Celcuity's Phase 3 VIKTORIA-1 Trial for PIK3CA Mutants Advances

Celcuity Announces Full Enrollment in VIKTORIA-1 Trial

Celcuity Inc. (Nasdaq: CELC), a forward-thinking biotechnology firm focused on oncology, has achieved a significant milestone in its Phase 3 VIKTORIA-1 clinical trial. The trial, which examines the effectiveness of gedatolisib in patients with PIK3CA mutated advanced breast cancer, is now fully enrolled. This advancement is anticipated to have an impactful influence on treatment methods for individuals with hormone receptor-positive (HR+) and HER2-negative tumors.

Significant Updates on Clinical Trials

The VIKTORIA-1 trial is particularly important as it assesses the use of gedatolisib— when combined with fulvestrant and optionally with palbociclib—against traditional treatments. The focus on patients with PIK3CA mutations stems from the urgency to provide targeted therapies for this subset of breast cancer patients, particularly after they have shown progression on other treatments.

Brian Sullivan, the CEO and co-founder of Celcuity, expressed great positivity regarding the enrollment stage, stating, "Completing the enrollment of the PIK3CA mutant cohort is a critical step in advancing our understanding of this treatment combination and its potential benefits for patients." The company is currently targeting late Q1 or early Q2 for the release of topline data from this crucial trial phase.

Revealing Insights From Phase 1b Clinical Trial

Recent analyses from the Phase 1b trial have spotlighted the efficacy of gedatolisib when utilized in combination with other drugs. Findings showcased a median progression-free survival (PFS) of 14.6 months in patients with HR+/HER2- advanced breast cancer who had PIK3CA mutations. This compelling data fuels the expectation for further successful outcomes in the ongoing Phase 3 trial.

Comparative Efficacy Data

While the Phase 1b study provides foundational insights, it also highlights the potential of the intermittent dosage method. Patients receiving the intermittent regimen demonstrated notably improved PFS at 19.7 months, compared to the overall median of 14.6 months for those with the PIK3CA mutant tumors. This is noteworthy as patients with PIK3CA wild-type tumors had a lower median PFS of 9 months, reinforcing the significance of personalized treatment approaches.

Celcuity's Commitment to Innovation

Celcuity continues to innovate in the field of biotechnology, with gedatolisib emerging as a leading candidate. This drug not only demonstrates crucial mechanisms of blocking pathways that contribute to cancer progression but also shows promise in treating various solid tumors. The differing pharmacokinetics of gedatolisib compared to existing therapies present a unique opportunity to refine treatment strategies significantly.

In addition to the ongoing VIKTORIA-1 trial, Celcuity is actively enrolling patients for the Phase 3 VIKTORIA-2 trial, which evaluates gedatolisib in combination with a CDK4/6 inhibitor and fulvestrant as a first-line treatment option. This pipeline reflects the company’s commitment to advancing targeted therapies, and they aim to provide robust treatment options to those impacted by breast cancer and other malignancies.

About Celcuity

Founded on the principle of developing precision medicines, Celcuity Inc. offers hope to patients fighting solid tumor cancers. The company’s cutting-edge approach focuses on targeted therapy aimed at specific mutations, which holds promise for a future where treatment can be tailored to individual patients' needs. To learn more about Celcuity’s mission and upcoming trials, interested individuals can visit their website.

Frequently Asked Questions

What is the VIKTORIA-1 trial about?

The VIKTORIA-1 trial evaluates the efficacy of gedatolisib in combination with fulvestrant and possibly palbociclib against standard treatments in patients with PIK3CA mutated breast cancer.

When is the topline data expected?

Topline data for the VIKTORIA-1 trial is expected to be reported in late Q1 or during Q2.

What was the median progression-free survival found in patients with PIK3CA mutations?

The median PFS for patients with PIK3CA mutations was found to be 14.6 months in the Phase 1b trial.

What sets gedatolisib apart from other therapies?

Gedatolisib offers a comprehensive blockade of the PI3K and mTOR pathways, differing significantly in mechanism and effectiveness compared to other existing therapies.

How can I learn more about ongoing clinical trials by Celcuity?

More detailed information about Celcuity's active trials can be found on their official website or at ClinicalTrials.gov.

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