Sightful Invest
  • Business
  • Investing
  • Politics
  • Stock
Top Posts
Trump dishes on Milley clash over leaving military...
TikToker knocks Harris’ ‘weird’ take on never released...
‘Who wouldn’t want it?’: Netanyahu open to receiving...
Supreme Court lets Trump’s ‘wrecking ball’ federal job...
Biden’s strange use of teleprompter in donor’s home...
Tariff case pits Cato Institute against Trump over...
GREGG JARRETT: CIA report makes it clear Trump...
State Department investigating Rubio AI impersonator who contacted...
DOJ lands legal victory as federal judge allows...
Senate Republican moves to give US an edge...
  • Business
  • Investing
  • Politics
  • Stock

Sightful Invest

Investing

Radiopharm Theranostics Receives FDA IND Approval for Phase 2b Imaging Trial in Brain Metastases

by admin July 23, 2024
July 23, 2024
Radiopharm Theranostics Receives FDA IND Approval for Phase 2b Imaging Trial in Brain Metastases

Radiopharm Theranostics (ASX:RAD, “Radiopharm” or the “Company”), a clinical-stage biopharmaceutical company focused on developing innovative oncology radiopharmaceuticals for areas of high unmet medical need, is pleased to announce that it has received clearance for its Investigational New Drug (IND) application with the US Food and Drug Administration (FDA), for F18-Pivalate (RAD 101).

Pivalate, labelled with the radioisotope F18, is a small molecule that selectively targets fatty acid synthetase, which is overexpressed in brain tumours but not in normal cells. Pivalate is a novel proprietary imaging agent under clinical investigation for the detection and characterisation of brain metastases.

The IND approval is a clear recognition by the FDA of clinical data already generated for RAD 101 and is a significant milestone towards starting a Phase 2b multi-center trial for the imaging of brain metastases. Radiopharm anticipates having the first patient dosed during the fourth quarter of 2024. Based on current enrolment expectations, the 30-patient Phase 2b read-out is expected by mid-2025 and will be followed by a Phase 3 registrational study.

Previously reported positive data from the Imperial College of London’s Phase 2a imaging trial of Pivalate in 17 patients with brain metastases showed significant tumour uptake that was consistent with and independent from the tumour of origin¹. This supports the potential use of pivalate to monitor brain metastases.

“Pivalate represents a potential new target for radiopharmaceutical brain imaging agents, and its unique mechanism of action may offer eligible patients and the medical community an alternative to overcome the limitations of current standard of care for imaging brain metastasis.” said Riccardo Canevari, CEO and Managing Director of Radiopharm Theranostics. “We are very pleased by this FDA approval as it allows us to commence late-stage clinical studies and address the high unmet medical need in around 300,000 patients that are diagnosed with brain metastases in the U.S. every year.”

Radiopharm holds an exclusive global license for the pivalate platform technology and has a collaboration in place with Imperial College of London to develop a therapeutic candidate leveraging the same mechanism of action.

¹ S. Islam, M. Inglese, P. Aravind, A. Waldman, M. Williams, E.O. Aboagye. 18F-Fluoropivalate PET/MRI: imaging of treatment naïve patients and patients treated with radiosurgery [Poster #135]. 24th EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics, October 26 2022.

About Radiopharm Theranostics

Radiopharm Theranostics is a clinical stage radiotherapeutics company developing a world-class platform of innovative radiopharmaceutical products for diagnostic and therapeutic applications in areas of high unmet medical need. Radiopharm has been listed on ASX (RAD) since November 2021. The company has a pipeline of distinct and highly differentiated platform technologies spanning peptides, small molecules and monoclonal antibodies for use in cancer, in pre-clinical and clinical stages of development from some of the world’s leading universities and institutes. The pipeline has been built based on the potential to be first-to-market or best-in-class. Learn more at Radiopharmtheranostics.com.

Click here for the full ASX Release

This post appeared first on investingnews.com

previous post
Elixir Energy Limited (ASX: EXR) – Trading Halt
next post
Biden returning to White House for first time since ending presidential bid, COVID diagnosis

You may also like

Randy Smallwood: Silver Set for Bull Run, Gold...

June 26, 2025

American Rare Earths: Advancing One of the Largest...

February 14, 2025

Silver47 Exploration: Advancing the “Red Mountain” Silver-Gold Rich...

November 6, 2024

Chris Blasi: Gold’s Biggest Gains Still to Come,...

September 24, 2024

Crypto Market Recap: WLFI Unveils Strategic Token Reserve

February 15, 2025

Source Rock Royalties Declares Monthly Dividend

August 16, 2024

Tech 5: Major Players Release Latest Results, Google’s...

April 27, 2025

NorthStar Gaming to Host Live Q2 Corporate Update...

July 31, 2024

5 Biggest Gold ETFs in 2024

August 23, 2024

A$9 Million Equity Placing to Contribute to the...

October 25, 2024

Recent Posts

  • Trump dishes on Milley clash over leaving military equipment in Afghanistan: ‘I knew he was an idiot’
  • TikToker knocks Harris’ ‘weird’ take on never released interview: ‘Not good’
  • ‘Who wouldn’t want it?’: Netanyahu open to receiving stealth bombers, bunker-busters from US
  • Supreme Court lets Trump’s ‘wrecking ball’ federal job cuts proceed while legal fight continues
  • Biden’s strange use of teleprompter in donor’s home infuriated supporters, dashed expectations

    Become a VIP member by signing up for our newsletter. Enjoy exclusive content, early access to sales, and special offers just for you! As a VIP, you'll receive personalized updates, loyalty rewards, and invitations to private events. Elevate your experience and join our exclusive community today!


    By opting in you agree to receive emails from us and our affiliates. Your information is secure and your privacy is protected.

    Categories

    • Business (818)
    • Investing (2,487)
    • Politics (3,085)
    • Stock (4)
    • About us
    • Privacy Policy
    • Terms & Conditions

    Disclaimer: sightfulinvest.com, its managers, its employees, and assigns (collectively “The Company”) do not make any guarantee or warranty about what is advertised above. Information provided by this website is for research purposes only and should not be considered as personalized financial advice. The Company is not affiliated with, nor does it receive compensation from, any specific security. The Company is not registered or licensed by any governing body in any jurisdiction to give investing advice or provide investment recommendation. Any investments recommended here should be taken into consideration only after consulting with your investment advisor and after reviewing the prospectus or financial statements of the company.

    Copyright © 2024 Sightful Invest. All Rights Reserved.