Cytori Therapeutics Inc (NASDAQ:CYTX) announced the publication of the results of a pilot clinical trial of Cytori Cell Therapy™ for the treatment of recalcitrant enterocutaneous fistula in patients with inflammatory bowel disease. This single center, single arm exploratory study enrolled six patients with fistulas that had failed to heal following conventional therapy including antibiotics, drainage, irrigation and ileostomy. Four patients had fistula associated with Ulcerative Colitis (one following surgery for rectal cancer) and two patients had fistula secondary to Crohn’s Disease. All patients received a single treatment with the adipose derived cellular therapeutic injected into the peri-fistular region and into the fistula tract. Patients received a total dose of between approximately 1×107 and 1.4×108 adipose cells. Patients were followed for fistula closure and epithelialization at 4, 12, and 24 weeks after treatment.
Two serious adverse advents were observed in the trial. One patient had extended hospitalization resulting from relapse of their underlying Crohn’s disease and a second patient experienced a parastomal hernia. Neither complication was considered to be associated with adipose tissue harvest or delivery of the cell therapy.
A fistula closure rate of 83% (5 of 6 patients) was observed within four weeks after treatment. A fistula closure rate of 100% (all six patients treated) was observed at 24 weeks after treatment. A single patient had a recurrent fistula 10 months after the initial procedure related to a relapse in the primary disease.
This trial, published in the journal “Surgery Today”, was executed at the Osaka University Graduate School of Medicine inOsaka, Japan, by Professor Masaki Mori and colleagues. The study builds on prior reports using Cytori Cell Therapy™ in a different kind of enterocutaneous fistula (fistula-in-ano) published by Dr. David Borowski and collaborators at North Tees Hospital in the United Kingdom in the journal “Surgical Innovation”. A follow on European physician initiated trial for patients with fistula-in-ano is planned to begin enrollment later in 2015.
“This small but carefully performed trial led by the Chief of Surgery at Osaka University in Japan is encouraging for a number of reasons,” said Dr. Marc H. Hedrick, President & CEO of Cytori. “This trial supports other published clinical data reporting benefit of our cellular therapeutics on impaired wound biology through mechanisms of actions that are likely similar to that proposed in many conditions and clinical situations such as scleroderma and further supported in our BARDA funded preclinical work. Poor wound healing, broadly construed, represents a very large market opportunity therefore we are carefully evaluating the business case to expand similar clinical trials.”
A fistula is an abnormal tunnel linking the interior of the stomach or intestines to the skin such that the contents of the intestines leak through. They are associated with substantial pain, risk of infection, and reduced quality of life. Fistulas of this kind are both more common and more difficult to treat in patients with inflammatory bowel diseases such as Crohn’s Disease and Ulcerative Colitis. Fistulas occur in 20-40% of patients with Crohn’s Disease with approximately 90% of these requiring surgical intervention. More than 20% of patients do not achieve complete healing and recurrence is common, occurring in 20-35% of cases. The Crohn’s and Colitis Foundation of America estimates that as many as 1.6 million Americans are affected by inflammatory bowel disease. It has been estimated that the incidence of rectoanal fistula in the USA is 68,000-96,000 cases per year. (Original Source)
Shares of Cytori Therapeutics closed yesterday at $0.37. CYTX has a 1-year high of $1.47 and a 1-year low of $0.29. The stock’s 50-day moving average is $0.38 and its 200-day moving average is $0.58.
On the ratings front, Roth Capital analyst Joseph Pantginis reiterated a Buy rating on CYTX, with a price target of $4, in a report issued on September 11. The current price target represents a potential upside of 981.1% from where the stock is currently trading. According to TipRanks.com, Pantginis has a total average return of -6.1%, a 33.7% success rate, and is ranked #3752 out of 3795 analysts.
Cytori Therapeutics Inc is engaged in the development of novel treatments for cardiovascular disease and soft tissue injuries and burns.