Healthcare Industry News: Neuropathic Pain
News Release - May 5, 2014
Immune Pharmaceuticals Announces Phase 3 Development and Commercialization Strategy for AMIKETNEW YORK and HERZLIYA-PITUACH, Israel, May 5, 2014 -- (Healthcare Sales & Marketing Network) -- Immune Pharmaceuticals Inc. (IMNP.ST) (IMNP.ST) ("Immune" or the "Company") announces its clinical trial and commercialization strategy for AmiKet, a topical drug for the treatment of Neuropathic Pain, pursuant to which the Company is ready to advance to phase 3 clinical trials, based on nine clinical trials in a total of 1700 patients. AmiKet is a topical combination of amitryptiline and ketamine designed to reduce the pain of patients with Post Herpetic Neuralgia (PHN), Diabetic Peripheral Neuropathy (DPN) and Chemotherapy Induced Neuropathic Pain (CIPN).
Following a clinical, regulatory and commercial assessment, Immune will prioritize Post Herpetic Neuralgia (PHN) as its first indication for the development and commercialization of AmiKet. AmiKet has received Orphan Drug Designation for PHN and completed successfully three phase 2 PHN trials. In the first trial, AmiKet demonstrated statistically significant efficacy in reducing pain in PHN patients in both low and high dose versus placebo. A second clinical trial rank ordered AmiKet as superior to each of its drug component and placebo. In a third clinical trial, AmiKet demonstrated statistically significant non-inferiority to high dose oral gabapentin, one of the most frequently used drug for Neuropathic Pain.
Dr. Daniel Teper, Chairman and CEO of Immune stated: "We are preparing a Phase 3 plan with PHN as a lead indication and will continue to seek pain specialist development and commercialization partners on a regional or global level."
Dr. Elliott Goldstein, Chief Medical Officer of Immune, commented: "There is an outstanding medical need for patients suffering with Neuropathic Pain, with no single drug achieving more than a 50% responder rate, accompanied by the unsatisfactory tolerability of oral therapies. Market research suggests a strong interest and preference of both physicians and patients for topical treatments."
About Immune Pharmaceuticals Inc.
Immune Pharmaceuticals Inc. applies a personalized approach to treatment, developing novel, highly targeted antibody therapeutics to improve the lives of patients with inflammatory diseases and cancer. The Company's lead product candidate, bertilimumab, is in clinical development for moderate to severe ulcerative colitis and Crohn's Disease as well as bullous pemphigoid, an orphan auto-immune dermatological condition, Immune licensed worldwide rights for systemic indications of bertilimumab from iCo Therapeutics (ICO.V) (ICOTF) in June 2011, while iCo retained rights to all ophthalmic indications. iCo originally licensed the exclusive world-wide rights to bertilimumab in 2006 from MedImmune, the Global Research and Development Arm of AstraZeneca. Immune's pipeline also includes NanomAbs(R), antibody nanoparticle conjugates, for the targeted delivery of chemotherapeutics., Crolibulin, a small molecule in Phase II in collaboration with the National Cancer Institute and Amiket(TM), a Neuropathic Pain drug candidate ready for Phase III. Amiket has received Orphan Drug Designation for Post Herpetic Neuralgia.
For more information, visit Immune's website at www.immunepharmaceuticals.com, the content of which is not a part of this press release.
Erik Penser Bankaktiebolag is engaged as Immune's Certified Adviser on NASDAQ OMX First North Premier.
This news release and any oral statements made with respect to the information contained in this news release contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. You are urged to consider statements that include the words "may," "will," "would," "could," "should," "believes," "estimates," "projects," "potential," "expects," "plans," "anticipates," "intends," "continues," "forecast," "designed," "goal" or the negative of those words or other comparable words to be uncertain and forward-looking. Such forward-looking statements include statements that express plans, anticipation, intent, contingency, goals, targets, future development and are otherwise not statements of historical fact. These statements are based on our current expectations and are subject to risks and uncertainties that could cause actual results or developments to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. Factors that may cause actual results or developments to differ materially include, but not limited to: the risks associated with the adequacy of our existing cash resources and our ability to continue as a going concern; the risks associated with our ability to continue to meet our obligations under our existing debt agreements; the risk that we will not be able to find a partner to help conduct the Phase 3 trials for AmiKet(TM) on attractive terms, a timely basis or at all the risk that we will not obtain approval to market and commercialize any of our product candidates; the risks associated with dependence upon key personnel; the risks associated with reliance on collaborative partners and others for further clinical trials, development, manufacturing and commercialization of our product candidates; the cost, delays and uncertainties associated with our scientific research, product development, clinical trials and regulatory approval process; our history of operating losses since our inception; the highly competitive nature of our business; risks associated with litigation; risks associated with our ability to protect our intellectual property; risks associate with our ability to raise additional funds; and our liquidity. These factors and other material risks are more fully discussed in our periodic reports, including our reports on Forms 8-K, 10-Q and 10-K and other filings with the U.S. Securities and Exchange Commission. You are urged to carefully review and consider the disclosures found in our filings which are available at www.sec.gov or at www.immunepharmaceuticals.com. You are cautioned not to place undue reliance on any forward-looking statements, any of which could turn out to be wrong due to inaccurate assumptions, unknown risks or uncertainties or other risk factors. We expressly disclaim any obligation to publicly update any forward-looking statements contained herein, whether as a result of new information, future events or otherwise, except as required by law.
Source: Immune Pharmaceuticals
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