Navigation Links
Lpath Demonstrates Strong Safety Profile of Lead Drug Candidate, Sphingomab(TM), in Non-Human Primates
Date:8/20/2007

SAN DIEGO, Aug. 20 /PRNewswire-FirstCall/ -- Lpath, Inc. (OTC Bulletin Board: LPTN), the category leader in therapeutic agents against bioactive lipids, reported that a standard panel of safety tests was recently completed with the humanized version of Sphingomab(TM), and the findings indicate no safety concern for systemic dosing of the antibody to humans.

Sphingomab, generated by Lpath's proprietary ImmuneY2(TM) platform technology, is a monoclonal antibody against the bioactive lipid S1P (sphingosine-1-phosphate). S1P has been well validated as a stimulator of angiogenesis (new blood-vessel growth), a process that has been strongly implicated in the pathology of both cancer and AMD.

The safety tests included cardiovascular studies in Cynomolgus monkeys as well as tests to evaluate the potential of the antibody to elicit the release of cytokines or an Antibody-Dependent Cell-mediated Cytotoxicity (ADCC) reaction. The cardiovascular study included evaluation of the effect of humanized Sphingomab treatment on blood pressure, heart rate, and respiratory rate. The cardiovascular, cytokine release, and ADCC tests with humanized Sphingomab were all negative at doses or concentrations well above those expected to be needed in man to provide an anti-angiogenic action.

The panel of tests also included a pivotal multiple-dosing 28-day study in Cynomolgus monkeys. This study featured intravenous administration of humanized Sphingomab at doses as great as 100 mg/kg every three days for 28 days (10 total doses). Parameters monitored during this study included mortality, body weight, organ weight, clinical observations, ophthalmology, clinical pathology (hematology, clinical chemistry, coagulation, and urinalysis), and immune-phenotyping, both pre-treatment and on day 28 in all animals, and after one, two, three, and four weeks of recovery in a large sub- group of the animals.

No animal deaths occurred during the study. There were also no significant clinical changes observed during, or following dose administration of 0, 3, 10, 30 or 100 mg/kg. The few minor clinical changes observed were all considered either not related to the administration of humanized Sphingomab or not toxicologically significant. No findings were observed in clinical chemistry, hematology, coagulation or lymphocyte subpopulation measures except for a slight decrease in blood lymphocytes at the highest dose administered, and this effect could not be observed within one week after cessation of dosing.

The histopathology results from this 28-day toxicology study are expected later this quarter, but no negative findings of any significance are expected.

In conclusion, the preclinical safety profile of humanized Sphingomab was extremely favorable throughout a wide variety of studies at high multiples of anticipated human exposure.

"These are extremely encouraging results," said William Garland, Ph.D., Lpath's vice president of drug development. "The favorable findings will provide Lpath with considerable dosing flexibility in our upcoming Phase I clinical trials."

Lpath plans to file an IND in November of 2007 for clinical use of ASONEP(TM) (the systemic formulation of humanized Sphingomab) in the treatment of cancer patients. During the first quarter of 2008, Lpath plans to file a second IND, this one for clinical use of iSONEP(TM) (the ocular formulation of humanized Sphingomab) in the treatment of AMD patients.

Scott Pancoast, Lpath's president and CEO, commented, "The strong safety profile of Sphingomab bolsters not only our cancer program, but also our ocular program, because the drug substance is humanized Sphingomab in both cases."

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 humanized form of Sphingomab(TM)) 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 humanized Sphingomab), has demonstrated superior results in various preclinical AMD 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 http://www.Lpath.com

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 required clinical trials will be successful, necessary regulatory approvals will be obtained, or the proposed treatments will prove to be safe or effective. 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.

Contact:

Scott Pancoast Investor Relations

(858) 678-0800 x104 Liolios Group, Inc.

spancoast@Lpath.com Scott Liolios or Ron Both

http://www.Lpath.com (949) 574-3860


'/>"/>
SOURCE Lpath, Inc.

Copyright©2007 PR Newswire.

Related medicine technology :

1. Lpath Demonstrates First-in-Class AMD Results With Its Lead Drug Candidate, Sphingomab
2. The International Myeloma Foundation Says Data Reported at a Global Medical Meeting in Greece Demonstrates Improved Survival for a Wide Range of Myeloma Patients
3. Publication on Pixantrone Preclinical Studies Demonstrates Reduced Cardiotoxicity Compared to Equiactive Doses of Doxorubicin and Mitoxantrone
4. New Research Demonstrates Broad Efficacy of Azixa (MPC-6827) Against Multiple Tumor Types and in Drug Resistant Cell Lines
5. Algeta Demonstrates Targeted Cancer-killing Potential of Novel Alpha Particle Linked Antibodies in Leading Medical Journal Blood
6. Gerons Telomerase Inhibitor Cancer Drug Demonstrates Good Pharmacokinetics and Tolerability in Phase I/II Trial
7. Frova Phase III Study Data Demonstrates That Short-Term Prevention Treatment Reduces Frequency and Severity of Menstrual Migraine
8. Mymetics HIV Vaccine Demonstrates First-Ever Production of Neutralizing IgA Antibodies in Non-Human Primate Model
9. Cipralex demonstrates superiority to duloxetine for acute treatment of depression in new study
10. Newly Published Data Demonstrates Superiority of Cipralex Over Duloxetine for Acute Treatment of Depression
11. Introgens Advexin Demonstrates Clinical Benefit in Inherited Cancer
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/23/2017)... Research and Markets has announced the addition of the "Menopause ... ... Drugs Price Analysis and Strategies - 2016, provides drug pricing data and ... questions: What are the key drugs marketed ... Global Menopause market? What are the unit prices and ...
(Date:2/23/2017)... Feb. 23, 2017 Research and Markets has ... Strategies - 2016" report to their offering. ... The latest research Fibromyalgia Drugs ... benchmarks in the global Fibromyalgia market. The research answers ... drugs marketed for Fibromyalgia and their clinical attributes? How are they ...
(Date:2/23/2017)... , February 23, 2017 Obese ... increasing caseload for varicose veins in their body. The ... are prompting the adoption of endovenous laser therapy for ... endovenous laser therapy market, published by Future ... lifestyle choices and consequences of obesity have collectively factored ...
Breaking Medicine Technology:
(Date:2/24/2017)... Texas (PRWEB) , ... February 24, 2017 , ... Yisrayl ... that focuses on Bible Prophecy concerning this present generation. Yisrayl makes an astounding ... this current generation. He explains that the Bible details the current times so ...
(Date:2/24/2017)... Emeryville, CA (PRWEB) , ... February 24, 2017 ... ... Esparza for qualifying into the Senior International Elite division on February 12th. ... All Around divisions at the elite qualifier competition held in Las Vegas, Nevada. ...
(Date:2/23/2017)... ... February 23, 2017 , ... ... exclusively to funding innovative lymphoma research and serving the lymphoma community through a ... to the La Gorce Country Club in Miami Beach to host its Swirl: ...
(Date:2/23/2017)... ... February 23, 2017 , ... Rosica Communications, a national ... marketing, social media management, corporate communications, SEO and cause marketing, is opening an ... nearby New Hampshire, Massachusetts and Canada, Rosica will focus on expanding its footprint. ...
(Date:2/23/2017)... ... February 23, 2017 , ... ERT, a ... today announced that Premier Research, a leading clinical development service provider, has selected ... becoming increasingly complex, due in part to an array of circumstances including the ...
Breaking Medicine News(10 mins):