lpath inc-class a (LPTN) Key Developments
Lpath Appoints Gary Atkinson Interim Chief Executive Officer
Sep 29 15
Lpath Inc. announced that Gary Atkinson has been appointed interim chief executive officer of Lpath, effective immediately. Mr. Atkinson will continue to serve as Lpath's chief financial officer. Mr. Atkinson joined Lpath as CFO in 2005, and has more than 20 years of experience with life science companies. Prior to Lpath, he served as the CFO for Quorex Pharmaceuticals, which was acquired by Pfizer. He also previously served as vice president of finance at Isis Pharmaceuticals, and as a financial consultant to Ichor Medical Systems. Earlier in his career, Mr. Atkinson served as the corporate controller at Loral Aerospace Corporation and as the director of financial planning at Cubic Corporation. Mr. Atkinson began his career at Ernst and Young. He is a graduate of Brigham Young University.
Lpath Inc. Initiates First-In-Human Dosing in Phase 1 Clinical Trial of Lpathomab
Sep 15 15
Lpath Inc. announced that the first cohort of six subjects has been dosed in the Phase 1 clinical trial with LpathomabTM. The double-blind, placebo-controlled, single ascending dose trial is designed to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of Lpathomab in healthy volunteers. The trial also aims to establish a maximum tolerated dose for future clinical studies in patients with neuropathic pain. The trial will include a total of five cohorts at increasing doses. Lpathomab is an antibody targeting lysophosphatidic acid, or LPA, a bioactive lipid that has been characterized in the scientific literature as playing a key role in nerve injury and neuropathic pain. Lpath's preclinical studies showed strong in vivo results with Lpathomab in several different pain models, which suggest that LPA may be an attractive target across a variety of chronic pain conditions, including diabetic peripheral neuropathy, post-herpetic neuralgia, chemotherapy-induced neuropathic pain and pain associated with lumbosacral adiculopathy. Other preclinical studies have also demonstrated the potential for Lpathomab as a treatment for traumatic brain injury.
Lpath Inc. Announces Plan to Begin Lpathomab Clinical Trial
Jul 23 15
Lpath Inc. announced that the U.S. Food and Drug Administration (FDA) has completed its review of the Investigational New Drug Application (IND) for Lpathomab. The FDA informed the company that the Phase 1 clinical trial to study Lpathomab may now be initiated. Lpath plans to begin this trial upon investigational review board approvals and anticipates the first subject to be dosed within two months.
Lpath, Inc. Receives Non-Compliance Notice From NASDAQ
Jul 14 15
On July 9, 2015, Lpath, Inc. received a notice letter from the Listing Qualifications Staff of The NASDAQ Stock Market LLC indicating that, based upon the closing bid price of the company’s common stock for the last 30 consecutive business days, the company no longer meets the requirement to maintain a minimum bid price of $1 per share, as set forth in Nasdaq Listing Rule 5550(a)(2). In accordance with Nasdaq Listing Rule 5810(c)(3)(A), Nasdaq will provide the company with a period of 180 calendar days, or until January 5, 2016, in which to regain compliance. In order to regain compliance with the minimum bid price requirement, the closing bid price of the company’s common stock must be at least $1 per share for a minimum of ten consecutive business days during this 180-day period. In the event that the company does not regain compliance within this 180-day period, the company may be eligible to seek an additional compliance period of 180 calendar days if it meets the continued listing requirement for market value of publicly held shares and all other initial listing standards for the Nasdaq Capital Market, with the exception of the bid price requirement, and provides written notice to Nasdaq of its intent to cure the deficiency during this second compliance period, by effecting a reverse stock split, if necessary. However, if it appears to the Nasdaq Staff that the company will not be able to cure the deficiency, or if the company is otherwise not eligible, Nasdaq will provide notice to the company that its common stock will be subject to delisting. The Notice does not result in the immediate delisting of the company’s common stock from the Nasdaq Capital Market. The company will continue to monitor the closing bid price of its common stock over the 180-day period to see if its closing bid price may increase based on its future filings with the Securities and Exchange Commission or any future announcements the company may be able to issue regarding its drug development programs and plans. The company will also consider its available options to regain compliance, including effecting a reverse stock split, which would be subject to the prior approval of the company’s stockholders. There can be no assurance that the company will be able to regain compliance with the minimum bid price requirement or maintain compliance with the other listing requirements necessary for company to maintain the listing of its common stock on the Nasdaq Capital Market.
Lpath Reports Results for iSONEP™ in Patients with Wet Age-related Macular Degeneration
May 20 15
Lpath Inc. announced that its multicenter, Phase 2 "Nexus" clinical trial evaluating iSONEP™ in patients with wet age-related macular degeneration (wet AMD) did not meet its primary or key secondary endpoints. Wet AMD patients who had not responded adequately to existing anti-vascular endothelial growth factor (VEGF) therapies including Lucentis®, Avastin® and Eylea® did not show any statistically significant improvement in visual acuity when treated with iSONEP as an adjunctive or monotherapy. Nexus is a prospective, randomized, double-masked, positive control, Phase 2 clinical trial conducted in the U.S. that enrolled 158 patients with wet AMD. All enrolled patients had been subresponsive to treatment with anti-VEGF drugs, and had received at least three previous injections of an anti-VEGF drug. Nexus study patients each received four intravitreal injections over the 90 day dosing period. There were approximately 39 patients in each of the four treatment arms. The pre-specified primary endpoint of the study was mean change in best corrected visual acuity (BCVA) by Early Treatment Diabetic Retinopathy Study (ETDRS) from Day 0 to Day 120. At day 120, patients who received intravitreal injections of (i) 4.0 mg iSONEP alone lost a mean of 3.17 letters on the ETDRS, (ii) a combination of 0.5 mg iSONEP and anti-VEGF therapy gained a mean of 4.22 letters, (iii) a combination of 4.0 mg iSONEP and anti-VEGF therapy gained a mean of 3.63 letters, and (iv) an anti-VEGF therapy alone gained a mean of 4.34 letters. Full study results will be presented during the Retina Subspecialty Days in conjunction with the American Academy of Ophthalmology in Las Vegas, Nevada in November 2015.