Clinical Laserthermia Systems AB, announced the clinical study performed in collaboration with Toronto General Hospital, Canada, and Dr. Sangeet Ghai now is recruiting patients for the extended Phase II trial where 30 additional patients, with localized low or intermediate risk prostate cancer, will be treated with MRI-guided focal laser ablation.
IRVINE, Calif., Nov. 17, 2020 (GLOBE NEWSWIRE) -- Clinical Laserthermia Systems AB (publ) (CLS), today announced the clinical study performed in collaboration with Toronto General Hospital, Canada, and Dr. Sangeet Ghai now is recruiting patients for the extended Phase II trial where 30 additional patients, with localized low or intermediate risk prostate cancer, will be treated with MRI-guided focal laser ablation.
The clinical trial started in 2018 to evaluate the safety and efficacy in treating prostate cancer with MRI-guided focal laser ablation (MRgFLA) in 25 patients. In October 2019, interim results were presented in a poster at the AdMeTech 4th Global Summit. At the time of the presentation, treatment was successfully completed in 21 patients and no adverse events were reported. The conclusion was that MRgFLA shows encouraging short-term oncologic and functional outcomes for the treatment of low-to-intermediate-risk prostate cancer. However, the long-term efficacy will be determined in the coming years. CLS and Dr. Sangeet Ghai decided to proceed with the collaboration, continue the clinical trial, and extend it to include an additional 30 patients under the same protocol. The necessary approvals for this extension are now obtained from Canada’s national authorities. The initial patients are already expected to be included and receive treatment during November and December 2020.
“CLS is very pleased to continue working together with Dr. Sangeet Ghai and his multidisciplinary team. The promising results we have seen so far in this clinical study targeting one of our key areas, prostate cancer, is something we want to continue to explore,” stated Dan Mogren, Chief Commercial Officer at CLS. “The data, as well as the user experience and feedback we get from the clinicians operating our TRANBERG-system, is extremely valuable to us.”
BACKGROUND: Men diagnosed with localized low-to-intermediate risk prostate cancer and with a significant life expectancy are usually offered the choice of two broad therapeutic options, either active treatment with surgery or irradiation with high risk of side effects.
Using its localizing strength, MRI has increased opportunities in management of prostate cancer. Additionally, MR thermometry allows real time, peri-procedural monitoring to ensure selective and adequate tumor ablation.
Focal therapy (FT) for prostate cancer (PCa) reduces functional complications with promising oncological results. Magnetic resonance image (MRI)-guided Focal Laser Ablation (MRgFLA) potentially maximizes precision. In this Phase II study, non water cooled 1064nm diode laser fibers were used for ablation.
PURPOSE & AIM: This study aims to determine the oncologic and functional outcomes of MRgFLA in low-to-intermediate risk localized prostate cancer in the single-center series of patients treated with the 1064nm diode laser fibers.
About CLS TRANBERG Thermal Therapy System
CLS developed its TRANBERG Thermal Therapy System with Thermoguide thermometry software and single-use accessories for image-guided, high precision soft tissue thermal therapy and laser ablation of tumors and soft tissues. The system’s tight integration with MRI scanners is designed to enable precise monitoring, real-time tissue temperature measurements, and cell damage calculations during treatments for exact therapy, precise guidance, and ablation control. The system includes a desk-top mobile laser unit, thermometry software for real-time temperature mapping of MRI images during treatments, and non-cooled laser applicators and single use devices.
Clinical Laserthermia Systems AB (publ), develops and sells the TRANBERG® |Thermal Therapy System including specially designed sterile disposable products for the minimally invasive ablative treatments of soft tissues and cancerous tumors, in accordance with regulatory approvals in EU and USA. The products are marketed for image-guided laser ablation (FLA, LITT) and for treatment with imILT®, the company’s interstitial thermotherapy with a potentially immune stimulating effect. CLS is headquartered in Lund, Sweden and has subsidiaries in Germany and Irvine, CA. CLS is listed on Nasdaq First North Growth Market under the ticker CLS B. Certified Adviser (CA) is FNCA Sweden AB, Ph: +46 8 528 00 399. E-mail: info@fnca.se. Further information is available on www.clinicallaser.se.
The TRANBERG®|Thermal Therapy System has not yet received market clearance for immune stimulating interstitial laser thermotherapy (imILT®) or its Thermoguide thermometry software by the Food and Drug Administration (FDA) in the United States of America (USA).
Company contact: Clinical Laserthermia Systems AB (publ) Lars-Erik Eriksson, CEO T: +46 – (0)703 – 90 33 00 Email: lee@clinicallaser.se Company Contact: CLS Americas: Michael Magnani, Managing Director T: +1 949-504-5440 E: michael.magnani@clinicallaser.com Media Contact: TopSpin Communications Joe Waldygo, President P: +1 480-363-8774 E: joe@topspinpr.com
