Pivotal trial

After Several Months of Providing Requested Information About Manufacturing and Safety of Leronlimab, U.K.’s MHRA Accepts CytoDyn’s Request to Enroll in its Current Phase 3 Trial for COVID-19 Patients with Severe-to-Critical Symptoms

Retrieved on: 
Thursday, August 20, 2020
Drugs, Hepatotoxins, Health, PRO 140, Medical specialties, Prevention of HIV/AIDS, HIV/AIDS, Coronavirus disease, Management of HIV/AIDS, Zidovudine, Pivotal trial, CCR5 receptor antagonist

The MHRAs decision follows several months of its review of CytoDyns manufacturing processes and leronlimabs safety profile.

Key Points: 
  • The MHRAs decision follows several months of its review of CytoDyns manufacturing processes and leronlimabs safety profile.
  • CytoDyn recently requested fast track approval from the MHRA for its completed Phase 2 COVID-19 trial for the mild-to-moderate population, with strong efficacy and safety data.
  • The symptoms of COVID-19 may appear in as few as two days or as long as 14 days after exposure.
  • CytoDyn has successfully completed a Phase 3 pivotal trial with leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients.

TRACON Pharmaceuticals Announces FDA Clearance of ENVASARC Pivotal Trial

Retrieved on: 
Monday, August 17, 2020
PC games, Clinical trials, Tracon II, Pivotal trial, Personal computers

TRACON expects to initiate enrollment in the ENVASARC trial at 25 sites in the U.S. in the fourth quarter of 2020.

Key Points: 
  • TRACON expects to initiate enrollment in the ENVASARC trial at 25 sites in the U.S. in the fourth quarter of 2020.
  • We are pleased to receive clearance from the FDA to initiate the pivotal ENVASARC trial of envafolimab in sarcoma and look forward to dosing the first patient in the fourth quarter of this year, said James Freddo, M.D., Chief Medical Officer of TRACON.
  • Key elements for the ENVASARC pivotal trial include:
    Multi-center, open-label, randomized, non-comparative, parallel cohort study at approximately 25 top cancer centers in the United States.
  • TRACON undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

Satsuma Pharmaceuticals Announces Enrollment of First Patient in the ASCEND™ Phase 3 open-label, safety trial of STS101

Retrieved on: 
Thursday, August 6, 2020
Health, Clinical research, Pharmaceutical industry, Medical research, Drug discovery, Clinical trials, Design of experiments, Pivotal trial

We are pleased to have enrolled the first patient in our Phase 3 open-label, safety trial of STS101, commented John Kollins, Satsumas President and Chief Executive Officer.

Key Points: 
  • We are pleased to have enrolled the first patient in our Phase 3 open-label, safety trial of STS101, commented John Kollins, Satsumas President and Chief Executive Officer.
  • The ASCEND trial is complementary to our STS101 EMERGE Phase 3 pivotal trial, which has completed the patient treatment phase and for which we expect to report topline results in late September or early October 2020.
  • The primary objective of the trial is to evaluate the long-term safety of STS101 as an as-needed acute treatment for migraine.
  • STS101 has undergone extensive pre-clinical development, completed a Phase 1 clinical trial, and is currently in Phase 3 development.

Photocure's Partner Asieris Received China NMPA's Approval to Start a Global Phase III Clinical Trial for APL-1702 (Cevira)

Retrieved on: 
Wednesday, July 8, 2020
Health, Pharmaceuticals policy, Science and technology in the People's Republic of China, Food safety in China, National Medical Products Administration, Cervical intraepithelial neoplasia, Pharmaceutical industry in China, Clinical trial, Pivotal trial

SHANGHAI, July 8, 2020 /PRNewswire/ -- Asieris Pharmaceuticals (Asieris), a China-based biotech company with global aspirations to discover, develop and commercialize innovative drugs for the treatment of genitourinary tumors and related diseases, announced today it has received Clinical Trial Approval (CTA) from China's National Medical Products Administration (NMPA) for the global,multi-centered Phase III clinical trial of its photodynamic drug-device combination product, APL-1702 (Cevira), which is being developed for the non-surgical treatment of high-grade cervical dysplasia (HSIL).

Key Points: 
  • SHANGHAI, July 8, 2020 /PRNewswire/ -- Asieris Pharmaceuticals (Asieris), a China-based biotech company with global aspirations to discover, develop and commercialize innovative drugs for the treatment of genitourinary tumors and related diseases, announced today it has received Clinical Trial Approval (CTA) from China's National Medical Products Administration (NMPA) for the global,multi-centered Phase III clinical trial of its photodynamic drug-device combination product, APL-1702 (Cevira), which is being developed for the non-surgical treatment of high-grade cervical dysplasia (HSIL).
  • In addition to China, Asieris has concurrently initiated this global pivotal trial in the United States, Germany, Romania, Hungary, Russia, Ukraine and other European countries.
  • Data from this trial will support the market approval applications in China, the United States, the European Union, and other countries.

Photocure's Partner Asieris Received China NMPA's Approval to Start a Global Phase III Clinical Trial for APL-1702 (Cevira)

Retrieved on: 
Wednesday, July 8, 2020
Health, Pharmaceuticals policy, Science and technology in the People's Republic of China, Food safety in China, National Medical Products Administration, Cervical intraepithelial neoplasia, Pharmaceutical industry in China, Clinical trial, Pivotal trial

SHANGHAI, July 8, 2020 /PRNewswire/ -- Asieris Pharmaceuticals (Asieris), a China-based biotech company with global aspirations to discover, develop and commercialize innovative drugs for the treatment of genitourinary tumors and related diseases, announced today it has received Clinical Trial Approval (CTA) from China's National Medical Products Administration (NMPA) for the global,multi-centered Phase III clinical trial of its photodynamic drug-device combination product, APL-1702 (Cevira), which is being developed for the non-surgical treatment of high-grade cervical dysplasia (HSIL).

Key Points: 
  • SHANGHAI, July 8, 2020 /PRNewswire/ -- Asieris Pharmaceuticals (Asieris), a China-based biotech company with global aspirations to discover, develop and commercialize innovative drugs for the treatment of genitourinary tumors and related diseases, announced today it has received Clinical Trial Approval (CTA) from China's National Medical Products Administration (NMPA) for the global,multi-centered Phase III clinical trial of its photodynamic drug-device combination product, APL-1702 (Cevira), which is being developed for the non-surgical treatment of high-grade cervical dysplasia (HSIL).
  • In addition to China, Asieris has concurrently initiated this global pivotal trial in the United States, Germany, Romania, Hungary, Russia, Ukraine and other European countries.
  • Data from this trial will support the market approval applications in China, the United States, the European Union, and other countries.

Revance Announces Last Patient Enrolled in Modified JUNIPER Phase 2 Upper Limb Spasticity Trial of DaxibotulinumtoxinA for Injection

Retrieved on: 
Tuesday, June 30, 2020
Biotechnology, Pharmaceutical, Health, Clinical trials, Drugs, Muscle relaxants, Organ systems, Botulinum toxin, Botulism, Neurotoxins, Toxins, Dystonia, Pivotal trial, Spasticity, JUNIPER Phase 2 Study, Revance Therapeutics, Inc.

Revance now expects to announce topline data from the JUNIPER Phase 2 trial in early 2021.

Key Points: 
  • Revance now expects to announce topline data from the JUNIPER Phase 2 trial in early 2021.
  • Fortunately, we have enrolled approximately two-thirds of the initial target subjects, which will produce phase 2 trial data that provides adequate information to advance our clinical program in upper limb spasticity.
  • Todays announcement means Revances therapeutic programs for DaxibotulinumtoxinA for Injection will generate three topline clinical results near term: A Phase 3 pivotal trial in cervical dystonia; a Phase 2 trial in plantar fasciitis; and a Phase 2 trial in upper limb spasticity.
  • Revance has successfully completed a Phase 3 program for DaxibotulinumtoxinA for Injection in glabellar (frown) lines and is pursuing U.S. regulatory approval in 2020.

Pharnext provides regulatory and clinical update on PXT3003 Phase III study for the treatment of Charcot-Marie-Tooth Type 1A

Retrieved on: 
Wednesday, June 10, 2020
Health, Articles, Medical research, Drug discovery, Pharmaceutical industry, Clinical research, Design of experiments, Food and Drug Administration, Clinical trial, Pivotal trial

Specifically, the FDA has indicated that a single pivotal Phase III study in CMT1A delivering robust results could be sufficient for approval of PXT3003.

Key Points: 
  • Specifically, the FDA has indicated that a single pivotal Phase III study in CMT1A delivering robust results could be sufficient for approval of PXT3003.
  • This study design will be similar to the earlier Phase III study of PXT3003 that yielded encouraging top line results in October 2018.
  • For the upcoming Phase III pivotal study, as recommended by FDA, Pharnext will use ONLS as the primary endpoint, as was used in the previous Phase III study.
  • Pharnext plans to initiate the final pivotal Phase III clinical study before the end of Q1 2021.

Albireo Announces Two Financing Transactions to Extend Cash Runway Into the Beginning of 2022

Retrieved on: 
Tuesday, June 9, 2020
Stars, Astronomical objects, Stellar astronomy, Cygnus, Albireo, Forward-looking statement, Pivotal trial

This strengthened financial foundation will also enable our continued growth as we deliver on additional odevixibat pivotal trials, NASH clinical development and pre-clinical programs.

Key Points: 
  • This strengthened financial foundation will also enable our continued growth as we deliver on additional odevixibat pivotal trials, NASH clinical development and pre-clinical programs.
  • Albireo was spun out fromAstraZenecain 2008.Albireo Pharmais located inBoston, Mass., and its key operating subsidiary is located inGothenburg, Sweden.
  • As a result of risks and uncertainties that Albireo faces, the results or events indicated by any forward-looking statement may not occur.
  • Albireo disclaims any obligation to update any forward-looking statement, except as required by applicable law.

Citius Receives Positive FDA Feedback on Its Submitted Plan to Study Catheter Compatibility for Mino-Lok® Therapy

Retrieved on: 
Tuesday, June 2, 2020
Health, Clinical research, Design of experiments, Medical research, Clinical pharmacology, Clinical trial, Pharmaceutical industry, Catheter, Pivotal trial

The catheter compatibility studies will be conducted in parallel with the completion of the ongoing Phase 3 clinical study.

Key Points: 
  • The catheter compatibility studies will be conducted in parallel with the completion of the ongoing Phase 3 clinical study.
  • The Company announced in early February 2020 that this pivotal trial had reached the halfway point for enrollment.
  • "We believe we continue to check all the boxes required for an NDA submission," commented Myron Holubiak, Chief Executive Officer of Citius.
  • This would be between 10 to 14 hours of aggregate, but intermittent, exposure time of the catheter to Mino-Lok.

Tufts Center for the Study of Drug Development Establishes Demographic Benchmarks for Pivotal Clinical Trials, Showing Areas of Under-Representation

Retrieved on: 
Tuesday, May 12, 2020
Health, Drug discovery, Pharmaceutical sciences, Pharmaceutical industry, Clinical research, Clinical trials, Design of experiments, Tufts Center for the Study of Drug Development, Drug development, Pivotal trial, Tufts University

Drug developers recognize the importance of participant demographic representation in the development of safe and effective medical treatments, said Ken Getz, professor and deputy director of Tufts CSDD and principal investigator of the study.

Key Points: 
  • Drug developers recognize the importance of participant demographic representation in the development of safe and effective medical treatments, said Ken Getz, professor and deputy director of Tufts CSDD and principal investigator of the study.
  • Our study found significant under-representation of participant subgroups in pivotal clinical trials based on population census and disease prevalence.
  • Other findings, summarized in the May/June Tufts CSDD Impact Report , released today, include the following:
    Only 37% of all pivotal trials provided data on study participant ethnicity.
  • The Tufts Center for the Study of Drug Development ( http://csdd.tufts.edu ) at Tufts University provides strategic information to help drug developers, regulators, and policy makers improve the efficiency and productivity of pharmaceutical R&D.