Salarius Pharmaceuticals Initiates Expansion Stage of Phase 1/2 Clinical Trial of Seclidemstat in Patients with Ewing Sarcoma and Ewing-Related Sarcomas
Relapsed and refractory Ewing sarcoma patients to receive seclidemstat in combination with chemotherapy agents as second- and third-line therapy; Protocol amendment expands and improves access to addressable patient population
Ewing-related sarcoma patients to receive single-agent therapy supported by preliminary signs of drug activity indicating an increase in patients time to progression
Salarius to host Conference Call and Live Audio Webcast Today, Wednesday, February 24, 2021, at 8:30 a.m. ET
Per the amended trial protocol, the expansion stage will consist of two treatment arms. The first arm will enroll up to 20 Ewing sarcoma patients and will investigate seclidemstat at the recommended Phase 2 dose (RP2D) in combination with the chemotherapy agents topotecan and cyclophosphamide (TC) as a potential second- and third-line therapy for Ewing sarcoma. The second arm will enroll up to 30 patients with Ewing-related sarcomas and will investigate seclidemstat as a single-agent therapy at the RP2D. Both the Ewing and Ewing-related sarcoma arms are designed to evaluate safety and efficacy endpoints, and Salarius expects to report data readouts from the trial towards the end of 2021 and into 2022.
“Combining seclidemstat with the chemotherapy agents topotecan and cyclophosphamide, a well-accepted second- or third-line treatment for patients with Ewing sarcoma, provides an opportunity to utilize seclidemstat earlier in the treatment continuum while increasing the patient population that receives seclidemstat,” stated
“This is an exciting opportunity to strengthen the treatment alternatives we can deliver to patients and to expand the number of patients who may benefit from seclidemstat,” stated
Ewing Sarcoma Dose-Escalation Trial Review
As previously announced, the recently completed dose-escalation stage of the Phase 1/2 trial demonstrated seclidemstat had a manageable safety profile and established the recommended Phase 2 dose (RP2D). Further, pharmacokinetic (PK) data from the dose-escalation study indicated that treatment at the RP2D achieved plasma concentrations above levels where seclidemstat demonstrated activity in preclinical studies.
Safety and efficacy results from both the Ewing sarcoma trial and the Advanced Solid Tumor trial are planned for presentation at an upcoming medical conference. Conference embargo rules prevent further disclosure at this time.
Conference Call Information:
- (833) 423-0481 (
- (918) 922-2375 (international)
- Conference ID: 9278225
About Salarius Pharmaceuticals
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 facts, included in this press release are forward-looking statements. These forward-looking statements may be identified by terms such as “anticipate,” “potential,” “progress,” “design,” “estimate,” “continue,” “will,” “aim,” “can,” “believe,” “plan,” “allow,” “expect,” “intend,” “goal,” “provide,” “able to,” “position,” “project,” “developing,” and similar terms or expressions or the negative thereof. Examples of such statements include, but are not limited to, statements relating to the following: The status and anticipated progress and milestones of Salarius’ clinical trials in relapsed and refractory Ewing sarcoma and Ewing-related sarcomas; Salarius’ developing cancer therapies for patients that need them the most; Salarius’ developing seclidemstat for several cancers with high unmet medical need; Salarius’ developing seclidemstat as a potential treatment for pediatric cancers, solid tumors and other cancers with limited treatment options; Salarius advancing seclidemstat to the dose-escalation stage of the Phase 1/2 clinical trial in relapsed and refractory Ewing sarcoma; the potential of seclidemstat as a treatment for Ewing-related sarcomas; the ability of seclidemstat to demonstrate drug activity; the ability and degree to which seclidemstat could have an impact on the treatment of Ewing sarcoma and Ewing-related sarcomas; the ability and degree to which seclidemstat administered in combination with the chemotherapy agents topotecan and cyclophosphamide could have an impact on the treatment of Ewing sarcoma. Salarius may not actually achieve the plans, carry out the intentions or meet the expectations or objectives disclosed in the forward-looking statements. You should not place undue reliance on these forward-looking statements. These statements are subject to risks and uncertainties which could cause actual results and performance to differ materially from those discussed in the forward-looking statements. These risks and uncertainties include, but are not limited to, the following: the sufficiency of Salarius’ capital resources; the ability of, and need for, Salarius to raise additional capital to meet Salarius’ business operational needs and to achieve its business objectives and strategy; Salarius’ ability to project future capital needs and cash utilization and timing and accuracy thereof; the ability of Salarius to access the remaining funding available under the CPRIT grant; future clinical trial results and impact of results on Salarius; that the results of studies and clinical trials may not be predictive of future clinical trial results; the sufficiency of Salarius’ intellectual property protection; risks related to the drug development and the regulatory approval process; the competitive landscape and other industry-related risks; market conditions and regulatory or contractual restrictions which may impact the ability of Salarius to raise additional capital; the possibility of unexpected expenses or other uses of Salarius’ cash resources; risks related to the COVID-19 outbreak; and other risks described in Salarius’ filings with the
Source: Salarius Pharmaceuticals, Inc.