HOUSTON, July 13, 2021 (GLOBE NEWSWIRE) — Salarius Pharmaceuticals, Inc. (Nasdaq: SLRX), a clinical-stage biopharmaceutical company developing potential new drugs for patients with childhood cancer, solid tumors and other cancers, today announced that Fox Chase Cancer Center in Philadelphia, PA, has been added as an active research site. for the dose-expansion phase of the ongoing clinical trial evaluating the company’s lead drug candidate, seclidemstat, in patients with relapsed or refractory Ewing sarcoma and advanced FET rearranged sarcomas.
The addition of Fox Chase expands the number of active sites participating in the open-label study designed to assess seclidemstat at the recommended Phase 2 dose (RP2D). Patients are now being recruited at all sites and the first patients in the dose extension phase of the clinical trial have been dosed.
Seclidemstat is a novel, oral, reversible inhibitor of lysine-specific histone demethylase 1 (LSD1), an enzyme that has been shown to play a key role in the development and progression of several cancers.
Under the modified protocol, the dose-expansion phase of the study now includes three patient arms. The first arm will enroll up to 30 patients with Ewing’s sarcoma, a rare and deadly pediatric bone cancer, and will study seclidemstat in combination with topotecan and cyclophosphamide, a widely used second- and third-line chemotherapy regimen. Salarius believes data released during ASCO 2021 showed synergy in an Ewing sarcoma cell line when seclidemstat was used in combination with topotecan and cyclophosphamide. Salarius believes that this treatment combination and its use as second- and third-line therapy could significantly expand the addressable patient population for seclidemstat and improve outcomes by enabling physicians to use seclidemstat earlier in the Ewing sarcoma continuum.
The second patient group of the study will study seclidemstat as a single agent in up to 15 patients with myxoid liposarcoma. The third patient group will study seclidemstat as monotherapy in up to 15 patients with selected sarcomas that share a biology similar to Ewing’s sarcoma, also known as FET-rearranged or Ewing-related sarcomas. In data released at ASCO 2021, a subset of patients with advanced FET-rearranged sarcomas treated with seclidemstat as monotherapy resulted in stable disease (SD) and prolonged time to progression (TTP), suggesting disease control, according to Salarius. relevant endpoint for soft tissue sarcomas.
All patient arms are designed to evaluate safety and efficacy endpoints in patients with advanced disease. Salarius expects to report data in 2022 and provide earlier updates if possible.
“We are excited to partner with Salarius and look forward to exploring the potential of seclidemstat and its ability to inhibit the LSD1 enzyme,” said Johnathan Whetstine, Ph.D., director of the Cancer Epigenetics Institute, Fox Chase Cancer Center. “Based on our extensive research into the epigenetic causes of cancer, we believe LSD1 inhibition shows promise in the treatment of many cancers. We believe data from preclinical studies with Ewing sarcoma cell lines have shown that the molecule is able to hit two aspects of the enzyme simultaneously. This, added to clinical data demonstrating drug activity in Ewing and other sarcomas, supports further exploration of seclidemstat in these high unmet need patient populations.” Dr. Whetstine is an advisor to Salarius and has also served in an advisory role.
David Arthur, CEO of Salarius Pharmaceuticals, stated: “Our goal is to make a difference in the lives of patients battling cancer, and we believe the data we have released so far is compelling. Now partnering with a Fox Chase Cancer Center caliber cancer research center further confirms seclidemstat’s potential to have a meaningful impact on the treatment of Ewing’s sarcoma and other cancers.We look forward to seeing you in 2021 provide additional updates.”
Trial registration at Fox Chase will be led by Margaret von Mehren, MD, chief of Sarcoma Oncology.
In addition to Fox Chase, there are also active clinical trial sites: Johns Hopkins All Children’s Hospital in St. Petersburg, FL; Children’s Hospital of Los Angeles in Los Angeles, CA; Moffitt Cancer Center in Tampa, FL; Dana-Farber Cancer Institute in Boston, MA; MD Anderson Cancer Center in Houston, TX; National Children’s Hospital in Columbus, OH; Memorial Sloan Kettering Cancer Center in New York City; and the Sarcoma Oncology Center in Santa Monica, CA.
About Fox Chase Cancer Center
The hospital of Fox Chase Cancer Center and its affiliates (collectively, “Fox Chase Cancer Center”), a member of the Temple University Health System, is one of the leading cancer research and treatment centers in the United States. Founded in 1904 in Philadelphia as one of the nation’s first cancer hospitals, Fox Chase was also one of the first institutions to be designated a National Cancer Institute Comprehensive Cancer Center in 1974. The recently established Cancer Epigenetics Institute is a national center for epigenetics research and collaboration focused on mechanisms that promote cancer and therapeutic resistance. Its mission is to facilitate academic-to-industry and academic-to-academic partnerships to advance discovery in cancer epigenetics. Fox Chase researchers have won the highest honors in their field, including two Nobel Prizes. Fox Chase physicians are also routinely recognized in national rankings, and the center’s nursing program has received Magnet recognition for excellence five consecutive times. Today, Fox Chase conducts a wide range of nationally competitive basic, translational, and clinical research, with specialty programs in cancer prevention, detection, survival, and community outreach. It is Fox Chase Cancer Center’s policy that no one should be excluded from or denied the benefits of or participation in the delivery of quality medical care based on race, ethnicity, religion, sexual orientation, gender, gender identity/expression, disability age, national origin, color, national origin, physical ability, level of education or source of payment.
About Salarius Pharmaceuticals
Salarius Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company developing cancer therapies for patients in need of new treatment options. Salarius’ lead candidate, seclidemstat, is under investigation as a potential treatment for childhood cancer, solid tumors and other cancers with limited treatment options. Seclidemstat is currently in a Phase 1/2 clinical trial for relapsed/refractory Ewing sarcoma and is selecting additional sarcomas that have a similar biology to Ewing sarcoma, also known as Ewing-related or FET rearranged sarcomas. Seclidemstat has received the Fast Track Designation, Orphan Drug Designation, and Rare Pediatric Disease Designation for Ewing sarcoma from the US Food and Drug Administration. Salarius is also developing seclidemstat for several cancers of high unmet medical need, with a second Phase 1/2 clinical trial in advanced solid tumors, including prostate, breast and ovarian cancer. Salarius has received funding from the National Pediatric Cancer Foundation to advance the clinical program for Ewing sarcoma and also received a Product Development Award from the Cancer Prevention and Research Institute of Texas (CPRIT). For more information, visit salariuspharma.com or follow Salarius on Twitter and LinkedIn.
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. These forward-looking statements can be identified by terms such as “anticipate”, “potential”, “progress”, “design”, “estimate”, “continue”, “will”, “striving”, “may”, “believe ”, “plan”, “allow”, “expect”, “intend”, “target”, “offer”, “can”, “position”, “project”, “develop” and similar terms or expressions or the negative thereof.Examples of such statements include, but are not limited to, statements regarding the following: the company’s growth strategy; the ability to enroll patients in an arm of current clinical trials; the value and efficacy of seclidemstat , alone or with other products, as a therapy in any indication; the status and anticipated progress and milestones of the Company’s clinical trials; the anticipated readout of clinical trial results; the expansion of the Company’s clinical trials; and Salarius is developing se clidemstat for various cancers with a high unmet medical need. Salarius may not actually realize the plans, carry out its intentions or meet the expectations or objectives stated in the forward-looking statements. You should not place undue reliance on these forward-looking statements. These statements are subject to risks and uncertainties that could cause actual results and performance to differ materially from those discussed in the forward-looking statements. These risks are described in Salarius’ filings with the Securities and Exchange Commission, including those discussed in the Company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2021 and in the Company’s Annual Report on Form 10-K for the year ended December 31, 2020. The forward-looking statements in this press release speak only as of the date of this press release and are based on management’s assumptions and estimates as of that date. Salarius disclaims any intent or obligation to update these forward-looking statements to reflect events or circumstances that exist after the date they are made.
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