September 8, 2017 — Augmenix Inc. announced that the National Institute for Health and Care Excellence (NICE) in the U.K. has issued Interventional Procedure Guidance (IPG) supporting the use of a hydrogel barrier to reduce the risk of toxicity to surrounding tissue in radiotherapy to treat prostate cancer. The guidance recommends use of hydrogel spacers under "standard arrangements". For a procedure to be recommended for use with standard arrangements (previously called “normal arrangements”), the evidence should be adequate to show safety and efficacy of the procedure both in the long term and short term. NICE’s guidance clearly indicates that this procedure meets the highest evidence standards.
The designation is based in part on three-year follow-up data from a Phase III prospective, randomized clinical trial involving the use of SpaceOAR hydrogel, a technology developed by Augmenix to reduce the risk of rectal injury in men receiving prostate cancer radiation therapy (RT) by acting as a spacer that pushes the rectum away from the prostate during treatment.
The IPG designation positions U.K. radiation oncologists and urologists to offer use of a hydrogel spacer such as SpaceOAR as an option for men with prostate cancer who want to reduce their risk of side effects including rectal toxicity, incontinence and loss of sexual function associated with radiotherapy.
“Radiation therapy has been proven to be a highly effective treatment option for many men with prostate cancer, but in many cases patients are concerned about potential side effects related to rectal toxicity, incontinence or sexual function,” said Prof. Heather Payne, a consultant in clinical oncology at University College Hospital, London. “The IPG designation provides important further validation of the benefits of a hydrogel barrier in reducing the risk of side effects, helping patients to proceed to treatment with greater comfort and confidence.”
SpaceOAR hydrogel reduces rectal injury in men receiving prostate cancer radiation therapy by acting as a spacer – pushing the rectum away from the prostate. This space between organs decreases the radiation dose to the rectum and other organs at risk (OAR). Earlier this year, Augmenix announced published data from their prospective, randomized clinical trial showing that patients treated with SpaceOAR hydrogel prior to prostate cancer radiotherapy demonstrated significant rectal (bowel), urinary and sexual benefits through three years of follow-up.
“Our goal in the management of prostate cancer is to identify the most effective treatment options for each patient, and we always have to keep in mind their concerns about side effects that can affect their health and quality of life,” said Suneil Jain, NMD, senior lecturer and consultant in clinical oncology at Queen’s University Belfast. “With SpaceOAR Hydrogel, we have a proven safe option to help address some of the most important concerns that patients have about radiotherapy, including bowel toxicity and loss of sexual function.”
For more information: www.augmenix.com