Concert Pharmaceuticals : Advancement of Novel Drug Candidates in Kidney Disease and Spasticity

June 20 , 2011 - Concert Pharmaceuticals, Inc. announced the advancement of two programs from its DCE Platform™ (deuterated chemical entity platform). CTP-499 is progressing into Phase 2 clinical trials for diabetic nephropathy and C-21191 has been selected as a lead candidate for spasticity.

CTP-499 is a novel anti-inflammatory, anti-oxidant and anti-fibrotic agent that Concert is developing for the potential treatment of diabetic nephropathy associated with chronic kidney disease (CKD). The company has successfully completed two Phase 1 clinical trials and expects to report results at a future scientific meeting. Concert intends to advance the CTP-499 clinical program into an approximately 170 patient Phase 2 proof-of-concept clinical study by year-end.

Concert also announced that C-21191 has been selected as a lead candidate. C-21191 is a non-sedating subtype-selective GABAA modulator that represents a new therapeutic modality for the potential treatment of spasticity, neuropathic pain and anxiety. Recently, the U.S. Patent and Trademark Office issued a notice of allowance for Concert’s patent application claiming C-21191 and other deuterium-containing GABAA modulators as novel compositions of matter. Concert expects to complete preclinical dose ranging studies during 2011 to support the potential advancement of C-21191 into human clinical testing... Concert Pharmaceuticals' Press Release -

Regeneron and Bayer HealthCare : Start of Phase 3 Clinical Program in Diabetic Macular Edema

April 8, 2011 -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Bayer HealthCare announced that they have initiated the first of two Phase 3 clinical trials evaluating the efficacy and safety of VEGF Trap-Eye (aflibercept ophthalmic solution), an investigational new agent for the treatment of certain eye diseases, in the treatment of Diabetic Macular Edema (DME). The companies are extending their development program for VEGF Trap-Eye in DME after promising results in the global Phase 2 DME program.

The first Phase 3 trial in DME, named VIVID-DME, is being led by Bayer HealthCare and has started in Australia. The trial will also be conducted in Europe and Japan. A second study led by Regeneron, named VISTA-DME, is expected to begin later in 2011 in the United States, Canada, and other countries.


"Clinically significant DME is a leading cause of vision loss in adults under the age of 50 suffering from diabetes," said Dr. Kemal Malik, Head of Global Development and member of the Bayer HealthCare Executive Committee. "After reporting positive results from our global Phase 3 program (VIEW 1 and VIEW 2 studies) for the treatment of the neovascular form of age-related macular degeneration (wet AMD), we are pleased to start a Phase 3 program with VEGF Trap-Eye in DME which may help to address this significant unmet medical need."

The Phase 3 program in DME expands the companies' global development collaboration for VEGF Trap-Eye. The companies announced positive data for two Phase 3 studies in patients with wet AMD in November 2010 and for the first of two Phase 3 studies in patients with Central Retinal Vein Occlusion (CRVO) in December 2010... Regeneron Pharmaceuticals's Press Release - Bayer HealthCare's Press Release -

Arcion Therapeutics : data from the Phase 2b trial of ARC-4558 for the treatment of pain associated with painful diabetic neuropathy (PDN)

June 14, 2011 -...Arcion previously announced positive top-line results from a Phase 2b double-blind, randomized, placebo-controlled clinical trial of ARC-4558 in adult patients with PDN. The U.S. Food and Drug Administration (FDA) granted Fast Track designation to ARC-4558 for the treatment of pain associated with PDN. The Company also held an End of Phase 2 meeting with the FDA and the ARC-4558 program is now poised to enter Phase 3 studies.

About ARC-4558

ARC-4558 is a 0.1% gel formulation of clonidine hydrochloride (HCL) for topical administration to the painful area in order to manage the neuropathic pain associated with painful diabetic neuropathy (PDN). Topical clonidine, through its agonist effects on (a2)-adrenergic receptors, is believed to reduce pain in PDN via local actions on the nociceptors that innervate the affected skin. Based on the results of clinical trials to-date, Arcion believes that ARC-4558 has a level of efficacy comparable to systemic therapies in the target population, but with substantially fewer side effects. The 0.1% gel formulation avoids the treatment area limitations and undesirable aesthetic and skin reaction issues associated with analgesic patches. Furthermore, the ARC-4558 gel has been shown to provide analgesia without numbing or anesthetizing the skin... [PDF] Arcion Therapeutics' Press Release -

Cebix : Long-Acting C-Peptide Ersatta Has Potential in Multiple Chronic Complications of Diabetes

June 24, 2011 – Cebix Incorporated announced that preclinical data for its long-acting form of C-peptide, ErsattaTM (CBX129801), demonstrated a half-life of three days as compared to one hour for native C-peptide. Ersatta halted the impairment in nerve conduction velocity, a measure of the rate at which electrical signals travel through the nerves, in an animal model of diabetic peripheral neuropathy. Additionally, clinical data showed that native C-peptide replacement therapy improved erectile function in 46% of type 1 diabetes patients as compared to 9% of patients receiving placebo. These preclinical and clinical data will be presented during two poster sessions at the 71st Annual Meeting of the American Diabetes Association in San Diego starting on Saturday, June 25.

“C-peptide replacement therapy is a clinically-validated approach to treating multiple serious long-term complications of diabetes, including erectile dysfunction, peripheral neuropathy, and nephropathy,” said John Wahren, M.D., Ph.D., Chief Scientific Officer of Cebix. “We see tremendous potential in Ersatta to treat all of these diseases, because its biological activity is comparable to that seen in the native peptide, and the long-acting form will require less frequent dosing, thereby improving patient convenience and compliance.”

Cebix has an established database of 19 clinical studies evaluating native C-peptide in more than 300 patients with type 1 diabetes. These studies demonstrate that C-peptide replacement therapy increases nerve blood flow and mitigates peripheral and autonomic neuropathy and nephropathy, as well as improves erectile function. To date, native C-peptide replacement therapy has an excellent safety profile... Cebix's Press Release -