SCHAUMBURG, Ill., May 11, 2020 /PRNewswire/ -- As patients, caregivers, and medical professionals focus on Bladder Cancer Awareness Month, many are encouraged that a novel gene therapy discovered during Society of Urologic Oncology Clinical Trials Consortium (SUO-CTC) Phase 2 and 3 trials is under review by the U.S. Food and Drug Administration (FDA) and may provide a potential new treatment option to healthcare practitioners. The breakthrough treatment is offering new options to those who suffer bladder cancer that has recurred after initial therapy.
The new treatment tested by the SUO-CTC is designed to assist patients that suffer from high-grade non-muscle-invasive bladder cancer that are unresponsive to previous treatments (BCG therapy). In the absence of such therapies, many of these patients face complete removal of their bladder due to the aggressive nature of the disease.
Nearly 68,000 people in the United States are impacted by bladder cancer every year, making it one of the most common cancers. It also one of the deadliest cancers that will claim close to 18,000 lives in the US this year alone.
The Phase 2 and Phase 3 clinical trials conducted by the SUO-CTC tested the treatment, nadofaragene firadenovec. The medication was administered to patients via a catheter, directly into the bladder. It was found that the medication helps the body produce high quantities of a protein that fights the cancer.
"We await with great anticipation FDA approval of nadofaragene firadenovec," stated Dr. Michael Cookson, President of SUO. "This treatment is truly a game-changer and adds a powerful new intravesical therapy for patients with BCG unresponsive bladder cancer."
"There have been so few developments over the past decades for patients with non-muscle invasive bladder cancer, making this potential treatment option especially encouraging," said Dr. Stephen Boorjian. "We are excited for the opportunity to be able to offer this treatment to patients as an alternative to surgical bladder removal."
"The SUO-CTC was created as a mechanism to promote the involvement of urologic oncologists in meaningful clinical trials. When the SUO-CTC undertakes a clinical trial, sponsors get much more than reliable accrual to their trials," stated Dr. Colin Dinney, Co-Founder of the SUO-CTC. "Our team of experts provide their expertise and insights into the design of the trial, and ongoing input to make it a true partnership among the biotech representatives, nonclinical experts, and practicing physicians. The development of nadofaragene firadenovec is a prime example of an effective collaboration between the SUO-CTC and Pharma to develop a novel therapeutic that addresses an unmet need for patients with bladder cancer."
"Despite the trial participants being a challenging population to treat, eligible patients were enrolled quickly," stated Dr. Gennady Bratslavsky, President of the SUO-CTC. "The ongoing cooperation and successful Phase 2 and Phase 3 clinical trials should encourage more organizations to take the innovative approach offered by the SUO-CTC and the expertise within the organization."
In addition to bladder cancer trials, the SUO-CTC also collaborates in partnership with pharmaceutical and biotechnology companies to develop and conduct trials for prostate cancer and renal cancer.
Created, owned and operated by its members, the Society of Urologic Oncology Clinical Trials Consortium (SUO-CTC) is a clinical research investigator network of more than 400 members from more than 200 clinical sites in the U.S. and Canada. This national alliance of leading academic and community based uro-oncologists is committed to furthering urology research. The SUO-CTC is a registered 501c3 not-for-profit corporation and has a cooperative relationship with the Society of Urologic Oncology (SUO).
Please visit http://www.suoctc.org
For more information or to schedule an interview with a SUO-CTC spokesperson, please contact Dan Rene of kglobal at 202-329-8357 or [email protected]
Dan Rene of kglobal
202-329-8357 or [email protected]
SOURCE Society of Urologic Oncology Clinical Trials Consortium