NEW YORK, NY, USA and HERZLIYA-PITUACH, Israel I May 5, 2014 I 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.
SOURCE: Immune Pharmaceuticals
Post Views: 86
NEW YORK, NY, USA and HERZLIYA-PITUACH, Israel I May 5, 2014 I 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.
SOURCE: Immune Pharmaceuticals
Post Views: 86
