OHMX CORPORATION — Department of Health and Human Services SBIR Phase II: NCI

Description

DESCRIPTION provided by applicant The principal goal of this SBIR Phase II proposal is to establish the clinical value of a novel prostate cancer PCa non aggressiveness biomarker present in various physiological samples e g Prostatic Fluids PFs Expressed Prostatic Secretions EPS or Post Massage Urine samples PMUs Once statistically validated in this study n this andquot non aggressivenessandquot biomarker will be the basis of a reliable and innovative prognostic test that will complement the current clinical guidelines for active surveillance alread established by the National Comprehensive Cancer Network NCCN Greater screening rates in conjunction with improved detection methods have resulted in a controversial upsurge in the number of men undergoing prostate biopsy and subsequent treatments Upon diagnosis of PCa physicians and patients typically choose clinical interventions despite evidence that intervention is not always warranted especially for low risk non aggressive cancers The negative side effects of these interventions which may include incontinence impotence and bowel dysfunction are perpetuating the controversy of PCa overdiagnosis andamp overtreatment attributed to increased screening Recent recommendations from the U S Preventative Services Task Force USPSTF and the American Urology Association AUA to discontinue routine PSA screening have further fueled the controversy However these recommendations for reducing screening have created concern about the potential uptick in mortality from andquot missedandquot cancers Recent academic studies suggest that the enzymatically active isoform of PSA plays a significant role in tumor invasion and metastasis In Phase I and subsequent studies Ohmx found the level of PSA Peptidase Activity PPA in prostatic fluid and expressed prostatic secretions to be inversely proportional to disease stage such that patients with the non aggressive PCa have on average significantly increased PPA levels compared to those with more aggressive disease Significantly preliminary results suggest many in an initial study population n of the diagnosed patients with non aggressive PCa could have averted or delayed radical prostatectomy Ohmx is proposing a paradigm shift that complements screening techniques and provides a prognostic test that can directly aid in the refinement of treatment decisions A non aggressive test result reduces the number of unnecessary clinical interventions thereby maintaining the patientandapos s quality of life while reducing overall healthcare costs This innovative test will enhance the differentiation of non aggressive cancer and in conjunction with recent NCCN guidelines based on biopsy stage Gleason score PSA results and the age of the patient will increase patientsandapos acceptance of active surveillance and confidence in risk stratification for delaying treatment PUBLIC HEALTH RELEVANCE One in six American men will develop prostate cancer in their lives making it the second leading cause of cancer death among males in North America Although greater screening rates have drastically decreased mortality they have also caused a controversial upsurge in overdiagnosis and overtreatment Physicians and patients often choose clinical interventions even for non aggressive prostate cancer despite evidence that intervention is not warranted This intervention however places immediate undue physical emotional and financial burdens on the patients which has led to the latest clinical guidelines recommending the reduction of screening altogether With a lot of physicians now concerned about the potential uptick in mortality Ohmx is proposing a test that address the root of the twin problems of overdiagnosis and overtreatment instead while maintaining vigilant screening The Ohmx test is an exceptionally effective non invasive prostate cancer test confirming the non aggressive low risk nature of the cancer thereby increasing patient acceptance of active surveillance as an alternative to intervention