Wed, May 20, 1:14 PM
- Thinly traded nano cap Lpath (LPTN -79.5%) craters on a massive 78x surge in volume in response to its announcement that its lead product candidate, iSONEP, failed to achieve its primary and key secondary efficacy endpoints in a Phase 2 trial in patients with wet age-related macular degeneration (wet AMD) who had not responded adequately to anti-vascular endothelial growth factor (VEGF) therapies such as Roche's (OTCQX:RHHBY -0.4%) Lucentis (ranibuzumab) or Avastin (bevacizumab) or Regeneron's (REGN +1.4%) Eylea (aflibercept).
- Patients treated with iSONEP, either alone or as an adjunct, did not show any statistically significant improvement in visual acuity.
- SVP and Chief Development Officer Dario Paggiarino, M.D., says, "This trial was designed to evaluate the activity of iSONEP in wet AMD patients that had previously received at least three prior injections of an anti-VEGF agent and had not responded well. While the primary endpoint of the trial was not met, we will be conducting a complete analysis of the data, including additional anatomical endpoints, to better understand the results from each arm of the trial."
- iSONEP is a monoclonal antibody that binds to a bioactive lipid called sphingosine-1-phosphate, a major regulator of vascular systems.
- Final results will be presented in November at the American Academy of Ophthalmology meeting in Las Vegas, NV.
- Related ticker: (PFE +0.4%)
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- A Phase 2a clinical trial evaluating Lpath's (NASDAQ:LPTN) candidate for advanced renal cell carcinoma (RCC), ASONEP, failed to achieve its primary efficacy endpoint of a statistically significant improvement in progression-free survival (PFS). The study enrolled RCC patients who had previously failed treatment with at least one anti-vascular endothelial factor (VEGF) agent and no more than one mTOR inhibitor. This patient population is considered "last line."
- To meet the endpoint, 25 of 39 patients needed to be progression-free at Month 2 of treatment, but the overall median time to progression was less than that. Seven patients were progression-free at least six months and three were progression-free for more than 29 months.
- ASONEP is an anti-S1P antibody formulated for systemic use. S1P is sphingosine-1-phosphate, a blood-borne lipid mediator that is a key regulator of vascular and immune systems. It is upregulated (there is more of it) in certain cancers so binding to it may potentially inhibit progression.
- The company will assess its options with a partner to explore areas that present the greatest chance of success for ASONEP. Another Phase 2 study is evaluating the ocular version, iSONEP, in wet age-related macular degeneration. Data readout should happen in Q2. Pfizer (NYSE:PFE) has an exclusive option for a global license. Pfizer has a time-limited right of first refusal for a license for ASONEP.
- LPTN is down 27% after hours on robust volume.
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- Lpath (LPTN) -9.8% AH after warning that Pfizer (PFE) may divest its exclusive option to co-develop LPTN's leading product candidate, iSONEP.
- In current Phase 2 clinical trials, iSONEP is given alone or in combination with other drugs to treat an ocular disease that often leads to blindness.
- The original agreement with PFE included a $14M upfront payment and shared cost of the Phase 2 clinical trial; also, if PFE opted in after more data was obtained, future payments could be received by LPTN.
Dec. 14, 2012, 3:29 PMLpath (LPTN -19.5%) tanks today after announcing a public offering for an undisclosed ammount of shares. Terms weren't disclosed, and the offering is subject to customary market conditions with no assurances as to whether or when it may be complete. Summer Street Research Partners is sole book-running manager for the offering. | Comment!
Jan. 27, 2012, 10:12 AMShares of Lpath (LPTN.OB -31.8%) plummet after the biotech company temporarily suspends trials for its PEDigree and Nexus lipidomics-based antibody therapeutics. LPTN says it took the action when it learned its fill/finish contractor was not in FDA compliance for manufacturing requirements. (submitted by M.E. Garza) | Comment!
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Lpath Inc is a biotechnology company engaged in the discovery and development of lipidomic-based therapeutic antibodies to treat a wide range of human diseases. The Company's product candidates include iSONEP, ASONEP, Lpathomab, and ImmuneY2 Technology.
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