Lpath, San Diego State University, And M. D. Anderson Cancer Center Scientists Show Novel Antibody May Reduce Or Eliminate Tumors

Published: Mar 14, 2006

SAN DIEGO, March 14 /PRNewswire-FirstCall/ -- Roger Sabbadini, the founder and chief scientific officer of Lpath, Inc. , has brought science one step closer to finding a cure for cancer.

As published in the March 14 issue of Cancer Cell, Sabbadini and his research team have created an antibody that reduces the size of tumors in animal models of human cancer. The antibody, dubbed Sphingomab(TM), binds and neutralizes sphingosine-1-phosphate (S1P), a member of a special class of lipids called sphingolipids. The antibody hinders the growth of tumors by preventing blood-vessel formation and by inhibiting metastatic potential (metastasis).

S1P has recently garnered considerable attention in the scientific community as a validated mediator of tumor cell proliferation and a validated protector of tumor cells from chemotherapy drugs. It has also been recently discovered that S1P stimulates the growth of new blood vessels that tumors require to thrive, a process called 'tumor angiogenesis.'

The Sphingomab antibody, developed in Lpath's lab, was used in collaboration with SDSU and M.D. Anderson Cancer Center to treat mice implanted with multi-drug-resistant human breast, lung, and ovarian cancer cell lines and in a mouse melanoma (skin cancer) cell line. In the lung, breast, and melanoma cancer models, tumor volumes were reduced by about 60 percent.

Results that are even more impressive were seen in the ovarian cancer models: Of the five Sphingomab-treated subjects, two of the tumors were eliminated altogether, and the three others showed an average tumor-volume reduction of 68 percent as compared with the controls.

In two of the studies, the tumors were excised and stained, revealing significant cell death and fibrosis in the Sphingomab-treated tumors as compared with the untreated tumors. As such, the already-impressive volume- reduction percentages may significantly underestimate the actual impact of Sphingomab.

"This groundbreaking research provides new hope for therapeutic treatments for those cancers that are resistant to current therapeutics," Sabbadini said. "The antibody is especially powerful as it is shown to prevent tumors from a variety of cancers, as opposed to being effective against only one type of cancer."

Given that nearly all drugs currently on the market bind (or target) proteins, Sabbadini's anti-sphingolipid approach is revolutionary, and it positions Lpath as the pioneer of a new and emerging field called lipidomic therapeutics.

"We're optimistic that our technology can markedly improve cancer therapy," says Scott Pancoast, Lpath's president and CEO. "While Genentech pioneered the anti-angiogenesis approach to treating cancer with their blockbuster drug, Avastin, we believe we have taken their approach one step further with an antibody that appears to be more potent and that has additional mechanisms of action. An added advantage of the Sphingomab story is its theranostics dimension, whereby we can use our proprietary diagnostic tools to determine which patients are most likely to benefit from treatment with Sphingomab...i.e., personalized therapy."

Besides Sabbadini, the authors of the Cancer Cell paper include: Barbara Visentin, John Vekich, Brad Sibbald, Amy Cavalli, Kelli Moreno, Rosalia Matteo, William Garland, all of Lpath; and Gordon Mills, Yiling Lu, Shuangxing Yu, Hassan Hall, and Vikas Kundra of the University of Texas M.D. Anderson Cancer Center in Houston.

Sabbadini will present some of the team's findings reported in Cancer Cell, as well as new findings relating to liquid tumors, at the annual conference for the American Association of Cancer Researchers, April 1-5, in Washington D.C. Lpath plans to apply for FDA approval for human clinical trials for Sphingomab in 2007.

Of Lpath's nearly 30 patents (issued and pending), more than ten of them provide broad protection of the Sphingomab technology.

About Lpath

Lpath, headquartered in San Diego, is a theranostics company focused on bioactive signaling lipids as targets for treating and diagnosing important human diseases, including cancer, heart failure, and age-related macular degeneration. Lpath's lead product candidate, Sphingomab, has demonstrated compelling results against seven different forms of solid-tumor and blood- borne cancers in pre-clinical studies. Like Avastin (Genentech's blockbuster cancer drug), Sphingomab is anti-angiogenic, but Sphingomab has other mechanisms of action that may prove advantageous in the clinical setting. As such, although Genentech pioneered the anti-angiogenesis approach to treating cancer, Lpath believes Sphingomab may prove to be the next generation of anti- angiogenesis-based therapeutics.

Lpath's unique ability to generate antibodies against bioactive lipids is based on its ImmuneY2(TM) technology. The Company is currently applying the ImmuneY2 process to other important lipid-signaling agents that are validated targets for disease treatment, thereby creating a pipeline of antibody-based drug candidates and positioning the company as the category leader in lipidomic therapeutics.

For more information, visit 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.

Lpath, Sphingomab, and ImmuneY2 are trademarks of Lpath, Inc.; Avastin is a trademark of Genentech, Inc.

Lpath, Inc.

CONTACT: Press, Ashley Korf, Media Relations Specialist, +1-858-678-0800x118, spancoast@lpath.com, or Investor Relations, Scott Liolios or Ron Bothof Liolios Group, Inc., +1-949-574-3860, for Lpath, Inc.; or Lorena Nava ofSan Diego State University, +1-619-594-3952, lnava@mail.sdsu.edu

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