SOURCE: Lpath, Inc.

December 20, 2007 08:00 ET

Anti-Bioactive-Lipid Category Leader, Lpath, Achieving Key 2007 Milestones

SAN DIEGO, CA--(Marketwire - December 20, 2007) - Lpath, Inc. (OTCBB: LPTN), the category leader in therapeutic agents against bioactive lipids, today issued a review of recent progress with its various drug-development and drug-discovery programs and presented an update on the company's objectives for 2007.

Review of 2007 Goals and Objectives

During the latter part of 2006, Lpath management announced a number of key goals and objectives for 2007 designed to enhance value for the company's shareholders. These were included in a press release issued September 11, 2006, and the company takes this opportunity to compare them against actual results and to discuss future plans.

A.  2007 Goals Relating to Drug Development Programs of Sonepcizumab
    (the humanized version of Sphingomab™) for Cancer and AMD:

       1.  Demonstrate favorable 28-day mouse tox results:  Earlier in
           2007, Lpath demonstrated a very satisfactory safety profile
           for the murine form of sonepcizumab in a 28-day mouse-tox
           study.  These results were used to help design the protocol
           for our safety studies of sonepcizumab in non-human
           primates (monkeys).

       2.  Demonstrate favorable GLP monkey-tox results:  As announced
           in a recent press release, the preclinical safety profile of
           sonepcizumab was extremely favorable throughout a wide
           variety of non-human primate studies at high multiples of
           anticipated human exposure.

       3.  File an IND for the use of sonepcizumab in cancer patients:
           Yesterday, Lpath submitted an IND application for the use
           of sonepcizumab in cancer patients.  As previously reported,
           given the compelling data seen with sonepcizumab in various
           ocular studies, Lpath has decided to move ahead with an IND
           filing for sonepcizumab to treat patients with AMD
           (Age-related Macular Degeneration).  Lpath plans to submit
           this second IND in the first half of 2008.

B.  2007 Goals Relating to Lpathomab™ Drug Development Program:

       1.  Demonstrate efficacy in mice:  Lpath recently reported robust
           anti-angiogenic activity of Lpathomab [an antibody against LPA
           (lysophosphatidic acid)] in several mouse models of human
           cancer, AMD, and other disorders.  In these studies, the
           company confirmed the expected anti-metastatic and
           anti-tumorigenic action of the antibody and also showed potent
           efficacy in other models of human disease where there are
           significant unmet needs.

       2.  Humanize the antibody:  Based on the compelling efficacy
           results with Lpathomab in various preclinical models of
           disease, Lpath recently entered into an agreement with
           DataMabs to humanize the antibody, a major step in moving
           Lpathomab into the clinic.

       3.  Demonstrate favorable safety profile in a 28-day mouse
           toxicity study:  Lpath expects to demonstrate a satisfactory
           safety profile for Lpathomab next year.

       4.  Begin cell-line development:  After Lpath humanizes,
           characterizes and, if necessary, optimizes the antibody,
           it will begin the cell-line development process to provide
           a method for producing larger quantities of the antibody.
           This effort will start early in 2008.

C.  2007 Goals Relating to Lpath's Third Drug Development Program:

       1.  Select the next bioactive-lipid target from Lpath's current
           list of candidates:  Lpath expanded this milestone in that
           it has already chosen its next three bioactive-lipid targets.

       2.  Generate immune response in mice to the desired target:
           Using its proprietary drug-development engine, ImmuneY2™,
           the company has already generated an immune response in mice
           (i.e., whereby antibodies are produced) against the first of
           these three targets.  It expects to have monoclonal
           antibodies against this target in early 2008.

       3.  Demonstrate functionality and specificity of selected
           antibodies:  Lpath looks to demonstrate the utility of at
           least one of the antibodies by mid-2008.

"All in all, we continue to meet our objectives and achieve key milestones," noted Scott Pancoast, Lpath president and CEO. "Given that we have now submitted our IND for use of sonepcizumab in cancer patients, and given the benign safety profile that we've seen with sonepcizumab, we now consider ourselves 'virtually clinical' and expect to begin dosing patients shortly."

Continued Pancoast, "Another reflection of our recent success is the extremely good score we received from the NIH for our grant application relating to sonepcizumab for the treatment of AMD. This score nearly assures the award of approximately $1.4 million from the NIH early next year to further our progress in an area where our results -- in two well accepted models of AMD -- have proven to be best-in-class.

"All of the progress we've demonstrated over the last several quarters has intensified the focus on Lpath amongst potential strategic partners. We will continue to explore all of our strategic options and will home in on those opportunities that drive the most value for our shareholders. In the early part of 2008, we will review with the investment community our goals and objectives for 2008."

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™ (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™ (the ocular formulation of sonepcizumab), has demonstrated superior results in various preclinical AMD and retinopathy models. Lpath's third product candidate, Lpathomab™, 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™ drug-discovery engine, which the company is using to add to its pipeline. For more information, visit

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.