Prostate Cancer Test and Pipeline

Prostate Cancer Test and Pipeline

Cellanyx’s most advanced phenotypic test is aimed at solving major clinical challenges in prostate cancer that include: better risk stratification of low and intermediate grade cancer (Gleason 6 or 7), and improved detection of cancer in men with negative initial prostate biopsies.

Clinical Need for Precision, Personalized Prostate Cancer Biomarkers

Lack of clinical tools for more precise individualized risk stratification results in significant over-diagnosis and overtreatment of low/intermediate Gleason 6 and 7 prostate cancer, the need for repeat biopsies with resultant reduced quality of life, and increased healthcare costs for treatment of prostate cancer.  Additionally, precision tools are needed to identify aggressive low/intermediate prostate cancer thereby reducing the risk of under-treatment.

Biopsies to detect prostate cancer sample less than one percent of the prostate gland, and as a result, for about one-half of approximately 1.3 million, their initial prostate biopsies are negative, leading to the need for re-biopsy in a significant percentage of men. Prostate cancer is detected in approximately 80 percent of such re-biopsied patients, representing an unmet need and a market opportunity for a supplementary, albeit simultaneous or contemporaneous test, to augment the conventional pathological evaluation.

Cellanyx Live Tumor Cell, Prostate Phenotypic Test

The Cellanyx phenotypic test is designed to complement the Gleason pathological scoring of prostate biopsies.

The Company has demonstrated initial clinical proof-of-concept and analytical validation of the prostate cancer test in a blinded study in more than 300 fresh tumor tissue specimens from radical prostatectomy surgical specimens collected in the operating room immediately after surgery.  The results of the proof of concept study have been presented in multiple peer-reviewed forums, most recently at the 2016 Annual Meeting of the American Urological Association AUA) in San Diego, CA (poster link). In the study, the Cellanyx test predicted adverse pathologies with greater than 85 percent sensitivity and specificity, as determined by Receiver Operator Curves (ROC) and associated Area Under the Curve (AUC) measurements.   The predictive power of the Cellanyx test was substantially higher than that reported for available genomic biomarker tests, which use information derived from analysis of various genes, and are intended to predict adverse pathologies from tumor biopsy samples.

The proof-of-concept prostate cancer study also evaluated 60 prostate tissue samples (“field tissue samples” obtained well away from the known area of cancer). The Cellanyx phenotypic test also successfully predicted adverse pathology from these “field tissue” samples with greater than 85 percent sensitivity and specificity.  The “field effect” data were presented in September 2016 at AdMeTech Foundation’s First Global Summit on Precision Diagnosis of Prostate Cancer in Boston, MA.

Based on the initial success with the proof of concept study, Cellanyx plans to conduct an additional clinical study to evaluate its clinical utility and ability to predict adverse pathology in men undergoing initial diagnostic needle biopsies of the prostate.

Cellanyx’s prostate test is being developed as a Laboratory Developed Test (LDT) for use in conjunction with traditional prostate pathology Gleason scoring test. The Cellanyx LDT will generate the predictive phenotypic biomarker scores within three days of receipt of the fresh tumor tissue.

Breast Cancer Test and Pipeline

Risk stratification of early-stage breast cancer is an active area of research and several commercially available products based on genotypic classification are currently available and in widespread use.  Even more vexing than early stage breast cancer is carcinoma in situ – which has no metastatic potential.  This comes as two sub types – Ductal Carcinoma in Situ (DCIS) and Lobular Carcinoma in Situ (LCIS).  The incidence of these entities is rising dramatically in the U.S. due to widespread mammography and the adoption of MRI which has led to dramatic increase in the incidence rates of carcinoma in situ.   Using its first-in-class phenotypic, live tumor cell platform, Cellanyx has conducted an evaluation of approximately 60 breast cancer samples obtained from patients undergoing radical surgery (either mastectomy or lumpectomy).  This initial clinical study has established analytical performance metrics for its first-in-class phenotypic test in breast cancer patients. The Cellanyx phenotypic test is intended to help stratify patients with DCIS or LCIS, who may not need aggressive treatment and could be spared unnecessary aggressive surgery and/or radiation therapy.

Other Tumor Types

The Company has also generated initial clinical data in tumor samples obtained at the time of radical surgeries in patients with renal, bladder and non-small cell lung cancers.

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