Promising Drug Candidate for Broad Range of Ocular Disorders Moves One Step Closer to Human Trials
SAN DIEGO, CA, USA | April 14, 2008 | Lpath, Inc. (OTCBB: LPTN), the category leader in therapeutic agents against bioactive lipids, has submitted an investigational new drug (IND) application to the U.S. Food and Drug Administration (FDA) for iSONEP(TM).
This drug candidate is the ocular formulation of sonepcizumab, a humanized monoclonal antibody against sphingosine-1-phosphate (S1P). The company expects to begin Phase 1 clinical trials of iSONEP as a treatment for age-related macular degeneration (AMD) early in the third quarter of 2008.
Although Lpath will conduct its Phase 1 for iSONEP in "wet" AMD patients, the company considers iSONEP a potential treatment for a broad range of ocular diseases that extend well beyond wet AMD.
According to Roger A. Sabbadini, Lpath’s founder and chief scientific officer, "Results of Lpath’s ocular discovery program suggest that iSONEP may be a valuable therapeutic in the treatment of diabetic retinopathy, dry AMD, and uveitis, and in the prevention of scar formation associated with many glaucoma-related surgeries. These disorders, besides representing significant market potential, also represent significant unmet medical needs at the present time."
Scott R. Pancoast, Lpath’s president and chief executive officer, added, "This IND is a significant achievement for our organization. Submission of the iSONEP IND package less than four months after the submission of the IND for our first drug candidate, ASONEP(TM), underlines the strength of our drug discovery and development programs."
About iSONEP
iSONEP has demonstrated multiple mechanisms of action in ocular models of disease, including anti-angiogenesis, anti-inflammatory, anti-vascular permeability, and anti-fibrosis. This combination of mechanisms suggests: (i) iSONEP might have a comparative advantage over currently marketed products for the long-term maintenance of wet AMD; and (ii) iSONEP might demonstrate clinical efficacy in a broad range of retinal diseases where there is currently a significant unmet medical need, including diabetic retinopathy, dry AMD, uveitis, glaucoma-related surgery, and proliferative retinopathy.
About Lpath
Lpath, Inc., headquartered in San Diego, California, is the category leader in lipidomics-based therapeutics, an emerging field of medical science whereby bioactive signaling lipids are targeted for treating important human diseases. ASONEP(TM) (the systemic formulation of sonepcizumab) is an antibody against S1P that holds promise for the treatment of cancer and other diseases. A second product candidate, iSONEP(TM) (the ocular formulation of sonepcizumab), has demonstrated superior results in various preclinical AMD and retinopathy models. Lpath’s third product candidate, Lpathomab(TM), is an antibody against LPA, a key bioactive lipid that has been long recognized as a valid disease target. The company’s unique ability to generate novel antibodies against bioactive lipids is based on its ImmuneY2(TM) drug-discovery engine, which the company is using to add to its pipeline. For more information, visit www.Lpath.com.
SOURCE: Lpath, Inc.
Post Views: 133
Promising Drug Candidate for Broad Range of Ocular Disorders Moves One Step Closer to Human Trials
SAN DIEGO, CA, USA | April 14, 2008 | Lpath, Inc. (OTCBB: LPTN), the category leader in therapeutic agents against bioactive lipids, has submitted an investigational new drug (IND) application to the U.S. Food and Drug Administration (FDA) for iSONEP(TM).
This drug candidate is the ocular formulation of sonepcizumab, a humanized monoclonal antibody against sphingosine-1-phosphate (S1P). The company expects to begin Phase 1 clinical trials of iSONEP as a treatment for age-related macular degeneration (AMD) early in the third quarter of 2008.
Although Lpath will conduct its Phase 1 for iSONEP in "wet" AMD patients, the company considers iSONEP a potential treatment for a broad range of ocular diseases that extend well beyond wet AMD.
According to Roger A. Sabbadini, Lpath’s founder and chief scientific officer, "Results of Lpath’s ocular discovery program suggest that iSONEP may be a valuable therapeutic in the treatment of diabetic retinopathy, dry AMD, and uveitis, and in the prevention of scar formation associated with many glaucoma-related surgeries. These disorders, besides representing significant market potential, also represent significant unmet medical needs at the present time."
Scott R. Pancoast, Lpath’s president and chief executive officer, added, "This IND is a significant achievement for our organization. Submission of the iSONEP IND package less than four months after the submission of the IND for our first drug candidate, ASONEP(TM), underlines the strength of our drug discovery and development programs."
About iSONEP
iSONEP has demonstrated multiple mechanisms of action in ocular models of disease, including anti-angiogenesis, anti-inflammatory, anti-vascular permeability, and anti-fibrosis. This combination of mechanisms suggests: (i) iSONEP might have a comparative advantage over currently marketed products for the long-term maintenance of wet AMD; and (ii) iSONEP might demonstrate clinical efficacy in a broad range of retinal diseases where there is currently a significant unmet medical need, including diabetic retinopathy, dry AMD, uveitis, glaucoma-related surgery, and proliferative retinopathy.
About Lpath
Lpath, Inc., headquartered in San Diego, California, is the category leader in lipidomics-based therapeutics, an emerging field of medical science whereby bioactive signaling lipids are targeted for treating important human diseases. ASONEP(TM) (the systemic formulation of sonepcizumab) is an antibody against S1P that holds promise for the treatment of cancer and other diseases. A second product candidate, iSONEP(TM) (the ocular formulation of sonepcizumab), has demonstrated superior results in various preclinical AMD and retinopathy models. Lpath’s third product candidate, Lpathomab(TM), is an antibody against LPA, a key bioactive lipid that has been long recognized as a valid disease target. The company’s unique ability to generate novel antibodies against bioactive lipids is based on its ImmuneY2(TM) drug-discovery engine, which the company is using to add to its pipeline. For more information, visit www.Lpath.com.
SOURCE: Lpath, Inc.
Post Views: 133
