Immune Pharmaceuticals Commences Patient Screening For Bertilimumab Phase II Clinical Trial In Bullous Pemphigoid
Cambridge, MA and Herzliya Pituach, Israel – July 30, 2014 – 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.
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.
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
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 III trials for AmiKet 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 Inc.
Posted: July 2014