Theragnostics Reports Positive Clinical Trial Results from Prostate Cancer Study

LONDON and BOSTON, Oct. 2, 2019 /PRNewswire/ -- Theragnostics, which is developing innovative radiopharmaceuticals to improve cancer diagnosis and treatment, announces the successful completion of a phase two clinical study of novel prostate cancer diagnostic imaging Gallium-68 (⁶⁸Ga) THP-PSMA PET/CT.

The PRONOUNCED trial is a prospective open-label study of 50 patients to evaluate the safety and clinical impact of ⁶⁸Ga THP-PSMA PET/CT imaging (THP-PSMA) on patient management and treatment decisions in men who are newly diagnosed or have biochemically recurrent prostate cancer after initial treatment.

The study met its primary and secondary endpoints. Data demonstrates that post THP-PSMA scan, one third of newly diagnosed prostate cancer patients, and over 50% of patients with biochemically recurrent disease including 75% in a post-radical radiotherapy setting, saw their treatment plan altered to be more appropriate as a result of re-staging their prostate cancer. The safety data showed that THP-PSMA was well tolerated with no serious adverse events reported and was therefore considered safe.

"The PRONOUNCED study was completed with a substantial number of changes to the treatment regime made following the THP-PSMA scan and shows how this exciting technology can influence the management of prostate cancer patients," said Professor Jamshed Bomanji, co-investigator and head of department at the Institute of Nuclear Medicine, UCLH. "The new THP-PSMA PET/CT imaging allows for prospective analysis of the clinical disease status rather than retrospective, allowing for better informed decision making."

Greg Mullen, PhD., CEO of Theragnostics added, "We are very pleased that the PRONOUNCED trial has completed with such a positive result, this combined with a positive meeting with the FDA earlier this year on our route to NDA submission are key milestones in bringing THP-PSMA to patients. We are convinced that a THP-PSMA scan will benefit the treatment of prostate cancer patients by better informed and faster decision making. We look forward to sharing these data with the medical community at upcoming scientific congresses and in peer-reviewed publications."

The trial is jointly funded by Innovate UK and Theragnostics and conducted at University College London Hospitals NHS Foundation Trust (UCLH) with multiple referral sites in the UK including Guys and St. Thomas' NHS Foundation Trust (GSTT), Barts Health NHS Trust, Royal Free London NHS Foundation Trust. The study was led by Dr Asim Afaq, UCLH Consultant Radiologist at the Institute of Nuclear Medicine, together with UCLH uro-oncology colleagues including Professor Heather Payne, Dr Reena Davda, Mr John Hines and Prof Gary Cook, Professor of Clinical PET imaging at King's College London and GSTT.

The study was completed with support from the National Institute for Health Research University College London Hospitals Biomedical Research Centre and the Cancer Research UK University College London Experimental Cancer Medicine Centre.

About the PRONOUNCED Trial

The PRONOUNCED trial, "⁶⁸Ga THP-PSMA PET/CT Imaging in High Risk Primary Prostate Cancer or Biochemical Recurrence of Prostate Cancer (PRONOUNCED)," was an open-label study in the UK designed to assess the clinical utility of THP-PSMA scan in the management of patients with primary prostate cancer or with biochemical recurrence of prostate cancer after initial treatment. The primary endpoint evaluated the clinical impact of PSMA (⁶⁸Ga) scan on treatment decisions, assessed by comparing records of the patient's treatment plan after a THP-PSMA scan with the treatment plan prior to the scan. Secondary endpoints included evaluation of the effect of treatment change in patients with positive THP-PSMA scan findings who had a treatment change involving radical salvage therapy; diagnostic performance; PSA threshold; safety assessment and comparison with standard of care imaging (if performed). Follow up of the efficacy and safety of THP-PSMA scan on impacting patient management decisions is ongoing. Theragnostics plans to present results of the PRONOUNCED trial at an upcoming medical congress and subsequently publish full results in a peer-reviewed publication.

About the PSMA (⁶⁸Ga) kit for PSMA PET/CT

PSMA stands for prostate-specific membrane antigen. Its presence is increased in prostate cancer tissue, especially in metastatic tissue. It has been a marker for adverse pathological characteristics and likelihood of relapse of prostate cancer. The THP-PSMA kit provides a clinical tool for detection and imaging of PMSA in real time in the patient.

The enabling THP-PSMA kit binding technology will widen the access of PSMA PET/CT to prostate cancer patients once approved. The ease of use of this kit as well as the lower regulatory requirements for labelling PSMA with ⁶⁸Ga allows for more clinics and pharmacies to perform the labelling in-house.

About Prostate / Recurrent Prostate Cancer

Prostate cancer is the second leading cause of cancer death in men in the United States and EU. The THP-PSMA scan will provide additional information in newly diagnosed high risk prostate cancer patients and determine whether the cancer has spread outside of the prostate bed. While most primary prostate cancer can be successfully treated, the disease recurs in approximately one-third of patients. Post radical treatment, in some patients, recurrent disease is detectable only by a rise in prostate specific antigen (PSA) levels, yet the location of the recurrence cannot be located by conventional imaging, potentially impacting subsequent management of these patients.

About Theragnostics

Theragnostics, a private biotech company based in UK and US, is developing innovative radiopharmaceuticals to improve cancer diagnosis and treatment. It has developed a radiopharmaceutical technology platform that allows for diagnostic tools as well as therapeutic solutions to inform clinical management, guide care and treat cancer patients in areas of unmet medical need. Three diagnostic imaging agents have been successfully developed. The first radiopharmaceutical therapy, rPARP inhibitor THG-009 (I-123 labelled PARPi) is expected to enter clinical development in 2020. Theragnostics is led by recognized experts in the clinical development and commercialization of innovative diagnostic and therapeutic nuclear medicine products.

For more information, visit www.theragnostics.com.

About UCLH

UCLH (University College London Hospitals NHS Foundation Trust) provides first-class acute and specialist services in six hospitals in North Central London. UCLH is committed to education and research and forms part of UCL Partners which in March 2009 was officially designated as one of the UK's first academic health science centres by the Department of Health. UCLH works closely with UCL, translating research into treatments for patients. Please see our website www.uclh.nhs.uk for more information, we are also on Facebook (UCLHNHS), Twitter (@uclh), Youtube (UCLHvideo) and Instagram (@uclh).

National Institute for Health Research

The National Institute for Health Research (NIHR) is the nation's largest funder of health and care research. The NIHR:

• Funds, supports and delivers high quality research that benefits the NHS, public health and social care
• Engages and involves patients, carers and the public in order to improve the reach, quality and impact of research
• Attracts, trains and supports the best researchers to tackle the complex health and care challenges of the future
• Invests in world-class infrastructure and a skilled delivery workforce to translate discoveries into improved treatments and services
• Partners with other public funders, charities and industry to maximise the value of research to patients and the economy

The NIHR was established in 2006 to improve the health and wealth of the nation through research, and is funded by the Department of Health and Social Care. In addition to its national role, the NIHR commissions applied health research to benefit the poorest people in low- and middle-income countries, using Official Development Assistance funding.

SOURCE Theragnostics

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