Dark Canyon Labs is pleased to announce the completion of a multicenter, randomized, investigator blinded, non-inferiority Phase 2 Clinical Trial. DCL-101, a novel Pill Prep, was compared to standard split-dose GoLYTELY® in adult outpatients undergoing routine colonoscopy.
Based on tolerability, safety, and efficacy results, Dark Canyon Labs is excited to announce that DCL-101 will move ahead for further evaluation in two definitive Phase 3 trials.
Watch for additional details soon. For more information, contact firstname.lastname@example.org
Dark Canyon Labs is pleased to announce that subject enrollment begins in December for a Phase 2 trial comparing the safety and efficacy of DCL-101 vs. GoLYTELY® in preparing the bowel for routine colonoscopy. DCL-101 is Dark Canyon Labs' novel capsule prep that eliminates the need to drink the salty-tasting solution of other preps, completely transforming the patient experience. GoLYTELY® is the current gold standard bowel prep in terms of efficacy, so will be used as the comparator.
The trial is now listed on ClinicalTrials.gov, a service of the National Institutes of Health.
To learn more about enrolling in the clinical trial, please contact Philip Calvillo from Robarts Clinical Trials, at 626-658-0870 or Philip.Calvillo@robartsinc.com
Dr. Bachwich will be presenting details about Dark Canyon Labs' new colonoscopy prep, DCL-101, at the "Shark Tank" Session of the 2016 AGA Tech Summit in Boston, MA on Thursday, March 31, 2016. This conference on GI Innovation and Technology identifies unmet needs in gastroenterology and highlights promising new technologies. A distinguished panel of moderators will provide valuable feedback.
Colon cancer kills 50,000 patients every year and is the third leading cause of cancer in men and women in the U.S. Many of these deaths can be prevented with regular screening. Dark Canyon Laboratories is committed to providing patients with a much better experience during the colonoscopy prep process. A better tolerated prep could help save lives by increasing the colon cancer screening rate. If patients don't dread the process, they will be more likely to comply with the current screening recommendations.
Robarts Clinical Trials, Inc. has been retained by Dark Canyon Labs to conduct a Phase 2 Clinical Trial beginning late 2016. The trial will enroll approximately 357 patients across 7 investigative sites. This randomized, investigator-blinded, non-inferiority study will compare the safety and efficacy of DCL-101 to the current gold standard of colonoscopy preps, GoLYTELY®. Additional data on tolerability and patient preferences will be collected.
A subsidiary of the University of Western Ontario, Robarts is a global academic Clinical Research Organization (CRO) that provides a broad range of clinical research services to pharmaceutical and biotechnology companies, government agencies and academic investigators.
Dark Canyon Labs is especially excited to be working with Robarts because they are globally recognized for their innovation and specialized expertise in the processing and centralized review of GI endoscopic video recordings with Central Image Management Solutions (CIMS).
Dark Canyon Labs has patents pending in both the European Union as well as Hong Kong. Long backlogs of applications have created delays. Check back for updates.
Dark Canyon Labs was granted Chinese patent No. 201080028806.1 for development of a novel Colon Lavage System.