NEW YORK and JERUSALEM, Sept. 21 /PRNewswire/ -- Chiasma, Inc., a privately held biopharma company, announced that Fredric Price, Chiasma's Chairman & CEO, will present an overview of the Company at the UBS Global Life Sciences Conference at the Grand Hyatt, New York, New York, on Wednesday, September 22, 2010 at 11:00 AM (ET).
Chiasma is currently conducting its second clinical trial of the investigational new drug Octreolin™, an oral form of octreotide acetate that uses the proprietary Transient Permeability Enhancer (TPE) system for the oral treatment of acromegaly, a hormonal disorder that results from an excess of growth hormone. A third clinical trial is planned to start by the end of 2010. The Food and Drug Administration has granted orphan drug designation for Octreolin and the Company will submit an application for Orphan Medicinal Product Designation to the European Medicines Agency (EMA) shortly.
Upon receipt of positive Phase 3 efficacy and safety data, the Company will submit an NDA using the "505(b)(2) regulatory pathway" in the United States and its equivalent, the "Hybrid Application," in Europe.
Chiasma is also developing Octreolin as a potential treatment for patients with portal hypertension (PHT); there are currently no drugs approved for PHT in the U.S.
Chiasma is evaluating the TPE technology with approved drugs, which may enable their being switched from injectable to oral, and potentially may also result in new indications or otherwise improved labels. The TPE technology promotes the delivery of drugs to the GI wall and from there to the liver. It is applicable to macromolecules that, to date, can be administered only by injection. TPE can be utilized also with small molecules that are already orally available but are poorly absorbed. The Company has successfully demonstrated proof-of-principle in
|SOURCE Chiasma, Inc.|
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