpoint of identifying safe dose levels for investigation in the Phase 2 setting. ASONEP was 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.
According to Michael Gordon, M.D., the principal investigator in this Phase 1 trial, "These Phase 1 results with ASONEP are encouraging. The safety of ASONEP as demonstrated in this study allows for its evaluation as a single agent or in combination with standard therapies without expectation of significant overlapping toxicities. This safety profile, along with the observation of stable disease in several late-stage cancer patients, provides strong justification for investigation of ASONEP in Phase 2 clinical trials."
Dr. Gordon will be presenting more detailed results of the ASONEP Phase 1 trial at the annual meeting of the American Society of Clinical Oncology in Washington, D.C. on June 7, 2010.
Scott R. Pancoast, Lpath president and CEO, commented: "Our Phase 1 trial further validates our novel approach of targeting bioactive signaling lipids and underscores the potential of our ImmuneY2(TM) drug-discovery engine. Moreover, achievement of the milestone provides evidence that ASONEP is having the expected pharmacological effect in human subjects, which is important with a first-in-class drug candidate."
About Lymphocytes
A lymphocyte is a type of white blood cell that plays an integral role in the body’s defenses. The finding of a reduction in blood lymphocyte counts is consistent with the known role of S1P in stimulating the movement of lymphocytes out of lymph tissue into the blood. As such, ASONEP does not kill lymphocytes; rather, it merely results in a temporary sequestering of them in lymph tissues (e.g., lymph nodes).
About Lpath
San Diego-based Lpath, Inc., a therapeutic antibody company, is the category leader in lipidomics-based therapeutics, an emerging field of medicine that targets bioactive signaling lipids for treating a wide range of human disease. Lpath’s ImmuneY2(TM) drug-discovery engine has the unique ability to generate therapeutic antibodies that bind to and inhibit bioactive lipids that contribute to disease. The company is currently advancing three drug candidates, two of which — ASONEP(TM) for cancer and iSONEP(TM) for wet age-related macular degeneration (AMD) — have completed Phase 1 clinical trials. For more information, go to www.Lpath.com.
SOURCE: Lpath, Inc.
Post Views: 111
