San Diego-based biotechnology company Cardiff Oncology has reported positive data from a drug targeting metastatic colorectal cancer.
Colorectal cancer is the third most common cancer worldwide, resulting in 50,000 deaths annually in the United States alone. When metastatic, or spread beyond the colon, the five-year survival rate is approximately 15%.
Cardiff Oncology tested the drug ovansertib in two dosages — 20 mg and 30 mg — and also compared its effects against the existing treatment of chemotherapy in conjunction with the drug Avastin.
The drug is specifically intended for patients with a mutation in the RAS genes, which is the case for approximately half of those diagnosed with metastatic colorectal cancer. The RAS mutation is associated with a worse prognosis, as the mutation results in resistance to certain treatments for metastatic colorectal cancer.
To quantify whether a drug has any effect on a cancerous tumor, patients receive a CT scan every two months to measure tumor shrinkage. If a tumor shrinks at least 30%, the treatment is considered to be effective.
The standard of care, or the existing treatment of chemotherapy and Avastin, demonstrates a 30% response rate. In contrast, the 20 mg dosage of ovansertib demonstrated a 42% response rate in the results, reported last week, with the 30 mg dosage demonstrating a 49% response rate.
The trial was conducted with approximately 37 individuals selected across the nation for each of three groups.
For several patients, taking ovansertib resulted in a complete response, or 100% tumor shrinkage.
“If you look at these patients, none in the control group (have tumor shrinkage) anywhere close to 100%,” said CEO Mark Erlander, CEO of Cardiff Oncology, which is near Torrey Pines. “In a nutshell, that’s why we’re so excited about this.”
Erlander noted that ovansertib is well-tolerated, as current data and testing indicate that the drug does not add any incremental toxicity to the patient — this is crucial, Erlander said, particularly because patients are already undergoing chemotherapy.
Cardiff Oncology plans on taking their data to the FDA by the end of this year to gain approval for a larger trial which also would assess the drug’s long-term effectiveness.
“This (drug) is for first-line therapy, which is exciting because that’s where you have the greatest impact,” Erlander said. “And we’re showing a significant difference (in response). The tumor is shrinking faster. Right now, our focus is to move this drug to the next step, which is to go to the FDA.”
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