VB-201 / VBL Therap - LARVOL DELTA

A Study to Evaluate the Efficacy and Safety of VB-201 in Patients With COVID-19 (clinicaltrials.gov) - P2 | N=5 | Completed | Sponsor: Vascular Biogenics Ltd. operating as VBL Therapeutics | Recruiting ➔ Completed | N=30 ➔ 5 | Trial completion date: Jun 2022 ➔ Oct 2022 | Trial primary completion date: Jun 2022 ➔ Oct 2022

Enrollment change • Trial completion • Trial completion date • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease

Immunomodulation Using VB-201 to Reduce Arterial Inflammation in Treated HIV - VITAL HIV Trial (clinicaltrials.gov) - P1/2 | N=0 | Withdrawn | Sponsor: Priscilla Hsue, MD | N=110 ➔ 0 | Not yet recruiting ➔ Withdrawn

Enrollment change • Trial withdrawal • Cardiovascular • Human Immunodeficiency Virus • Immune Modulation • Immunology • Infectious Disease • Inflammation • CD14 • CD38 • CD4 • CRP • IL6

Immunomodulation Using VB-201 to Reduce Arterial Inflammation in Treated HIV - VITAL HIV Trial (clinicaltrials.gov) - P1/2; N=110; Not yet recruiting; Sponsor: Priscilla Hsue, MD

New P1/2 trial • Cardiovascular • Human Immunodeficiency Virus • Immune Modulation • Immunology • Infectious Disease • Inflammation • CD14 • CD38 • CD4 • CRP • FDG PET • IL6

VB-201: Expiry of composition-of-matter patent in US in 2027 (VBL Therapeutics) - Annual Report 2020: Expiry of patent related to its use for NASH and fibrosis indications beyond 2030 and corona virus indication beyond 2040

Patent • Immunology

VBL Therapeutics Treats First Patient in Phase 2 Randomized Controlled Study of VB-201 in COVID-19 Patients (GlobeNewswire) - "VBL Therapeutics...announced the dosing of the first patient in a randomized controlled Phase 2 study of...VB-201 for the treatment of COVID-19. The study will assess the ability of VB-201 to prevent clinical deterioration and reduce morbidity and mortality in patients with severe COVID-19....'Treating the immune system of COVID-19 patients requires a delicate balance between preventing cytokine storm and suppressing the body's ability to fight the virus,'..."

Cytokine storm • Trial status • Infectious Disease • Novel Coronavirus Disease

A Study to Evaluate the Efficacy and Safety of VB-201 in Patients With COVID-19 (clinicaltrials.gov) - P2; N=30; Recruiting; Sponsor: Vascular Biogenics Ltd. operating as VBL Therapeutics

Clinical • New P2 trial • Infectious Disease • Novel Coronavirus Disease

Use of Uterine Tamponade and Interventional Radiology Procedures During Delivery Hospitalizations. (PubMed, Obstet Gynecol) - "This analysis found that uterine tamponade and interventional radiology procedures became increasingly common over the study period, are used across obstetric volume settings, and in the setting of hysterectomy may be associated with increased risk of morbidity, although this relationship is not necessarily causal."

Clinical • Journal • Hematological Disorders • Postpartum Hemorrhage

Comparison of common perioperative blood loss estimation techniques: a systematic review and meta-analysis. (PubMed, J Clin Monit Comput) - "The bias for estimated blood loss (ml) was lowest for colorimetric methods (57.59 95% CI 23.88-91.3) compared to the reference, followed by gravimetric (326.36 95% CI 201.65-450.86) and visual methods (456.51 95% CI 395.19-517.83)...Colorimetric methods offer the highest degree of accuracy in blood loss estimation. Systems that use colorimetric techniques have a significant advantage in the real-time assessment of blood loss."

Journal • Retrospective data • Review • Anesthesia

VBL Therapeutics reports topline results from phase 2 studies of VB-201 in psoriasis and ulcerative colitis (GlobeNewswire) - P2, N=112; NCT01839214; P2, N=194; NCT01837420; Sponsor: VBL Therapeutics; "VBL Therapeutics...announced that its Phase 2 studies evaluating lead Lecinoxoid compound VB-201 in patients with psoriasis and ulcerative colitis did not meet their primary endpoints. The Company does not plan to continue development of VB-201 in these indications."

Discontinued • P2 data • Immunology • Inflammatory Bowel Disease • Psoriasis

VBL Therapeutics announces novel mechanistic data for VB-201, a first in class orally available anti-inflammatory compound that inhibits CD14-TLR4 and TLR2-dependent innate cell activation (VBL Therapeutics Press Release) - "The pre-clinical findings reported in this manuscript seem to be well translated to humans, as the clinical data we have gathered so far consistently demonstrate the potential of VB-201 as a safe, novel oral therapeutic option for chronic immune-inflammatory diseases” 

Preclinical • Immunology • Inflammatory Bowel Disease • Psoriasis • Rheumatoid Arthritis

VBL presents positive preclinical data on immune modulator in Rheumatoid Arthritis at EULAR annual meeting (VBL Therapeutics) - VB-201  / VBL; Preclinical data  in 2 validated models shows encouraging results, anti-inflammatory properties reported, plans to move forward with P2 in psoriasis

Study to assess the safety and efficacy of multiple doses of VB-201 on biomarkers (clinicaltrials.gov) - P2, N=320; Recruiting -> Completed

Trial completion • Immunology • Psoriasis • Rheumatoid Arthritis

VB-201: Anticipated expiry of patent in US related to composition-of-matter in 2027 (VBL Therapeutics) - Annual Report 2016: Anticipated expiry of patent related to use in 2030 or later

Patent expiry • Immunology • Psoriasis

VBL Therapeutics presents positive phase 2 data for VB-201 in psoriasis and atherosclerosis at the late-breaking abstract session of the American Academy of Dermatology 70th Annual Meeting (Businesswire) - P2, N=185; There were no treatment-related serious adverse events observed, & the overall rates of adverse events were similar across the VB-201 drug & placebo dosing arms; Statistically significant improvements in the psoriasis efficacy endpoints, Physician Global Assessment & Patient Global Assessment (p=0.019), were achieved; A statistically significant dose response in Psoriasis Area and Severity Index (PASI) was demonstrated across quintiles of VB-201 through blood levels (p= 0.04)

P2 data • Immunology • Psoriasis

VB-201, an oxidized phospholipid small molecule, inhibits CD14- and TLR2-dependent innate cell activation and constrains atherosclerosis (Clin Exp Immunol) - PMID: 24116867; "In a rabbit model, oral administration of VB-201 constrained atherosclerosis progression. This effect was not due to reduced cholesterol abundance, as hyperlipidemia was sustained....VB-201 may counter inflammation where TLR2 and/or CD14 complicity is essential and is therefore beneficial for the treatment of atherosclerosis."

Preclinical • Atherosclerosis

VBL Therapeutics to present at the UBS Global Life Sciences Conference (VBL) - VBL announced that the CEO of VBL is scheduled to present at UBS Global Life Sciences Conference on Sep 20, 2011; He will also outline company’s goals to advance development of VB-201, which is currently in P2 clinical trials in pts with psoriasis

Anticipated company presentation • Immunology • Psoriasis

VBL Therapeutics: Oppenheimer Healthcare Conference (VBL Therapeutics) - "Phase 2 sub-study of VB-201 in vascular inflammation"; "Primary endpont Met: ~13% reduction from baseline in the high dose group (p=0.04)"; "Dose-response pattern observed"; "18.5% reduction of inflammation on top of statin therapy"; "Higher VB-201 trough levels were associated with a better response (>20% in the highest dose range)"; "VB-201 therapy reduced vascular inflammation in patients with psoriasis and cardiovascular risk factors"

P2 data • Immunology • Psoriasis

VBL Therapeutics announces last patient out in phase 2 clinical studies of VB-201 in psoriasis and ulcerative colitis (GlobeNewswire) - P2, N=112; NCT01839214; P2, N=194; NCT01837420; Sponsor: Vascular Biogenics; "VBL Therapeutics...has achieved completed dosing of the last patient in both of its Phase 2 studies evaluating the efficacy of lead Lecinoxoid compound VB-201 for the treatment of psoriasis and ulcerative colitis. Top line results from both studies are expected in the first quarter of 2015."

Anticipated P2 data • Trial primary completion • Immunology • Inflammatory Bowel Disease • Psoriasis

VBL Therapeutics: Oppenheimer Healthcare Conference (VBL Therapeutics) - "VB-201 Exploratory Phase 2 trial in Psoriasis"; "Randomized, double-blind study with 185 patients (US, Germany, Israel)"; "Placebo, 20mg or 80mg of VB-201 for 12 weeks"; "VB-201 found to be safe and well-tolerated"; "Met several secondary endpoints showing statistically significant reduction in disease severity: reduction in PASI, patient global assessment, physician global assessment"; "Clear dose-response, but VB-201 did not reach a plateau"

P2 data • Psoriasis

VBL: Annual Report 2014 (VBL Therapeutics) - Anticipated patent expiry in 2027

Anticipated patent expiry • Immunology • Psoriasis

(Thia)calixarenephosphonic acids as potent inhibitors of the nucleic acid chaperone activity of the HIV-1 nucleocapsid protein with a new binding mode and multi-target antiviral activity. (PubMed, ACS Infect Dis) - "Moreover, CIP201 was also found to inhibit the flipping and polymerization activity of reverse transcriptase. Calixarenes form thus a class of noncovalent NC inhibitors, endowed with a new binding mode and multi-target antiviral activity."

Journal

Detecting high-risk chronic kidney disease-mineral bone disorder phenotypes among patients on dialysis: a historical cohort study. (PubMed, Nephrol Dial Transplant) - "There were 15 795 deaths [126.7 deaths/1000 person-years; 95% confidence interval (CI) 124.7-128.7]; 18 014 had at least one hospitalization (203.9 hospitalizations/1000 person-years; 95% CI 201.0-206.9); the incidence of the composite endpoint was 280.0 events/1000 person-years (95% CI 276.6-283.5)...We identified several CKD-MBD phenotypes associated with reduced hospitalization-free survival and increased mortality. Ranking of relative risk estimates or excess events concurs in informing healthcare priority setting."

Biomarker • Clinical • Journal

Efficacy of 'drive and retrieve' as a cooperative method for prompt endovascular treatment for acute ischemic stroke. (PubMed, J Neurointerv Surg) - "The drive and retrieve method may be an effective form of cooperation between facilities located within 1 hour of a comprehensive stroke center."

Clinical • Journal

VBL Therapeutics announces first quarter 2019 financial results (GlobeNewswire) - "Executed a strategic exclusive option license agreement with one of the world-leading European animal health companies, for the development of VBL’s proprietary anti-inflammatory molecule, VB-201...VBL received an undisclosed up-front payment and upon exercising the option to license, VBL expects to receive additional milestones and royalties, which may exceed €50 million. VBL retains worldwide rights for the use of VB-201 for the treatment of humans. We are also pleased to announce that there will be two presentations on VB-111 at the upcoming 2019 ASCO Annual Meeting in early June, by Dr. Richard Penson...on the final Phase 2 results in ovarian cancer..."

Announcement • Licensing / partnership

VB-201: Expiry of composition-of-matter patent in US in 2027 (VBL Therapeutics) - Annual Report 2018: Expiry of patent related to use in 2030 or later

Patent