Bristol-Myers Squibb and Ambrx : Collaboration for Novel Biologics Programs in Diabetes and Heart Failure

September 22, 2011 - Bristol-Myers Squibb Company (NYSE: BMY) and Ambrx, Inc. announced a collaboration under which Bristol-Myers Squibb will receive exclusive worldwide rights to research, develop and commercialize biologics based on Ambrx’s research surrounding the Fibroblast Growth Factor 21 (FGF-21) protein, for potential use in treating type 2 diabetes, and the Relaxin hormone, for potential use in treating heart failure. Derivatives of FGF-21 and Relaxin were developed using Ambrx’s unique ReCODE™ platform technology to modify the native proteins with amino acid building blocks beyond the common 20 to engineer enhanced versions for investigation for therapeutic use.

Under the terms of the agreement, Bristol-Myers Squibb will make an upfront payment of $24 million to Ambrx. In addition, Bristol-Myers Squibb will make potential milestone payments and royalty payments on worldwide sales for both programs. Bristol-Myers Squibb and Ambrx will also enter research collaborations for both programs.

FGF-21 is a naturally occurring protein that has been characterized as a potent metabolic regulator, and has been shown to lower blood glucose, elevate good cholesterol and promote weight loss in preclinical studies. The lead compound in this program, ARX618, or PEG-FGF-21, is in the final stages of preclinical development.

Relaxin is a naturally occurring hormone known for its role in pregnancy and childbirth. Preclinical studies suggest Relaxin may aid in the treatment of heart failure by improving cardiac function. This program is in preclinical development... Bristol-Myers Squibb's Press Release - Ambrx's Press Release -

Kuros : Patient Recruitment in a Phase IIb Clinical Trial With KUR-211 for Diabetic Foot Ulcers

01.09.2011 - Kuros Biosurgery AG, a biotechnology company focused on the development of novel biomaterials and bioactive-biomaterial combination products for trauma, wound and spinal indications, announced that it has completed recruitment in a Phase IIb clinical trial designed to investigate KUR-211 (Viz.I-020201) in the treatment of diabetic foot ulcers.

 This Phase IIb clinical trial is a randomised, multi-center, controlled, parallel group dose-finding study to evaluate the efficacy and safety of KUR-211 used as an adjunct to standard of care in patients with diabetic foot ulcers. KUR-211 is a bioactive therapy intended for topical treatment of diabetic foot ulcers, stimulating the granulation tissue formation, that aids wound closure. The study evaluates the effects of KUR-211 applied twice a week for maximum 16 weeks in addition to standard of care versus standard of care (SOC) alone.

 KUR-211 consists of a modified variant of platelet-derived growth factor (PDGF) incorporated into a fibrin sealant and is applied to the wound as a foam. The innovative Kuros "TG-hook" technology enables the PDGF to be retained at the site for local exposure to migrating cells and for sustained delivery of PDGF on enzymatic cleavage of the matrix. It is believed that this novel approach may improve the frequency and speed of healing... [PDF] Kuros Biosurgery's Press Release -

KalVista Pharmaceuticals Launched with £8 Million in Series A Funding to Develop Novel Class of Drugs for Diabetic Macular Edema

23 August 2011 – KalVista Pharmaceuticals (“KalVista”), a new ophthalmology company with a focus on diabetic macular edema (DME), has raised £8 million in a series A round from leading life sciences investors Novo A/S and SV Life Sciences. The Company is developing novel, small molecule plasma kallikrein inhibitors, which represent a new approach to the treatment of DME, a leading cause of adult visual loss in developed countries and a major unmet medical need. KalVista’s advanced pre-clinical product pipeline is targeting both intravitreal injection and oral administration routes. KalVista acquired these inhibitors plus all relevant intellectual property from Vantia Therapeutics.

KalVista’s scientific founders include world-leading experts in ophthalmology, diabetes and diabetes-related complications, Dr Lloyd Paul Aiello and Dr Edward P. Feener. Dr Aiello is Professor of Ophthalmology at Harvard Medical School, Director of the Joslin’s Beetham Eye Institute and Inaugural Chair of the National Eye Institute Diabetic Retinopathy Clinical Research Network. Dr Feener is Associate Professor of Medicine at Harvard Medical School and an Investigator in Vascular Cell Biology at the Joslin Diabetes Center, where his team led the discovery of plasma kallikrein in the vitreous fluid from people with DME and has shown that inhibition of plasma kallikrein decreases pathological retinal vascular permeability in pre-clinical studies. Dr Aiello has guided the clinical development programs for a wide range of recent ophthalmology drugs, and has been a lead investigator in the trials determining the benefit of VEGF (vascular endothelial growth factor) inhibitors for the treatment of DME... KalVista Pharmaceuticals' Press Release -

Lpath Addresses Diabetic Neuropathic Pain With Financial Support by National Institutes of Health

Aug 15, 2011 - Lpath to Conduct In Vivo Studies in Diabetic Neuropathy With Lpathomab(TM), Its Monoclonal Antibody Against Lysophosphatidic Acid (LPA) -- Lpath, Inc. (OTCBB: LPTN), the industry leader in lipidomics-based therapeutics, announced the Type 1 Diabetes Preclinical Testing Program of the National Institutes of Health (NIH) will provide financial support for the further study of Lpathomab's efficacy in animal models of disease, particularly diabetic neuropathy.

"Bristol Myers Squibb's recent $325 million acquisition of Amira, whose lead program is an LPA-receptor antagonist with Phase 1 results, underscores the potential value of a compound that neutralizes the LPA signaling pathway," said Lpath's CEO Scott Pancoast. "With assistance from the NIH for neuropathic pain and from various partners/collaborators for other central-nervous-system disorders and for fibrosis, we believe we can generate compelling data that validates Lpath's unique approach to neutralizing LPA with Lpathomab." As a monoclonal antibody, Lpathomab functions like a 'molecular sponge' that binds to and neutralizes the bioactive lipid signaling molecule, lysophosphatidic acid (LPA), thus silencing LPA receptors associated with the transmission of pain through the nervous system. Lpathomab was generated using Lpath's proprietary ImmuneY2(TM) technology... Lpath's Press Release -