Anti-Bioactive-Lipid Category Leader to Initiate Phase 1 Clinical Trial for the Use of ASONEP in Cancer Patients
SAN DIEGO, CA, USA | February 5, 2008 | Lpath, Inc. (OTCBB: LPTN), the category leader in therapeutic agents against bioactive lipids, today announced the FDA, after review of the company’s December 2007 Investigational New Drug (IND) submittal, has allowed the administration of ASONEP(TM) into human cancer patients in a Phase 1 clinical trial.
Generated via Lpath’s proprietary ImmuneY2(TM) drug discovery engine, ASONEP is a humanized monoclonal antibody that neutralizes Sphingosine-1-Phosphate ("S1P"), a bioactive lipid that stimulates tumor cell migration, invasion, and survival, while also promoting in vivo angiogenesis.
Lpath will soon begin dosing patients in the first clinical study ever performed involving an antibody that inhibits a bioactive lipid. Lpath plans a multi-center Phase 1 open-label, single-arm, dose escalation trial in the United States. Investigators will assess the safety and tolerability of the intravenous infusion of ASONEP in patients with refractory advance solid tumors. Other endpoints include ASONEP’s pharmacokinetics, pharmacodynamics, and immunogenicity, as well as exploration of the molecule’s mechanism of action. Doses will be given for a four-week period, with an option for an additional four weeks of therapy if disease improvement or stabilization is observed.
"Given how well ASONEP was tolerated in our pivotal non-human-primate study, we anticipate ASONEP will be shown to be safe in human cancer patients at dose levels that we believe will be efficacious," said Lpath’s vice president of drug development, William Garland, Ph.D.
Roger Sabbadini, Ph.D., Lpath’s founder and chief scientific officer, added, "This is a historic moment for our first-in-class therapeutic, as never before has anyone directly targeted and neutralized a bioactive lipid in patients."
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 LPA 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
About Forward-Looking Statements:
Except for statements of historical fact, the matters discussed in this press release are forward looking and reflect numerous assumptions and involve a variety of risks and uncertainties, many of which are beyond our control and may cause actual results to differ materially from stated expectations. For example, there can be no assurance that results will be timely, necessary regulatory approvals will be obtained, the proposed treatments will prove to be safe or effective, or required clinical trials will be ultimately successful. Actual results may also differ substantially from those described in or contemplated by this press release due to risks and uncertainties that exist in our operations and business environment, including, without limitation, our limited experience in the development of therapeutic drugs, our dependence upon proprietary technology, our history of operating losses and accumulated deficits, our reliance on research grants, current and future competition, and other risks described from time to time in our filings with the Securities and Exchange Commission. We undertake no obligation to release publicly the results of any revisions to these forward-looking statements to reflect events or circumstances arising after the date hereof.
SOURCE: Lpath, Inc.
Post Views: 146
Anti-Bioactive-Lipid Category Leader to Initiate Phase 1 Clinical Trial for the Use of ASONEP in Cancer Patients
SAN DIEGO, CA, USA | February 5, 2008 | Lpath, Inc. (OTCBB: LPTN), the category leader in therapeutic agents against bioactive lipids, today announced the FDA, after review of the company’s December 2007 Investigational New Drug (IND) submittal, has allowed the administration of ASONEP(TM) into human cancer patients in a Phase 1 clinical trial.
Generated via Lpath’s proprietary ImmuneY2(TM) drug discovery engine, ASONEP is a humanized monoclonal antibody that neutralizes Sphingosine-1-Phosphate ("S1P"), a bioactive lipid that stimulates tumor cell migration, invasion, and survival, while also promoting in vivo angiogenesis.
Lpath will soon begin dosing patients in the first clinical study ever performed involving an antibody that inhibits a bioactive lipid. Lpath plans a multi-center Phase 1 open-label, single-arm, dose escalation trial in the United States. Investigators will assess the safety and tolerability of the intravenous infusion of ASONEP in patients with refractory advance solid tumors. Other endpoints include ASONEP’s pharmacokinetics, pharmacodynamics, and immunogenicity, as well as exploration of the molecule’s mechanism of action. Doses will be given for a four-week period, with an option for an additional four weeks of therapy if disease improvement or stabilization is observed.
"Given how well ASONEP was tolerated in our pivotal non-human-primate study, we anticipate ASONEP will be shown to be safe in human cancer patients at dose levels that we believe will be efficacious," said Lpath’s vice president of drug development, William Garland, Ph.D.
Roger Sabbadini, Ph.D., Lpath’s founder and chief scientific officer, added, "This is a historic moment for our first-in-class therapeutic, as never before has anyone directly targeted and neutralized a bioactive lipid in patients."
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 LPA 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
About Forward-Looking Statements:
Except for statements of historical fact, the matters discussed in this press release are forward looking and reflect numerous assumptions and involve a variety of risks and uncertainties, many of which are beyond our control and may cause actual results to differ materially from stated expectations. For example, there can be no assurance that results will be timely, necessary regulatory approvals will be obtained, the proposed treatments will prove to be safe or effective, or required clinical trials will be ultimately successful. Actual results may also differ substantially from those described in or contemplated by this press release due to risks and uncertainties that exist in our operations and business environment, including, without limitation, our limited experience in the development of therapeutic drugs, our dependence upon proprietary technology, our history of operating losses and accumulated deficits, our reliance on research grants, current and future competition, and other risks described from time to time in our filings with the Securities and Exchange Commission. We undertake no obligation to release publicly the results of any revisions to these forward-looking statements to reflect events or circumstances arising after the date hereof.
SOURCE: Lpath, Inc.
Post Views: 146
