[Asia Economy Reporter Lim Jeong-su] Hyundai Bioscience is advancing global clinical trials for the pancreatic cancer treatment 'Polytaxel'.
On the 1st, Hyundai Bioscience announced that it had signed an agreement with N Company, a major clinical contract research organization (CRO) in Australia, to conduct Phase 1/2a clinical trials. In cooperation with the Australian CRO, the company plans to promptly commence Phase 1/2a clinical trials locally to obtain new drug approval for Polytaxel as soon as preparations for the clinical trial are completed.
On the 26th of last month, Hyundai Bioscience signed an intellectual property rights transfer agreement related to the pancreatic cancer treatment with C&Pharm. This was seen as a significant step in securing exclusive business rights for the production and sales of new drugs for pancreatic cancer treatment based on Polytaxel, laying the foundation to lead related businesses.
Polytaxel is the first new drug developed by C&Pharm, the major shareholder of Hyundai Bioscience, using its proprietary polyphosphazene-based drug delivery technology. It has been reported that in preclinical studies, Polytaxel demonstrated relatively superior safety and efficacy compared to the existing pancreatic cancer treatment nab-paclitaxel, suppressing tumor growth by 99.8% at doses within the No Observed Adverse Effect Level (NOAEL) without showing side effects.
Regarding the choice of Australia for conducting Phase 1 clinical trials, Hyundai Bioscience explained that the clinical procedures in Australia are relatively faster compared to other advanced countries such as the United States. In fact, Australia is known internationally as a preferred country for early-stage clinical trials because it grants clinical trial initiation approvals within just 6 to 8 weeks, allowing clinical procedures to proceed quickly.
Hyundai Bioscience described the contracted CRO as a global company with extensive experience in conducting oncology clinical trials and the largest bio-specialized CRO in not only Australia but the entire Asia-Pacific region. The company also anticipated that completing Phase 1 trials in Australia would be advantageous for bridging studies to enter global Phase 2 trials in the United States.
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