Immune Pharmaceuticals Commences Patient Screening For Bertilimumab Phase II Clinical Trial In Bullous Pemphigoid, A Rare Auto-Immune Disease Of The Skin
CAMBRIDGE, Mass. and HERZLIYA PITUACH, Israel, July 30, 2014 /PRNewswire/ -- Immune Pharmaceuticals Inc. (OTCQX and NASDAQ OMX First North Premier, Stockholm: "IMNP."; "Immune" or "the Company") announces today that it has initiated the screening of patients for a Phase II proof of concept clinical trial exploring the safety and efficacy of bertilimumab in the treatment of moderate to severe bullous pemphigoid. This open-label trial will enroll 10-15 patients who will receive two bertilimumab infusions, at a dose of 10 mg/kg, on days 0 and 14. Patients will also start concomitant treatment with an initial moderate dose of oral prednisone (30 mg daily) to be tapered down rapidly starting as early as week 1 based on patient response. Patients will be followed for eight weeks with primary efficacy end points focused on disease control measured by the Bullous Pemphigoid Disease Area Index, a validated index developed by international experts in this indication, and steroid sparing, the proportion of patients who achieve a steroid dose of </= 10 mg daily at the end of follow up. The study principal investigator is Eli Sprecher, M.D., Ph.D., Professor of Dermatology, Sackler Faculty of Medicine, Tel Aviv University, and Chairman of the Department of Dermatology at the Sourasky Medical Center in Tel Aviv, Israel.
Dr. Daniel Teper, Chairman and CEO of Immune comments: "Following the announcement last week of our partnership with Lyfebulb, and future collaborative activities with the International Pemphigus and Pemphigoid Foundation (IPPF), we are pleased to announce the commencement of patient screening in a Phase II bullous pemphigoid clinical trial with bertilimumab. We will continue to work closely with key opinion leaders, patient advocacy organizations and regulatory authorities to design a clinical development program that we believe will help bring needed new options for patients with bullous pemphigoid."
About Bullous Pemphigoid
Bullous pemphigoid (BP) is a rare, potentially life threatening autoimmune disease where painful blisters develop on the skin, eyes, mouth, and throat. Each year, BP affects over 30,000 patients in the United States and Europe. Typically, patients are over 65 years old and their immediate support system may include their adult children. The disease is treated by a small group of specialists in dermatology and oral medicine.
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 (TSX: ICO; OTCQX: 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 Astra-Zeneca. Immune's pipeline also includes NanomAbs®, a portfolio of antibody nanoparticle conjugates, for the targeted delivery of chemotherapeutics, crolibulin, a small molecule in Phase II for (indication) in collaboration with the National Cancer Institute and Amiket™, a Phase III-ready neuropathic pain candidate. Amiket has received Orphan Drug Designation for Post-Herpetic Neuralgia in the US.
For more information, please 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.
Lyfebulb was founded in 2014 by Karin Hehenberger M.D., Ph.D., with a mission of helping those living with a chronic disease lead an optimal lifestyle. Through an online platform and offline events, Lyfebulb connects, educates, and inspires individuals living with chronic illnesses. The Lyfebulb Social Club is a monthly series of meetings bringing together thought leaders, patients, experts and renowned professionals in an informative and relaxed environment.
For more information, please visit www.lyfebulb.com.
About International Pemphigus & Pemphigoid Foundation
The International Pemphigus & Pemphigoid Foundation (IPPF) provides support, advocacy, awareness, and education to those affected by the rare, autoimmune blistering diseases (AIBD) pemphigus and pemphigoid. Since 1994, the IPPF has helped thousands of patients, caregivers, and medical professionals by reducing diagnostic delays in increasing P/P awareness and knowledge. For more information on the IPPF, call (855) 4-PEMPHIGUS, (916) 922-1298, or visit us online at www.pemphigus.org
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SOURCE Immune Pharmaceuticals Inc.