Healthcare Industry News: Cinacalcet
News Release - October 13, 2017
Dr. Bastian Dehmel Appointed CMO of OxTheraSTOCKHOLM, October 13, 2017 -- (Healthcare Sales & Marketing Network) -- OxThera AB, a Stockholm-based privately-held biopharmaceutical company today announced the appointment of Dr. Bastian Dehmel as their new Chief Medical Officer.
OxThera is developing a novel treatment, Oxabact, for Primary Hyperoxaluria (PH), a severe and often fatal disease in children, and where there are currently no available therapies. The company is poised to initiate a pivotal Phase III study in PH with Oxabact in order to stop and/or delay disease progression.
"It is my pleasure to welcome Bastian as CMO of OxThera," said Matthew Gantz, CEO of OxThera. "His ?extensive experience in the renal space and successful track record of drug development in both the US and Europe will enable OxThera to rapidly progress the development of Oxabact for treating Primary Hyperoxaluria."
"I am excited to join OxThera at this important juncture as we launch into the Oxabact Phase III pivotal study for patients with PH," said Dr. Dehmel. "This is a devastating disease for patients and their families and I truly hope that we can make a real difference. I am excited to work with Matthew and the entire OxThera team to deliver on the promise of this new therapy."
Dr. Dehmel joins OxThera after serving as Executive Medical Director and Global Development Leader for Amgen's calcimimetic franchise. He has extensive experience in the life science sector, having led Medical Affairs and Clinical Development teams responsible for drugs in Diabetes and End Stage Renal Disease. Bastian brings extensive experience in working with global regulatory agencies and was responsible for FDA and EMA approval of etelcalcetide, and more recently for the orphan pediatric drug approval of Cinacalcet by EMA.
Oxabact is an oral product, composed of highly concentrated freeze-dried live bacteria (Oxalobacter formigenes), designed for enteric elimination of plasma oxalate. A complete clinical development plan for Oxabact has been presented in Protocol Assistance and End-of-Phase II meetings with EMA and FDA respectively.
PH is a rare autosomal recessive disorder leading to markedly elevated levels of endogenous oxalate causing kidney deterioration and a gradual calcification of soft tissues. If left untreated, the disease can cause kidney failure and premature death. Currently, the sole available cure is a combined transplantation of liver and kidneys.
Oxabact holds orphan drug designations in the EU and the US for the treatment of PH, and in EU for treatment of Short Bowel Syndrome (SBS).
OxThera holds worldwide rights for compositions and methods of use for treatment of hyperoxaluria for two products; Oxabact and Oxazyme.
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