First Patient Enrolled in Teleflex’s Barrigel™ Rectal Spacer Trial for Post Radical Prostatectomy Radiation Therapy (PPRT)
Teleflex (NYSE: TFX) announced enrollment of the first patient in the PPRT Trial, a randomized controlled study evaluating the Barrigel™ rectal spacer in patients undergoing radiation therapy after prostatectomy. The study aims to demonstrate the safety and effectiveness of Barrigel™, the first sculptable hyaluronic acid rectal spacer, in reducing radiation side effects.
The trial will be conducted across sites in the U.S. and Australia, focusing on patients who have undergone nerve-sparing prostatectomy with no evidence of metastatic disease. Barrigel™'s unique properties allow physicians to sculpt and optimize rectal protection during radiation therapy, remaining soft and pliable unlike other spacers that harden immediately after administration.
Teleflex (NYSE: TFX) ha annunciato l'arruolamento del primo paziente nel Trial PPRT, uno studio controllato randomizzato che valuta il Barrigel™ rectal spacer in pazienti sottoposti a radioterapia dopo prostatectomia. Lo studio mira a dimostrare la sicurezza e l'efficacia del Barrigel™, il primo spacer rettale in acido ialuronico modellabile, nel ridurre gli effetti collaterali della radioterapia.
Il trial sarà condotto in diversi centri negli Stati Uniti e in Australia, con un focus sui pazienti che hanno subito una prostatectomia conservativa dei nervi senza evidenza di malattia metastatica. Le proprietà uniche del Barrigel™ consentono ai medici di modellare e ottimizzare la protezione rettale durante la radioterapia, mantenendo una consistenza morbida e flessibile, a differenza di altri spacer che induriscono immediatamente dopo l'uso.
Teleflex (NYSE: TFX) anunció la inscripción del primer paciente en el Ensayo PPRT, un estudio controlado y aleatorizado que evalúa el Barrigel™ rectal spacer en pacientes sometidos a radioterapia después de una prostatectomía. El estudio tiene como objetivo demostrar la seguridad y efectividad del Barrigel™, el primer espaciador rectal de ácido hialurónico moldeable, para reducir los efectos secundarios de la radioterapia.
El ensayo se llevará a cabo en diferentes centros en EE. UU. y Australia, centrándose en pacientes que se han sometido a una prostatectomía preservadora de nervios sin evidencia de enfermedad metastásica. Las propiedades únicas del Barrigel™ permiten a los médicos modelar y optimizar la protección rectal durante la radioterapia, manteniendo una textura suave y flexible a diferencia de otros espaciadores que se endurecen inmediatamente después de la administración.
텔레플렉스 (NYSE: TFX)는 전립선 절제술 후 방사선 치료를 받는 환자에서 배리겔™ 직장 스페이서를 평가하는 무작위 대조 연구인 PPRT 시험의 첫 번째 환자 등록을 발표했습니다. 이 연구의 목표는 방사선 부작용을 줄이기 위해 첫 번째로 조형 가능한 히알루론산 직장 스페이서인 Barrigel™의 안전성과 효과를 입증하는 것입니다.
이 시험은 미국과 호주에서 진행되며, 전이성 질병의 증거 없이 신경 보존 전립선 절제술을 받은 환자에 초점을 맞추고 있습니다. Barrigel™의 독특한 특성은 의사가 방사선 치료 중 직장 보호를 조형하고 최적화할 수 있게 하며, 다른 스페이서가 투여 후 즉시 단단해지는 것과는 달리 부드럽고 유연한 상태를 유지합니다.
Teleflex (NYSE: TFX) a annoncé l'inscription du premier patient dans l'essai PPRT, une étude contrôlée randomisée évaluant le Barrigel™ espaceur rectal chez des patients subissant une radiothérapie après prostatectomie. L'étude vise à démontrer la sécurité et l'efficacité du Barrigel™, le premier espaceur rectal en acide hyaluronique sculptable, pour réduire les effets secondaires de la radiothérapie.
L'essai sera mené sur des sites aux États-Unis et en Australie, en se concentrant sur des patients ayant subi une prostatectomie préservant les nerfs sans preuve de maladie métastatique. Les propriétés uniques du Barrigel™ permettent aux médecins de façonner et d'optimiser la protection rectale pendant la radiothérapie, tout en restant souple et malléable, contrairement à d'autres espaceurs qui durcissent immédiatement après l'administration.
Teleflex (NYSE: TFX) hat die Rekrutierung des ersten Patienten in der PPRT-Studie bekannt gegeben, einer randomisierten kontrollierten Studie, die den Barrigel™ Rektilraum bei Patienten, die sich einer Strahlentherapie nach einer Prostatektomie unterziehen, bewertet. Ziel der Studie ist es, die Sicherheit und Wirksamkeit von Barrigel™, dem ersten formbaren hyaluronsäure-basierten Rektilraum, zur Reduzierung von Nebenwirkungen der Strahlentherapie zu demonstrieren.
Die Studie wird an Standorten in den USA und Australien durchgeführt und konzentriert sich auf Patienten, die sich einer nervenschonenden Prostatektomie unterzogen haben und keine Hinweise auf eine metastasierende Erkrankung aufweisen. Die einzigartigen Eigenschaften von Barrigel™ ermöglichen es Ärzten, den rectalen Schutz während der Strahlentherapie zu modellieren und zu optimieren, während es weich und formbar bleibt, im Gegensatz zu anderen Spacern, die sofort nach der Anwendung hart werden.
- First-to-market advantage with unique sculptable hyaluronic acid rectal spacer technology
- Expansion of clinical evidence through new multicenter study
- Product addresses significant market with prostate cancer recurrence rates of 16-46% post-prostatectomy
- None.
Insights
The initiation of the PPRT Trial for Barrigel™ rectal spacer represents a significant development in post-prostatectomy radiation therapy. The trial addresses a important medical need, targeting the
The trial's distinguishing feature is Barrigel's unique sculptable properties, allowing for customized spacing during radiation therapy. This characteristic, combined with its high visibility under ultrasound, could potentially lead to improved treatment precision and reduced side effects. However, investors should note that this is just the beginning of the trial and meaningful results that could impact market adoption will take time to materialize.
Randomized, controlled study will be first in personalized spacing evidence to include patients who have a prostate cancer recurrence after prostatectomy.
WAYNE, Pa., Oct. 29, 2024 (GLOBE NEWSWIRE) -- Teleflex Incorporated (NYSE: TFX), a leading global provider of medical technologies, today announced the first patient enrolled in the latest Barrigel™ rectal spacer randomized, controlled, single-blinded multicenter study: The PPRT Trial.
Barrigel™ rectal spacer is the first and only sculptable hyaluronic acid rectal spacer designed to significantly reduce radiation that reaches the rectum during prostate radiation therapy.1-3 This new study will evaluate Barrigel™ rectal spacer in patients undergoing hypofractionated post-prostatectomy radiation therapy across sites in the U.S. and one site in Australia.
“Our first enrolled patient represents a significant milestone as we grow our body of clinical evidence for Barrigel™ rectal spacer with patients undergoing radiation therapy after a prior prostatectomy,” said Martin T. King, MD, PhD, Radiation Oncologist with the Dana-Farber Brigham Cancer Center, Harvard Medical School Assistant Professor of Radiation Oncology, and principal investigator of the study.* “Our study endpoints are to demonstrate Barrigel™ rectal spacer as a safe and effective option that reduces prostate radiation side effects for this patient population.”
Based on the segmentation of risk groups between low, medium and high, prostate cancer reoccurrence after radical prostatectomy ranges from 16 to 46 percent.4
Rectal spacers are used during prostate cancer radiation therapy to enable effective radiation dosage to the prostate while sparing healthy rectal tissue. This is especially important in hypofractionated treatment regimens, in which radiation is delivered at higher doses over a fewer number of treatment sessions. Unlike other rectal spacers made from different materials, which harden almost immediately after administration, the hyaluronic acid in Barrigel™ rectal spacer remains soft and pliable. This gives physicians time to sculpt, layer, and add more Barrigel™ rectal spacer as needed to optimize rectal protection.1,5-7 Additionally, Barrigel™ rectal spacer is highly visible in real time using transrectal ultrasound, which helps to ensure optimal spacing.1,5-7
“Scientific evidence serves as the cornerstone for the advancement and expansion of medical technologies, fostering trust between clinicians and patients,” stated Michael Chao, MD, a Radiation Oncologist at the Olivia Newton John Cancer Wellness & Research Centre in Victoria, Australia.* “I take great pride in being the first physician to treat a patient in this clinical trial.”
Study sites will enroll patients who have:
- Undergone nerve-sparing prostatectomy (intrafascial)
- No radiographic evidence of local, regional, or distant metastatic disease via (PSMA) PET imaging
- An intact facial layer to support the Barrigel™ rectal spacer
- Had six months of androgen deprivation therapy, a first-line treatment for advanced prostate cancer
About Barrigel™ Rectal Spacer
Barrigel™ rectal spacer 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.1 Barrigel™ rectal spacer is made from Non-Animal Stabilized Hyaluronic Acid (NASHA).8
Hyaluronic acid is a substance naturally present in the human body and is highly biocompatible and fully absorbable. NASHA has a proven history of safety and efficacy in a wide variety of medical applications in men, women and children worldwide.5,9
Barrigel™ rectal spacer has been proven to significantly reduce unwanted side effects from prostate cancer radiation therapy and is approved for rectal spacing in the United States, Australia, and Europe. Barrigel™ rectal spacer can be used for prostate cancer patients with T1-T3b disease. For more information about Barrigel™ rectal spacer, please visit https://barrigel.com/hcp/barrigel-control-matters.
Barrigel™ Rectal Spacer Important Safety Information
Barrigel™ rectal spacer is intended to temporarily position the anterior rectal wall away from the prostate during radiotherapy for prostate cancer and, in creating this space, it is the intent of Barrigel™ rectal spacer to reduce the radiation dose delivered to the anterior rectum. Barrigel™ rectal spacer is composed of biodegradable material and maintains space for the entire course of prostate radiotherapy treatment and is intended to be absorbed by the patient’s body over time.
Barrigel™ rectal spacer should only be administered by qualified and properly trained physicians with experience in ultrasound guidance and injection techniques in the urogenital/pelvic area.
As with any medical treatment, there are some risks involved with the use of Barrigel™ rectal spacer. Potential complications associated with the use of Barrigel™ rectal spacer include, but are not limited to: pain associated with Barrigel™ rectal spacer injection; needle penetration of the bladder, prostate, rectal wall, rectum, or urethra; injection of Barrigel™ rectal spacer into the bladder, prostate, rectal wall, rectum, urethra, or intravascularly; local inflammatory reactions; infection; urinary retention; rectal mucosal damage, ulcers, necrosis; bleeding; constipation; and rectal urgency. More information on indications, contraindications, warnings and instructions for use can be found in the Instructions For Use at www.barrigel.com.
Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.
*Martin T. King and Michael Chao are paid consultants of Teleflex.
About Teleflex Incorporated
As a global provider of medical technologies, Teleflex is driven by our purpose to improve the health and quality of people’s lives. Through our vision to become the most trusted partner in healthcare, we offer a diverse portfolio with solutions in the therapy areas of anesthesia, emergency medicine, interventional cardiology and radiology, surgical, vascular access, and urology. We believe that the potential of great people, purpose driven innovation, and world-class products can shape the future direction of healthcare.
Teleflex is the home of Arrow™, Barrigel™, Deknatel™, LMA™, Pilling™, QuikClot™, Rüsch™, UroLift™ and Weck™ – trusted brands united by a common sense of purpose.
At Teleflex, we are empowering the future of healthcare. For more information, please visit teleflex.com.
Forward-Looking Statements
Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements. Any forward-looking statements contained herein are based on our management's current beliefs and expectations, but are subject to a number of risks, uncertainties and changes in circumstances, which may cause actual results or company actions to differ materially from what is expressed or implied by these statements. These risks and uncertainties are identified and described in more detail in our filings with the Securities and Exchange Commission, including our Annual Report on Form 10-K.
Teleflex, the Teleflex logo, Arrow, Barrigel, Deknatel, LMA, Pilling, QuikClot, Rüsch, UroLift, and Weck are trademarks or registered trademarks of Teleflex Incorporated or its affiliates, in the U.S. and/or other countries.
© 2024 Teleflex Incorporated. All rights reserved.
References:
- Mariados NF, Orio PF, Schiffman Z, et al. Hyaluronic acid spacer for hypofractionated prostate radiation therapy: a randomized clinical trial. JAMA Oncol. 2023; e1-e8.**
- King MT, Svatos M, Orio PF III et al. Evaluating the Quality-of-Life Effect of Apical Spacing with Hyaluronic Acid Prior to Hypofractionated Prostate Radiation Therapy: A Secondary Analysis, Pract Radiat Oncol. 2023;e1-e6. (Study sponsored by Palette Life Sciences, now part of Teleflex).**
- Data on File. As of 06/01/2024.
- Falagario UG et al. Biochemical Recurrence and Risk of Mortality Following Radiotherapy or Radical Prostatectomy. JAMA Netw Open (2023).
- Svatos M, Chell E, Low DA, et al. Symmetry, separation, and stability: Physical properties for effective dosimetric space with a stabilized hyaluronic acid spacer. Med Phys. 2024; 1-15. https://doi.org/10.1002/mp.17292**
- Gejerman G, Goldstein MM, Chao M et al. Barrigel spacer injection technique. Pract Radiat Oncol. 2023:e1-e5. (Drs Gejerman, Chao, Lederer, and Orio are paid consultants of Palette Life Sciences, now part of Teleflex).
- Williams J, Mc Millan K, Chao M et al. Hyaluronic acid rectal spacer in EBRT: Usability, safety and symmetry related to user experience. J Med Imag Radiat Sci (2022).
- Barrigel Injectable Gel Instructions for Use (2022).
- Restylane® celebrates 25 years of natural-looking results with its signature line of hyaluronic acid fillers. 2021. Available at: https://www.prnewswire.com/news-releases/restylane-celebrates-25-years-of-natural-looking-results-with-its-signature-line-of-hyaluronic-acid-fillers-301388779.html. Accessed Sept 30, 2021.
**Study sponsored by Palette Life Sciences, now part of Teleflex.
Contacts:
Teleflex
Lawrence Keusch
Vice President, Investor Relations and Strategy Development
investor.relations@teleflex.com
610-948-2836
Media Contact:
Glenn Silver
Partner National Media Relations Specialist
glenn.silver@finnpartners.com
646-871-8485
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