SAN DIEGO, March 24, 2015 /PRNewswire/ -- Lpath, Inc. (NASDAQ: LPTN) announced today that its Phase 2a single-agent, open-label study of ASONEP did not meet the primary endpoint of statistically significant progression-free survival in patients with advanced renal cell carcinoma (RCC). The study enrolled RCC patients who had previously failed treatment with at least one anti-vascular endothelial growth factor (VEGF) agent (e.g., Sutent®) and no more than one mTOR inhibitor (e.g., Afinitor®). This patient population is considered “last line,” and the literature suggests cancer progression in this population within a one to two month time frame.
To successfully meet the primary endpoint of progression-free survival, at least 25 out of 39 patients needed to be progression-free at two months of treatment. The overall median time to progression was less than two months. In addition, seven patients were progression-free at least six months, with three patients progression-free for over 20 months. Six patients currently continue to receive weekly infusions of ASONEP.
ASONEP was well-tolerated by patients overall. Serious adverse events were reported in 11 patients with only one, constipation, deemed by the investigator to be related to ASONEP.
Dario Paggiarino, M.D., chief development officer of Lpath, commented, “Our Phase 2a data suggest that in some patients with lower risk of disease progression based on prognostic factors, ASONEP may produce prolonged disease stability for up to 20 months. We have also recently analyzed the expression profile of the S1P pathway from a genetic database of thousands of cancer patient genomes and believe there could be a rationale for ASONEP in other cancer types where S1P pathway dysregulation suggests a stronger pharmacological rationale. At the conclusion of this RCC trial, we will take a strategic look at exploring with a partner those other opportunities where ASONEP may have the best chance of success.”
The Phase 1 and Phase 2a clinical trials of ASONEP were partially funded by a $3.0 million grant from the National Cancer Institute under its Small Business Innovation Research Program.
ASONEP is the systemic formulation of a first-in-class humanized antibody that binds and neutralizes the bioactive lipid, sphingosine-1-phosphate (S1P). Lpath is also developing an ocular formulation, iSONEP, that was also discovered using Lpath’s ImmuneY2 drug-discovery engine.
Lpath is also conducting a clinical trial referred to as the “Nexus” study, which is a four-arm, double-blind Phase 2 study where iSONEP is being evaluated for safety and efficacy in wet age-related macular degeneration subjects. The company expects to release data late in the second quarter of 2015. Lpath entered into an agreement with Pfizer in 2010 that provides Pfizer an exclusive option for a worldwide license to develop and commercialize iSONEP.
Investor Update Conference Call Today at 4:30 p.m. ET
Lpath will host a conference call and live webcast today, Tuesday, March 24, 2015 beginning at 4:30 p.m. Eastern Standard Time/1:30 p.m. Pacific Standard Time to update investors on the progress of Lpath’s programs. To participate in the live call, please dial 1-877-870-4263 (domestic) or 1-412-317-0790 (international) or 1-855-669-9657 (Canada) and ask to join the Lpath conference call. A telephone replay will be available approximately one hour after the live call by dialing 1-877-344-7529 (domestic) or 1-412-317-0088 (international) or 855-669-9658 (Canada), access code 10056823. A live webcast of the call can be accessed on the “Investor Calendar of Events” section of Lpath’s corporate website at www.Lpath.com. A webcast replay will be available shortly after the call at the same web address.
About Lpath
San Diego-based Lpath, Inc. (NASDAQ: LPTN) is an antibody-platform company and the category leader in lipid-targeted therapeutics. The company’s ImmuneY2 drug-discovery engine has the unique ability to generate therapeutic antibodies that bind to and inhibit bioactive lipids that contribute to disease. The company’s lead drug candidate, iSONEP, is currently being investigated in a Phase 2 trial in patients with wet age-related macular degeneration. The second proprietary drug candidate, Lpathomab, is an anti-lysophosphatidic acid antibody that is expected to enter clinical development in the second quarter of 2015 for neuropathic pain. An anti-leukotriene antibody, Altepan, is being studied in models of inflammation, including inflammatory bowel disease and respiratory disease. For more information, visit www.Lpath.com.
About Forward-Looking Statements
The Company cautions you that the statements included in this press release that are not a description of historical facts are forward-looking statements. These include statements regarding: the Company’s ability to identify additional clinical opportunities for ASONEP and the time period for the Company’s release of data from the Nexus clinical trial. Actual results may differ materially from those set forth in this press release due to the risks and uncertainties inherent in the Company’s business, including, without limitation: the final results of Lpath’s preclinical studies and clinical trials may be different from Lpath’s studies or interim data results and may not support further clinical development and/or the commercialization of its drug candidates; Lpath may not successfully complete its existing and any additional clinical trials for its drug candidates on a timely basis, or at all; Lpath may fail to obtain required governmental approvals for any of its drug candidates; Lpath may not be successful in maintaining its commercial relationship with Pfizer Inc. or any third party that may acquire the exclusive option Lpath granted to Pfizer for iSONEP; and Lpath may not be able to secure the funds necessary to support its preclinical-development and clinical-development plans. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q filed with the SEC. Such documents may be read free of charge on the SEC’s web site at www.sec.gov. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement and the Company undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof. This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995.
CONTACT:
Gary Atkinson
Chief Financial Officer
Lpath, Inc.
858-926-3202
gatkinson@lpath.com
PUBLIC RELATIONS CONTACT:
Canale Communications
Rachel Hutman
619-849-5384
rachel@canalecomm.com
Sutent® is a registered trademark of Pfizer, Inc.
Afinitor® is a registered trademark of Novartis Pharmaceuticals Corp.
To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/lpath-reports-results-for-asonep-phase-2a-study-in-renal-cell-carcinoma-300053872.html
SOURCE Lpath, Inc.
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