On October 18, 2022 Helsinn Group ("Helsinn"), a fully integrated global biopharma company with a diversified pipeline of innovative oncology assets, reported that research from an in vitro study of chlormethine gel has been published in the journal Dermatology and Therapy (Press release, Helsinn, OCT 18, 2022, View Source [SID1234622127]).

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This article, "Chlormethine Gel for the treatment of Mycosis Fungoides Cutaneous T-Cell Lymphoma: In Vitro Release and Permeation Testing", evaluated part of the mode of action of chlormethine (CL) gel once applied to the skin. In a preliminary, proof-of-concept, in vitro study, the release profile of 0.016% chlormethine gel was evaluated compared to an ointment-based formulation of CL. The absorption profile of the CL gel was also evaluated in ex vivo healthy human skin using in vitro permeation testing (IVPT).

Results from the study indicate that the rate of chlormethine release from the CL gel formulation was statistically higher in comparison to the ointment formulation. In addition, data indicate that only a minimal amount of the CL can pass through the epidermis reaching the dermis, suggesting that most of the applied CL reacted within the epidermal layer. This finding is consistent with the lack of evidence of systemic absorption seen with CL gel(1,2) and further supports the notion that drug-drug interactions are very unlikely.

Details of the publication:

Title: "Chlormethine Gel for the treatment of Mycosis Fungoides Cutaneous T-Cell Lymphoma: In Vitro Release and Permeation Testing."
Authors: Claudio Giuliano, Stefano Frizzarin, Alessandro Alonzi, Virginia Stimamiglio and Pablo L. Ortiz-Romero
Link: View Source
Chlormethine gel 0.016%, also known as mechlorethamine gel, is approved in multiple countries, including the EU and US, and is marketed under the trade names LEDAGA and VALCHLOR. The authorized use for each country varies based on the design of the registrational trial and the individual health authority requirements. For more details, please refer to the approved product information for each respective jurisdiction.

Dr. Silvia Sebastiani, Group Head of Medical Affairs, commented: "Chlormethine is a well-established and effective topical therapy for treating lesions in patients with MF-CTCL and is available in a variety of formulations. Understanding CL gel’s mode of action and how it permeates through the skin is extremely important for its use in clinical practice."

On October 18, 2022 Salarius Pharmaceuticals, a clinical-stage biopharmaceutical company using protein inhibition and protein degradation to develop cancer therapies for patients in need of new treatment options, reported that, as per protocol design, it is voluntarily pausing new patient enrollment in the company’s Phase 1/2 trial of seclidemstat as a treatment for Ewing sarcoma and FET-rearranged sarcomas (Press release, Salarius Pharmaceuticals, OCT 18, 2022, View Source [SID1234622124]).

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The pause in new patient enrollment is due to a metastatic FET-rearranged sarcoma patient death that was classified as a suspected unexpected serious adverse reaction (SUSAR). Upon review of the SUSAR and available information by the company’s independent Safety Review Committee for the clinical trial, patients currently receiving seclidemstat treatment may continue treatment after consulting with their physician.

Salarius communicated the details of the SUSAR to the U.S. Food and Drug Administration (FDA) and intends to further analyze the available data with the goal of understanding how best to proceed and restart enrollment as soon as possible. Salarius continues to plan to release interim sarcoma clinical trial results later this year.

"Patient safety is our primary concern, and this is reflected in the design of our clinical trial protocol, which automatically paused enrollment based upon this SUSAR," said David Arthur, chief executive officer of Salarius. "Unfortunately, pauses to enrollment occur in early-stage drug development, but these pauses allow time to understand new data and adjust clinical protocols and development plans as needed. We plan to restart enrollment as soon as possible."

About the Phase 1/2 Ewing sarcoma and other FET-rearranged sarcomas trial
The Phase 1/2 trial currently is in its dose-expansion stage, which includes three patient arms. The first patient arm is enrolling up to 30 patients with Ewing sarcoma, a rare and deadly pediatric bone cancer, and will investigate seclidemstat in combination with topotecan and cyclophosphamide, a commonly used second- and third-line chemotherapy regimen. Salarius believes data released during ASCO (Free ASCO Whitepaper) 2021 demonstrated synergy in a Ewing sarcoma cell line when seclidemstat was used in combination with these agents. Salarius also believes this treatment combination and its use as a second- and third-line therapy could greatly expand the addressable patient population for seclidemstat and improve outcomes by allowing physicians to introduce seclidemstat earlier in the Ewing sarcoma continuum of care.

The trial’s second patient arm is investigating seclidemstat as a single agent in up to 15 patients with myxoid liposarcoma. The third patient arm is investigating seclidemstat as a single agent in up to 15 patients with select sarcomas that share a similar biology to Ewing sarcoma, also referred to as FET-rearranged or Ewing-related sarcomas. In data released at ASCO (Free ASCO Whitepaper) 2021, a subset of patients with advanced FET-rearranged sarcomas treated with single-agent seclidemstat resulted in stable disease and prolonged time to progression, which Salarius believes suggests disease control, a clinically relevant endpoint for soft tissue sarcomas.

All three patient arms are designed to evaluate safety and efficacy in patients with advanced disease. Per protocol design, new patient enrollment will be stopped, or paused, when 1) any death or life-threatening adverse experience deemed possibly or definitely related to the investigational product is observed, or 2) it is determined that the protocol precipitates multiple patient non-compliance beyond reasonably missed visits.

On October 18, 2022 Exelixis (Nasdaq: EXEL) reported that its third quarter 2022 financial results will be released on Tuesday, November 1, 2022 after the markets close (Press release, Exelixis, OCT 18, 2022, View Source [SID1234622121]). At 5:00 p.m. ET / 2:00 p.m. PT, Exelixis management will host a conference call and webcast to discuss the results and provide a general business update. Access to the event is available via the Internet from the company’s website.

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To access the webcast link, log onto www.exelixis.com and proceed to the News & Events / Event Calendar page under the Investors & Media heading. Please connect to the company’s website at least 15 minutes prior to the conference call to ensure adequate time for any software download that may be required to listen to the webcast. Alternatively, please call 888-338-9509 (domestic) or 412-902-4281 (international) and ask to be joined into the Exelixis conference call to participate by phone.

A telephone replay will be available until 8:00 p.m. ET on November 3, 2022. Access numbers for the telephone replay are: 877-344-7529 (domestic) and 412-317-0088 (international); the passcode is 6992264. A webcast replay will also be archived on www.exelixis.com for one year.

On October 18, 2022, Denovicon Therapeutics reported that its Founder & CEO, Scott Bembenek, presented on ‘An AI–Molecular Modeling Platform for Streamlining Small-Molecule Drug Discovery’ at the Biovia User Group Meeting 2022 (Press release, Denovicon Therapeutics, OCT 18, 2022, View Source [SID1234622115]).

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On October 18, 2022 Guangzhou Zhiyi Biotech reported that it was approved to start US Phase I trial of its live biopharmaceutical product to treat chemotherapy-induced diarrhea (CID) (Press release, Guangzhou Zhiyi Biotech, OCT 18, 2022, View Source [SID1234622113]). SK10, an inactivated Bacteroides fragilis-based LBP, has shown efficacy in CID models, according to Zhiyi. It is the first LBP product approved for CID trials globally. Zhiyi says the US approval is a milestone for the company, starting trials of an LBP product in the US and China. Earlier this year, Zhiyi raised $15 million in its B++ funding, bringing the total of three B rounds to $45 million.

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