Cytori Therapeutics Inc (NASDAQ:CYTX) announced that the first patient has been enrolled and treated in the ADRESU trial, a late phase, physician-initiated Japanese clinical trial to study the efficacy and safety of Cytori Cell Therapy™ in men with urinary incontinence after prostatic surgery for prostate cancer or benign prostatic hypertrophy.
ADRESU is a multicenter, 45 patient open label controlled trial of the ECCI-50 cellular therapeutic and is based on promising pilot trial data published in the International Journal of Urology in 2014. Details of the pilot trial can be found on clinicaltrials.govand the MHLW website. The primary endpoint for the ADRESU trial will be the number of patients who experience reduction of urinary leakage volume (as measured by the weight of diaper pads used over 24 hours) 52 weeks after treatment. If the endpoint is successfully achieved, the data will be used to seek approval of Cytori Cell Therapy for this indication. The trial costs are substantially supported by Japan’s Ministry of Health, Labour and Welfare, with additional support by Cytori. The trial is sponsored by Nagoya University.
“Cytori is committed to the goal of obtaining the first approval for a cellular therapeutic product since the new Regenerative Medicine Law was implemented in November 2014,” said Dr. Marc H. Hedrick, President and CEO of Cytori Therapeutics. “The administration of Prime Minister Abe has made a substantial commitment of Japanese resources to this field and we feel likewise committed to this important market.”
Cytori has been commercially active in the Japanese market since 2008 through its Japanese subsidiary and has had a full-time office and in-country leadership in Japan since 2005. Over that period of time, Cytori has built a user base of approximately 50 sites, including both hospitals and individual clinics. Many users are in leading academic institutions throughout Japan, such as Nagoya University.
Dr. Momokazu Gotoh, Professor and Chairman of the Department of Urology at Nagoya University and Principal Investigator on the ADRESU trial, said, “Prostatic disease is a very common cancer in aging males. Incontinence after prostatic manipulation or surgery is notoriously hard to treat and physicians have little to offer these patients beyond adult diapers and psychological support. Cytori Cell Therapy technology performed well in the pilot trial and holds promise as an effective therapy for this indication.”
The ADRESU trial was based on preliminary safety and efficacy data published in 2014 in the International Journal of Urology. Following enrollment and assessment of the results of the trial, Cytori and Nagoya University intend to file for medical device approval for the therapy, which in Japan is typically combined with reimbursement. (Original Source)
Shares of Cytori Therapeutics closed yesterday at $0.3533 . 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 $0.41 and its 200-day moving average is $0.75.
On the ratings front, Cytori has been the subject of a number of recent research reports. In a report issued on August 10, Roth Capital analyst Joseph Pantginis reiterated a Buy rating on CYTX, with a price target of $4, which represents a potential upside of 1032.2% from where the stock is currently trading. Separately, on June 15, Maxim Group’s Jason Kolbert reiterated a Buy rating on the stock and has a price target of $7.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Joseph Pantginis and Jason Kolbert have a total average return of -2.7% and -10.1% respectively. Pantginis has a success rate of 36.1% and is ranked #3530 out of 3748 analysts, while Kolbert has a success rate of 29.6% and is ranked #3733.
Cytori Therapeutics Inc is engaged in the development of novel treatments for cardiovascular disease and soft tissue injuries and burns.