Lund Sweden – Active Biotech AB (publ) (NASDAQ STOCKHOLM: ACTI) and NeoTX today announced that they have received clearance from the U.S. Food and Drug Administration (FDA) for the Investigational New Drug (IND) application of the tumor targeted superantigen naptumomab estafenatox (Naptumomab). The Phase IIa open label trial will evaluate...
treatment News
Barcelona, Spain – The Alliance for Clinical Trials in Oncology today announced final results will be presented at ESMO 2024 from CABINET (A021602), a phase III trial evaluating cabozantinib compared with placebo in two cohorts of patients with previously treated neuroendocrine tumors: one cohort of patients with advanced pancreatic neuroendocrine tumors...
NIJMEGEN, the Netherlands — Philikos B.V., a Dutch biotechnology company developing antibody-based therapies to treat severe immune disorders, today announced that it has enrolled the first patient in a Phase 1/2 clinical trial designed to evaluate the use of T-Guard for the treatment of patients with diffuse cutaneous systemic sclerosis...
MARLBOROUGH, Mass. — Phio Pharmaceuticals Corp. (Nasdaq: PHIO), a clinical stage biotechnology company whose proprietary INTASYL™ siRNA gene silencing technology is designed to make immune cells more effective in killing tumor cells, today announced that new preclinical data demonstrating the potential of INTASYL self-delivering siRNA targeting Cbl-b improves natural killer...
Approved as the first subcutaneous treatment for paroxysmal nocturnal hemoglobinuria (PNH) in Taiwan, applying Chugai’s proprietary Recycling Antibody Technology Approval based on data including COMMODORE 2 study, which demonstrated non-inferiority in efficacy of every four weeks subcutaneous PiaSky compared to intravenous eculizumab every two weeks in the maintenance dosing period...
Global Phase 3 MANEUVER study of pimicotinib in tenosynovial giant cell tumor (TGCT) met the primary endpoint, demonstrating objective response rate at week 25 of 54.0% versus 3.2% for placebo (p<0.0001) MANEUVER met all five key secondary endpoints, with statistically significant and clinically meaningful improvements in pain, stiffness, range of...
By Raffaele Pereno – PhD, MBA VIENNA, Austria – A discussion with AATech CEO Rüdiger Jankowsky at BioEurope highlighted a decisive shift in how alpha‑1 antitrypsin (AAT) may be deployed in respiratory medicine. While most companies in the field continue to focus on treating the rare genetic disorder alpha‑1 antitrypsin...
In patients with fibrotic interstitial lung diseases (ILDs) other than idiopathic pulmonary fibrosis (IPF), adding pirfenidone to treatment may attenuate disease progression, according to the results of a multicenter, double-blind, phase 2b trial (EU Clinical Trials Register Identifier: EudraCT 2014-000861-32) published in the journal Lancet Respiratory Medicine. Pirfenidone slows disease progression in...
COPENHAGEN, Denmark — Ascendis Pharma A/S (Nasdaq: ASND) today announced that pivotal Week 52 results from its randomized double-blind, placebo-controlled ApproaCH Trial of investigational once-weekly TransCon® CNP (navepegritide) in children with achondroplasia have been published in JAMA Pediatrics, a journal of the American Medical Association. In the publication, titled “Once-Weekly Navepegritide in Children with Achondroplasia:...
Nijmegen, Netherlands – The U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to Pleco Therapeutics BV’s lead compound, PTX-252 for the treatment of Acute Myeloid Leukemia (AML). PTX-252 is a novel molecular entity developed to increase the sensitivity of cancer cells to chemotherapy. The FDA’s designation acknowledges...