Cytori Therapeutics Inc (NASDAQ:CYTX) announced enrollment of the first two patients in an investigator-initiated clinical trial of Cytori Cell Therapy™ for the treatment of the orphan indication, fistula-in-ano associated with Crohn’s Disease.
This 10 patient open label trial is being performed by Professor Jean-Charles Grimaud and colleagues at the Hôpital Nord,Marseille, France under the authority of the Agence Nationale de Sécurité du Médicament (ANSM), the French equivalent of theUS Food and Drug Administration (FDA). As with the SCLERADEC I trial of Cytori Cell Therapy performed by a different group in Marseille, this trial is being executed in an indication that has been recognized as orphan by both the European Medicines Agency and the US FDA.
“This trial continues and expands the use of Cytori Cell Therapy in strategic niche indications such as orphan diseases. When coupled with the previously published trial data in fistula repair from Japan and the United Kingdom this trial could provide the basis for a follow-on sponsored clinical trial as part of a formal clinical development program,” said Dr. Steven Kesten, Chief Medical Officer at Cytori.
Fistula-in-ano is an abnormal tunnel linking the interior of the lower intestine to the skin adjacent to the anus such that the contents of the intestines can leak through by-passing the anal sphincter. They are associated with substantial pain, risk of infection, and reduced quality of life. 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.
The approach taken by Prof. Grimaud combines placement of a mixed cell/tissue product into the tissue surrounding the fistula while placing additional therapeutic cells within the fistula itself. Prof. Grimaud has considerable experience in this field with several published studies in the surgical management of fistula in patients with Crohn’s disease.
This trial builds on prior reports using Cytori Cell Therapy in fistula repair published by Mr. David Borowski and collaborators atNorth Tees Hospital in the United Kingdom and, most recently, by Professor Masaki Mori at Osaka University Graduate School of Medicine in Osaka, Japan. Links to further information about these studies are copied below. (Original Source)
Shares of Cytori Therapeutics closed last Friday at $0.15. CYTX has a 1-year high of $1.47 and a 1-year low of $0.14. The stock’s 50-day moving average is $0.24 and its 200-day moving average is $0.36.
On the ratings front, Cytori has been the subject of a number of recent research reports. In a report issued on December 18, Maxim Group analyst Jason Kolbert reiterated a Buy rating on CYTX, with a price target of $5, which represents a potential upside of 3255.7% from where the stock is currently trading. Separately, on November 9, Roth Capital’s Joseph Pantginis maintained a Buy rating on the stock and has a price target of $2.50.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Jason Kolbert and Joseph Pantginis have a total average return of -22.4% and -12.8% respectively. Kolbert has a success rate of 22.3% and is ranked #3580 out of 3582 analysts, while Pantginis has a success rate of 31.8% and is ranked #3566.
Cytori Therapeutics Inc is engaged in the development of novel treatments for cardiovascular disease and soft tissue injuries and burns.