JSS Medical Research, Inc. operates as a comprehensive clinical research organization, providing a range of services including clinical trials, market access and HEOR, consulting, biostatistics, medical writing, and insourcing. With its headquarters located in Montreal, Canada, the company was established by John S. Sampalis in 1985.

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Drugs associated with JSS Medical Research, Inc.

Glycovax-002

Target-

Mechanism

Immunostimulants

Active Org.

Seppic S.A. [+3]

Originator Org.

Glycovax Pharma, Inc.Startup

Active Indication-

Inactive Indication-

Drug Highest PhasePhase 1

First Approval Ctry. / Loc.-

First Approval Date-

Clinical Trials associated with JSS Medical Research, Inc.

NCT06036186

/ CompletedNot Applicable

Early Feasibility, Randomized Crossover and Double-Blind Design, Study for the Treatment of Heart Failure With Preserved Ejection Fraction (HFpEF) Associated With Hypertension Utilizing Right Atrial Pacing Regulated by the PressurePace™ System (RelieveHFpEF-II)

This study is a prospective, double blind, self-controlled, randomized, cross-over study to evaluate the feasibility, efficacy, and safety of treating patients with Heart Failure with preserved Ejection Fraction (HFpEF) associated with hypertension using the PressurePace™ system of Right Atrial Pacing regulated by blood pressure in subjects with dual chamber pacemakers.
The objective of this study is to show that blood pressure-controlled right atrial pacing improves exercise tolerance, improves heart failure symptoms, and improves hypertension control in subjects with HFpEF associated with hypertension compared to conventional bradycardia pacing alone.

Start Date26 Aug 2023

Sponsor / Collaborator

Baropace, Inc.

[+1]

NCT05799651

/ Active, not recruitingPhase 1

A Randomised, Double-Blind, Dose-Escalation Phase I Study in Healthy Adults to Assess the Safety, Tolerability and Immunogenicity of Glycovax-002, a Novel Vaccine Candidate Against COVID-19

Glycovax Pharma has developed a glycoconjugate vaccine candidate called Glycovax-002 to fight the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) at the origin of COVID-19.
The aim of the study is to assess the safety, reactogenicity and immunogenicity of Glycovax-002 in humans. The study is a phase I, placebo-controlled, dose-escalation study conducted in 36 healthy females and males aged between 18 and 55 years old. The vaccine will be administered three times with a two-week time interval between each dose.
Dose escalation is conducted in three steps. At each step, 9 participants receiving the vaccine will be randomized with 3 participants receiving placebo (normal saline). Progression to next step is conditional to a DSMB's approval.

Start Date28 Apr 2023

Sponsor / Collaborator

Glycovax Pharma, Inc.Startup

[+4]

CTRI/2023/02/049717

/ RecruitingPhase 2

A Phase II, Open-Label Study of NM8074 in Patients with Paroxysmal Nocturnal Hemoglobinuria(PNH)

Start Date20 Mar 2023

Sponsor / Collaborator

NovelMed Therapeutics, Inc.

[+1]

100 Clinical Results associated with JSS Medical Research, Inc.

0 Patents (Medical) associated with JSS Medical Research, Inc.

Literatures (Medical) associated with JSS Medical Research, Inc.

01 Dec 2024·Rheumatology and Therapy

Tofacitinib Safety and Effectiveness in Canadian Patients with Rheumatoid Arthritis by Cardiovascular Risk Enrichment: Subanalysis of the CANTORAL Study

Article

Author: Keystone, Edward C. ; Roy, Patrice ; Sampalis, John S. ; Vaillancourt, Julie ; Haraoui, Boulos ; Sampalis, John S ; Kinch, Cassandra D ; Gruben, David ; Kinch, Cassandra D. ; Choquette, Denis ; Khraishi, Majed ; Galos, Corina ; Keystone, Edward C ; Fortin, Isabelle

INTRODUCTION:

ORAL Surveillance, a post-authorisation safety study of patients with rheumatoid arthritis (RA) enriched for cardiovascular (CV) risk, demonstrated increased risk of major adverse CV events (MACE) and malignancies (excluding non-melanoma skin cancer [NMSC]) for tofacitinib versus tumour necrosis factor inhibitors (TNFi). This analysis of a real-world Canadian observational study evaluated tofacitinib safety/effectiveness in patients meeting or not meeting CV risk criteria.

METHODS:

CANTORAL included patients with moderate-to-severe RA initiating tofacitinib (10/2017-07/2020; N = 504). Interim data (data-cut: 07/2021) were stratified as CV risk-enriched (CV+ ; patients ≥ 50 years with ≥ 1 additional CV risk factor) or not CV risk-enriched (CV-; ≥ 50 years without additional CV risk factors and 18-49 years with/without CV risk factors). Safety and persistence were evaluated to month (M) 36. Effectiveness outcomes to M18 included Clinical Disease Activity Index (CDAI)-defined low disease activity (LDA)/remission (CANTORAL co-primary endpoints) and Disease Activity Score in 28 joints, C-reactive protein (DAS28-4[CRP]) < 3.2/ < 2.6.

RESULTS:

Overall, 272/232 patients were included in CV+ /CV- cohorts (full analysis set) (435/356 patient-years [safety analysis set]). Incidence rates (events/100 patient-years) in CV+ /CV- cohorts were 138.5/112.5 for treatment-emergent adverse events (AEs); 17.0/5.6 for serious AEs; 1.2/0.3 for deaths; 5.5/1.7 for serious infections; 1.4/1.1 for herpes zoster; 1.6/0.0 for MACE; 2.1/0.3 for malignancies (excluding NMSC); 0.7/0.6 for NMSC; 0.5/0.0 for venous thromboembolic events. Persistence was generally comparable between cohorts. In CV+ /CV- cohorts, at M6, CDAI LDA and remission rates were 51.5%/54.6% and 12.0%/19.6%; DAS28-4(CRP) < 3.2/ < 2.6 rates were 44.0%/39.3% and 31.5%/28.8%, respectively; effectiveness was generally maintained to M18.

CONCLUSIONS:

In concordance with studies of background risk, AEs were more common in patients with CV risk enrichment, particularly those aged ≥ 65 years. Tofacitinib effectiveness/persistence were generally similar regardless of CV risk enrichment. These findings support individualised treatment benefit-risk assessment, including CV assessment/management, to optimise RA outcomes.

01 Dec 2024·Rheumatology and Therapy

Early Improvements with Guselkumab Associate with Sustained Control of Psoriatic Arthritis: Post hoc Analyses of Two Phase 3 Trials

Article

Author: Shawi, May ; Curtis, Jeffrey R ; Deodhar, Atul ; Curtis, Jeffrey R. ; Tillett, William ; Soriano, Enrique R. ; Gladman, Dafna D ; Gladman, Dafna D. ; Soriano, Enrique R ; Shiff, Natalie J ; Han, Chenglong ; Shiff, Natalie J. ; Rampakakis, Emmanouil

INTRODUCTION:

Patterns of treatment response can inform clinical decision-making. This study assessed the course and impact of achieving minimal clinically important improvement (MCII) in clinical measures and patient-reported outcomes (PROs) with guselkumab in patients with active psoriatic arthritis (PsA).

METHODS:

Post hoc analyses evaluated 1120 patients with PsA receiving guselkumab every 4 or 8 weeks (Q4W/Q8W) or placebo from DISCOVER-1 (31% tumor necrosis factor inhibitor-experienced) and DISCOVER-2 (biologic-naïve). Achievement of MCII in clinical Disease Activity Index for PsA (cDAPSA), patient global assessment (PtGA) of arthritis, PtGA of psoriasis, patient-reported pain, Functional Assessment of Chronic Illness Therapy-Fatigue, Health Assessment Questionnaire-Disability Index, 36-item Short-Form Health Survey Physical Component Summary score, PtGA Arthritis + Psoriasis, and PsA Disease Activity Score (PASDAS) was compared between the guselkumab and placebo groups using Cox regression. Logistic regression adjusting for baseline factors evaluated associations between early (W4/W8) MCII achievement and stringent response (≥%50/%70 improvement in American College of Rheumatology response criteria, cDAPSA low disease activity [LDA], PASDAS LDA, and minimal disease activity) at W24/W52 among guselkumab-randomized patients.

RESULTS:

Among patients with highly active PsA (baseline cDAPSA = 44.1-45.0, PASDAS = 6.4-6.5), times to MCII were significantly faster for guselkumab vs. placebo (hazard ratios 1.3-2.5; P < 0.05). Across measures, at first timepoint assessed, MCII rates were significantly higher with guselkumab (Q4W/Q8W 28-68%/29-65%) vs. placebo (19-47%; both P < 0.05). Early (W4/W8) MCII with guselkumab associated with higher odds of achieving stringent responses at W24/W52 (odds ratios 1.4-17.2/1.4-5.4).

CONCLUSIONS:

In a mixed PsA population, significant proportions of patients treated with guselkumab achieved early (W4/W8) MCII across clinical and PRO measures, which associated with a higher likelihood of attaining clinically relevant improvements and low levels of disease activity at W24/W52.

TRIAL REGISTRATION:

DISCOVER-1 (NCT03162796). DISCOVER-2 (NCT03158285).

01 Aug 2024·CLINICAL RHEUMATOLOGY

Durable control of psoriatic arthritis with guselkumab across domains and patient characteristics: post hoc analysis of a phase 3 study

Article

Author: Schiopu, Elena ; Deodhar, Atul ; Shawi, May ; Merola, Joseph F ; McInnes, Iain B ; Ritchlin, Christopher T ; Boehncke, Wolf-Henning ; Rampakakis, Emmanouil ; Chakravarty, Soumya D ; Mease, Philip J ; Tesser, John

Abstract:

Objectives:

Evaluate patterns of stringent disease control with 2 years of guselkumab across key disease-identified domains and patient-reported outcomes (PROs) in subgroups of patients with psoriatic arthritis (PsA) defined by baseline characteristics.

Method:

This post hoc analysis of DISCOVER-2 (Clinicaltrials.gov NCT03158285) evaluated biologic-naïve PsA patients (≥ 5 swollen/ ≥ 5 tender joints, C-reactive protein [CRP] ≥ 0.6 mg/dL) randomized to guselkumab every 4 weeks (Q4W); guselkumab at Weeks 0 and 4, then Q8W; or placebo with crossover to guselkumab Q4W at Week 24. Achievement of American College of Rheumatology 50/70% improvement (ACR50/70), Investigator’s Global Assessment (IGA) 0, dactylitis/enthesitis resolution, Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue response (≥ 4-point improvement), HAQ-Disability Index (HAQ-DI) response (≥ 0.35-point improvement), PsA Disease Activity Score (PASDAS) low disease activity (LDA), and minimal disease activity (MDA) was assessed at Weeks 24, 52, and 100 in subgroups defined by sex and baseline medication use, body mass index, PsA duration, swollen/tender joints, CRP, and psoriasis severity/extent. Patients with missing categorical response data were considered nonresponders.

Results:

442/493 (90%) guselkumab-randomized patients completed treatment through Week 100. Significant multi-domain efficacy of guselkumab versus placebo was shown across adequately sized patient subgroups. A pattern of continuous improvement was observed across key PsA domains and PROs within patient subgroups: 65%–85% of guselkumab-randomized patients had enthesitis/dactylitis resolution, 50%–70% achieved complete skin clearance, 60%–80% reported meaningful improvements in function/fatigue, 40%–65% achieved PASDAS LDA, and 35%–50% achieved MDA at Week 100.

Conclusion:

Patients with active PsA receiving guselkumab demonstrated durable achievement of stringent endpoints associated with disease control across key PsA domains and PROs, regardless of baseline characteristics. Key Points• Among biologic-naïve patients with highly active psoriatic arthritis (PsA), efficacy of guselkumab across stringent disease endpoints and patient-reported outcomes (PROs) at Week 24 was consistent regardless of baseline demographics and disease characteristics.• Within guselkumab-randomized PsA patient subgroups, major improvements in joint disease activity, complete skin clearance, dactylitis/enthesitis resolution, clinically meaningful improvements in PROs, and achievement of low overall disease activity were maintained through Week 100.• Durable stringent endpoint achievement indicating disease control was observed with guselkumab, regardless of baseline patient or disease characteristics.

Graphical Abstract:

News (Medical) associated with JSS Medical Research, Inc.

15 Nov 2023

·www.prnewswire.com

Drug Delivery Collaboration and Licensing Analysis Report 2023 with Directory of 1,551 Deals Signed Since 2016

DUBLIN, Nov. 14, 2023 /PRNewswire/ -- The "Drug Delivery Collaboration and Licensing Deals 2016-2023" report has been added to ResearchAndMarkets.com's offering. Drug Delivery Collaboration and Licensing Deals provides a comprehensive understanding and unprecedented access to the drug delivery deals entered into by the worlds leading biopharma companies. This report contains a comprehensive listing of 1551 drug delivery deals announced since 2016 including financial terms where available including links to online deal records of actual drug delivery partnering deals as disclosed by the deal parties. Fully revised and updated, the report provides details of drug delivery deals from 2016 to 2023. The report provides a detailed understanding and analysis of how and why companies enter drug delivery deals. These deals tend to be multicomponent, starting with collaborative R&D, and commercialization of outcomes. The report includes collaboration, development, research and licensing deals. In addition, where available, records include contract documents as submitted to the Securities Exchange Commission by companies and their partners. The initial chapters of this report provide an orientation of drug delivery dealmaking. The report also includes numerous table and figures that illustrate the trends and activities in drug delivery deal making since 2016. In addition, a comprehensive deal directory is provided organized by company A-Z, deal type and therapeutic target. Each deal title links via Weblink to an online version of the deal record and where available, the contract document, providing easy access to each contract document on demand. Key benefits Understand deal trends since 2016 Browse drug delivery collaboration and licensing deals Benchmark analysis - identify market value of transactions Financials terms - upfront, milestone, royalties Directory of deals by company A-Z, deal type and therapy area Leading deals by value Most active dealmakers Identify assets and deal terms for each transaction Access contract documents - insights into deal structures Due diligence - assess suitability of your proposed deal terms for partner companies Save hundreds of hours of research time Analyzing contract agreements allows due diligence of: What are the precise rights granted or optioned? What is actually granted by the agreement to the partner company? What exclusivity is granted? What is the payment structure for the deal? How are sales and payments audited? What is the deal term? How are the key terms of the agreement defined? How are IPRs handled and owned? Who is responsible for commercialization? Who is responsible for development, supply, and manufacture? How is confidentiality and publication managed? How are disputes to be resolved? Under what conditions can the deal be terminated? What happens when there is a change of ownership? What sublicensing and subcontracting provisions have been agreed? Which boilerplate clauses does the company insist upon? Which boilerplate clauses appear to differ from partner to partner or deal type to deal type? Which jurisdiction does the company insist upon for agreement law? Key Topics Covered: Executive Summary Chapter 1 - Introduction Chapter 2 - Trends in drug delivery dealmaking 2.1. Introduction 2.2. Drug delivery deals over the years 2.3. Most active drug delivery dealmakers 2.4. Drug delivery deals by deal type 2.5. Drug delivery deals by therapy area 2.6. Drug delivery deals by industry sector 2.7. Deal terms for drug delivery deals 2.7.1 Drug delivery deals headline values 2.7.2 Drug delivery deal upfront payments 2.7.3 Drug delivery deal milestone payments 2.7.4 Drug delivery royalty rates Chapter 3 - Leading drug delivery deals 3.1. Introduction 3.2. Top drug delivery deals by value Chapter 4 - Most active drug delivery dealmakers 4.1. Introduction 4.2. Most active drug delivery dealmakers 4.3. Most active drug delivery deals company profiles Chapter 5 - Drug delivery contracts dealmaking directory 5.1. Introduction 5.2. Drug delivery contracts dealmaking directory Chapter 6 - Drug delivery dealmaking by technology type Deal directory Deal directory - Drug delivery deals by company A-Z Deal directory - Drug delivery deals by deal type Deal directory - Drug delivery deals by therapy area Companies Mentioned Delta 9 Cannabis Korea Advanced Institute of Science and Technology STADA Arzneimittel TFB & Associates Imbed Bio Sesen Bio Motif Bio Avior Bio Tetra Bio-Pharma Helix BioPharma Carna BioSciences AMPEL BioSolutions Leads Biolabs Orbit Biomedical Proxy Biomedical Dance Biopharm NEMUS Bioscience Artes Biotechnology Tamir Biotechnology Juyou Biotechnology Small Business Innovation Research Auxly Cannabis Group North Carolina State University Magle Chemoswed LatAm Clinical Trials Eve & Co Aceto Corporation Green Cross LabCell Nitto Denko Kwang Dong Pharmaceutical Rapid Dose Therapeutics Fidia Farmaceutici Apsen Farmacutica Grupo Ferrer Altus Formulation Aspen Global Eitan Group Clear Guide Medical Evero Health World Health Organization Bayer Healthcare For more information about this report visit About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends. Media Contact: Research and Markets Laura Wood, Senior Manager [email protected] For E.S.T Office Hours Call +1-917-300-0470 For U.S./CAN Toll Free Call +1-800-526-8630 For GMT Office Hours Call +353-1-416-8900 U.S. Fax: 646-607-1907 Fax (outside U.S.): +353-1-481-1716 SOURCE Research and Markets

01 Jun 2007

·www.biospace.com

Neptune Technologies & Bioressources Inc. Business and Market Update

LAVAL, QC, May 31 /PRNewswire-FirstCall/ - Neptune Technologies and Bioressources Inc. ("Neptune") would like to update investors on recent developments and trading activity in Neptune's stock. There have been no material developments at the company, which would justify the recent stock price volatility. In Neptune's opinion, this volatility in the market can only be explained by market speculation. Neptune does not expect anything other than good news and soon. Update on Clinical Studies JSS Medical Research Inc. JSS Medical Research Inc., an independent Contract Research Organization (CRO), has completed studies entitled "Evaluation of the Effects of Neptune Krill Oil on the Clinical Course of Hyperlipidemia", "Neptune Krill Oil (NKO(TM)) Human Safety Assessment" and "Evaluation of the Effects of Neptune Krill Oil on the management of Premenstrual Syndrome and Dysmenorrhea". Additionally, Sciopsis Inc, a division of JSS that deals with biotechnology, conducted "Evaluation of the Effects of Neptune Krill Oil on Chronic Inflammation and Arthritic Symptoms". Dr. John Sampalis B.Sc, Hon-B.A, M.Sc, Ph.D., F.A.C.E, is the President of JSS Medical Research and is the brother of Dr. Tina Sampalis M.D., Ph.D, Ph.D. Neptune's V.P., Research/Business & Development. It is an important part of Neptune's strategy to have solid and credible clinical studies completed from the outset. "We chose JSS Medical Research to perform Neptune research based on the following facts: a) The undisputed credibility of Dr. John Sampalis, a clinical epidemiologist and tenured professor at McGill University, University of Montreal and University of Laval with numerous scholarships, awards and academic salary support from the Medical Research Council of Canada (currently CIHR) and FRSQ with over 80 publications in high ranking peer reviewed journals and over 20 million dollars in academic grants. The credibility and experience of this person was essential for us to ensure good clinical studies and the validity of these results" stated Mr Henri Harland, President and CEO of Neptune. "b) JSS Medical Research is one of the few CROs evaluated biannually by external independent auditors to ensure compliance with government regulation and clinical research ethics." Following the path of large and medium size biopharmaceutical companies, Neptune initiated safety and efficacy research similar in size and duration, fulfilling the requirements of Ethics Board approval at the given stage of clinical development. Data from small scale Phase II/IIIa clinical studies requires approval of an independent ethics committee alone and is used for the completion of the safety and efficacy submission to regulatory bodies such as FDA for NDI approval. "The clinical research performed by JSS for Neptune has already passed rigorous due diligence by governmental agencies and scientific personnel of international food and pharmaceutical giants with whom Neptune continues to negotiate strategic alliances being on line with commitments and timelines" added Mr. Harland. Update on Insider Trading Reports: On May 18th President and CEO Henri Harland ceased to be the sole trustee of his family trust and, as required by law, removed the 3,159,000 shares of Neptune from his insider profile. None of these 3,159,000 shares of Neptune were sold and they remain the property of the trust. Prior to the change, Mr. Harland was the sole trustee of the personal family trust. Upon the settling of the family trust, in April 1996, it was stipulated that when the youngest of his three children reached the age of 18, Mr. Harland would cease to be the controlling trustee. This change has resulted in the 3,159,000 shares of Neptune no longer being under the control of Mr. Harland and were accordingly removed from Mr. Harland's insider profile. "I wish to reassure our shareholders that I, as the founder of Neptune, and my family are invested for the long-term. Following the good clinical results from the past years, Neptune started receiving high levels of interest from major international food organizations and pharmaceuticals for the development of strategic alliances" stated Mr. Harland. "We have developed a unique business model and a cutting edge natural health ingredient that addresses some of the largest health concerns in the world today while we have also carefully designed a business plan and a strategic approach to maximize our shareholders' wealth. And given that my family and I are the largest shareholders, I am more than dedicated to it." added Mr. Harland. About Neptune Technologies & Bioressources Inc. Neptune Technologies & Bioressources Inc. develops high value added nutritional products from underexploited marine biomasses, such as krill, with its patented extraction process (Neptune OceanExtract(TM)). Using an exclusive process, Neptune Technologies & Bioressources Inc. is well positioned in the $182 billion global nutrition market (Nutrition Business Journal, Oct/Nov 2004) of health and wellness concepts. Natural biomass extraction is now playing an important role in developing nutrigenomics, the next wave in nutritional research. Through strategic alliances and partnerships, as well as through clinical studies, the Company continues to demonstrate the immense beneficial effects of these products. The Company develops and markets new formulas and new products for specific applications in high growth markets such the nutraceutical, cosmeceutical, biopharmaceutical and nutrigenomics markets. The TSX Venture Exchange does not accept responsibility for the adequacy or accuracy of this press release NEPTUNE TECHNOLOGIES & BIORESSOURCES INC. CONTACT: Neptune Technologies & Bioressources Inc., Andre Godin, V.PAdministration and Finance, a.godin@neptunebiotech.com, The Howard Group Inc., Grant Howard, David Gordon,Toll free: (888) 221-0915, info@howardgroupinc.com,

100 Deals associated with JSS Medical Research, Inc.

100 Translational Medicine associated with JSS Medical Research, Inc.

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