CG Pharmaceuticals to Present Phase 2 Ivaltinostat Study in Metastatic PDAC

ORINDA, Calif., May 29, 2024 -- CG Pharmaceuticals, a company at the forefront of cancer treatment innovation, is set to highlight its latest advancements in metastatic pancreatic ductal adenocarcinoma (PDAC) therapy. The company's groundbreaking Phase 2 US clinical trial, which is currently recruiting participants, will be showcased at the upcoming ASCO Annual Meeting on June 1st from 1:30 to 4:30 PM CDT (ClinicalTrials.gov NCT05249101).

Anna Berkenblit, MD, MMSc, Chief Scientific and Medical Officer at the Pancreatic Cancer Action Network (PanCAN), commented on the initiative, emphasizing the aggressive nature of metastatic PDAC and the scarcity of effective treatments. She praised CG Pharmaceuticals for their commitment to pancreatic cancer research and expressed anticipation for the trial outcomes. Berkenblit highlighted the critical role of clinical trials in advancing treatment options and improving patient prognoses, urging PDAC patients to consider trial participation.

In the preceding Phase 1b study, 28 patients with locally advanced or metastatic PDAC, all of whom had undergone at least one previous treatment regimen, were treated with ivaltinostat combined with capecitabine across three dosage levels (60, 125, and 250 mg/m²). The study revealed a favorable safety profile, with no serious adverse events attributed to the treatment. As of the data cutoff on May 6, 2024, 16 patients were still alive, with 3 continuing treatment, and 7 patients had been treated for over 6 months, with the longest treatment duration reaching 16 months.

The ongoing Phase 2 study aims to evaluate the effectiveness of ivaltinostat combined with capecitabine versus capecitabine monotherapy in patients with metastatic PDAC who have not exhibited disease progression following first-line chemotherapy. Key efficacy endpoints being assessed include progression-free survival, objective response rate, disease control rate, and overall survival.

About Ivaltinostat

Ivaltinostat is a promising new therapeutic candidate for PDAC, notable for its inhibition of histone deacetylase enzymatic activity. It is under investigation for use in both solid tumors and hematologic cancers. CG Pharmaceuticals remains dedicated to developing innovative treatments for patients suffering from metastatic PDAC.

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