Mestastop Solutions Seeks Approval for Phase II Trial Targeting Colorectal Cancer Metastasis
Key Insights
Bengaluru-based Mestastop Solutions (search) has applied to CDSCO (search) for approval of a Phase II clinical trial to delay metastasis in colorectal cancer (search) patients following surgery or chemotherapy.
The randomized controlled, double-blind trial will involve 60 patients and is expected to run for at least two years, with patient recruitment beginning upon approval.
Mestastop's approach focuses on preventing cancer cells from colonizing secondary sites, potentially transforming cancer treatment paradigms from damage control to disease containment.
Bengaluru-based biotech startup Mestastop Solutions (search) has filed an application with the Central Drugs Standard Control Organisation (CDSCO (search)) for approval of its first clinical candidate aimed at delaying metastasis in patients with primary colorectal cancer (search) tumors. The Phase II study will focus on adjuvant settings for patients who have already undergone surgery and/or chemotherapy.
Founded in 2018, Mestastop has spent years developing a deep understanding of metastasis biology through extensive research using primary tumor patient samples. This work has been conducted in close collaboration with the Rajiv Gandhi Cancer Institute.
Novel Approach to Cancer Metastasis
The company's innovative approach targets the process by which cancer cells spread from primary tumors to establish colonies in secondary locations—the primary cause of cancer mortality. Rather than focusing solely on treating existing tumors, Mestastop aims to prevent the colonization process itself.
"Metastasis is the principal cause of cancer mortality and the greatest obstacle to curative treatment," explained Dr. (Col) Anurag Mehta, MD, Pathology and Director of Laboratory, Molecular Diagnostics and Transfusion Services at Rajiv Gandhi Cancer Institute. "Unravelling its underlying biology and identifying biomarkers that can intercept the spread from the primary site could redefine cancer management, shifting the focus from damage control to true disease containment."
Trial Design and Collaboration
The randomized controlled, double-blinded trial will involve 60 primary colorectal cancer (search) patients who have undergone surgery and/or chemotherapy. Expected to run for at least two years, the company plans to begin patient recruitment immediately upon receiving regulatory approval.
For this critical study, Mestastop has partnered with Mumbai-based contract research organization Raptim Research (search), which brings substantial experience having conducted over 50 late-stage trials across multiple therapeutic areas and successfully cleared more than nine US FDA inspections for late-phase oncology trials.
Dr. Chirag Shah, Head of Clinical and Business Operations at Raptim Research (search), expressed enthusiasm about the collaboration: "We are highly excited to associate with Mestastop at this important juncture of their growth trajectory, as the founder's dream is coming into reality, as we are progressing towards clinical evaluation after extensive lab work of more than five years."
Potential Impact on Cancer Treatment
Dr. Arnab Roy Chowdhury, founder and director of Mestastop, highlighted the transformative potential of their approach: "The novelty of the Mestastop approach in preventing cells from colonizing in the secondary axis has a tremendous potential to impact how we treat cancer, and we all believe that this will help a lot of patients in the future."
The focus on preventing metastasis rather than just treating established tumors represents a significant shift in cancer treatment strategy. If successful, this approach could fundamentally change how certain cancers are managed, potentially improving survival rates and quality of life for patients.
Recent Achievements and Future Plans
2025 has already proven to be a milestone year for Mestastop. The company has secured approval for two of its initial patents in both India and the United States, while also filing for two new international patents covering its potential clinical candidates.
Beyond the current Phase II trial, Mestastop continues to advance its research pipeline. The company is currently developing a novel discovery program focused on a first-in-class target for metastasis, with plans to present new data at the upcoming European Association of Cancer Research meeting in June 2025.
As the company awaits regulatory approval for its Phase II trial, the potential implications for colorectal cancer (search) patients and possibly patients with other cancer types remain significant. By targeting the metastatic process itself, Mestastop's approach could represent an important advancement in cancer treatment strategies.