#United States #CG Pharmaceuticals #Ivaltinostat #pancreas cancer #Orinda

CG Pharmaceuticals Presents Key Clinical Trial Updates

CG Pharmaceuticals, based in the San Francisco Bay Area, has been making headlines recently with its ongoing Phase 1b/2 clinical trial focusing on metastatic pancreatic ductal adenocarcinoma (mPDAC). As an independent entity since 2024, the company has undertaken significant research initiatives, primarily centered around ivaltinostat, a novel investigational agent.

Overview of the Clinical Trial

The trial has garnered attention for its innovative approach to treatment, particularly following the culmination of the Phase 1b study. With results set to be showcased at the ASCO Gastrointestinal Symposium on January 24, 2025, this trial represents a crucial milestone for CG Pharmaceuticals and the field of oncology.

In the Phase 1b portion of the trial, 28 patients with locally advanced or metastatic PDAC provided a glimpse into ivaltinostat's potential. Participants, having previously received at least one line of therapy, received ivaltinostat at varying dosages alongside capecitabine. The dosages were 60, 125, and 250 mg/m², administered on specific days within a 21-day cycle. Capecitabine was consistently administered at a dose of 1000 mg/m² twice daily for 14 days.

Safety Profile and Patient Outcomes

The safety profile of ivaltinostat was consistent across all dose levels. Predominantly, patients reported mild treatment-emergent adverse events (TEAEs), significantly grade 1-2 issues such as fatigue, nausea, and palmar-plantar erythrodysesthesias, among others. Remarkably, there were no serious adverse events attributable to ivaltinostat observed across the three dose cohorts.

By the time of the data cutoff on December 28, 2024, the findings revealed encouraging stability among patients. Out of 28 participants, 7 were still alive, with 18 deaths occurring—each directly tied to disease progression rather than treatment complications. Two-thirds, or 65%, of these patients exhibited stable disease or no evidence of disease, while 14% experienced progression, leaving 22% unassessed for this outcome.

Moving to Phase 2

The promising data from Phase 1b laid the groundwork for the Phase 2 portion of the trial. Now tailored to evaluate the efficacy of ivaltinostat in conjunction with capecitabine compared to capecitabine alone, this randomized segment focuses on patients who have undergone fluoropyrimidine-based therapy without progression for at least four months.

Enrollment for the Phase 2 trial began in January 2024, with significant progress already achieved—over 62% of the target enrollment across 17 U.S. sites. CG Pharmaceuticals anticipates reaching full enrollment and concluding follow-up assessments throughout this year, aiming for a complete clinical study report by mid-2026.

Future Outlook

Ivaltinostat stands out not only for its potential efficacy but also its safety and pharmacokinetic profiles when compared to other agents in clinical testing for similar indications. The need for new therapies is paramount in combating the challenges posed by metastatic pancreatic cancer, which has historically been associated with limited options and poor prognoses.

Leadership Insights

Dr. Joong Myung Cho, the founder of CrystalGenomics and a key figure at CG Pharmaceuticals, stressed the commitment to developing solutions for unmet medical needs in cancer treatment. His insights reflect a personal journey of dedication over four decades towards innovative treatment options.

Furthermore, Dr. Gene Cho, the Vice President of Global Strategy at CG Pharma, mentioned their proactive engagement with various partners and investors, suggesting that significant announcements may follow soon as the company continues its upward trajectory.

Closing Thoughts

As CG Pharmaceuticals prepares to share its findings, the mPDAC clinical trial holds promise for transforming treatment paradigms within oncology, reaffirming the significance of conducting rigorous research to find a cure for one of the most challenging cancer types. Patients and stakeholders alike are hopeful that clinical advancements like those seen with ivaltinostat will pave the way for more accessible and effective cancer care.

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For more information or inquiries, contact:
Dr. Gene Young Cho
Vice President of Global Strategy
CG Pharmaceuticals, Inc.
Phone: 925-259-7333
Mobile: 925-899-9637
Email: [email protected]