Design of experiments

MindMed Announces Initiation of Phase 1 Clinical Trial of Intravenous DMT

Retrieved on: 
Wednesday, July 28, 2021
Entheogens, Health sciences, Amines, Health, Ayahuasca, Clinical research, N,N-Dimethyltryptamine, Drug discovery, Design of experiments, Clinical trial, MindMed

The outcome of this Phase 1 clinical trial is expected to facilitate potential future Phase 2 clinical trials of DMT in patients.

Key Points: 
  • The outcome of this Phase 1 clinical trial is expected to facilitate potential future Phase 2 clinical trials of DMT in patients.
  • The Phase 1 clinical trial has received all necessary regulatory approvals in Switzerland and subject enrollment has been initiated.
  • MindMed plans to study an intravenous administration method [during its Phase 1 clinical trial] that would induce a stable and prolonged DMT experience.
  • Forward-looking information in this news release include, but are not limited to, statements regarding the start of MindMed's Phase 1 clinical trial of DMT, the successful outcome of the Phase 1 clinical trial, the ability to initiate a Phase 2 clinical trial of DMT, regulatory approvals, the effects of DMT, subject enrollment and the administration method of DMT.

MediWound Announces Positive Outcome of Interim Assessment for its EscharEx U.S. Phase 2 Adaptive Design Study

Retrieved on: 
Wednesday, July 28, 2021
Design of experiments, Clinical trials, Health sciences, Science, Health, Clinical research, Medical statistics, Drugs, Clinical study design, Adaptive design, Placebo-controlled study, COVID-19 vaccine

YAVNE, Israel, July 28, 2021 (GLOBE NEWSWIRE) -- MediWound Ltd. (Nasdaq: MDWD), a fully-integrated biopharmaceutical company focused on next-generation biotherapeutic solutions for tissue repair and regeneration, today announced a positive outcome from a planned interim sample size re-estimation of its ongoing EscharEx® U.S. phase 2 adaptive design study for the treatment of venous leg ulcers (VLUs), designed to assess the safety and efficacy of EscharEx compared to gel vehicle (placebo control) and non-surgical standard-of-care (either enzymatic or autolytic debridement).

Key Points: 
  • "We are very pleased with the IDMC's recommendation to continue the EscharEx study as originally planned without modifying the study sample size, said Sharon Malka, Chief Executive Officer of MediWound.
  • The multicenter, prospective, randomized, placebo-controlled, adaptive design study, evaluating the safety and efficacy of EscharEx in debridement of VLUs.
  • The study includes a pre-defined interim assessment for futility and potential sample size adjustment.
  • EscharEx is an investigational product, currently under a U.S. phase 2 adaptive design study.

Optimi Health Strengthens Clinical and Regulatory Expertise

Retrieved on: 
Tuesday, July 27, 2021
Health sciences, Health, Medical research, Clinical research, Pharmaceutical industry, Design of experiments, Food and Drug Administration, Drug discovery, Clinical trials

Mr. Simon stated, Working on the Optimi project is an exciting opportunity to help people with unmet medical needs.

Key Points: 
  • Mr. Simon stated, Working on the Optimi project is an exciting opportunity to help people with unmet medical needs.
  • The IMPACT team is aiming for a clinical trial that meets international standards and this is the sort of goal I find compelling.
  • His clinical trial experience includes advanced studies for therapeutic cancer vaccines, as well as numerous projects supporting clinical trials for drugs, natural health products and medical devices.
  • The IMPACT program provides Optimi expert clinical support towards commercializing proposed psilocybin-based formulations through the conduct of clinical trials and expert assistance towards securing regulatory approval.

Patients Rate their Clinical Trial Experience Positively, but Trial Locations Still Pose Barriers to Enrollment

Retrieved on: 
Tuesday, July 27, 2021
Health sciences, Health, Clinical research, Clinical trials, Medical research, Pharmaceutical industry, Design of experiments, Patient participation, Patient recruitment

Our study found that individuals are generally pleased with their clinical trial experience, but organizers could benefit from working more closely with physicians and being strategic about trial locations to boost enrollment and increase accessibility.

Key Points: 
  • Our study found that individuals are generally pleased with their clinical trial experience, but organizers could benefit from working more closely with physicians and being strategic about trial locations to boost enrollment and increase accessibility.
  • Considering the patient experience in the design of clinical trials is essential, said Pam Cusick, Senior Vice President of Rare Patient Voice.
  • Even though personal physicians may not be directly involved in ongoing clinical trials, they do drive the majority of patient enrollment.
  • According to the survey, nearly half (48%) of respondents who had participated in a clinical trial found out about the trial through their physician.

Relmada Therapeutics Announces Top-Line Results of Study Evaluating REL-1017 vs Oxycodone for Abuse Potential

Retrieved on: 
Tuesday, July 27, 2021
Drugs, Health care, Health sciences, Morphinans, Euphoriants, Drug culture, Oxycodone, Clinical research, Design of experiments, Clinical trial, Medroxyprogesterone acetate

The study comparing REL-1017 to oxycodone is the first of two clinical trials to assess abuse potential per FDA guidance as part of the planned REL-1017 NDA for the treatment of MDD.

Key Points: 
  • The study comparing REL-1017 to oxycodone is the first of two clinical trials to assess abuse potential per FDA guidance as part of the planned REL-1017 NDA for the treatment of MDD.
  • The scheduling of a drug depends on the analysis of several parameters (receptor studies, animal studies, human studies, history of abuse).
  • Oxycodone, the active control, was administered at the dose of 40 mg, a standard dose in HAP studies.
  • Relmada undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise.

Global Decentralized Clinical Trial 2021 Insights - Growth Opportunities and Strategic Imperatives - ResearchAndMarkets.com

Retrieved on: 
Monday, July 26, 2021
Health, Clinical trials, Health sciences, Health, Pharmaceutical industry, Clinical research, Clinical trial, Design of experiments, Drug discovery, Medical research

The "Global Decentralized Clinical Trial (DCT) Growth Opportunities" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Global Decentralized Clinical Trial (DCT) Growth Opportunities" report has been added to ResearchAndMarkets.com's offering.
  • The report presents post-COVID-19 growth opportunities and strategic imperatives for the global decentralized clinical trials (DCT) market, covering the market's maturity, key participants, adoption drivers and restraints, and recent mergers and acquisitions.
  • However, adoption of decentralized trials is challenged by concerns about data privacy, scalability, and seamless implementation across different continents.
  • Home health services patients with physical disabilities and restricted access due to location can promote retention in clinical trials.

Oligomerix to Present at Alzheimer's Association International Conference

Retrieved on: 
Monday, July 26, 2021
Health, Clinical trials, Research, Pharmaceutical, Science, Biotechnology, Health sciences, Physicists, Drug discovery, Pharmaceutical industry, Articles, Clinical research, Design of experiments, Montefiore Health System, Albert Einstein College of Medicine, Preclinical development, Clinical trial, OLX, Oligomerix’s Lead Program, Oligomerix, Inc., OLIGOMERIX’S LEAD PROGRAM, OLIGOMERIX, INC.

Oligomerix plans to complete preclinical testing of OLX-07010 by year end and begin Phase 1 clinical trials by 2Q22.

Key Points: 
  • Oligomerix plans to complete preclinical testing of OLX-07010 by year end and begin Phase 1 clinical trials by 2Q22.
  • Oligomerix is headquartered at the Westchester Park Center in White Plains, New York and has lab facilities at the Ullmann Research Center for Health Sciences within the Albert Einstein College of Medicine.
  • Oligomerix is seeking strategic partners to support the acceleration and advancement of these important programs.
  • For more information about Oligomerix, please visit our new website at https://oligomerix.com/ .

SciSparc Announces Updates Regarding its Phase IIb Study in Tourette Syndrome

Retrieved on: 
Monday, July 26, 2021
Health sciences, Health, Clinical research, Design of experiments, Medical research, Psychiatric diagnosis, Tourette syndrome, Clinical trial, Placebo-controlled study

TEL AVIV, Israel, July 26, 2021 /PRNewswire/ -- SciSparc Ltd. (OTCQB: SPRCY), a specialty, clinical-stage pharmaceutical company focusing on the development of cannabinoid-based treatments, today announced a number of updates regarding its Phase IIb clinical study in Tourette Syndrome using the proprietary cannabinoid-based treatment- SCI-110.

Key Points: 
  • TEL AVIV, Israel, July 26, 2021 /PRNewswire/ -- SciSparc Ltd. (OTCQB: SPRCY), a specialty, clinical-stage pharmaceutical company focusing on the development of cannabinoid-based treatments, today announced a number of updates regarding its Phase IIb clinical study in Tourette Syndrome using the proprietary cannabinoid-based treatment- SCI-110.
  • The company is currently in contact with two clinical sites that will potentially host and conduct the clinical study.
  • Tourette Syndrome (TS) is a movement and neurobehavioral disorder characterized by motor and vocal chronic tics with onset before age 18.
  • SciSparc intends to evaluate the efficacy, safety and tolerability of its SCI-110 in a randomized, double-blind, placebo controlled, cross-over study.

Tonix Pharmaceuticals Announces Outcome of Interim Analysis of Phase 3 RALLY Study of TNX-102 SL for the Management of Fibromyalgia

Retrieved on: 
Friday, July 23, 2021
Clinical research, Design of experiments, Knowledge, Health sciences, Research, Clinical trials, Tonix Pharmaceuticals, Randomized controlled trial, Placebo-controlled study, Placebo

CHATHAM, N.J., July 23, 2021 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, announced today that the Company has decided to stop enrollment in the Phase 3 RALLY study of TNX-102 SL (cyclobenzaprine HCl sublingual tablets) 5.6 mg for the management of fibromyalgia following an unblinded, pre-planned interim analysis by the Independent Data Monitoring Committee (IDMC) of the RALLY study. Based on interim analysis results of the first 50% (n=337) enrolled participants, the IDMC recommended stopping the trial for futility as TNX-102 SL is unlikely to demonstrate a statistically significant improvement in the primary endpoint of overall change from baseline in daily diary pain severity scores between those treated with TNX-102 SL 5.6 mg (2x 2.8 mg tablets) and those receiving placebo. Tonix remains blinded to the detailed interim analysis results and only received the recommendation made by the IDMC. Preliminary blinded safety data from these participants did not reveal any new safety signals, and the decision to discontinue enrolling new participants is not related to safety. The Company intends to continue studying those participants currently enrolled until completion and then proceed with a full analysis of the unblinded data, with the topline results expected to be reported in the fourth quarter of 2021, to determine the next steps in this program.

Key Points: 
  • Tonix remains blinded to the detailed interim analysis results and only received the recommendation made by the IDMC.
  • We are surprised and disappointed that the interim analysis did not support continued enrollment in this Phase 3 RALLY study, especially considering the previous Phase 3 RELIEF study, which had a similar design and achieved statistical significance on the primary endpoint.
  • We thank the patients, caregivers and investigators who participated in the RALLY study.
  • The RALLY study is a double-blind, randomized, placebo-controlled trial designed to evaluate the efficacy and safety of TNX-102 SL (cyclobenzaprine HCl sublingual tablets).

The Worldwide Clinical Trial Industry is Expected to Reach a Value of $57+ Billion by 2026 - ResearchAndMarkets.com

Retrieved on: 
Thursday, July 22, 2021
Health, Clinical trials, Clinical research, Health sciences, Health, Medical research, Pharmaceutical industry, Drug discovery, Food and Drug Administration, Design of experiments, Clinical trial, Investigational New Drug, Preclinical development, Drug development

Research centers and numerous organizations enhance clinical trials' productivity and effectiveness by advancing and managing clinical trials globally.

Key Points: 
  • Research centers and numerous organizations enhance clinical trials' productivity and effectiveness by advancing and managing clinical trials globally.
  • After preclinical development, the investigational new drug passes through clinical phases I, II, III, and IV during the clinical trial.
  • It expected that the Global Clinical Trials Market will expand, registering a CAGR of 14.13% during the forecast period, 2020-2026.
  • North America is a conventional clinical trial region, and because of the legal, regulatory considerations, the clinical trial market shifted to developing nations.