Oregon Health & Science University

Pasithea Therapeutics Selects PAS-003 Lead Development Candidate, a Humanized Monoclonal Antibody that Targets α5β1 Integrin for the Treatment of both Sporadic and Familial ALS

Retrieved on: 
Thursday, November 9, 2023

SOUTH SAN FRANCISCO, Calif. and MIAMI, Nov. 09, 2023 (GLOBE NEWSWIRE) -- Pasithea Therapeutics Corp. (NASDAQ: KTTA) (“Pasithea” or the “Company”), a biotechnology company focused on the discovery, research, and development of innovative treatments for central nervous system (CNS) disorders, announced today that it has selected a lead therapeutic candidate for its PAS-003 program, a proprietary humanized monoclonal antibody (mAb) that targets α5β1 integrin, a protein found to be overexpressed in both human and mouse subjects with amyotrophic lateral sclerosis (ALS).

Key Points: 
  • Scientists at Pasithea have performed extensive mAb screening and characterization to enable selection of a lead therapeutic candidate with optimal properties for the treatment of ALS.
  • This work included further validation of α5β1 integrin as a target in both familial (SOD1) and sporadic (TDP-43) ALS mouse models with reproducible improvements on behavior and survival.
  • Extensive mechanism of action studies link disease model efficacy to effects on the migration and adhesion of immune cells.
  • Dr. Tiago Reis Marques, Chief Executive Officer of Pasithea commented, “We have chosen the most optimal anti-α5β1 humanized mAb for the treatment of both sporadic and familial ALS.

Patient Experience Journal, published in association with The Beryl Institute, Releases Volume 10, Issue 3

Retrieved on: 
Tuesday, November 7, 2023

NASHVILLE, Tenn., Nov. 7, 2023 /PRNewswire-PRWeb/ -- The Beryl Institute announces the publication of Volume 10, Issue 3 of Patient Experience Journal (PXJ), an international, open access, peer-reviewed journal focused on research and proven practices related to understanding and improving the patient experience. Read in over 220 countries and territories, PXJ articles have been downloaded over 1,100,000 times and reflect the journal's commitment to disseminating rigorous knowledge and expanding the global conversation on evidence and innovation in patient and human experience.

Key Points: 
  • "This issue closes the first decade of Patient Experience Journal's (PXJ) contribution to evidence and innovation, to sharing stories and research, to elevating the conversation and pushing the boundaries of the experience movement."
  • said Jason Wolf, Founding Editor of PXJ and President & CEO of The Beryl Institute.
  • "We have never hesitated to nudge at the status quo or to respond with agility to the challenging moments we have faced.
  • We have welcomed diverse voices as contributors, and we have seen an even more diverse readership."

Cardiff Oncology Reports Third Quarter 2023 Results and Provides Business Update

Retrieved on: 
Thursday, November 2, 2023

"This has been a transformational quarter for Cardiff Oncology.

Key Points: 
  • "This has been a transformational quarter for Cardiff Oncology.
  • Contingent upon the results of CRDF-004, Cardiff Oncology plans to initiate CRDF-005, a Phase 3, randomized trial with registrational intent.
  • As of September 30, 2023, Cardiff Oncology had approximately $81.4 million in cash, cash equivalents, and short-term investments.
  • Cardiff Oncology will host a corresponding conference call and live webcast at 4:30 p.m. ET/1:30 p.m. PT on November 2, 2023.

Velocity aggressively expands MASH/MASLD capabilities with latest site acquisitions

Retrieved on: 
Wednesday, October 25, 2023

DURHAM N.C., Oct. 25, 2023 (GLOBE NEWSWIRE) -- Velocity Clinical Research (“Velocity”), the leading multi-specialty clinical sites business, announced it has acquired Impact Research Institute (Waco, TX) and the clinical trials unit of Liver Institute Northwest (Seattle, WA), aggressively expanding its capabilities in liver disease research, including MASH (metabolic dysfunction-associated steatohepatitis) and MASLD (metabolic dysfunction-associated steatotic liver disease).

Key Points: 
  • Velocity is a major player in this space with 23 sites capable of performing MASH/MASLD studies globally.
  • With the two recent site acquisitions, Velocity adds two internationally renowned researchers and key opinion leaders (KOL) in liver disease research as principal investigators, Kris Kowdley, MD, AGAF, FAASLD, FACP, FACG, and Nadege Gunn, MD, CPI, who join Roland Kuchta, MD, in Germany.
  • Dr. Gunn commented, “We are fully prepared to make Velocity the first-choice site network for liver disease clinical trials worldwide.
  • Velocity has over 80 locations globally and access to more than 220 principal investigators and one million patients.

Global Platform Study Presents Results to Guide Care of Severely Ill Patients With COVID-19 Using Routinely Available Drugs – Simvastatin and Vitamin C

Retrieved on: 
Wednesday, October 25, 2023

Vitamin C is widely available around the world and was used in some settings for the treatment of COVID-19.

Key Points: 
  • Vitamin C is widely available around the world and was used in some settings for the treatment of COVID-19.
  • Through harmonizing two clinical trials – REMAP-CAP and LOVIT-COVID – over 2500 patients in 20 countries took part, including both critically ill and non-critically ill patients with COVID-19 in hospital.
  • It was shown that high dose vitamin C did not improve outcomes for patients.
  • Intravenous Vitamin C for Patients Hospitalized with COVID-19: Two Harmonized Randomized Clinical Trials.

JAMA Publishes Geneoscopy’s Pivotal CRC-PREVENT Trial Results, Reporting Highest Sensitivity for Detecting Colorectal Cancer and Advanced Adenomas Among Available Noninvasive Screening Tests

Retrieved on: 
Monday, October 23, 2023

The novel study will be presented at the American College of Gastroenterology (ACG) Annual Scientific Meeting in Vancouver, Canada, October 20-25, showcasing its highly sensitive screening test for colorectal cancer (CRC) and advanced adenomas (AA).

Key Points: 
  • The novel study will be presented at the American College of Gastroenterology (ACG) Annual Scientific Meeting in Vancouver, Canada, October 20-25, showcasing its highly sensitive screening test for colorectal cancer (CRC) and advanced adenomas (AA).
  • “Geneoscopy is dedicated to addressing this challenge and improving access to a reliable, noninvasive CRC screening test, especially as incidence is rising among younger populations.
  • Notably, for younger participants (ages 45 to 49), CRC sensitivity was 100% and AA sensitivity was 45%.
  • There is a notable gap in data regarding the efficacy of noninvasive screening tests for this age group, including the sensitivity for colorectal cancer (CRC) and advanced adenomas,” said Dr. Lieberman.

New Study Using Biological Dynamics’ ExoVerita Platform Validates Exosome Detection of Early-Stage Pancreatic Ductal Adenocarcinoma (PDAC)

Retrieved on: 
Thursday, October 19, 2023

Biological Dynamics, Inc., a leader in exosome-isolation technology for early disease detection, announced a newly published study in Nature’s Communications Medicine titled “ Development of a Blood-Based EV Classifier for Detection of Early-Stage Pancreatic Ductal Adenocarcinoma .” The research demonstrates the effectiveness of exosome-isolation technology in detecting Stage I and II pancreatic ductal adenocarcinoma (PDAC), using an independent validation cohort.

Key Points: 
  • Biological Dynamics, Inc., a leader in exosome-isolation technology for early disease detection, announced a newly published study in Nature’s Communications Medicine titled “ Development of a Blood-Based EV Classifier for Detection of Early-Stage Pancreatic Ductal Adenocarcinoma .” The research demonstrates the effectiveness of exosome-isolation technology in detecting Stage I and II pancreatic ductal adenocarcinoma (PDAC), using an independent validation cohort.
  • Biological Dynamics’ ExoVita Pancreas assay, powered by the ExoVerita™ platform, uses the AC Electrokinetics method for exosome isolation.
  • “Driven by our Verita technology, the ExoVita test can detect challenging diseases like pancreatic cancer earlier than ever.
  • With further testing in real-world settings, we are confident our exosome enabled test will be useful for high-risk surveillance and early detection of pancreatic cancer, resulting in improved patient outcomes.”

Hoag Welcomes Dr. Ronald Wolf as Medical Director of Hepatobiliary and Pancreatic Surgery

Retrieved on: 
Tuesday, October 17, 2023

NEWPORT BEACH, Calif. and IRVINE, Calif., Oct. 17, 2023 /PRNewswire/ -- Hoag is proud to announce the recruitment of Ronald Wolf, M.D., F.A.C.S., as medical director of hepatobiliary and pancreas surgery at Hoag Family Cancer Institute.

Key Points: 
  • NEWPORT BEACH, Calif. and IRVINE, Calif., Oct. 17, 2023 /PRNewswire/ -- Hoag is proud to announce the recruitment of Ronald Wolf, M.D., F.A.C.S., as medical director of hepatobiliary and pancreas surgery at Hoag Family Cancer Institute.
  • Dr. Wolf comes to Hoag from concurrent posts at UC Irvine School of Medicine, where he served as professor of clinical surgery in the hepatobiliary and pancreas surgery/islet cell transplantation division.
  • Prior to that, he served as Medical Director of Hepatic and Pancreatic Surgery at Legacy Good Samaritan Medical Center in Portland, Oregon, and as the Medical Director of Liver and Pancreas Surgery at Providence Cancer Center, also in Portland.
  • Dr. Wolf received his medical degree from Oregon Health & Science University in Portland, followed by an internship and two residencies in general surgery at UC Davis.

Synlogic Announces Publication of Synpheny-1 Phase 2 Study of Synthetic Biotic for Phenylketonuria in Nature Metabolism

Retrieved on: 
Thursday, September 28, 2023

CAMBRIDGE, Mass., Sept. 28, 2023 (GLOBE NEWSWIRE) -- Synlogic, Inc. (Nasdaq: SYBX), a clinical-stage biotechnology company advancing novel, oral, non-systemically absorbed biotherapeutics to transform the care of serious diseases, today announced the publication of results from its Synpheny-1 Phase 2 study of its drug candidates, labafenogene marselecobac (SYNB1934) and SYNB1618 in patients with phenylketonuria (PKU) in the journal Nature Metabolism.

Key Points: 
  • CAMBRIDGE, Mass., Sept. 28, 2023 (GLOBE NEWSWIRE) -- Synlogic, Inc. (Nasdaq: SYBX), a clinical-stage biotechnology company advancing novel, oral, non-systemically absorbed biotherapeutics to transform the care of serious diseases, today announced the publication of results from its Synpheny-1 Phase 2 study of its drug candidates, labafenogene marselecobac (SYNB1934) and SYNB1618 in patients with phenylketonuria (PKU) in the journal Nature Metabolism.
  • The publication, entitled “Efficacy and Safety of a Synthetic Biotic for Treatment of Phenylketonuria: a Phase 2 Clinical Trial” is now available online at https://www.nature.com/articles/s42255-023-00897-6 .
  • The paper includes a comprehensive review of the data, showing clinically meaningful, dose-dependent reductions in plasma phenylalanine (Phe).
  • “These positive results build on a body of data supporting the role of labafenogene marselecobac for patients with PKU,” said Dr. Neal Sondheimer, Head of Clinical Development at Synlogic.

Cardiff Oncology Announces Positive Clinical Data in Pancreatic Cancer and Small Cell Lung Cancer, including Single-Agent Activity from Onvansertib Monotherapy

Retrieved on: 
Tuesday, September 26, 2023

In small cell lung cancer, we are encouraged to observe single-agent activity with onvansertib monotherapy in this difficult-to-treat extensive stage refractory setting."

Key Points: 
  • In small cell lung cancer, we are encouraged to observe single-agent activity with onvansertib monotherapy in this difficult-to-treat extensive stage refractory setting."
  • "We will continue to explore onvansertib in the first-line mPDAC investigator-initiated trial at the OHSU Knight Cancer Institute."
  • In cohort 2, patients will receive 10 days of onvansertib monotherapy followed by onvansertib + SoC to identify biomarkers that predict response to onvansertib.
  • Cardiff Oncology will host a corresponding conference call and live webcast at 5:00 p.m. ET/2:00 p.m. PT on September 26, 2023.