Clinical Intelligence

Akaal Pharma to initiate phase II trial for the topical treatment of psoriasis

Wednesday, June 17, 2015

Akaal Pharma, a clinical-stage biopharmaceutical company, has received approval to initiate a randomized, double-blind, placebo-controlled phase-II clinical trial of its topical drug candidate AKP-11. AKP-11 is a novel First-in-Class topical Sphingosine 1-Phosphate receptor-1 (S1P1) modulator for the treatment of mild-to-moderate plaque psoriasis in patients. Patients will be treated daily for six weeks with the topical drug AKP-11.

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FDA grants Breakthrough designation for Actemra in Systemic Sclerosis

Thursday, June 11, 2015

Genentech, a member of the Roche Group, has announced that the FDA has granted Breakthrough Therapy designation status to Actemra (tocilizumab) for systemic sclerosis, also known as scleroderma. This designation is intended to expedite the development and review of medicines with early signals of potential clinical benefit in serious diseases and to help ensure patients have access to them as soon as possible. Genentech also has initiated a phase III study in systemic sclerosis (NCT02453256), a disease for which there are inadequate treatment options.

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Arrowhead receives Orphan designation for liver disease treatment ARC-AAT

Thursday, June 11, 2015

The FDA has granted Arrowhead Research’s ARC-AAT Orphan Drug designation. ARC-AAT is Arrowhead’s RNAi-based therapeutic candidate being investigated for the treatment of liver disease associated with Alpha-1 Antitrypsin Deficiency (AATD), a rare genetic disease that severely damages the liver and lungs of affected children and adults. Arrowhead currently is conducting part B of a phase I study of ARC-AAT in patients with PiZZ genotype AATD.

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bluebird bio completes NIH review, moved forward with trial against recommendation

Thursday, June 11, 2015

bluebird bio, a clinical-stage company committed to developing potentially transformative gene therapies for severe genetic and rare diseases and T cell-based immunotherapies, has completed the NIH Recombinant DNA Advisory Committee’s (RAC) public review of the HGB-208 pediatric study protocol for bluebird bio’s LentiGlobin BB305 product candidate in beta-thalassemia major. The RAC recommendation was to delay initiation of the study in the U.S. for one to two years. This recommendation has no effect on the HGB-207 protocol plan.

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Merck, Dynavax collaborate on immuno-oncology therapies

Thursday, June 4, 2015

Merck & Co. and Dynavax Technologies have entered into two clinical trial collaboration agreements to investigate the potential synergistic effect of combining immunotherapies from both companies’ pipelines: Merck’s anti-PD-1 therapy, Keytruda (pembrolizumab), and its investigational anti-interleukin-10 (anti-IL-10) immunomodulator, MK-1966, with Dynavax’s investigational toll-like receptor 9 (TLR9) agonist, SD-101.

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