Cytori Therapeutics Inc (NASDAQ:CYTX) announced that it has recently been informed that a company-supported trial in Japan has received approval to begin enrollment from Japan MHLW (Ministry of Health, Labor and Welfare).
The ‘ADRESU’ trial is a 1-year open-label, multi-center, single arm trial to evaluate the efficacy and safety of periurethral injection of autologous adipose derived regenerative cells for the treatment of male stress urinary incontinence following prostatectomy for prostate cancer. The goal of the investigator-initiated trial will be to gain product approval for Cytori Cell Therapy technology for this indication.
The trial will be led by both Momokazu Gotoh, MD, Ph.D., Professor and Chairman of the Department of Urology and Tokunori Yamamoto, MD, Ph.D., Associate Professor Department of Urology at Nagoya University Graduate School of Medicine, and is primarily sponsored and funded by the Japanese Government.
The ADRESU trial will enroll 45 patients and the primary endpoint will assess the improvement in urine leakage volume from baseline by 24-hour pad test. Each patient will serve as his own control in the trial. Key secondary endpoints will include: urine leakage volume at each evaluation time point by 24-hour pad test, improvement in the number of incontinence episodes per day with greater than 50% reduction from baseline, number of incontinence episodes per day, number of pads used per day, key quality of life scores, patient overall satisfaction, key urodynamic parameters, blood flow at the injection site measured by transrectal ultrasonography and evaluation of the injection site by pelvic MRI scan. (Original Source)
Shares of Cytori Therapeutics closed yesterday at $0.44. CYTX has a 1-year high of $2.21 and a 1-year low of $0.36. The stock’s 50-day moving average is $0.54 and its 200-day moving average is $0.76.
On the ratings front, Cytori Therapeutics has been the subject of a number of recent research reports. In a report issued on June 15, Roth Capital analyst Joseph Pantginis maintained a Buy rating on CYTX, with a price target of $6, which implies an upside of 1263.6% from current levels. Separately, on the same day, 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 5.7% and -4.8% respectively. Pantginis has a success rate of 47.1% and is ranked #520 out of 3718 analysts, while Kolbert has a success rate of 34.6% and is ranked #3646.
Cytori Therapeutics Inc is engaged in the development of novel treatments for cardiovascular disease and soft tissue injuries and burns.