Bexion Pharmaceuticals, Inc. Announces First Patient Dosed with BXQ-350 in the RETRO Clinical Study

Study Aims to Assess Potential for BXQ-350 to Reduce the Intensity and/or Duration of Chemotherapy-Induced Peripheral Neuropathy (CIPN), a Prevalent Limitation of Existing Chemotherapies

COVINGTON, Ky., Oct. 18, 2022 /PRNewswire/ -- Bexion Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company developing biologics for the treatment of cancer and neuropathy, announced today that the first adult patient has been dosed in the Pilot Proof of Concept Pharmacokinetic/Pharmacodynamic (PK/PD) Study in Cancer Patients (RETRO). The study will examine the effects of BXQ-350 on cancer patients exposed to Oxaliplatin and/or Taxane-based chemotherapy exhibiting chemotherapy-induced peripheral neuropathy (CIPN) symptoms.

"We are delighted with the news that the first patient has been dosed in our Phase 1 RETRO study. This study is a natural follow-on to data reported from our recent Phase 1 solid tumor study in cancer patients, in which patients reported potential reduction of existing CIPN symptoms," said Scott Shively, Chief Executive Officer of Bexion Pharmaceuticals. "CIPN is an enormous problem in which over 700,000 surviving cancer patients per year in the US alone have peripheral neuropathies caused by their prior chemotherapy. We are targeting to have initial data read-out from this study in 3Q2023."

The aim of this pilot proof-of-concept study is to assess PK/PD relationships in cancer patients with CIPN symptoms to determine the impact BXQ-350 has on ceramide, S1P, and inflammatory cytokine levels; thereby potentially reducing the intensity and/or duration of CIPN, improving quality of life, and establishing these signaling molecules as biomarkers in future studies.

The trial is being conducted at CTI Clinical Research Center in Cincinnati, Ohio. The plan is to enroll twenty patients. Interested patients can find more information here: https://www.clinicaltrials.gov/ct2/show/NCT05291286 

Bexion Pharmaceuticals, a clinical-stage biopharmaceutical company, is developing a new generation of biologic immunotherapy to treat solid tumor cancers and Chemotherapy Induced Peripheral Neuropathy (CIPN) with potential portfolio expansion opportunities in other cancers and broader neuropathic pain indications. Bexion's lead drug candidate is BXQ-350, a first-in-class biologic containing the multifunctional, lysosomal activator protein, Saposin C and a phosphatidylserine. 

BXQ-350, an "S1P Activator", has demonstrated pre-clinical antitumor effects in vitro and in vivo, particularly in colorectal, brain and other solid tumors. Bexion has completed two single agent Phase 1 programs in adults and in a pediatric population. The Phase 1 programs demonstrated a strong safety profile with evidence of single agent activity across a range of tumors including Glioblastoma Multiforme (GBM), colorectal cancer and appendiceal cancer. Additionally, other clinical and non-clinical data suggest BXQ-350 has activity in chemotherapy induced peripheral neuropathy.

Media Contact: Margaret van Gilse ● 859.757.1652 ● [email protected].

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SOURCE Bexion Pharmaceuticals, Inc.