Tag: Presentations

Lipocine Announces Presentations at the 21st Annual Fall Meeting of the Sexual Medicine Society of North America

SALT LAKE CITY, Oct. 14, 2020 /PRNewswire/ — Lipocine Inc. (NASDAQ: LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, today announced it will present results from studies suggesting that low testosterone levels may play an important role on the clinical outcomes of COVID-19 in men as well as the safety and efficacy of TLANDO™, an oral testosterone replacement therapy without a dose titration requirement, at the 21st Annual Fall Scientific Meeting of the Sexual Medicine Society of North America (“SMSNA”). Lipocine will outline the possible mechanisms and clinical evidence that suggests men with low testosterone have poor COVID-19 outcomes, and the rationale of using an oral testosterone therapy for men with COVID-19. Results from the previously completed dose validation (“DV”) study of a fixed dose TLANDO in hypogonadal males will also be presented at the meeting.  The presentations will take place virtually on November 9, 2020 from 7:00 p.m.9:00 p.m. EST during Session 2 (Androgens and Ejaculation/Orgasm Disorders). 

https://www.smsna.org/V1/2020/program/scientific-program?where_person=44
https://www.smsna.org/V1/2020/program/scientific-program?where_person=42

“We know that while COVID-19 infection rates are comparable between men and women, men are developing severe symptoms and dying at a significant higher rate than women. Furthermore, men with comorbidities commonly associated with lower testosterone are at greater risk for severe disease and death,” said Dr. Mahesh Patel, Chairman, President and CEO of Lipocine Inc.  “The presentation on COVID-19 highlight key clinical evidences suggesting that low testosterone levels may play an important role on the clinical outcomes of COVID-19 in men. Based on the published data, the use of oral testosterone with the goal of achieving physiological testosterone levels should be evaluated in clinical trials of COVID-19.”

Dr. Anthony DelConte, Chief Medical Director of Lipocine further stated, “TLANDO will be the first oral testosterone for treatment hypogonadism without titration requirement. It is expected to be easy to prescribe and use.” Dr. DelConte added, “The SMSNA presentation on TLANDO highlights the key safety and efficacy data from multiple clinical studies supporting TLANDO’s ability to effectively restore testosterone levels in hypogonadal men without need for any dose adjustment.”

Is Oral Testosterone a Potential Treatment for COVID-19 in Men? (Benjamin J. Bruno et al)

The authors performed a literature search to understand the possible mechanisms and clinical evidence concerning testosterone levels in COVID-19 patients.  A recent clinical study investigating testosterone levels in men with COVID-19 found 80% of men who died due to COVID-19 had low total or bioavailable testosterone levels at the time of hospital admission. Those with severe Acute Respiratory Distress Syndrome (“ARDS”) had acutely depressed total testosterone compared to patients who did not exhibit severe ARDS. The mean total testosterone levels for men who required invasive ventilation was 29 ng/dL (normal range ~300-1100 ng/dL), whereas those who were discharged from the ICU had mean total T of 254 ng/dL at the time of ICU admission.

In comparison to other routes of testosterone administration, oral testosterone therapy may be the most convenient and suitable for acute treatment of COVID-19 in

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Tricida Announces Twelve Data Presentations on Veverimer and Metabolic Acidosis to be Given at the Virtual American Society of Nephrology Kidney Week 2020

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Tricida, Inc. (Nasdaq: TCDA), a pharmaceutical company focused on the development and commercialization of its investigational drug candidate, veverimer (TRC101), a non-absorbed, orally-administered polymer designed to treat metabolic acidosis in patients with chronic kidney disease (CKD), announced today that it has authored or sponsored 12 presentations at the upcoming American Society of Nephrology (ASN) Kidney Week 2020 being held virtually October 22-25, 2020. Data to be presented at multiple sessions at the meeting will expand the breadth of information about the implications of metabolic acidosis and CKD. All Tricida presentations will be available on Thursday, October 22, 2020 at 10:00am ET. Session and presentation titles are listed below:

Session Title: CKD Risk Factors: Diet, Environment, Lifestyle

Title:

Relationship Between Metabolic Acidosis and Chronic Kidney Disease Progression is Evident Across United States Racial and Ethnic Groups

Author:

N. Tangri et al.

ePoster #:

PO0468

 

 

Title:

Metabolic Acidosis is Associated with Chronic Kidney Disease Progression: A Longitudinal Analysis of >100,000 United States Community-Based Patients

Author:

V. Mathur et al.

ePoster #:

PO0469

 

 

Title:

Metabolic Acidosis and Progression to Renal Replacement Therapy (Encore Presentation)

Author:

V. Mathur et al.

ePoster #:

PO0467

Session Title: Advances in Geriatric Nephrology

Title:

Effects of Veverimer on Serum Bicarbonate and Physical Function in Elderly Patients with Metabolic Acidosis in Chronic Kidney Disease

Author:

D. Wesson et al.

ePoster #:

PO1685

 

 

Title:

Correlation Between Patient-Reported Physical Limitation and Objective Physical Performance on the Repeated Chair Stand Test Among Patients with Non-Dialysis Dependent Chronic Kidney Disease and Metabolic Acidosis

Author:

V. Mathur et al.

ePoster #:

PO1687

Session Title: CVD, BP, and Kidney Diseases: Exploring the Link

Title:

No Adverse Effects of Veverimer on Volume Status or Blood Pressure in Patients with Chronic Kidney Disease and Metabolic Acidosis

Author:

D. Wesson et al.

ePoster #:

PO2116

Session Title: Women’s Health and Kidney Diseases

Title:

Effects of Veverimer on Serum Bicarbonate and Physical Function in Women with Chronic Kidney Disease: A Subgroup Analysis from a Randomized Controlled Trial

Author:

V. Mathur et al.

Session:

Women’s Health and Kidney Diseases

ePoster #:

PO2612

Session Title: Diabetic Kidney Disease: Clinical – 2

Title:

Effects of Veverimer on Serum Bicarbonate and Physical Function in Patients with Diabetes and Chronic Kidney Disease: Subgroup Analysis from a Randomized Trial (Encore presentation)

Author:

D. Wesson et al.

ePoster #:

PO1033

Session Title: Fluid, Electrolyte, and Acid-Base Disorders: Clinical – 2

Title:

Metabolic Acidosis is a Predictive Factor for All-Cause Mortality in Patients with Chronic Kidney Disease (Encore presentation)

Author:

N. Tangri et al.

ePoster #:

PO1483

Session Title: Pharmacology (PharmacoKinetics, -Dynamics, -Genomics)

Title:

Action of Veverimer on Gastrointestinal Acid Binding is Not Affected by Omeprazole

Author:

D. Parsell et al.

ePoster #:

PO2374

 

 

Title:

Evaluation of Veverimer Drug Interaction Potential (Encore presentation)

Author:

J. Shao et al.

ePoster #:

PO2373

Session Title: Informational Posters

Title:

Understanding the Long-Term Impact of Metabolic Acidosis in Chronic Kidney Disease: Design of the ULTIMA-CKD Patient Registry

Author:

V. Mathur et al.

ePoster #:

INFO16

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Endo Aesthetics Data to be Featured in Five Presentations at the American Society for Dermatologic Surgery’s Annual Meeting (ASDS)

DUBLIN, Oct. 9, 2020 /PRNewswire/ — Endo International plc (NASDAQ:ENDP) today announced that data relevant to the use of Endo Aesthetics’ Qwo™ (collagenase clostridium histolyticum-aaes) for the treatment of moderate to severe cellulite in the buttocks of adult women will be featured during the American Society for Dermatologic Surgery’s Annual Meeting (ASDS). These data will be highlighted in three posters and two oral presentations during the virtual meeting taking place October 9 – 11, 2020.

Oral Presentations

On Friday, October 9th a presentation titled “Results From a 1000+ Subject Survey Assessing Satisfaction With a Hypothetical 1-Point Improvement on the Validated Patient-Reported Photonumeric Cellulite Severity Scale (PR-PCSS) Analysis,” will be given by Sabrina Fabi, M.D., a board-certified dermatologist in California. Dr. Fabi will share results from a study designed to determine if a 1-point improvement in PR-PCSS score is a clinically meaningful outcome and will highlight the importance of patient education during consultations.

On Sunday, October 11th, Melanie Palm, M.D., will present “Real-World Effectiveness and Safety of Collagenase Clostridium Histolyticum-aaes Injections for the Treatment of Thigh Cellulite in Women: An Interim Analysis”. During this presentation, Dr. Palm, a board-certified dermatologist and cosmetic surgeon in California, will outline the 90-day findings from ongoing phase 3b REAL™ and PIXELS™ studies assessing not only investigator-perceived and patient-reported results at 90-days, but also the quantitative corroboration of these findings, with 3D-image scans.

Poster Presentations

All poster presentations will be available for ASDS attendees throughout the Congress.

  • Title: Long-Term Durability of Collagenase Clostridium Histolyticum-aaes Treatment Effectiveness for Cellulite in Women
  • Authors: Joely Janette Kaufman, M.D., Vernon Leroy Young, M.D., Matthew Zook, M.D., Saji Vijayan, MBBS, D.Diab., Michael McLane PhD., Xiang Q Ph.D., Chajko KA, Lawrence Bass, M.D.
     
  • Title: Patient Retention Strategies for Long-Term Extension Aesthetic Studies: Collagenase Clostridium Histolyticum-aaes (QWO™) Phase 3 Clinical Study Experience
    • Authors: Joely Janette Kaufman, M.D., James Clark M.D., Kappa Peddy, M.D., Alex Cazzaniga Ph.D., Davina Cupo, Robert Yon, Rosalie Filling
       
  • Title: A Survey of Dermatology Healthcare Professional Knowledge, Perception, and Experience Regarding Cellulite and Its Treatment
    • Authors: Jill Edgecombe, Daniel Connolly, Sherry Chen, Stephanie Wenstrup

    “We are pleased with the breadth and depth of the data that will be presented at the ASDS meeting,” said Matthew Davis, M.D., R.Ph., Senior Vice President and Chief Medical Officer of Endo. “Endo Aesthetics is committed to offering aesthetic healthcare providers data not only on the safety and efficacy of QWO, but also on the real world implications of this treatment, including patient retention and perceptions, as we prepare for the product’s launch in spring 2021.”

    INDICATION
    QWO is indicated for the treatment of moderate to severe cellulite in the buttocks of adult women.

    IMPORTANT SAFETY INFORMATION FOR QWO CONTRAINDICATIONS
    QWO is contraindicated in patients with a history of hypersensitivity to collagenase or to any of the excipients or the presence of infection at the injection sites.

    WARNINGS AND PRECAUTIONS
    Hypersensitivity Reactions
    Serious hypersensitivity

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    Rocket Pharmaceuticals Announces Two Presentations at the European Society for Immunodeficiencies 2020 Meeting

    Rocket Pharmaceuticals Announces Two Presentations at the European Society for Immunodeficiencies 2020 Meeting

    –Oral Presentation to Provide Update on Phase 1/2 Clinical Trial Data of RP-L201 for Leukocyte Adhesion Deficiency-I–

    –Poster Presentation to Highlight Preclinical Data on RP-L401 for Infantile Malignant Osteopetrosis–

    Rocket Pharmaceuticals, Inc. (NASDAQ: RCKT) (“Rocket”), a clinical-stage company advancing an integrated and sustainable pipeline of genetic therapies for rare childhood disorders, today announces two presentations at the European Society for Immunodeficiencies (ESID) 2020 Meeting to be held virtually October 14-17, 2020. An oral presentation will provide an update on data from the Phase 1/2 clinical trial of RP-L201 for Leukocyte Adhesion Deficiency-I (LAD-I). An e-poster will highlight preclinical study data on RP-L401 for Infantile Malignant Osteopetrosis (IMO).

    Additional presentation details can be found below:

    Oral Presentation

    Title: A Phase 1/2 Study of Lentiviral-Mediated Ex-Vivo Gene Therapy for Pediatric Patients with Severe Leukocyte Adhesion Deficiency-I (LAD-I): Results from Phase 1

    Session Title:
    Treatment

    Presenter: Donald B. Kohn, M.D., Professor of Microbiology, Immunology and Molecular Genetics, Pediatrics (Hematology/Oncology), Molecular and Medical Pharmacology, and member of the Eli and Edythe Broad Center of Regenerative Medicine and Stem Cell Research at the University of California, Los Angeles

    Session Date: Friday, October 16, 2020

    Session Time: 10:45 a.m. – 12:01 p.m. CEST

    Lecture Time: 11:45 a.m. CEST

    Location: Hall D

    This session will be followed by a Q&A from 12:01 p.m. to 12:30 p.m. CEST

    E-Poster

    Title: Preclinical Efficacy and Safety of EFS.HTCIRG1-LV Supports IMO Gene Therapy Clinical Trial Initiation

    Presenter: Ilana Moscatelli, Ph.D., Associate Researcher, Division of Molecular Medicine and Gene Therapy, Lund University, Sweden

    About Leukocyte Adhesion Deficiency-I

    Severe Leukocyte Adhesion Deficiency-I (LAD-I) is a rare, autosomal recessive pediatric disease caused by mutations in the ITGB2 gene encoding for the beta-2 integrin component CD18. CD18 is a key protein that facilitates leukocyte adhesion and extravasation from blood vessels to combat infections. As a result, children with severe LAD-I (less than 2% normal expression) are often affected immediately after birth. During infancy, they suffer from recurrent life-threatening bacterial and fungal infections that respond poorly to antibiotics and require frequent hospitalizations. Children who survive infancy experience recurrent severe infections including pneumonia, gingival ulcers, necrotic skin ulcers, and septicemia. Without a successful bone marrow transplant, mortality in patients with severe LAD-I is 60-75% prior to the age of 2 and survival beyond the age of 5 is uncommon. There is a high unmet medical need for patients with severe LAD-I.

    Rocket’s LAD-I research is made possible by a grant from the California Institute for Regenerative Medicine (Grant Number CLIN2-11480). The contents of this press release are solely the responsibility of Rocket and do not necessarily represent the official views of CIRM or any other Agency of the State of California.

    About Infantile Malignant Osteopetrosis

    Infantile Malignant Osteopetrosis (IMO) is a rare, severe autosomal recessive disorder caused by mutations in the TCIRG1 gene, which is critical for the process of bone resorption. Mutations in TCIRG1 interfere with the function of osteoclasts, cells which

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    Fulcrum Therapeutics Announces Multiple Presentations During the Virtual 25th International Congress of the World Muscle Society

    CAMBRIDGE, Mass., Oct. 01, 2020 (GLOBE NEWSWIRE) — Fulcrum Therapeutics, Inc. (Nasdaq: FULC), a clinical-stage biopharmaceutical company focused on improving the lives of patients with genetically defined rare diseases, today announced it will present multiple posters on the company’s ongoing studies in patients with facioscapulohumeral muscular dystrophy (FSHD) during the 25th International Congress of the World Muscle Society.

    “FSHD is a serious and debilitating disease for which there are currently no approved therapies,” said Diego Cadavid, MD, Fulcrum’s senior vice president, clinical development. “We are pleased to share these data at this important scientific meeting as we continue to pursue losmapimod as a potential treatment for FSHD by addressing the root cause of the disease. We greatly appreciate the patients who have participated in our trials and the support we have received from key opinion leaders and investigators.”

    During the Virtual Poster Session today, October 1, 2020 from 12:30pm – 2:30pm ET, Fulcrum will present four posters on its integrated approach to the evaluation of FSHD patients, highlighting the progress made in the development of imaging and molecular biomarkers in FSHD and the design of clinical trials to evaluate potential benefits of losmapimod in FSHD patients:

    • Development and Evaluation of a Whole-body MRI Protocol and Analysis Algorithms to Measure Changes in Skeletal Muscle in FSHD

    • A Biomarker of Aberrant DUX4 Activity to Evaluate Losmapimod Treatment Effect in FSHD Phase 2 Trials

    • Open-Label Pilot Study of Losmapimod in FSHD1 (NCT04004000)

    • A Phase 2, Randomized, Placebo-Controlled, 48-Week Study of the Efficacy and Safety of Losmapimod in Treating Subjects with FSHD: ReDUX4 (NCT04003974) Interim Analysis

    The poster sessions will be available to registered conference attendees. The posters will also be made available in the “Publications” section of fulcrumtx.com.

    About FSHD
    FSHD is characterized by progressive skeletal muscle loss that initially causes weakness in muscles in the face, shoulders, arms and trunk, and progresses to weakness throughout the lower body. Skeletal muscle weakness results in significant physical limitations, including an inability to smile and difficulty using arms for activities, with many patients ultimately becoming dependent upon the use of a wheelchair for daily mobility.

    FSHD is caused by mis-expression of DUX4 in skeletal muscle, resulting in the presence of DUX4 proteins that are toxic to muscle tissue. Normally, DUX4-driven gene expression is limited to early embryonic development, after which time the DUX4 gene is silenced. In people with FSHD, the DUX4 gene is turned “on” as a result of a genetic mutation. The result is death of muscle and its replacement by fat, leading to skeletal muscle weakness and progressive disability. There are no approved therapies for FSHD, one of the most common forms of muscular dystrophy, with an estimated patient population of 16,000 to 38,000 in the United States alone.

    About Losmapimod
    Losmapimod is a selective p38α/β mitogen activated protein kinase (MAPK) inhibitor that was exclusively in-licensed from GSK by Fulcrum Therapeutics following Fulcrum’s discovery of the role of p38α/β inhibitors in the reduction of DUX4 expression and an extensive

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