Pulse Biosciences, Inc. (Nasdaq: PLSE) today announced the initiation of a clinical feasibility study using its novel Nano-Pulse Stimulation„¢ (NPS„¢) platform to treat patients with cutaneous warts. The initiation of this feasibility study reflects the Companys continued efforts to develop a portfolio of dermatologic applications building on the success of recently completed and ongoing clinical studies.
Nano-Pulse Stimulation is a novel, precise non-thermal treatment technology delivering nanosecond duration energy pulses that impact cells in treated tissue while sparing surrounding acellular tissue. With its broadly applicable cell-targeting mechanism, NPS disrupts the functions of internal cell structures while maintaining the outer cell membrane. The unique NPS mechanism of action has been shown in previous clinical studies to eliminate treated cells with mild inflammatory response that results in favorable healing and cosmetic outcomes, making NPS well suited for a broad range of skin lesions.
Cutaneous warts are benign grainy skin growths that are typically caused by the human papillomavirus (HPV). According to an updated 2018 published article, 22.8 million patients per year suffer from warts (https://emedicine.medscape.com/article/1133317).
This feasibility study will include up to 20 subjects at the prestigious Scripps Clinic in San Diego, CA. Eligible subjects receive NPS treatment(s) followed by evaluations at 7-days, 30-days, and 60-days post-initial NPS treatment. Patient enrollment, treatment and follow-up are expected to be completed during the first quarter of 2019.
Although common warts are a widespread skin condition that every dermatologist sees regularly, we do not have reliable solutions to offer our patients, said E. Victor Ross, M.D., principal investigator and leading dermatologic surgeon at Scripps Clinic, San Diego, who is initiating the first patient treatments. The unique non-thermal mechanism of NPS has been shown to affect deeper cellular structures without damaging the adjacent dermis. Our hope is that NPS treatment can reach and eliminate these deeper warts with better efficacy and without as much collateral tissue damage as thermal methods like laser heating or cryogen freezing of the tissue.
The clinical study announced today is one of several clinical programs underway to evaluate Pulse Biosciences proprietary Nano-Pulse Stimulation therapy. Beyond the initiation of the warts feasibility study, Pulses clinical programs continue to advance:
- NPS for the treatment of Sebaceous Hyperplasia (SH). A multi-center study to evaluate the safety and efficacy of Nano-Pulse Stimulation for the treatment of Sebaceous Hyperplasia, a common but difficult-to-treat facial lesion. The study has fully enrolled, and all patient NPS treatments have been completed. Data on the first 79 treated lesions (approximately 35% of study total) that have reached the final 60-day post-treatment evaluation show lesion efficacy greater than 95%. Data collection and analysis is on schedule to be completed during the fourth quarter of 2018. (NCT03612570)
- NPS Basal Cell Carcinoma (BCC) Biomarker Study. A multi-center treat and resect study evaluating local lesion affect and immune response changes to NPS. Direct evidence of basal cell elimination as well as immunologic biomarker data are being collected and analyzed in collaboration with the Fred Hutchinson Cancer Research Center. Study completion is slated for year-end 2018 with data to be reported during the first quarter of 2019.
Dr. George Hruza, a research leader in dermatologic and Mohs surgery in St. Louis, MO, will present his positive results of a data subset demonstrating 93% clinical efficacy rate for clearing of Seborrheic Keratoses lesions with a single treatment of non-thermal NPS. The full dataset was presented at the 2018 American Society of Lasers, Medicine and Surgery in April. His presentation will take place on Friday, October 12, 2018 at the American Society for Dermatologic Surgery (ASDS) Annual Meeting in Phoenix.
Were pleased with the clinical progress were making in dermatology as we drive towards commercialization in this exciting market, said Darrin Uecker, Pulse Biosciences President and Chief Executive Officer. We continue to demonstrate safety and efficacy in compelling dermatologic indications that also provide proof of the NPS mechanism in support of future indications in both benign and non-benign conditions.
About Pulse Biosciences and Nano-Pulse Stimulation
Pulse Biosciences is a novel medical therapy company bringing to market its proprietary Nano-Pulse Stimulation„¢ (NPS„¢) platform. NPS is a novel, precise, non-thermal, treatment technology delivering nanosecond duration energy pulses that impact cells in treated tissue while sparing surrounding acellular tissue. NPSs unique mechanism of action disrupts the functions of internal cell structures while maintaining the outer cell membrane initiating a cascade of events within the cell that results in regulated cell death. In pre-clinical studies, NPS has demonstrated an ability to induce immunogenic cell death in cancer cell lines. The novel characteristics of NPSs unique mechanism of action has the potential to significantly benefit patients for multiple medical applications, including dermatology, the Companys first planned commercial application, with future potential in other disease states where an enhanced immune response may be beneficial. More information is available at http://www.pulsebiosciences.com.
All statements in this press release that are not historical are forward-looking statements, including, among other things, statements relating to Pulse Biosciences expectations regarding the mechanism of action of NPS treatments, current and planned future clinical studies, other matters related to its pipeline of product candidates, future financial performance, regulatory clearance and the timing of FDA filings or approvals, and other future events. These statements are not historical facts but rather are based on Pulse Biosciences current expectations, estimates, and projections regarding Pulse Biosciences business, operations and other similar or related factors. Words such as may, will, could, would, should, anticipate, predict, potential, continue, expects, intends, plans, projects, believes, estimates, and other similar or related expressions are used to identify these forward-looking statements, although not all forward-looking statements contain these words. You should not place undue reliance on forward-looking statements because they involve known and unknown risks, uncertainties, and assumptions that are difficult or impossible to predict and, in some cases, beyond Pulse Biosciences control. Actual results may differ materially from those in the forward-looking statements as a result of a number of factors, including those described in Pulse Biosciences filings with the Securities and Exchange Commission. Pulse Biosciences undertakes no obligation to revise or update information in this release to reflect events or circumstances in the future, even if new information becomes available.
Caution: Pulse Biosciences Nano-Pulse Stimulation (NPS) is an investigational use therapy.
Pulse Biosciences, Inc.
Vice President and Chief Financial Officer
Gitanjali Jain Ogawa, 646-378-2949
Nadine D. Tosk, 504-453-8344