Ut oh! Lpath Suspends Dosing of iSONEP in Clinical Trials Print E-mail
By M.E.Garza   
Friday, 27 January 2012 09:13
FDA CalendarShares of Lpath, Inc. rose over 40% since we helped break their story to biotech investors who have been paying close attention since the firm announced a partnership with Pfizer to develop a wet AMD drug candidate called iSONEP.  Yesterday evening came news that the firm has suspended-- at least temporarily-- the dosing of patients in its PEDigree and Nexus trials and share prices are taking a beating in early trading.

In these trials, iSONEP™ is being tested as a treatment for wet AMD (Nexus) and a related complication called Pigmented Epithelial Detachment (PEDigree) and a news release early Friday morning indicated that the company had taken this action because it learned from the FDA that the company's fill/finish contractor, Formatech, Inc., was not in compliance with FDA's current Good Manufacturing Practice (cGMP) requirements during the period that the iSONEP clinical vials were filled.

Although Lpath believes it has taken appropriate steps to oversee Formatech's manufacturing in order to ensure product quality, it has suspended dosing as a precaution to ensure the continued safety of all patients in its clinical trials. iSONEP was well tolerated by all patients in the Phase 1 trial and by all patients thus far in the PEDigree and Nexus trials. The company has received no claims raising safety concerns regarding iSONEP.

Earlier this week, MarketScanners had called a top to the trading action on the stock from a technical perspective and had advised our premium subscribers first and subsequently others to take profits and close out their positions in the stock. In addtion to several bearish technical indicators, David Ibrahim warned traders that: "In addition to everything else, the company has filed a registration statement to raise up to $10 million through the sale of units comprised of common shares and warrants to purchase common shares. Why wait to be hit with dilution? Wait it out with money in your pockets instead."

Others had continued singing the company's praises in recent days and many had anticipated that 2012 would be a break-out year for the firm. That momentum has certainly been broken by this news and until we learn more, that future seems a little cloudy.

Scott Pancoast, Lpath's president and chief executive officer, commented: "While we are disappointed to learn about these FDA concerns, we believe this issue does not affect the prospects for value creation by our PEDigree and Nexus studies."

"We continue to expect that the resolution of RPE detachments that we saw in each of the two patients in our Phase 1 trial will be repeated in our PEDigree study, and that the significant reductions in lesion size that we also saw in the Phase 1 trial will be repeated in the Nexus study," added Pancoast.

Lpath will be holding a conference this morning at 8:45 a.m. Eastern time to discuss today's news and the company's outlook for 2012.

Details about that call here.

San Diego-based Lpath, a therapeutic antibody company, is the category leader in lipidomics-based antibody therapeutics, an emerging field of medicine that targets bioactive signaling lipids for treating a wide range of human disease. Lpath's ImmuneY2™ drug-discovery engine has the unique ability to generate therapeutic antibodies that bind to and inhibit bioactive lipids that contribute to disease.

Disclosure: None


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