• Skip to primary navigation
  • Skip to main content
  • Skip to primary sidebar
  • Skip to footer

Drug Delivery Business

  • Clinical Trials
  • Research & Development
  • Drug-Device Combinations
  • FDA
  • Pharmaceuticals
  • Policy

FDA accepts IND application for Samus Therapeutics’ oral glioma drug

May 11, 2021 By Sean Whooley

Samus_TherapeuticsSamus Therapeutics announced today that the FDA cleared its investigational new drug (IND) application for its glioma treatment.

Boston-based Samus Therapeutics develops the PU-AD (icapamespib) orally administered small molecule drug for the treatment of recurrent malignant glioma, according to a news release.

Under the IND, Samus will move forward with its Phase 1b study to address the safety, tolerability and pharmacokinetics of PU-AD, a specific inhibitor of epichaperomes, in treating recurrent malignant glioma.

Dr. John de Groot of the University of Texas M.D. Anderson Cancer Center and Dr. Howard Colman of the University of Utah’s Huntsman Cancer Institute will conduct the Phase 1b study in two stages across multiple U.S. sites. The study will address daily administration of icapamespib in patients with a first, second or third recurrence of isocitrate dehydrogenase (IDH) wild-type glioblastoma or grade 3 or 4 IDH mutant astrocytoma.

“The expansion stage of this trial will not only confirm safety of the Phase 2 dose, but also investigate the biology of recurrent disease through biomarker analysis and evidence of target engagement,” Samus Therapeutics president & CEO Dick Bagley said in the release.

“Through the work of our scientific founder Gabriela Chiosis and her collaborators, we have established that glioblastomas express high levels of epichaperomes as evidenced in explants, primary and secondary neurospheres, and glial stem cells,” added CSO Barbara Wallner. “Epichaperome driven glioblastoma cells respond well to icapamespib treatment in xenograft mouse models and ex vivo studies even when resistant to Temodar (temozolomide) and Avastin (bevacizumab), giving us a signal that icapamespib could have a clinical impact on this devastating disease.”

Filed Under: Clinical Trials, Featured, Food & Drug Administration (FDA), Immunotherapy, Oncology Tagged With: FDA, Samus Therapeutics

IN CASE YOU MISSED IT

  • Shareholder lawsuit over BD’s Alaris pumps recall moves forward
  • Embecta stock soars on first full-quarter results after BD spinoff
  • Abbott will spend $450M to up FreeStyle Libre production in Ireland
  • Better Therapeutics Q2 beats Street as it prepares to submit diabetes therapy for FDA review
  • Study backs Fluidx embolic device for vessel filling

Primary Sidebar

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.
Need Drug Delivery Business News in a minute? We Deliver!
Drug Delivery Enewsletters get you caught up on all the mission critical news you need in med tech. Sign up today.

Signup for the newsletter

Footer

Drug Delivery Business News Logo

MassDevice Medical NETWORK

MassDevice
DeviceTalks
Medical Tubing & Extrusion
Medical Design & Outsourcing
MedTech100 Index
Drug Discovery & Development
Pharmaceutical Processing World
Medical Design Sourcing
R&D World

DRUG DELIVERY BUSINESS NEWS

Subscribe to Drug Delivery’s E-Newsletter
Advertise with us
About
Contact us
Privacy
Listen to our Weekly Podcasts
Add us on FacebookFollow us on TwitterConnect with us on LinkedIn

Copyright © 2022 · WTWH Media LLC and its licensors. All rights reserved.
The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media.

Advertise | Privacy Policy | RSS