Clinical trial

Lysogene announces important updates on AAVance phase 2/3 clinical trial with LYS-SAF302 in MPS IIIA

Friday, June 5, 2020 - 7:00am

The primary and secondary trial endpoints are based on the analyses of these 19 patients already enrolled and there is no anticipated impact on the current clinical trial timelines.

Key Points: 
  • The primary and secondary trial endpoints are based on the analyses of these 19 patients already enrolled and there is no anticipated impact on the current clinical trial timelines.
  • The clinical hold follows observations in some patients of localized findings on MRI images at the intracerebral injection sites.
  • A phase 2/3 clinical trial in MPS IIIA in partnership with Sarepta Therapeutics, Inc. is ongoing and a phase 1/3 clinical trial in GM1 gangliosidosis is in preparation.
  • This press release may contain certain forward-looking statements, especially on the Companys progress of its phase 2-3 clinical trial and cash runway.

ConvergeHEALTH by Deloitte Waives Licensing Fees for MyPath for Clinical for COVID and COVID-Impacted Trials

Thursday, June 4, 2020 - 7:30pm

MyPath for Clinical is a cloud-based digital platform designed to enhance the patient experience as well as the success and efficiency of global clinical trials.

Key Points: 
  • MyPath for Clinical is a cloud-based digital platform designed to enhance the patient experience as well as the success and efficiency of global clinical trials.
  • License fees will be waived for organizations that sign up for MyPath for Clinical through August 31, 2020.
  • Fees also will be waived for the duration of the clinical trial in process through its completion.
  • MyPath for Clinical is a modular, patient-centric platform that can help accelerate the execution of digital clinical trials by taking a holistic approach to connect clinical trial participants, investigators and clinical research associates.

Algernon Receives U.S. FDA Clearance for Multinational Phase 2b/3 Human Study to Evaluate Ifenprodil as a Potential Therapeutic for COVID-19

Thursday, June 4, 2020 - 5:11pm

The clinical study for Ifenprodil is entitled, "A Randomized Open Label Phase 2b/3 Study of theSafety and Efficacy of NP-120 (Ifenprodil) for the Treatment of Confirmed COVID-19 Infected Hospitalized Patients."

Key Points: 
  • The clinical study for Ifenprodil is entitled, "A Randomized Open Label Phase 2b/3 Study of theSafety and Efficacy of NP-120 (Ifenprodil) for the Treatment of Confirmed COVID-19 Infected Hospitalized Patients."
  • As part of the multinational Phase 2b/3 COVID-19 clinical study, Algernon has already received clearance in Canada and has also filed for ethics approval in Australia.
  • The data will determine the number of expected patients needed to reach statistical significance in the Phase 3 trial.
  • Algernon specifically investigates compounds that have never been approved in the U.S. or Europe to avoid off label prescription writing.

Cure SMA Announces New Funding For Network Of Prominent SMA Clinical Research And Treatment Centers

Thursday, June 4, 2020 - 4:01pm

In 2020, Cure SMA will provide $1.2 million to this Network of highly skilled clinical trial investigators, clinical evaluators, clinical coordinators, statisticians, and data management personnel.

Key Points: 
  • In 2020, Cure SMA will provide $1.2 million to this Network of highly skilled clinical trial investigators, clinical evaluators, clinical coordinators, statisticians, and data management personnel.
  • Originally funded by the SMA Foundation in 2004, the PNCRN established a team of SMA clinical trial experts that have integrated clinical research, education, and care to achieve the best possible clinical trial outcomes.
  • Cure SMA is dedicated to the treatment and cure of spinal muscular atrophy (SMA).
  • Since 1984, Cure SMA has grown to be the largest network of individuals, families, clinicians, and research scientists working together to advance SMA research, support affected individuals/caregivers, and educate public and professional communities about SMA.

Inteliquet Taps Industry Veteran Peter B. Malamis to Lead Life Sciences Group

Thursday, June 4, 2020 - 2:30pm

Inteliquet , a leading provider of intelligent technology, insights, and services for optimizing clinical trials and research, announced today that it has hired industry veteran Peter B. Malamis as Senior Vice President, Life Sciences, effective immediately.

Key Points: 
  • Inteliquet , a leading provider of intelligent technology, insights, and services for optimizing clinical trials and research, announced today that it has hired industry veteran Peter B. Malamis as Senior Vice President, Life Sciences, effective immediately.
  • He also oversees the expansion of the companys life sciences offerings.
  • View the full release here: https://www.businesswire.com/news/home/20200604005377/en/
    Inteliquet Taps Industry Veteran Peter B. Malamis to Lead Life Sciences Group.
  • Before Inteliquet, Peter was co-founder and CEO of CRO Analytics, a provider of a cloud-based clinical trial performance system platform.

Therapeutic Solutions International Announces Positive Preclinical and Clinical Evaluation of Nutritional Supplement QuadraMune™, Designed to Protect Against COVID-19

Thursday, June 4, 2020 - 2:08pm

QuadraMune was provided by Therapeutic Solutions International.

Key Points: 
  • QuadraMune was provided by Therapeutic Solutions International.
  • "We aimed to perform a series of experiments to assess preclinical and pilot clinical feasibility of QuadraMune to address the issue of immune stimulation while inhibiting inflammation.
  • The Company plans to expand clinical trials to patients suffering from COVID-19 and/or individuals at risk of COVID-19.
  • Therapeutic Solutions International is focused on immune modulation for the treatment of several specific diseases.

Heron Therapeutics Announces Publication of Results from Study 209, a Phase 2b Study of HTX-011 in Patients Undergoing Total Knee Arthroplasty

Thursday, June 4, 2020 - 2:00pm

In Study 209, patients undergoing primary unilateral TKA who received a single, needle-free application of HTX-011demonstrated superior pain reduction when compared to patients receiving placebo or bupivacaine solution through 48 and 72 hours.

Key Points: 
  • In Study 209, patients undergoing primary unilateral TKA who received a single, needle-free application of HTX-011demonstrated superior pain reduction when compared to patients receiving placebo or bupivacaine solution through 48 and 72 hours.
  • In addition, patients receiving HTX011consumed fewer opioids when compared to patients receiving placebo or bupivacaine solution.
  • HTX-011 was well tolerated in Study 209, with a safety profile comparable to placebo and bupivacaine solution.
  • Study 209 was a randomized, placebo- and active-controlled, double-blind, Phase 2b clinical study in patients undergoing primary unilateral total knee arthroplasty to evaluate the analgesic efficacy, safety and pharmacokinetics of HTX-011 locally administered into the surgical site.

Moleculin Announces Submission to Expand Clinical Sites in European AML Trial

Thursday, June 4, 2020 - 12:30pm

"We are pleased to report that the Annamycin trial in AML continues forward despite the disruptions from the COVID-19 pandemic," commented Walter Klemp, Chairman and CEO of Moleculin.

Key Points: 
  • "We are pleased to report that the Annamycin trial in AML continues forward despite the disruptions from the COVID-19 pandemic," commented Walter Klemp, Chairman and CEO of Moleculin.
  • "Two additional hospitals in Poland, one in Szczecin and one in Kielce, have been moving quickly to participate in this trial.
  • Assuming these requests are granted in a timely manner, we expect both sites to begin recruiting in the third quarter."
  • Moleculin currently has 5 clinical sites for the Annamycin AML clinical trial operating in Europe.

Announcing New QuickSTAT Podcast-- Life Science Logistics in a Life-changing World

Thursday, June 4, 2020 - 11:00am

But in life sciences, even during a pandemic, patients who are being treated for non-COVID-19 illnesses still need to receive their treatments.

Key Points: 
  • But in life sciences, even during a pandemic, patients who are being treated for non-COVID-19 illnesses still need to receive their treatments.
  • The usually fast-paced world of life science logistics is now moving even faster.
  • QuickSTAT , part of the Kuehne + Nagel Group, manages global clinical trial logistics for all phases of research and drug development, for all temperature ranges and life science products from pre-clinical, to clinical, through to commercialization.
  • Its strong market position lies in Sea Logistics, Air Logistics, Road Logistics and Contract Logistics, with a clear focus on integrated logistics solutions.

MSC Therapy for Acute Respiratory Distress Syndrome; It's Time to Accelerate Clinical Trials for COVID-19 Patients in Need

Wednesday, June 3, 2020 - 8:40pm

To date, nearly two million Americans have tested positive for COVID-19 and more than 100,000 Americans have died.

Key Points: 
  • To date, nearly two million Americans have tested positive for COVID-19 and more than 100,000 Americans have died.
  • In its most severe form, COVID-19 leads to ARDSa life-threatening lung injury that allows fluid to leak into the lungs and makes it difficult for patients to breathe.
  • There is no effective treatment for ARDS today; MSCs potentially offer a unique therapeutic option to help patients in need.
  • "The potential benefitcombined with the demonstrated safety of these therapiessupports the need for rapid commencement of more clinical trials."