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3-Year Clinical Outcomes and BPH Subgroup Analysis of Profound Medical’s Phase I Clinical Trial to be Included in Presentation at DGU 2018
TORONTO, Sept. 18, 2018 (GLOBE NEWSWIRE) -- Profound Medical Corp. (TSX:PRN; OTCQX:PRFMF) (“Profound” or the “Company”), the only company to provide a therapeutics platform that provides the precision of real-time Magnetic Resonance (“MR”) imaging combined with the safety and ablation power of directional and focused ultrasound technology for the incision-free ablation of diseased tissue, announced that 3-year clinical outcomes and a subgroup analysis of Benign Prostatic Hyperplasia (“BPH”) patients enrolled in the previously-reported prospective Phase I Safety & Feasibility Study of TULSA-PRO® (Chin et al, Eur Urol 2016) designed to evaluate the safety and precision of TULSA-PRO® to ablate prostate tissue in patients with localized prostate cancer, will be presented by Dr. Jurgen Futterer during a lecture session at the German Society For Urology 70th Annual Congress 2018 (“DGU 2018”) in Dresden, Germany.
Dr. Futterer’s presentation, entitled “MRI-Guided TULSA in Patients with Localized Prostate Cancer: Phase I 3-year Outcomes and Early Experience in TACT Pivotal Study,” is scheduled for Thursday, September 27 at 8:39 AM CEST.
BPH is a non-cancerous enlargement of the prostate gland due to an overgrowth of prostate cells. It is a common condition as men age, often impeding the flow of urine and creating significant Lower Urinary Tract Symptoms (“LUTS”). Current surgical treatment of BPH can result in potential complications such as retrograde ejaculation, erectile dysfunction, significant bleeding, and require long recovery times. Therefore, for several years many alternative minimally-invasive treatments have been investigated.
As part of his presentation at DGU 2018, Dr. Futterer will report on an analysis of LUTS in a subgroup (n=9) of the Phase I study patients who had at least moderately symptomatic BPH, based on International Prostate Symptoms Score (“IPSS”) ≥ 12, in addition to their cancer at baseline. At 12 months after TULSA, IPSS improved by 9.8 ± 7.1 (58 ± 34%) from 16.1 ± 3.8 to 6.3 ± 5.0 (paired t-test p=0.0033), similar to levels reached with modern surgical therapies, and with at least a moderate (> 5 point) reduction experienced by 8/9 patients (89%). IPSS quality of life improved by 2.0 ± 1.7 from 2.8 ± 1.1 to 0.8 ± 1.0 (p=0.0068), with 8/9 patients (89%) reporting as “pleased” or “delighted." Prostate volume measured on T2-weighted MRI decreased by 70 ± 19% from 54 ± 23 to 14 ± 5 cc (p=0.001), and uroflowmetry peak flow rate (QMax) improved by 7.4 ± 13 ml/s from 14.5 ± 4.1 to 21.9 ± 12.7 ml/s, but did not reach statistical significance due to the small sample size (p=0.13). All patients (9/9) had full urinary continence (leak-free, pad-free) at 6 and 12 months. Erectile function (International Index of Erectile Function, “IIEF”) was stable from 15 ± 9 at baseline to 16 ± 9 at 12 months (p=0.81), as was the proportion of patients with erections sufficient for penetration (IIEF question 2), from 7/9 at baseline to 8/9 at 12 months.
"We are excited to share this BPH subgroup analysis from our Phase I clinical trial at this prestigious urology meeting,” commented Arun Menawat, Profound’s CEO. “As with localized prostate cancer, TULSA-PRO® may present a promising modality for treatment of BPH, as it enables incision-free and targeted ablation of excessive prostate tissue by providing real-time MRI visualization as well as millimeter precision. The enhanced precision, the ability to personalize the treatment to the patient’s anatomy, and the promise of providing a one-time, minimally-invasive solution is now leading to expanded clinical use of TULSA-PRO® in prostate care to include BPH by clinicians in Europe that are gaining early experiences with this technology for the ablation of localized prostate cancer.”
“We are also pleased to be presenting initial data from the TACT pivotal clinical trial at DGU 2018 and continue to expect that, once the full results from the study are available, they will help pave the path for the successful commercialization of TULSA-PRO® in the United States and further drive clinical adoption of the technology in Europe,” added Dr. Menawat.
About the Phase I Safety & Feasibility Study of TULSA-PRO®
Thirty (30) patients with low/intermediate risk, organ confined prostate cancer were enrolled in this multi-jurisdictional trial. Inclusion criteria included ages 65 years or older, clinical stage T1-T2a; PSA ≤ 10 ng/ml; Gleason Score 3+3 (USA/Europe) and ≤ 3+4 (Canada). Treatment planning was performed under MRI visualization with therapeutic intent of conservative whole-gland ablation, including 3 mm safety margins around the periphery and at the apex. These safety margins were included due to the nature of this first-in-human Phase I safety and feasibility study, leading to approximately 10% residual viable tissue expected around the gland periphery. Ultrasound treatment was delivered under real-time active MRI thermometry feedback control.
In the Phase I study, TULSA-PRO® demonstrated accurate and precise ablation of targeted prostate tissue, while providing a well-tolerated favorable safety profile with minor impact on urinary, erectile and bowel function at 12 months. There were no intraoperative complications, no rectal injury or fistula, no Grade 4 or higher adverse events, only one attributable Grade 3 adverse event (GU infection, resolved within 2 weeks), and an erectile dysfunction rate of 8% (IIEF item 2 ≥ 2). At 12 months, 1/30 (3.3%) patients had Grade 1 urinary urge incontinence, meaning that it was occasional (with coughing, sneezing) and does not require pads. Functional quality-of-life outcomes showed a favorable, anticipated trend of initial deterioration with subsequent improvement in performance back to baseline levels, within 3 months (IPSS, UCLA-PCI-SF Bowel Habits) and 12 months (IIEF). Exploratory endpoints of treatment efficacy (including PSA and biopsy) showed median PSA decreasing 90% to nadir 0.60 ng/ml, and overall absence of clinically significant disease in 69% of patients, in spite of the deliberately conservative safety margin.
TACT, a prospective, open-label, single-arm pivotal clinical study, enrolled 115 patients with biopsy-proven, organ-confined prostate cancer across 13 research sites in the United States, Canada and Europe. The pre-treatment median age of the patients enrolled in TACT was 64 years and their median PSA was 6.5 ng/ml. Approximately 61% of patients had a Gleason score of 7 and 39% had a Gleason score of 6, pre-treatment. The primary efficacy endpoint of TACT is the proportion of patients achieving a post-treatment prostate-specific antigen (“PSA”) reduction ≥ 75% of their pre-treatment baseline value. The Company’s pre-established performance goal for the success proportion is 50% of patients.
As previously reported at the 2018 American Urological Association Annual Meeting, the median PSA reduction to-date is 95% (nadir 0.36 ng/ml), and 95% (109 out of 115) patients have met the PSA endpoint.
The primary safety endpoint of TACT is the frequency and severity of adverse events. The rate and nature of attributable serious adverse events were similar to those reported in the Phase I Safety & Feasibility Study of TULSA-PRO®. Additional secondary endpoints of TACT are focused on quality-of-life side effects commonly associated with current prostate cancer therapies, such as erectile dysfunction and urinary incontinence. As the standard evaluation period for these side effects is 12 months post-treatment, the sample size of evaluable patients is not yet large enough to assess.
About Profound Medical Corp.
The Profound Medical Corp. team is committed to creating the powerful combination of real-time magnetic resonance guidance as the imaging platform and ultrasound as the energy source for delivering non-invasive ablative tools to clinicians. These key technology pillars, linked with intelligent software and robotics, have the potential to fulfill unmet needs of patients and clinicians in many anatomies and disease states, including prostate cancer, uterine fibroids, and bone metastases. Our mission is to “profoundly” change the standard of care by creating a tomorrow where clinicians can confidently ablate tissue with precision; a tomorrow where patients have access to safe and effective treatment options, so they can quickly return to their daily lives.
Profound is commercializing a novel technology, TULSA-PRO®, which combines real-time Magnetic Resonance Imaging with transurethral, robotically-driven therapeutic ultrasound and closed-loop thermal feedback control that is designed to provide precise ablation of the prostate while simultaneously protecting critical surrounding anatomy from potential side effects. TULSA-PRO® is CE marked and Profound is currently conducting a pilot commercial launch of the technology in key European and other CE mark jurisdictions. The Company is also sponsoring a multicenter, prospective FDA-registered clinical trial, TACT, which, if successful, is expected to support its application to the U.S. Food and Drug Administration for clearance to market TULSA-PRO® in the United States.
Profound is also commercializing Sonalleve®, an innovative therapeutic platform that combines real-time MR imaging and thermometry with thermal ultrasound to enable precise and incision-free ablation of diseased tissue. Sonalleve® is CE marked for the treatment of uterine fibroids and palliative pain treatment of bone metastases. The technology was also recently approved by the Chinese Food and Drug Administration for the non-invasive treatment of uterine fibroids. The Company is also in the early stages of exploring additional potential treatment markets for Sonalleve®, such as non-invasive ablation of abdominal cancers and hyperthermia for cancer therapy, where the technology has been shown to have clinical application.
This release includes forward-looking statements regarding Profound and its business which may include, but is not limited to, the expectations regarding the efficacy of Profound’s technology in the treatment of prostate cancer, uterine fibroids and palliative pain treatment. Often, but not always, forward-looking statements can be identified by the use of words such as "plans", "is expected", "expects", "scheduled", "intends", "contemplates", "anticipates", "believes", "proposes" or variations (including negative variations) of such words and phrases, or state that certain actions, events or results "may", "could", "would", "might" or "will" be taken, occur or be achieved. Such statements are based on the current expectations of the management of Profound. The forward-looking events and circumstances discussed in this release, may not occur by certain specified dates or at all and could differ materially as a result of known and unknown risk factors and uncertainties affecting the company, including risks regarding the pharmaceutical industry, economic factors, the equity markets generally and risks associated with growth and competition. Although Profound has attempted to identify important factors that could cause actual actions, events or results to differ materially from those described in forward-looking statements, there may be other factors that cause actions, events or results to differ from those anticipated, estimated or intended. No forward-looking statement can be guaranteed. Except as required by applicable securities laws, forward-looking statements speak only as of the date on which they are made and Profound undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, or otherwise, other than as required by law.
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