Clinical Trial Marks First Time Any Human Has Been Dosed With a Compound That Inhibits a Bioactive Lipid
SAN DIEGO, CA, USA | April 21, 2008 | Lpath, Inc. (OTCBB: LPTN), the category leader in bioactive-lipid-based therapeutics, initiated its first Phase 1 clinical trial on April 16, 2008 by dosing a cancer patient with its lead drug candidate, ASONEP(TM), a monoclonal antibody targeting sphingosine-1-phosphate ("S1P"). ASONEP is the systemic version of sonepcizumab and the humanized version of Sphingomab(TM).
"We view this to be a historic moment for our company," noted Roger Sabbadini, Ph.D., founder and chief scientific officer of Lpath, "as it represents the first time any human has been dosed with a drug candidate that inhibits a bioactive lipid."
Like Genentech’s Avastin(R), ASONEP is an anti-angiogenic agent, restricting new blood-vessel growth that tumors need to proliferate and metastasize. According to a large body of scientific literature, ASONEP’s target, S1P, is a potent angiogenic factor, with not only direct effects on angiogenesis, but also profound indirect effects as well.
S1P has also been highly correlated with drug resistance across a wide array of tumor types, as well as with increased mortality of many different types of cancer patients. By inhibiting S1P activity with ASONEP, Lpath believes cancer patients can overcome drug resistance and experience increased survivability.
According to Scott Pancoast, Lpath president and chief executive officer, "The initiation of this human trial represents Lpath’s most significant milestone to date. With its multiple mechanisms of action, ASONEP has the potential to take the treatment of cancer to the next level."
Lpath’s ASONEP Phase 1 trial is a dose-escalation study, with an initial dose of 1 milligram per kilogram of body weight ("mg/kg") and subsequent doses of 3, 10, 17, and 24 mg/kg. Patients with solid tumors will be enrolled; and, assuming ASONEP is well tolerated, each patient will receive a minimum of eight intravenous treatments at a specific dose level.
After a maximum tolerated dose is established, Lpath will conduct a Phase 1b trial extension, whereby up to ten patients, likely with the same tumor type, will be treated.
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), in Phase 1 trials, is an antibody against S1P that holds promise for the treatment of cancer, multiple sclerosis, and other diseases. iSONEP(TM), an anti-S1P antibody formulated for ocular applications, 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
Post Views: 122
Clinical Trial Marks First Time Any Human Has Been Dosed With a Compound That Inhibits a Bioactive Lipid
SAN DIEGO, CA, USA | April 21, 2008 | Lpath, Inc. (OTCBB: LPTN), the category leader in bioactive-lipid-based therapeutics, initiated its first Phase 1 clinical trial on April 16, 2008 by dosing a cancer patient with its lead drug candidate, ASONEP(TM), a monoclonal antibody targeting sphingosine-1-phosphate ("S1P"). ASONEP is the systemic version of sonepcizumab and the humanized version of Sphingomab(TM).
"We view this to be a historic moment for our company," noted Roger Sabbadini, Ph.D., founder and chief scientific officer of Lpath, "as it represents the first time any human has been dosed with a drug candidate that inhibits a bioactive lipid."
Like Genentech’s Avastin(R), ASONEP is an anti-angiogenic agent, restricting new blood-vessel growth that tumors need to proliferate and metastasize. According to a large body of scientific literature, ASONEP’s target, S1P, is a potent angiogenic factor, with not only direct effects on angiogenesis, but also profound indirect effects as well.
S1P has also been highly correlated with drug resistance across a wide array of tumor types, as well as with increased mortality of many different types of cancer patients. By inhibiting S1P activity with ASONEP, Lpath believes cancer patients can overcome drug resistance and experience increased survivability.
According to Scott Pancoast, Lpath president and chief executive officer, "The initiation of this human trial represents Lpath’s most significant milestone to date. With its multiple mechanisms of action, ASONEP has the potential to take the treatment of cancer to the next level."
Lpath’s ASONEP Phase 1 trial is a dose-escalation study, with an initial dose of 1 milligram per kilogram of body weight ("mg/kg") and subsequent doses of 3, 10, 17, and 24 mg/kg. Patients with solid tumors will be enrolled; and, assuming ASONEP is well tolerated, each patient will receive a minimum of eight intravenous treatments at a specific dose level.
After a maximum tolerated dose is established, Lpath will conduct a Phase 1b trial extension, whereby up to ten patients, likely with the same tumor type, will be treated.
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), in Phase 1 trials, is an antibody against S1P that holds promise for the treatment of cancer, multiple sclerosis, and other diseases. iSONEP(TM), an anti-S1P antibody formulated for ocular applications, 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
Post Views: 122
