BOL-DP-o-04 / BOL Pharma - LARVOL DELTA

Medical cannabis for pain management in patients undergoing chronic hemodialysis: randomized, double-blind, cross-over, feasibility study. (PubMed, Clin Kidney J) - "In a prospective randomized, double-blind, cross-over design, patients undergoing HD with chronic pain were assigned to one of three arms: BOL-DP-o-04-WPE whole-plant extract (WPE), BOL-DP-o-04 cannabinoid extraction (API) or placebo...Short-term medical cannabis use in patients treated with HD was generally well tolerated. The safety data supports further studies to assess the overall risk-benefit of a treatment paradigm utilizing medical cannabis to control pain in this patient population."

Clinical • Journal • Chronic Kidney Disease • Infectious Disease • Nephrology • Pain • Renal Disease • Septic Shock

BOL-DP-o-04 in Patients With Low Back Pain and Sciatica (clinicaltrials.gov) - P1/2 | N=26 | Completed | Sponsor: Breath of Life International Pharma Ltd | Active, not recruiting ➔ Completed | Trial completion date: Dec 2021 ➔ Jul 2022 | Trial primary completion date: Dec 2021 ➔ Jul 2022

Trial completion • Trial completion date • Trial primary completion date • Back Pain • Lumbar Back Pain • Musculoskeletal Pain • Pain

BOL-DP-o-04 in Patients With Low Back Pain and Sciatica (clinicaltrials.gov) - P1/2; N=26; Active, not recruiting; Sponsor: Breath of Life International Pharma Ltd; Recruiting ➔ Active, not recruiting; N=150 ➔ 26; Trial completion date: Nov 2020 ➔ Dec 2021; Trial primary completion date: Nov 2020 ➔ Dec 2021

Clinical • Enrollment change • Enrollment closed • Trial completion date • Trial primary completion date • Back Pain • Lumbar Back Pain • Musculoskeletal Pain • Pain • Peripheral Neuropathic Pain • MRI

[VIRTUAL] EXPLORATORY STUDY TO ASSESS THE SAFETY OF SUBLINGUAL OIL BASED MEDICAL CANNABIS BOL-DP-O-04 IN DIALYSIS PATIENTS WHO HAVE CHRONIC PAIN (ISN-WCN 2021) - "Conclusions Overall, sublingual oil based medical cannabis appeared to be safe and well tolerated in hemodialysis patients as long as treatment is performed under close medical supervision and carful titration. This data supports further clinical development."

Clinical • Atrial Fibrillation • Cardiovascular • Constipation • Gastroenterology • Gastrointestinal Disorder • Hypotension • Infectious Disease • Oncology • Pain • Sarcoma • Septic Shock • Soft Tissue Sarcoma • Solid Tumor

Phase 2a Study Examining the Safety and Efficacy of BOL-DP-o-04 for Treating Diabetic Neuropathy (clinicaltrials.gov) - P2a; N=2; Terminated; Sponsor: Breath of Life International Pharma Ltd; N=100 ➔ 2; Recruiting ➔ Terminated; study stopped due to company strategic prioritization

Clinical • Enrollment change • Trial termination • Diabetic Neuropathy • Pain

BOL-DP-o-04 in Patients With Low Back Pain and Sciatica (clinicaltrials.gov) - P1/2; N=150; Recruiting; Sponsor: Breath of Life International Pharma Ltd

Clinical • New P1/2 trial