Clinical trial

Atreca Reports Fourth Quarter and Full Year 2020 Financial Results and Recent Corporate Developments

Thursday, February 25, 2021 - 9:05pm

To date, 10 clinical trial sites have been initiated in the Phase 1b trial evaluating ATRC-101 in multiple solid tumor cancers.

Key Points: 
  • To date, 10 clinical trial sites have been initiated in the Phase 1b trial evaluating ATRC-101 in multiple solid tumor cancers.
  • Three patients have been enrolled in the fourth dose cohort (10mg/kg) of the dose escalation portion of the trial.
  • Research and development expenses for the year ended December 31, 2020 were $62.0 million, including non-cash share-based compensation expense of $5.9 million.
  • General and administrative expenses for the year ended December 31, 2020 were $26.8 million, including non-cash share-based compensation expense of $6.6 million.

Tricida Provides Update on FDA Interactions

Thursday, February 25, 2021 - 9:05pm

Tricida initiated enrollment in the VALOR-CKD trial in the fourth quarter of 2018 and has established sites throughout North America, Europe, Latin America and Asia-Pacific.

Key Points: 
  • Tricida initiated enrollment in the VALOR-CKD trial in the fourth quarter of 2018 and has established sites throughout North America, Europe, Latin America and Asia-Pacific.
  • In November 2020, based on feedback from the FDA, recruitment for VALOR-CKD was closed in all regions except for the United States, Canada and Western Europe.
  • Tricida intends to ensure that no single site in the VALOR-CKD trial provides 5% of the total number of trial subjects.
  • Tricida is currently conducting a renal outcomes clinical trial, VALOR-CKD, to determine if veverimer slows CKD progression in patients with metabolic acidosis associated with CKD.

Matrix Medical Network Announces Newly Defined Lines of Business with a Strategic Focus on Bringing Expert Care to Individuals Where They Live and Work

Thursday, February 25, 2021 - 5:43pm

Today's announcement represents a long-term strategic roadmap for Matrix recognizing new and unique health and safety needs in 2021 and beyond.

Key Points: 
  • Today's announcement represents a long-term strategic roadmap for Matrix recognizing new and unique health and safety needs in 2021 and beyond.
  • The newly defined business units are Clinical Care, Clinical Solutions, Clinical Trials and Clinical Labs.
  • Matrix Medical Network has provided expert care and health services to millions of at-risk individuals where they live and work for more than 20 years.
  • *Matrix Medical Network is the registered trademark of Community Care Health Network, LLC.

Adial Pharmaceuticals Achieves 50% Enrollment in ONWARD™ Phase 3 Trial

Thursday, February 25, 2021 - 2:30pm

CHARLOTTESVILLE, Va., Feb. 25, 2021 (GLOBE NEWSWIRE) -- Adial Pharmaceuticals, Inc. (NASDAQ: ADIL; ADILW), a clinical-stage biopharmaceutical company focused on the development of treatments for addictions, today announced that it has reached 50% enrollment in the Companys landmark ONWARD pivotal Phase 3 clinical trial.

Key Points: 
  • CHARLOTTESVILLE, Va., Feb. 25, 2021 (GLOBE NEWSWIRE) -- Adial Pharmaceuticals, Inc. (NASDAQ: ADIL; ADILW), a clinical-stage biopharmaceutical company focused on the development of treatments for addictions, today announced that it has reached 50% enrollment in the Companys landmark ONWARD pivotal Phase 3 clinical trial.
  • We are pleased to have achieved this important enrollment milestone in our ONWARD pivotal Phase 3 clinical trial, stated Schuyler Vinzant, Adials Vice President of Development.
  • We have a high degree of confidence that ONWARD will be fully enrolled this summer.
  • Patients are genetically screened prior to enrollment in the ONWARD trial so that only genetically positive patients are enrolled.

ERT Survey Reveals Challenges and Innovations within CNS Clinical Trials

Thursday, February 25, 2021 - 1:00pm

PHILADELPHIA, Feb. 25, 2021 /PRNewswire/ -- ERT , the global leader in clinical endpoint data collection, today released a new report, Innovation Frontiers in CNS Research , which analyzes the results of a recent industry survey on central nervous system (CNS) clinical trials.

Key Points: 
  • PHILADELPHIA, Feb. 25, 2021 /PRNewswire/ -- ERT , the global leader in clinical endpoint data collection, today released a new report, Innovation Frontiers in CNS Research , which analyzes the results of a recent industry survey on central nervous system (CNS) clinical trials.
  • The report reveals key challenges for sponsors and study teams, as well as the innovations they are implementing to address them, including wearable technologies and virtual trial solutions.
  • Current or planned use of wearables: 80% of survey respondents have used, or are planning to use, wearable technology in their CNS Trials.
  • Current adoption of virtual trial technologies in CNS trials: More than one third of respondents report running fully virtual, or decentralized, CNS trials or a hybrid model featuring some virtual solutions.

Altimmune Commences Enrollment in Phase 1 Clinical Trial of AdCOVID™ -- a Needle-Free, Single-Dose Intranasal COVID-19 Vaccine Candidate

Thursday, February 25, 2021 - 12:03pm

GAITHERSBURG, Md., Feb. 25, 2021 (GLOBE NEWSWIRE) -- Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, today announced that it has commenced enrollment in a Phase 1 clinical trial of AdCOVID, a single-dose intranasal COVID-19 vaccine candidate.

Key Points: 
  • GAITHERSBURG, Md., Feb. 25, 2021 (GLOBE NEWSWIRE) -- Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, today announced that it has commenced enrollment in a Phase 1 clinical trial of AdCOVID, a single-dose intranasal COVID-19 vaccine candidate.
  • The Phase 1 clinical trial will evaluate the safety and immunogenicity of AdCOVID in up to 180 healthy adult volunteers between the ages of 18 and 55.
  • Altimmune anticipates having a full data readout from this Phase 1 study in Q2 2021.
  • Altimmune is a clinical stage biopharmaceutical company focused on developing intranasal vaccines, immune modulating therapies and treatments for liver disease.

BioAge Initiates Phase 2a Trial of BGE-117 in Elderly Patients with Unexplained Anemia

Thursday, February 25, 2021 - 1:00pm

BioAge Labs, Inc., a clinical-stage biotechnology company developing medications that target aging to treat severe diseases, today announced that it has commenced a Phase 2a clinical trial of BGE-117, an activator of hypoxia signaling, for unexplained anemia of aging (UAA).

Key Points: 
  • BioAge Labs, Inc., a clinical-stage biotechnology company developing medications that target aging to treat severe diseases, today announced that it has commenced a Phase 2a clinical trial of BGE-117, an activator of hypoxia signaling, for unexplained anemia of aging (UAA).
  • In this randomized, placebo-controlled, double-blind, multi-center Phase 2a trial, 160 UAA patients 65 years or older will receive daily oral doses of BGE-117 or placebo (80 patients in each group) for 3 months.
  • In 33% of elderly patients, anemia cannot be attributed to iron deficiency or underlying medical conditions; accordingly, these cases are classified as unexplained anemia of aging (UAA).
  • The pharmacoeconomic burden is considerable: in elderly anemic patients, Medicare costs for falls alone are several billion dollars per year.

Enveric Biosciences Launches Development Collaboration and Supply Agreement with PureForm Global to Support Cannabinoid Clinical Programs

Thursday, February 25, 2021 - 12:00pm

"As a market leader in producing pure, consistent, synthetic CBD from non-cannabis plant sources, PureForm should complement Enveric's supportive care expertise.

Key Points: 
  • "As a market leader in producing pure, consistent, synthetic CBD from non-cannabis plant sources, PureForm should complement Enveric's supportive care expertise.
  • Under the terms of the agreement, PureForm will work exclusively to support Enveric's development plans in the cancer treatment and supportive care space, with Enveric owning the intellectual property.
  • Additionally, Enveric gains a guaranteed long term supply of high quality CBD, making consistent product available for preclinical and clinical studies."
  • Enveric Biosciences is a patient-first biotechnology company developing rigorously tested, novel cannabinoid medicines to improve quality of life for cancer patients.

Cyclerion Therapeutics Reports Full Year 2020 Financial Results and Corporate Update

Thursday, February 25, 2021 - 12:00pm

CY6463 administration resulted in improvement in the levels of various neuroinflammatory biomarkers, including alpha-2-macroglobulin (A2M) and Complement C3 (C3).

Key Points: 
  • CY6463 administration resulted in improvement in the levels of various neuroinflammatory biomarkers, including alpha-2-macroglobulin (A2M) and Complement C3 (C3).
  • ADv Clinical Trial Initiation: The Company anticipates initiating a 12-week Phase 2a clinical trial in patients with ADv midyear.
  • Cash Position:Cash, cash equivalents, and restricted cash balance onDecember 31, 2020 was approximately$58 million, as compared toapproximately$71milliononSeptember 30, 2020.
  • For more information about Cyclerion, please visit https://www.cyclerion.com/ and follow us on Twitter (@Cyclerion) and LinkedIn ( www.linkedin.com/company/cyclerion ).

Solano Hematology Oncology Adopts Deep Lens’ VIPER™ to Improve Patient Access to Clinical Trials

Wednesday, February 24, 2021 - 3:05pm

Solano Hematology Oncology and Deep Lens today announced a strategic collaboration designed to more effectively identify, screen and match patients to precision-based clinical oncology trials using VIPER, Deep Lens artificial intelligence-based screening and enrollment platform.

Key Points: 
  • Solano Hematology Oncology and Deep Lens today announced a strategic collaboration designed to more effectively identify, screen and match patients to precision-based clinical oncology trials using VIPER, Deep Lens artificial intelligence-based screening and enrollment platform.
  • VIPER will be utilized by oncology care teams at Solano Hematology Oncology in Vallejo and the Cancer Treatment Center of Vacaville.
  • It is estimated that more than 15,000 oncology clinical trials are actively recruiting patients; however, patient participation in these trials is often as low as three percent.
  • Deep Lens is a software company focused on a groundbreaking approach to faster recruitment of the best-suited cancer patients to clinical trials.