Q4 Events List Updated
posted on
Oct 19, 2015 10:37AM
Resverlogix has updated their Q4 Events list.
Oct. 20-21: Bio Investor Forum, San Francisco, CA. Resverlogix is presenting Wednesday, October 21 at 11 AM in a 25 minute presentation in the Cardiovascular BIO Presentation Track. On this same day, notes from the AGM indicate that the BETonMACE trial will be officially listed on clinicaltrials.gov. Though, if one checks the EU Clinical Trials Register and searches for Resverlogix or BETonMACE, you can find BETonMACE listed there already!
Oct. 25-28: Cavendish Global Health Impact Forum, Cleveland, OH. Unclear to me if Resverlogix is just attending or presenting.
Oct. 26-28: BioNetwork, Laguna Nigel, CA. Ken Lebioda is giving a talk on Day 2. Thanks to Fundamentals6 on the InvestorVillage board for first posting on this.
Nov. 2-4: Bio-Europe 2015, Munich, Germany. Resverlogix presents on Tuesday Nov 3rd.
Nov. 3-8: ASN Kidney Week, San Diego, CA. American Society for Nephrology conference. Thanks to Fundamentals6 on the InvestorVillage board for first posting that Dr. Kaymar Kalantar-Zadeh is presenting the following (full abstracts at end of message):
Nov. 5-9: Zenith is attending AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics, Nov 5-9 2015 in Boston. Yet to be disclosed by Zenith or on the conference website whether they are presenting.
Nov. 5-7: CTAD 2015, Barcelona, Spain. Clinical Trials on Alzheimer's Disease conference.
Nov. 7-11: AHA Conference 2015, Orlando, FL. American Heart Association Scientific Sessions. Norman Wong is listed as first author for "S 1006 - RVX-208 a Selective Bromodomain and Extra-terminal BET Protein Inhibitor Acts on Several Pathways to Benefit Cardiovascular Risks" on November 8, part of the session "APS.01.01 - New Insights into Treatment of Cardiovascular Disease." Looks like Dr. Henry Ginsberg, who is on the BETonMACE clinical steering committee, is chairing this session.
Nov. 30 – Dec. 4: IDF 2015, Vancouver, BC. International Diabetes Federation conference. I'm not sure if they are presenting or just attending.
Here are the ASN Kidney week full abstracts.
Abstract: [TH-PO666] The Epigenetic BET-Inhibitor RVX-208/Apabetalone Shows Favorable Effects on ALP and eGFR in Chronic Kidney Disease (CKD) Patients – A Post-Hoc Analysis of Phase 2 Clinical Trials
Kamyar Kalantar-Zadeh, MD, PhD, MPH, FASN, Jan O. Johansson, MD, PhD, Michael Sweeney, MD, Kenneth E. Lebioda, Ewelina Kulikowski, PhD, Christopher Halliday, Norman Cw Wong, MD. Div of Nephrology & Hypertension, 1Univ of California Irvine School of Medicine, Irvine, CA; Research and Development, Resverlogix Corporation, Calgary, AB, Canada.
Background: The epigenetic BET inhibitor RVX-208 is a small molecule with anti-inflammatory and apolipoprotein A-I (apoA-I) enhancing effects. It exerts its' actions by inhibiting bromodomain extra-terminal proteins (BET) thus inhibiting acetylated lysine, present in histones, from binding to the same site. In this process chromatin structure is altered and activity of select genes inhibited. A subpopulation analysis from the double-blind placebo controlled phase 2b program in cardiovascular disease (CVD) identified 81 subjects with CKD based on eGFR < 60 ml/min/1.73m2. Methods: The effect of selective BET inhibition on key renal parameters in 81 CKD subjects (RVX-208 n=58/Placebo n=23) that were treated with either RVX-208 100mg/day or 150 mg b.i.d or matching placebo for 3 to 6 months were studied. A pooled analysis was performed to assess the changes from baseline for eGFR, ALP and creatinine at 3 and 6 months. Results: ALP changes for RVX-208 and placebo were -14.2% and -0.34% at 3 months (p<0.05 vs. placebo) and -13.9% vs. -6.28% (p<0.05 vs. placebo) at 6 months. Following 6 months of RVX-208 treatment, eGFR showed an increase of +3.4% (p=0.04 vs. baseline) in the RVX-208 group compared to a decrease of -5.9% in the placebo group. After 6 months treatment serum creatinine was decreased (-2.82%, p<0.10 vs. baseline) compared to increases in the placebo group of +3.0% and +4.85% at 3 and 6 months, respectively. No significant change in eGFR and serum creatinine were observed after 3 months RVX-208 treatment, albeit nominal numbers went in the normalization directions. Conclusions: Six months treatment with RVX-208, a selective BD2 selective BET-inhibitor significantly lowers serum ALP, and shows trends for eGFR and serum creatinine improvements. A phase 3 study BETonMACE is being planned in which these effects will be assessed in the prospective setting in diabetic CVD patients with or without CKD.
Abstract: [TH-PO609] Alkaline Phosphatase Lowering by Selective BET Inhibition, a Novel Mechanism for MACE Reduction in High Risk CVD, Diabetes and CKD Patients – A Post-Hoc Analysis of Phase 2b Studies with RVX-208
Kamyar Kalantar-Zadeh, MD, PhD, MPH, FASN, Jan O. Johansson, MD, PhD, Michael Sweeney, MD, Kenneth E. Lebioda, Ewelina Kulikowski, PhD, Christopher Halliday, Norman Cw Wong, MD. Div of Nephrology and Hypertension, 1Univ of California Irvine School of Medicine, Irvine, CA; Reseerch and Development, Resverlogix Corp, Calgary, AB, Canada.
Background: RVX-208 development is focused on reducing major adverse cardiovascular events (MACE) in high risk CVD, diabetes and CKD patients. RVX-208 is a first in class select BET inhibitor small molecule that interacts with the second ligand domain found in bromodomain and extra-terminal proteins (BET). It is characterized by reductions in alkaline phosphatase (ALP) and anti-inflammatory effects. Methods: In the SUSTAIN and ASSURE phase 2b clinical studies, high risk CVD patients were treated with 200 mg b.i.d RVX-208 or placebo for up to 26 weeks duration. Patients with a history of diabetes were analysed as a subgroup. Results: A significant reduction in MACE in all the RVX-208 treated patients (n=331) compared to placebo (n=168) was observed (p=0.02) as well as in those with diabetes (RVX-208 n=127/placebo n=65) (p<0.01). MACE included death, non-fatal myocardial infarct, and hospital admittance for cardiac reasons. In all patients (n=499), MACE compared to non-MACE patients had higher baseline ALP; 77.0 U/L vs. 72.0 U/L (p<0.05). Similar trends were observed in diabetes patients, 81.0 U/L vs. 75.5 U/L. RVX-208 treatment significantly lowered ALP vs. placebo in all patients (p<0.0001) and especially in those with diabetes (p<0.0001). In addition, in the RVX-208 treated group, patients who did not experience a MACE had greater reductions of ALP compared to those who experienced a MACE (-8.0 U/L vs. +3.0 U/L) (p<0.05). Conclusions: In phase 2b studies in high risk CVD and diabetes patients treated with RVX-208, a select BET-inhibitor, baseline ALP levels were significantly different between the MACE and non-MACE patients. Furthermore, RVX-208 significantly lowered serum ALP. A prospective phase 3 study currently planned, called BETonMACE, will need to further examine RVX-208's potential in reducing MACE in high risk CVD, diabetes and CKD patients.
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BearDownAZ