Dresden, Germany, July 2, 2008 -- JADO Technologies GmbH, the leading developer of RAFT intervention therapeutics, announced today the start of a Phase II study to evaluate the safety and efficacy of oral TF002, a formulation of miltefosine, in patients with antihistamine resistant urticaria. TF002 exerts anti-inflammatory activity via RAFT modulation. RAFTs are sub-compartments in the lipid membrane of cells that play a role in the complex physiological processes, such as immune and inflammatory response.
“The start of this systemic trial continues JADO’s product development strategy in allergy. Having identified that miltefosine acts via a RAFT mechanism, we want to ensure that we continue to capture the value of the product in the allergy field with our formulations,” noted Charl van Zyl, CEO of JADO. “We have made excellent progress with our studies and believe data from this study will continue to support our multi-faceted development program for TF002.”
The randomized, double-blind, placebo-controlled study will enroll a total of 75 patients in 7 German centers. The primary end-point of the study is urticaria symptoms assessed by urticaria activity score (UAS) at the end of treatment.
JADO is investigating topical and oral versions of TF002 in Phase II trials in several allergy indications. Proof of concept with the topical formulation in a Phase II study of atopic dermatitis has been achieved. The company and academic collaborators also recently published in Science proof of concept for its Alzheimer’s RAFT inhibitor program.
Urticaria is a group of diseases characterized by mast cell (MC) and histamine-dependent wheal and flair type-skin responses. The disease is very common and not always easy to treat. Mainstay therapeutics are antihistamines, which, in chronic spontaneous urticaria, show poor response rates (about 20%-50%) when used in standard dosage. Increasing the dose of antihistamines to four-times the recommended daily dose (the maximum dose recommended by current guidelines) does improve the response rate, leaving a significant percentage of patients not reaching sufficient symptom control (about 25%).
RAFTS are discrete sub-compartments in the lipid membrane of cells that play a central role in the complex physiological processes, such as immune response or in many pathological situations. In an infectious disease event, RAFTS are hijacked by pathogens to gain entry into cells. By blocking this process, JADO is pursuing the development of novel therapeutics.
About JADO Technologies
JADO is a leader in the emerging field of RAFT intervention therapeutics. Representing a paradigm shift in drug development, RAFT therapeutics have the potential to address multiple unmet needs, particularly in allergy, infectious diseases, Alzheimer's disease and cancer.
RAFTS are sub-compartments of cell membranes that play an integral role in key biological pathways. The Company's RAFT Intervention Technology® provides a unique platform, protected by a strong patent position, to drive significant pipeline development opportunities. JADO has leveraged its technology to generate multiple small molecule drug candidates, with its lead program in Phase IIa clinical trials for allergy indications. The Company is supported by a global network of clinical and academic experts, including JADO founders, Prof. Kai Simons, Prof. Marino Zerial, Dr. Teymuras Kurzchalia (Max-Planck Institute of Molecular Cell Biology and Genetics, Dresden) and Prof. Hans-Joachim Knölker (Technical University of Dresden). JADO is headquartered in Dresden, Germany with a subsidiary in Bethlehem, Pennsylvania (USA). For more information, please visit our website: www.jado-tech.com.
Charl van Zyl, CEO
+49 (0) 351 796 3800
Mike Sinclair, Director
+44 (0)20 7084 5955