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Thursday, 6 September 2012
Soligenix gets go-ahead from US FDA for clinical development of pediatric Crohn's disease drug
Soligenix (OTCQB:SNGX) said today that it has received the green light from the US FDA to start a clinical program testing SGX203 as a potential treatment for pediatric Crohn's disease - sending shares up more than 7 per cent this morning.
The company had previously received orphan drug designation for this indication for SGX203, or the oral form of beclomethasone 17,21-dipropionate (BDP).
The clearance of the investigational new drug application allows Soligenix to start a phase 1/2 study of the drug in healthy adolescents and young adults.
The data from the study will help inform dose selection for phase 2/3 clinical trials that follow.
The first trial is expected to be initiated in 2012.
"We are very excited to begin the clinical development of SGX203 which we believe may prove to have significant advantages relative to systemic steroids such as prednisone, which are currently administered to the vast majority of newly diagnosed pediatric Crohn's disease patients," said senior VP and chief medical officer of Soligenix, Dr. Kevin Horgan.
"Our proprietary two-tablet system with immediate and delayed release capabilities allows for comprehensive treatment of a patient's disease regardless of its location in the gastrointestinal tract."
Crohn's Disease is an ongoing disorder that causes inflammation of the gastrointestinal (GI) tract. It can affect any area of the GI tract, from the mouth to the anus, but it most commonly affects the lower part of the small intestine.
The swelling caused by the disease extends deep into the lining of the affected organ, and can induce pain and cause diarrhea.
People of Ashkenazy Jewish heritage have an increased risk of developing Crohn's disease, the company noted.
The disease can appear at any age, but it is most often diagnosed in adults in their 20s and 30s. Around 30 per cent of people with Crohn's develop symptoms before 20 years of age.
Pediatric Crohn's is a subpopulation of approximately 80,000 patients from 0-19 years of age in the United States.
The disease tends to be both severe and extensive in the pediatric population, and can also stunt growth, delay puberty, and weaken bones.
The company's drug, SGX203, contains BDP, a potent, topically active corticosteroid that has a local effect on inflamed tissue. BDP has been marketed globally since the early 1970s as the active pharmaceutical ingredient in inhalation products for the treatment of patients with allergic rhinitis and asthma.
SGX203 is a two tablet delivery system of BDP, specifically designed for oral use that allows for the delivery of the drug throughout the small bowel and the colon.
Soligenix is a development stage biopharmaceutical company developing products to treat life-threatening side effects of cancer treatments and serious gastrointestinal diseases, as well as vaccines for certain bioterrorism agents.
Its lead product, orBec, is a locally acting corticosteroid that has been initially developed for the treatment of gastrointestinal Graft-versus-Host disease (GI GVHD), a life-threatening complication of hematopoietic cell transplantation.
Through its biodefense division, the company is developing vaccines including RiVax, designed to protect against the lethal effects of exposure to ricin toxin and VeloThrax, a vaccine against anthrax exposure.
Shares of the company rose 7.3 per cent to trade at 44 cents Thursday morning.