Intention-to-treat analysis

Tonix Pharmaceuticals Announces Results from a Preclinical Study of Murine TNX-1700 Presented in a Poster at the Keystone Symposia, “Cancer Immunotherapy: Mechanisms of Response Versus Resistance”

Retrieved on: 
Tuesday, March 7, 2023
Science, Cancer, Colorectal cancer, Poster, Serum albumin, Human, HSA, Conference, Research, Myeloid-derived suppressor cell, Tumor microenvironment, Neoplasm, Activation, Survival, MDSC, MSA, Colon, Intention-to-treat analysis, Vaccine, Tonix Pharmaceuticals

CHATHAM, N.J., March 07, 2023 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced that preclinical results of mTNX-1700 (recombinant murine TFF2-murine serum albumin, or MSA, fusion protein) were presented in a poster at the Keystone Symposia, “Cancer Immunotherapy: Mechanisms of Response Versus Resistance” on March 6, 2023, at the Fairmont Banff Springs Conference Center in Banff, Alberta, Canada. The poster can be found on the Scientific Presentations page of Tonix’s website.

Key Points: 
  • TNX-1700 targets myeloid-derived suppressor cells (MDSCs) which interfere with the immune response to cancer by suppressing the CD8+ T cell response and creating a toxic tumor microenvironment.
  • Tonix is developing TNX-1700 (recombinant human TFF2-human serum albumin or HSA) for the treatment of colon and gastric cancers.
  • “Anti-PD-1 treatment has revolutionized the treatment of other cancers and is known as immuno-oncology,” said Seth Lederman, M.D., Chief Executive Officer of Tonix.
  • In addition, it was shown that mTNX-1700 inhibits the MDSCs which contribute to the toxic element of the tumor microenvironment.

Biophytis announces positive final results of the phase 2-3 COVA study with Sarconeos (BIO101) in severe COVID-19

Retrieved on: 
Thursday, February 2, 2023
Disease, News, Euronext Growth, EAP, PP, Kaplan–Meier estimator, CET, American Thoracic Society, Ageing, COVID-19, EUA, Intention-to-treat analysis, Trial of the century, Death, Safety, Risk, Vaccination, Severe acute respiratory syndrome coronavirus 2, CMA, ICU, Special access program, Therapy, Patient, ITT, Mortality, Male, Marketing authorisation, Protocol, Hypoxemia, Pharmaceutical industry

Biophytis announces today final results following the reintegration of data from 54 patients, among 233 patients treated, that were missing in the Top Line analysis released on September 7, 2022.

Key Points: 
  • Biophytis announces today final results following the reintegration of data from 54 patients, among 233 patients treated, that were missing in the Top Line analysis released on September 7, 2022.
  • Stanislas Veillet, CEO of Biophytis, said: " The COVA study is positive, with a statistically significant reduction of 44% in the risk of respiratory failure or early death, demonstrating the therapeutic potential of Sarconeos (BIO101) in the treatment of severe COVID-19.
  • This huge success is the result of Biophytis scientific excellence and hard work of the clinical and medical teams involved in the COVA clinical study in France, Belgium, the USA and in Brazil.
  • Biophytis is now initiating key regulatory activities to give access to Sarconeos (BIO101) to hospitalized patients with severe COVID-19 at risk of respiratory failure and death in 2023.

Evofem Reports Top-Line Results from Phase 3 EVOGUARD Clinical Trial Evaluating EVO100 for Prevention of Chlamydia and Gonorrhea Infection in Women

Retrieved on: 
Wednesday, October 12, 2022
SAN, Reproductive health, STI, SEC, Mitt, Growth, Population, VP, Woman, Infection, COVID, Annual report, Gonorrhea, Citric acid, GC, Chlamydia, Risk, Intention-to-treat analysis, Private Securities Litigation Reform Act, Obstetrics, CT, Lactic acid, Sex, Trial of the century, Company, Martin PBM Mariner, Acquisition, MD, Research, Securities Exchange Act of 1934, CRO, Clinical trial, Environment, Fertility, FDA, COVID-19, OTCQB, Prescription, FACOG, Pharmaceutical industry, Birth control, Biostatistics

SAN DIEGO, Oct. 11, 2022 /PRNewswire/ -- Evofem Biosciences, Inc. (OTCQB: EVFM) announced today that the recently completed Phase 3 EVOGUARD clinical trial evaluating EVO100 for the prevention of chlamydia and gonorrhea infection in women did not achieve its endpoints.

Key Points: 
  • SAN DIEGO, Oct. 11, 2022 /PRNewswire/ -- Evofem Biosciences, Inc. (OTCQB: EVFM) announced today that the recently completed Phase 3 EVOGUARD clinical trial evaluating EVO100 for the prevention of chlamydia and gonorrhea infection in women did not achieve its endpoints.
  • "We are disappointed that EVO100 did not achieve the desired outcome in this STI clinical trial, despite the data observed in our prior study," said Saundra Pelletier, Chief Executive Officer of Evofem.
  • "As clinical study lead for the Phase 2b/3 AMPREVENCE STI trial and the Phase 3 EVOGUARD trial, I believe the study environment changed significantly from the AMPREVENCE trial to the EVOGUARD trial, specifically subject risk behaviors as well as site and CRO turnover.
  • The EVOGUARD trial was a Phase 3, double-blind, placebo-controlled efficacy trial of Phexxi vaginal gel for the prevention of urogenitalChlamydia trachomatis(CT) andNeisseria gonorrhoeae(GC) infection.

Alphageneron to Participate in Cell Therapy Durability Response Summit

Retrieved on: 
Wednesday, August 17, 2022
Woman, JD, CAR, Cell, GLOBE, Standard of care, Cancer, American Society of Clinical Oncology, Antibody-drug conjugate, Toxicity, Clinical trial, NK, Potency (pharmacology), Lung cancer, NSCLC, Man, Endpoint security, Patient, CBR, Companion diagnostic, Large-cell lung carcinoma, Company, Control, Partial-response maximum-likelihood, Safety, SOC, Treatment of lung cancer, Intention-to-treat analysis, Private Securities Litigation Reform Act, CR, Liquid biopsy, Engagers, Exosome, Disease, Pharmaceutical industry, Vaccine

CAMBRIDGE, Mass., Aug. 17, 2022 (GLOBE NEWSWIRE) -- Alphageneron Pharmaceuticals, Inc. (Alphageneron or the Company), a clinical stage pharmaceutical company developing a diverse platform of cell and antibody-based therapeutic candidates to treat cancer, announced today that their Chief Executive Officer, Robert K. Brooks, JD, will participate in the Cell Therapy Durability Response Summit that will be held August 22-23, 2022.

Key Points: 
  • CAMBRIDGE, Mass., Aug. 17, 2022 (GLOBE NEWSWIRE) -- Alphageneron Pharmaceuticals, Inc. (Alphageneron or the Company), a clinical stage pharmaceutical company developing a diverse platform of cell and antibody-based therapeutic candidates to treat cancer, announced today that their Chief Executive Officer, Robert K. Brooks, JD, will participate in the Cell Therapy Durability Response Summit that will be held August 22-23, 2022.
  • Membrane Hsp70 (mHsp70) is a cancer biomarker, highly expressed on the cellular membrane of a wide range of cancers, not on normal cells.
  • ENKASTIM is an autologous cell therapy that activates the patients NK cells to kill cancer cells.
  • A prior Phase IIa (randomized, controlled) clinical trial involving fourteen (14) patients with advanced (Stage IIIb) inoperable NSCLC was conducted.

COPAXONE® Label Now Indicates Its Use in Breastfeeding Mothers with Relapsing Multiple Sclerosis

Retrieved on: 
Thursday, February 10, 2022
Biotechnology, Pharmaceutical, Health, Clinical Trials, Private Securities Litigation Reform Act, Pain, Growth, Woman, Safety, Master of Science, NYSE, MS, RMS, All European Academies, Pregnancy, Glatiramer acetate, Neurology, Department, TEVA, Intention-to-treat analysis, Teva Pharmaceuticals, DOI, EAN, Research, Multiple sclerosis, Frequency, Teva, Failure, MD, TASE, Mother, Medication package insert, Incidence, Pregnancy rate, Chest pain, Patient, Review, Epidemiology, Doctor of Science, Travel, Flushing, BA, COVID-19, Department of Neurology, Xuanwu hospital, Itch, Rash, Investment, Annual report, Human, HIV disease progression rates, GA, Diagnosis, Compliance, MS1, Congress, COBRA, Swelling, Forward-looking statement, Medical device, Birth control, Pharmaceutical industry, EU, the COBRA Study, COPAXONE®, COPAXONE®, Teva, THE COBRA STUDY, COPAXONE®, COPAXONE®, TEVA

The COPAXONE label change provides breastfeeding patients with MS the choice to breastfeed while on MS treatment.

Key Points: 
  • The COPAXONE label change provides breastfeeding patients with MS the choice to breastfeed while on MS treatment.
  • Real-world safety of COPAXONE in Offspring of Breastfeeding and Treated Relapsing Multiple Sclerosis (RMS) patients (COBRA study) was retrospective data analysis using the national German Multiple Sclerosis and Pregnancy Registry.
  • COPAXONE (Glatiramer Acetate injection) is indicated for the treatment of patients with relapsing forms of multiple sclerosis.
  • New Safety Data on treatment with COPAXONE (glatiramer acetate) of Breastfeeding Mothers who Live with Relapsing Multiple Sclerosis: COBRA study presented at the 7th Congress of the European Academy of Neurology (EAN).

New Safety Data on treatment with COPAXONE® (glatiramer acetate) of Breastfeeding Mothers who Live with Relapsing Multiple Sclerosis

Retrieved on: 
Wednesday, October 13, 2021
Biotechnology, Pharmaceutical, Health, Clinical Trials, Meta-analysis, Teva, Flushing, Mother, DMT, DMTS, Itch, Management of multiple sclerosis, EAN, NYSE, Patient, Incidence, Hospital, RMS, COVID-19, MS, Physician, GA, Growth, Child, Human, Multiple sclerosis, Woman, Rash, Teva Pharmaceuticals, TEVA, TASE, Disease, Travel, Pain, Failure, Chest pain, Annual report, Investment, Intention-to-treat analysis, Frequency, Private Securities Litigation Reform Act, Forward-looking statement, Live birth, Data, Pregnancy, Thought, Breastfeeding, Compliance, COBRA, Glatiramer acetate, Swelling, Birth control, Frankincense, Pharmaceutical industry, the Study, COPAXONE®, Teva, THE STUDY, COPAXONE®, TEVA

There is historically limited clinical safety data for infants who are breastfed by mothers undergoing treatment for MS including during the pregnancy period.

Key Points: 
  • There is historically limited clinical safety data for infants who are breastfed by mothers undergoing treatment for MS including during the pregnancy period.
  • Patients were eligible for the study if they were diagnosed with relapsing MS (RMS), gave a live birth, were breastfeeding under GA treatment (COPAXONE 20 or 40 mg/mL) or breastfeeding under no DMT treatment.
  • Al, Safety analysis of offspring breastfed by mothers on glatiramer acetate therapy for relapsing multiple sclerosis; presented at EAN 2021.
  • Real-world safety of Copaxone in Offspring of Breastfeeding and Treated Relapsing Multiple Sclerosis (RMS) pAtients (COBRA study) is a retrospective data analysis using data of the German Multiple Sclerosis and Pregnancy Registry.

Rafael Pharmaceuticals Announces Positive Preplanned Interim Futility Analysis of Pivotal Phase 3 Trial (ARMADA 2000) of CPI-613® (Devimistat) for Relapsed or Refractory Acute Myeloid Leukemia (AML)

Retrieved on: 
Thursday, July 1, 2021
Health sciences, Clinical research, Medical research, Health, Clinical trials, Medical statistics, Devimistat, Thioethers, Futility, Intention-to-treat analysis

25 and based on the 142 within the intention to treat population, the trial was determined to be non-futile.

Key Points: 
  • 25 and based on the 142 within the intention to treat population, the trial was determined to be non-futile.
  • The findings from this interim futility analysis further solidify the potential that devimistat holds in safely and effectively treating AML and other hard-to-treat cancers, said Sanjeev Luther, President and CEO of Rafael Pharmaceuticals.
  • As we continue to advance devimistat through clinical trials, we remain hopeful for the cancer community.
  • The business and operations of the company are subject to substantial risks which increase the uncertainty inherent in forward-looking statements.

Cerecor Announces CERC-002 Significantly Reduced Respiratory Failure and Mortality in Phase 2 Clinical Trial in Patients Hospitalized with COVID-19 ARDS

Retrieved on: 
Tuesday, March 2, 2021
Medical specialties, Medicine, Respiratory diseases, Clinical trials, Acute respiratory distress syndrome, Intensive care medicine, Respiratory physiology, Respiratory distress syndrome, Ards, Intention-to-treat analysis, Coronavirus disease, Proning

All patients in this trial were hospitalized with COVID-19 associated pneumonia and mild-to-moderate acute respiratory distress syndrome (ARDS).

Key Points: 
  • All patients in this trial were hospitalized with COVID-19 associated pneumonia and mild-to-moderate acute respiratory distress syndrome (ARDS).
  • Due to the protocol allowing patients to receive high flow oxygen prior to randomization, 62 patients were included in the intention-to-treat (ITT) analysis of the primary endpoint.
  • At both the 28-day and the 60-day final timepoints, an approximately 50% trend in mortality reduction (22.5% vs 10.8%) was observed.
  • No drug-related serious adverse effects (SAEs) were reported in the trial, and there was no increase in infections in CERC-002 treated patients.

Ortho Dermatologics Announces Publication Of Pivotal Phase 3 Data On ARAZLO™ (tazarotene) Lotion, 0.045% In The Journal Of Drugs In Dermatology (JDD)

Retrieved on: 
Monday, January 13, 2020
Health, Clinical research, Medicine, Articles, Clinical trials, RTT, Breastfeeding, Placebo, Intention-to-treat analysis, Lotion, Dermatitis, Nipple

Patients were randomized to receive ARAZLO or placebo lotion, and all patients who were provided the study drug were included in the intent-to-treat (ITT) population.

Key Points: 
  • Patients were randomized to receive ARAZLO or placebo lotion, and all patients who were provided the study drug were included in the intent-to-treat (ITT) population.
  • It is not known if ARAZLO is safe and effective in children under 9 years of age.
  • Before using ARAZLO, tell your healthcare provider about all your medical conditions, including if you:
    have eczema or any other skin problems.
  • Do not apply ARAZLO directly to the nipple and surrounding area to avoid exposing your child to the medicine.

Celgene Updated Analysis of JAKARTA2 Fedratinib Study Shows Clinically Meaningful Responses in Patients Previously Treated for Myelofibrosis with Ruxolitinib

Retrieved on: 
Monday, June 3, 2019
Health, Biotechnology, Clinical trials, Oncology, Chemical compounds, Chemistry, Organic compounds, Nitriles, Pyrazoles, Cyclopentanes, Ruxolitinib, Pyrimidines, Celgene, Myelofibrosis, Intention-to-treat analysis, Fedratinib

Celgene Corporation (NASDAQ: CELG) announced an updated analysis of data from the Phase 2 JAKARTA2 clinical study demonstrating clinically meaningful response rates with investigational fedratinib in patients with myelofibrosis previously treated with ruxolitinib.

Key Points: 
  • Celgene Corporation (NASDAQ: CELG) announced an updated analysis of data from the Phase 2 JAKARTA2 clinical study demonstrating clinically meaningful response rates with investigational fedratinib in patients with myelofibrosis previously treated with ruxolitinib.
  • This updated analysis of fedratinib employed intent-to-treat (ITT) principles and utilized a narrower definition of ruxolitinib relapsed, refractory, or intolerant patients.
  • These updated results show meaningful reductions in spleen volume and symptoms and reinforce the potential of fedratinib in these difficult-to-treat patients who no longer receive benefit from ruxolitinib.
  • Fedratinib has the potential to be the first new treatment option since 2011 for patients with myelofibrosis, said Dr. Alise Reicin, President, Global Clinical Development, for Celgene.