Cytori Therapeutics (NASDAQ: CYTX) sent out an email alert to investors on 10/15/09 in the evening pertaining to results that were presented at the 7th Annual Meeting of the International Federation for Adipose Therapeutics and Science (IFATS) that demonstrated the safety and feasibility of using a patient’s own adipose-derived stem and regenerative cells (ADRCs) processed by Cytori’s Celution 800 System to treat stress urinary incontinence (SUI) in a five patient pilot study conducted in Japan.
The study was led by 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 a case report on the first two patients has been accepted for publication in the International Journal of Urology . As part of the procedure, ADRCs were delivered by two distinct formulations, including
1.) injection directly into the sphincter muscle with the goal of improving muscle contraction;
2.) combined with the patient’s own fat tissue to create a cell-enriched bulking agent with the goal of improving closure upon sphincter contraction.
The patients underwent follow-up examinations at two, four, eight, and 12 weeks and were assessed on the basis of continence, intra-urethral and leak point pressures (measures of urethral sphincter tone), patient quality-of-life assessment, and a variety of imaging studies. SUI in all five study patients resulted from prior radical prostatectomy procedures.
Dr. Yamamoto made the comment, "We confirmed that the transplanted cells stimulate new blood supply in the treated area, stabilize the transplanted tissue over time, and increase the urethral pressure in the majority of patients treated. These early findings give hope to the millions of patients suffering from untreatable incontinence and the resulting impact on quality of life. Based on these results, we look forward to expanding the study to a larger population of patients.”
At 12 weeks following treatment, three of five patients showed improvement in measures of leakage, urethral closure, and patient quality-of-life assessment. These three patients were diagnosed as having severe incontinence. Two of the five patients did not show improvement in these measures and were diagnosed as having very severe incontinence prior to the study. It is likely that these very extreme cases, which represent the most difficult clinical challenge, could require multiple treatments.
On 10/15/09, Questcor Pharma (NASDAQ: QCOR) announced shortly after the market close that it resubmitted its sNDA filing to the FDA seeking approval to market H.P. Acthar Gel (repository corticotrophin injection) for the treatment of infantile spasms after performing the additional statistical analysis requested by the FDA. Acthar is currently approved in the U.S. for the treatment of MS exacerbations, nephrotic syndrome and many other conditions and the FDA previously granted Orphan Designation to Acthar for the treatment of IS.
On 5/12/09, QCOR received notice from the FDA that in order for its supplemental New Drug Application (sNDA) seeking approval to market H.P. Acthar Gel (repository corticotropin injection) for the treatment of infantile spasms (IS) to be considered a Complete Response, QCOR must perform additional statistical analyses relating to data from one study within the filing and submit this data to the Agency. The H.P. Acthar Gel sNDA is a previously submitted application, but on 2/24/09 QCOR announced that the FDA asked them to reformat the sNDA and resubmit before accepting for review to expand use.
QCOR resubmitted the sNDA on 3/17/09, but the FDA requested additional statistical analyses relating to data from one secondary study within the filing. On 9/21/09, QCOR announced its plans to submit a sNDA for H. P. Acthar Gel (repository corticotropin injection or Acthar) for the treatment of IS in October. This notification follows the completion by the Company of additional statistical analyses requested by the FDA. These analyses were conducted on data from one supportive study within the Company's filing.
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