Rectal spacing with Barrigel® is proven safe and effective in improving rectal dosimetry and reducing acute Grade 2+ GI toxicity in first FDA-reviewed randomized controlled trial of rectal spacing using hypofractionated radiotherapy
SANTA BARBARA, Calif. and STOCKHOLM, Sweden, Feb. 09, 2023 (GLOBE NEWSWIRE) -- Palette Life Sciences (https://www.palettelifesciences.com/), a fully-integrated global life sciences company dedicated to improving patient outcomes, today announced the publication of the Barrigel® Pivotal Trial, the first U.S. Food and Drug Administration (FDA)-reviewed randomized controlled study of rectal spacing using hypofractionated radiation therapy (HFRT), in the prestigous JAMA Oncology. The publication is an international peer-reviewed journal and the definitive journal for scientists, clinicians, and trainees in the field of oncology.
"Palette Life Sciences is extremely proud of our safety and efficacy data being published in JAMA Oncology and is proud to advance better health outcomes for the approximately 290,000 men in the U.S. who are diagnosed with prostate cancer each year," said Per G. Langö, Chief Executive Officer and Board Director of Palette Life Sciences. "Radiation therapy is becoming the gold standard for prostate cancer treatment, and this study shows that Barrigel is proven safe and effective at achieving a clinically significant reduction in radiation dose to the rectum, leading to fewer rectal side effects."
"In the study, 98.5% of patients who were treated with Barrigel met the primary endpoint of achieving at least a 25% reduction in radiation dose to the rectum, leading to fewer side effects," said Neil Mariados, MD, Cancer Care of Western New York, and first author of the Barrigel Pivotal Trial. "Patients who met the primary endpoint averaged an 85% reduction in radiation to the rectum. Additionally, Barrigel was proven superior in the reduction of acute Grade 2+ GI toxicity compared to the control cohort and there were zero Barrigel-related adverse events reported."
Barrigel is the first and only hyaluronic acid rectal spacer that separates the prostate from the rectum to protect the rectum during radiation therapy treatment for prostate cancer. It has been proven to significantly reduce unwanted side effects from prostate cancer radiation therapy and it recently received 510(k) clearance by the U.S. FDA. Barrigel is indicated for prostate cancer patients with T1-T3b disease.
"HFRT for the treatment of prostate cancer has dramatically increased in recent years because of its shorter treatment schedule and mounting clinical evidence supporting similar efficacy to conventional radiation therapy," said Dr. Martin King, Assistant Professor of Radiation Oncology at Harvard Medical School, Dana-Farber Cancer Institute in Boston and Medical Director of the Barrigel Prostate Trial. "Despite these benefits, HFRT has been associated with greater acute Grade 2+ GI toxicity compared with conventional radiation therapy. Consequently, rectal spacing may address a clinically important need for the many patients receiving this treatment."
Of the 201 patients enrolled in the one-year, multi-center, single patient-blinded, randomized controlled trial among 12 centers in the U.S., Australia and Spain, 136 were randomized to Barrigel and 65 to control. All patients in the study received HFRT.
Publication:
Neil F. Mariados Jr, MD, Peter F. Orio, III, DO MS, Martin T. King, MD PhD et. al. Hyaluronic Acid Spacer for Hypofractionated Prostate Radiation Therapy: A Randomized Clinical Trial. JAMA Oncology https://jamanetwork.com/journals/jamaoncology/fullarticle/2801296 (https://urldefense.com/v3/__https:/jamanetwork.com/journals/jamaoncology/fullarticle/2801296__;!!DlCMXiNAtWOc!zhz8KPdEeNQczcFNNVTfdZ76QDgmvR4lWzPhm5vywfWfejNdXXzWP4_849Cg3GdMILcj6uRfz-SXukX_Ctsz62tsOtkm1vhWUQ$)
About Barrigel
Barrigel is made from safe, proven, Non-Animal Stabilized Hyaluronic Acid (NASHA®), the first material documented for prostate spacing. NASHA has a long history of safety, efficacy and biocompatibility in a wide variety of medical applications, including pediatrics. NASHA can withstand high levels of radiation without any compromise to its functional capabilities. Further, NASHA will decompose and disappear in a natural way following radiation therapy.
"NASHA provides a natural alternative to synthetic materials, providing safe and effective experience to patients and providers," said Travis Gay, Chief Commercial Officer of Palette Life Sciences. "Its unique characteristics enable Barrigel to provide the control and coverage necessary to sculpt an anatomy-specific implant. NASHA is the foundation of our expansive product portfolio of minimally invasive treatments in radiotherapy and interventional oncology procedures, urology/urogynecology disorders and colorectal conditions."
Barrigel has previously been approved for rectal spacing in Australia and Europe and is being developed for future market introduction in Japan.
About the Study
The Barrigel Prostate Trial included 201 adult patients with up to unfavorable intermediate prostate cancer who were randomized into two study cohorts. The Barrigel cohort included 136 patients while the Control group was comprised of 65 patients. All patients will continue to be followed for three years.
Barrigel was proven effective at achieving a clinically significant reduction in radiation dose to the rectum. The hypofractionated regimen of radiation provided 60 Gy in 20 fractions (3 Gy/fraction). For full study results, please visit https://jamanetwork.com/journals/jamaoncology/fullarticle/2801296 (https://urldefense.com/v3/__https:/jamanetwork.com/journals/jamaoncology/fullarticle/2801296__;!!DlCMXiNAtWOc!zhz8KPdEeNQczcFNNVTfdZ76QDgmvR4lWzPhm5vywfWfejNdXXzWP4_849Cg3GdMILcj6uRfz-SXukX_Ctsz62tsOtkm1vhWUQ$)
About Palette Life Sciences
Palette Life Sciences is a fully integrated life sciences company. Palette Life Sciences' products improve patient outcomes in urology and urogynecology disorders, colorectal conditions, radiotherapy, and interventional oncology procedures. The company's portfolio of available products includes Barrigel®, Deflux®, Solesta®, and Lidbree. Palette Life Sciences moves rapidly to leverage novel applications of existing technologies to create breakthrough medical solutions. This focus enables the company to serve those often overlooked by traditional medical companies and improve patient quality of life. Led by experienced healthcare executives, Palette Life Sciences is headquartered in Stockholm, Sweden, with offices in Santa Barbara, California, Dallas, Texas, Sydney, Australia and Tokyo, Japan. Learn more at http://www.palettelifesciences.com (http://www.palettelifesciences.com/).
Palette has a license to worldwide commercialization and development rights for Barrigel from Galderma S.A.
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