SYDNEY, March 31, 2020 /PRNewswire/ -- Clarity Pharmaceuticals, a radiopharmaceutical company focused on the treatment of serious disease, is pleased to announce that Dr Gillies O'Bryan-Tear will be chairing Clarity's newly formed Global Clinical Development group.
Dr O'Bryan-Tear joined the pharmaceutical industry in 1986 where he has spent 30 years in clinical development, medical management and commercial roles. In 2009, he became Chief Medical Officer of Algeta ASA, a listed Norwegian biotech company developing a radiopharmaceutical for prostate cancer, Xofigo, which was launched worldwide in 2013. Algeta was acquired in 2014 by Bayer AG for US$2.9 billion.
The Global Clinical Development Group will also include other former members of Algeta including Dr Robert Miller, Clarity's Chief Medical Officer, who has provided medical management and clinical development support over his 30-year career in the industry including many years at Algeta. Dr Anne-Kirsti Aksnes will also join the group and has over 20 years of experience within clinical research and development in the pharmaceutical and biotechnology industry and 10 years' experience in clinical physiology. Dr Aksnes is a consultant with Smerud CRO in Norway and was previously VP Clinical Research at Algeta where she played a key role across strategy, scientific, clinical development and medical affairs.
The Global Clinical Development Group has been formed to fast-track the development of Clarity's next-generation theranostic radiopharmaceuticals based on copper-64 (Cu-64) for diagnosis and copper-67 (Cu-67) for therapy in combination with Clarity's best-in-class chelator for copper.
With all of Clarity's SARTATETM, SAR-Bombesin and SAR-bisPSMA products in clinical trials in 2020, Clarity will use the significant experience of the Global Clinical Development Group to optimise the development pathway to market by using the combined clinical development experience of the group, together with Key Opinion Leaders (KOLs) and Clarity's Scientific Advisory Board (SAB). The group's specific experience in the successful development of prostate cancer therapeutics is extremely relevant to the clinical development of Clarity's SAR-bisPMSA asset which has blockbuster potential as both a stand-alone diagnostic and as a combined therapy.
Dr O'Bryan-Tear commented on his appointment, "I am delighted to be supporting Clarity in the further clinical development of its pipeline of assets together with former colleagues from Algeta. Critical to the success of any product is correctly designing the clinical trials, utilising world leading clinical investigators and focusing on a solid regulatory pathway to market in order to allow Clarity's products to move quickly and efficiently through clinical trials towards commercialisation. By designing these studies correctly from the beginning, we can ensure we have optimised the benefits of the products before coming to market. We are already putting in place plans to strengthen our SAB, which includes the recent appointment of Professor Oliver Sartor, and bring together world class KOLs in the prostate space to support this group."
Clarity's Executive Chairman, Dr Alan Taylor commented, "The outstanding preclinical results to date with our Cu-64 and Cu-67 SAR-bisPSMA prostate cancer agents suggest we may have a best-in-class PSMA molecule despite a small number of competing PSMA agents in clinical trials in the prostate cancer space. When combined with the logistical advantages of Cu-64 and Cu-67, which include longer shelf life, off-site manufacturing and no reliance on generators or nuclear reactors, we see this as a potential game changer for radiopharmaceuticals, allowing us to move into the larger oncology market. By structuring the development pathway correctly, we avoid issues of taking products to market based on the back of studies where therapeutic dosing may not be optimised."
Clarity's Managing Director, Dr Colin Biggin commented, "I am excited to be working again with former Algeta colleagues in the development of a new prostate cancer product. Dr O'Bryan-Tear, Dr Miller and Dr Aksnes have unique experience in having brought a new radiopharmaceutical product to market and we hope to leverage their expertise across our platform of products."
About Clarity
Clarity is a personalised medicine company focused on the treatment of serious diseases. The Company is a leader in innovative radiopharmaceuticals, developing targeted therapies for the treatment of cancer and other serious diseases in adults and children.
www.claritypharmaceuticals.com
Media Contact
Dr Alan Taylor
Executive Chairman
+61(0)413 871 165
ataylor@claritypharm.com
![Figure 1. Images show considerable reduction in lesion uptake (64Cu-SAR-bisPSMA PET) following 4 doses of 67Cu-SAR-bisPSMA (4GBq each; PET conducted in July 2024, approximately 14 months post-fourth cycle). Reduction in uptake (maximum standardised uptake value [SUVmax]) and tumour volume: 72.5% and 41.6%, respectively. New bone lesions identified (red circles) in the most recent image prior to the fifth dose. The fifth dose was delivered on 30 July 2024, with PSA having fallen 47.5% as of 24 September 2024 and trending downward. Post-treatment scans are pending.](https://mma.prnasia.com/media2/2531886/Images_show_considerable_reduction_lesion_uptake__64Cu_SAR_bisPSMA_PET__4_doses.jpg?p=medium600)
