Primary malignant tumors that originate in the abdomen, such as colon, stomach and ovarian cancer, can metastasize into the abdominal cavity. We call this peritoneal metastatic cancer. This form of metastasis has a particularly poor prognosis and there is an urgent need for new, better treatments. The effectiveness of current treatment options, such as cytoreductive surgery followed by hyperthermic intraperitoneal chemotherapy (CRS-HIPEC), is mainly limited by the insensitivity of peritoneal metastases to the chemotherapy currently used.
Research direction/proposed solution
Recent preclinical studies have shown that peritoneal metastases in colorectal cancer are a manifestation of a specific molecular subtype called CMS4. These CMS4 tumors consist of cells that grow invasively and are resistant to common chemotherapeutics. We have found that CMS4 tumors are sensitive to the molecule YM155, which is very effective in killing CMS4 cancer cells in preclinical models of peritoneal metastatic cancer. This project aims to prepare this new treatment for a clinical trial against peritoneal metastases in colon cancer.
Relevance
Every year, 1500 patients are diagnosed with peritoneal metastatic colon cancer and there is an urgent medical need to better treat these patients. By further investigating and developing YM155 as a potential therapeutic agent, this research may improve the prognosis and quality of life of these patients.
Research questions
To conduct a clinical study with YM155, we set the following goals in this project:
What is the most appropriate clinical application of YM155 against peritoneal metastatic colon cancer? Which groups of patients are best included in an initial clinical study? What is a suitable formulation to administer YM155 intraperitoneally? What is the optimal strategy for protecting the intellectual property (IP) of intraperitoneally administered YM155? What are the steps and requirements for the successful implementation and commercialization of YM155 as a treatment for peritoneal metastatic cancer?
Research design
This Proof-of-Concept program is a bridge to the next research phase, namely a phase I/IIa clinical study. YM155 shows promising results as a cancer drug against peritoneal metastatic cancer in preclinical models, but the route to concrete clinical application of YM155 must first be further explored in this project.
Expected outcomes
The expected outcomes of this study are a better understanding of the clinical utility of YM155 for peritoneal metastatic cancer, the development of a suitable formulation for intraperitoneal administration, an effective IP protection strategy and a detailed plan for the implementation and commercialization of YM155.
Description of steps needed to implement results
YM155 has previously been developed as an anti-cancer drug and this offers several potential benefits, including access to toxicity data and shorter, cost-effective drug development. Following this project, a phase I/IIa clinical trial will be conducted in patients with peritoneal metastatic cancer. If this phase I/IIa study shows good effectiveness, we will likely establish a collaboration with a pharmaceutical company for further clinical development and commercialization.
2023-11-22 01:14:56
#treatment #peritoneal #metastatic #cancer
