PR Newswire
09 Feb 2023, 19:33 GMT+10
![]() |
SYDNEY, Feb. 9, 2023 /PRNewswire/ -- Clarity Pharmaceuticals (ASX: CU6) ("Clarity"), a clinical-stage radiopharmaceutical company with a mission to develop next-generation products that improve treatment outcomes for children and adults with cancer, is pleased to announce its diagnostic 64Cu SAR-bisPSMA trial COBRA (NCT05249127)1 for patients with prostate cancer has reached its recruitment target.
COBRA (Copper-64 SAR-bisPSMA in Biochemically Recurrent prostAte cancer) is a Phase I/II Positron Emission Tomography (PET) trial of participants with biochemical recurrence (BCR) of prostate cancer following definitive therapy. It is a multi-centre, single arm, non-randomised, open-label trial of 64Cu-labelled SAR-bisPSMA in 50 participants. The primary objectives of the trial are to investigate the safety and tolerability of 64Cu-SAR-bisPSMA as well as its ability to correctly detect the recurrence of prostate cancer.
Dr Neal Shore MD, FACS Lead Principal Investigator in the COBRA trial and CMO - Urology/Surgical Oncology, GenesisCare, US and the Medical Director of Carolina Urologic Research Centre, commented, "We are very pleased to have reached our recruitment target for the COBRA trial. The data generated thus far on the SAR-bisPSMA product is very encouraging and shows high uptake of the agent by prostate cancer cells. The high uptake of product and the ability to image the patients at later timepoints adds both patient and clinic flexibility for locating and visualising even low volume tumours, a unique feature of this imaging technology. It is important for improving prostate cancer recurrence detection where the cancer burden may be quite low and thus identifying the specific location provides clinically important implications for the patients' therapeutic selection. We look forward to analysing the COBRA trial data and advancing the clinical development of SAR-bisPSMA together with Clarity."
Clarity's Executive Chairman, Dr Alan Taylor, commented, "We are very pleased with the progress in the development of the SAR-bisPSMA product across all of our trials, which continues to build a lot of excitement and was reflected by the pace of recruitment in the COBRA trial. In addition to potential clinical benefits due to higher uptake and the flexibility of imaging timepoints, 64Cu SAR-bisPSMA has a number of logistical and manufacturing advantages in comparison to other currently used PSMA agents. The ready-to-use product has been shipped to the trial sites in the US from a central manufacturing facility on-demand and on time, providing flexibility and reliability to the patients and their treating staff. This facilitates expanding the radiopharmaceutical field into the large oncology market, minimising logistical and image timing hindrances associated with the current generation of radio-diagnostics, and helping to focus on the needs of patients and their clinicians.
"COBRA is our second diagnostic trial of SAR-bisPSMA in prostate cancer. It reaches its recruitment target shortly after receiving positive top-line results in our PROPELLER trial. Running two trials with this product is in line with advice received from the US FDA to address the two relevant patient populations for registration of 64Cu SAR-bisPSMA: in pre-prostatectomy/pre-definitive treatment of patients with confirmed prostate cancer (PROPELLER trial); and in patients with suspected BCR of prostate cancer (COBRA trial).
"We look forward to analysing the data from the COBRA trial with a view to initiating a Phase III trial in this patient population."
About SAR-bisPSMA
SAR-bisPSMA derives its name from the word "bis", which reflects a novel approach of connecting two prostate-specific membrane antigen (PSMA) binding motifs to Clarity's proprietary sarcophagene (SAR) technology that securely holds copper isotopes inside a cage-like structure, called a chelator. Unlike other commercially available chelators, the SAR technology prevents copper leakage into the body. SAR-bisPSMA is a Targeted Copper Theranostic (TCT) that can be used with isotopes of copper-64 (Cu-64 or 64Cu) for imaging and copper-67 (Cu-67 or 67Cu) for therapy.
About Prostate Cancer
Prostate cancer is the second most common cancer diagnosed in men globally and the fifth leading cause of cancer death worldwide2. The American Cancer Institute estimates in 2023 there will be 288,300 new cases of prostate cancer in the US and around 34,700 deaths from the disease3.
About Clarity Pharmaceuticals
Clarity is a clinical stage radiopharmaceutical company focused on the treatment of serious disease. The Company is a leader in innovative radiopharmaceuticals, developing Targeted Copper Theranostics based on its SAR Technology Platform for the treatment of cancer in children and adults.
www.claritypharmaceuticals.com
References
For more information, please contact:
Clarity Pharmaceuticals | ||||
Dr Alan Taylor | Catherine Strong | |||
Executive Chairman | Investor/Media Relations | |||
+61 406 759 268 |
This announcement has been authorised for release by the Executive Chairman.
Get a daily dose of Asia Bulletin news through our daily email, its complimentary and keeps you fully up to date with world and business news as well.
Publish news of your business, community or sports group, personnel appointments, major event and more by submitting a news release to Asia Bulletin.
More InformationPARIS, France: France is taking stronger steps to reduce smoking. A new health rule announced on Saturday will soon ban smoking in...
WASHINGTON, DC - U.S. President Donald Trump on Tuesday claimed Elon Musk's success has been built on government subsidies. Without...
EVERGLADES, Florida: Over the weekend, a diverse coalition of environmental activists, Native American leaders, and residents gathered...
BEIJING, China: China's national soccer team may struggle to stir excitement, but its humanoid robots are drawing cheers — and not...
]LONDON, U.K.: A World Health Organization (WHO) expert group investigating the origins of the COVID-19 pandemic released its final...
DOVER, Delaware: California Governor Gavin Newsom has taken legal aim at Fox News, accusing the network of deliberately distorting...
KABUL, Afghanistan: Afghanistan, long associated with war and instability, is quietly trying to rebrand itself as a destination for...
SANTA CLARA, California: Executives at Nvidia have quietly been cashing in on the AI frenzy. According to a report by the Financial...
NEW YORK, New York - Global stock indices closed with divergent performances on Tuesday, as investors weighed corporate earnings, central...
TORONTO, Canada: Canadian Prime Minister Mark Carney announced late on June 29 that trade negotiations with the U.S. have recommenced...
Vancouver, Canada: A high-stakes legal showdown is brewing in the world of athleisure. Lululemon, the Canadian brand known for its...
LONDON, U.K.: British oil giant Shell has denied reports that it is in talks to acquire rival oil company BP. The Wall Street Journal...