Treatment for Lupus (Lupuzor TM)
Background
Lupus is a chronic, potentially life-threatening autoimmune disease. By 2010 there will be an estimated 1.4 million people diagnosed in the seven key markets. Lupus is an inflammatory disease which attacks multiple organs such as the skin, joints, kidneys, blood cells, heart and lungs. There is currently no cure or specific treatment.
ImmuPharma's compound
Lupuzor™ (previously known as IPP-201101) has a novel mechanism of action aimed at modulating the body’s immune system so it does not attack healthy cells without causing adverse side effects. It has the potential to halt the progression of the disease in a substantial proportion of patients.
Lupuzor™ has successfully completed phase I, Phase IIa and Phase IIb studies and is now in preparation for phase III. The Phase IIa study, in Lupus patients was a proof of concept, dose ranging, safety, multi-centre European study. The proof of concept was assessed by measuring the decrease of anti dsDNA antibodies as a surrogate marker for efficacy and IL10, a cytokine, to ascertain its mechanism of action. The drug was administered 3 times by subcutaneous injections 2 weeks apart at doses of 200 µg and 1000 µg and the patients were monitored one month after treatment stop.
Lupus patients who received Lupuzor™ on only 3 occasions, 2 weeks apart, demonstrated a significant clinical improvement in their condition in addition to the decrease of their biomarkers.
The phase IIa trial of Lupuzor™ met its primary end-points. The study was designed to measure biomarkers, including reduction in anti-dsDNA auto-antibodies and increase in IL-10. Many of the patients that were treated with the drug showed reduction in their auto-antibodies and showed also significant improvement in their condition.
A Phase IIb clinical trial started dosing of patients in February 2008 in Europe and Latin America. comparing Lupuzor™ to placebo in patients with systemic lupus erythematosus and an interim analysis has demonstrated statistically significant superiority of Lupuzor™ over placebo.
The interim analysis was performed and reviewed by an independent Data Monitoring Committee according to ICH guidelines. This analysis was conducted after 125 randomized patients had completed the 12 week treatment period, half of them having also completed the additional 12 week follow-up (week 24).
The primary efficacy measure was a 'SLEDAI response' defined as a decrease of at least 4 points in the SLEDAI score, a scale generally accepted by physicians as an assessment of the clinical activity of Lupus patients, a lower score representing lower disease activity. The analysis of the data has demonstrated that the 200mcg dose of Lupuzor™ administered every four weeks was statistically significantly superior to placebo (p = 0.015). Lupuzor™ was generally well-tolerated with no significant drug related adverse events recorded. All these data follows on from the successful results which we saw with the preliminary Phase IIa trial.
Based on this interim analysis, ImmuPharma has discontinued the recruitment of more patients for the Phase IIb study. The 147 patients already randomized will continue the study to completion according to the protocol. A full analysis of the data will be provided in due course.
Lupuzor™ is a drug that specifically modulates the immune system of Lupus patients by modifying the behaviour of some of the key cells involved in the pathogenesis of the disease. The clinical profile of Lupus patients is generally assessed by standardized scales such as SLEDAI (SLE Disease Activity Index): the lower the score, the better the condition of the patient. During this Phase II study, the SLEDAI scores were assessed on multiple occasions even though the study was not designed or powered to demonstrate clinical benefit as primary endpoint due to the short treatment period.
ImmuPharma entered into a corporate deal with Cephalon Inc in November 2008 whereby Cephalon licensed worldwide the exclusive rights to Lupuzor. Cephalon is now responsible for the development and commercialisation of Lupuzor.
About Cephalon, Inc.
Founded in 1987, Cephalon, Inc. is an international biopharmaceutical company dedicated to the discovery, development and commercialization of many unique products in four core therapeutic areas: central nervous system, pain, oncology and addiction. A member of the Fortune 1000, Cephalon currently employs approximately 3,000 people in the United States and Europe. U.S. sites include the company's headquarters in Frazer, Pennsylvania, and offices, laboratories or manufacturing facilities in West Chester, Pennsylvania, Salt Lake City, Utah, and suburban Minneapolis, Minnesota. The company's European headquarters are located in Maisons-Alfort, France.
Cephalon's proprietary products in the United States include: AMRIX® (cyclobenzaprine hydrochloride extended-release capsules), TREANDA® (bendamustine hydrochloride) for Injection, FENTORA® (fentanyl buccal tablet) [C-II], PROVIGIL® (modafinil) Tablets [C-IV], TRISENOX® (arsenic trioxide) injection, VIVITROL® (naltrexone for extended-release injectable suspension), GABITRIL® (tiagabine hydrochloride), NUVIGIL™ (armodafinil) Tablets [C-IV] and ACTIQ® (oral transmucosal fentanyl citrate) [C-II]. The company also markets numerous products internationally. Full prescribing information on its U.S. products is available at www.cephalon.com or by calling 1-800-896-5855.
