New corporate identity to better reflect the company’s advanced stage
IND approval allows initiation of Phase I/II clinical trial with lead compound CAM-H2 in advanced/metastatic HER2-positive cancer
Brussels, Belgium, 21 September 2020 – Camel-IDS, a private, clinical-stage biotechnology company developing novel radiopharmaceuticals in oncology, today announces the launch of a new corporate identity and company name change to PRECIRIX®, effective immediately. Further, the company announces it has received Investigational New Drug (IND) approval to initiate a Phase I/II clinical trial with CAM-H2 in patients with advanced/metastatic HER2-positive breast and gastric cancer.
Ruth Devenyns, CEO of Precirix, commented: “The significant progress in the development of our company, such as the IND approval for CAM-H2, has lead us to adopt a new corporate identity. Precirix reflects our mission to become a leader in precision radiopharmaceuticals as we aim to improve and extend the lives of patients with hard-to-treat cancers.”
Precirix received IND approval from the US FDA and Clinical Trial Approval (CTA) from the Canadian authorities, which allows the initiation of a Phase I/II trial with lead product candidate, CAM-H2 (NCT04467515). Recruitment is expected to commence in 4Q20. The international, multicenter, Phase I/II trial will evaluate CAM-H2 in patients with advanced/metastatic HER2-positive breast and gastric cancer. In the dose-escalation phase, cohorts of three patients will be treated with increasing doses of CAM-H2. In the dose-expansion phase, over 50 patients will be treated with the selected dose.
Research demonstrated the potential of CAM-H2 to target brain lesions. This life-threatening complication still represents a significant unmet need as over 30% of HER2-positive metastatic breast cancer patients will be affected and limited treatment options are available1. Therefore, the trial will include and enrich for patients with HER2-positive brain metastases. In addition to safety, tolerability and dosimetry, the study will report on objective response rates, progression-free survival, overall survival, and duration of responses.
With its name change, the company also launches a new website, logo and corporate presentation (www.precirix.com)
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