7 December 2018 - - US-based biotechnology company OncoNano Medicine, Inc. has completed its Phase 1a clinical trial and expansion into Phase 1b to evaluate ONM-100, the intravenously administered imaging agent to detect tumors and metastatic lymph nodes in solid cancers during surgery, the company said.

The results of Phase 1a will be included in a poster presentation at the San Antonio Breast Cancer Symposium being held on December 4-8, 2018.

This trial is being conducted at Tracer Center of Expertise, University Medical Center Groningen in Groningen, The Netherlands with Professor Go van Dam as the Principal Investigator.

The Phase 1b portion of the study is currently enrolling patients and is an expansion phase at the highest dose tested in Phase 1a.

In addition to testing for breast cancer and head and neck squamous cell carcinoma (HNSCC) which were studied in Phase 1a, Phase 1b includes patients with colorectal and esophageal cancers.

Surgery remains the standard treatment for most solid tumors, with postoperative margin status and tumors left behind being the leading prognostic factor to predict tumor metastasis and potential recurrence.

Despite tremendous advances in imaging modalities, current techniques do not provide real-time feedback and surgeons must rely upon pre-operative imaging data with visual information during surgery.

ONM-100 targets the acidic pH environment within tumors, potentially providing surgeons with a method to assess lymph nodes and tumor margins in real-time. ONM-100 features a digital on-off response to pH changes switching on in the tumor's acidic environment and remaining off in blood circulation and normal cells.

OncoNano Medicine is developing a new class of pH-activated compounds that digitalise and exploit the variability of pH in disease.

pH variability is an identifier of diseased tissue and provides a foundation for the development of a range of highly targeted therapeutics and imaging agents. 

OncoNano said it is the first company to advance product candidates using pH as a biomarker for cancer immunotherapy, therapeutic use and intra-operative imaging based on its pH-sensitive micelle technology.