2021年3月9日

一个“S-HERTOGENBOSCH,荷兰,2021年3月9日,虎鲸疗法从帐面价值临床分期生物制药公司开发溶瘤病毒治疗实体肿瘤,高兴地宣布,在审查所有安全数据的全面登记,低收入和mid-dose病人群不断1/2a期临床研究的虎鲸- 010在首次治疗局限性前列腺癌患者,独立的数据和安全监测委员会(DSMB)一致推荐研究的延续没有修改。从这个建议,虎鲸疗法将启动政府计划剂量水平最高的虎鲸- 010的单剂量研究的一部分。这个建议后,虎鲸疗法帐面价值的最高剂量的手臂已经开始招生的剂量递增阶段这一研究中,第一个病人安排在政府2021年3月。在手臂的入学人数最高的研究结论,DSMB将进行额外审查开始重复之前虎鲸- 010剂量试验的一部分。在最低剂量研究,虎鲸- 010很强的单抗肿瘤活性的第一个病人。此外,核磁共振数据反映出一个令人印象深刻的和显著降低前列腺体积恢复正常大小,以及持续降低PSA。这种模式已被证实在第二个病人完成了6个月的随访MRI,并显示前列腺体积恢复接近正常大小。投资者积极看待DSMB建议和最近的临床成功通过投资另一轮的融资进展虎鲸- 010的发展。虎鲸- 010得到了研究人员的注意,最近,虎鲸疗法容积已开始讨论准备研究不可切除的患者临床上食道癌。 "12% of all men will be diagnosed with prostate cancer in their lifetime. We are encouraged by the safety profile and preliminary efficacy of ORCA-010 and are excited to continue enrollment in the highest dose cohort of this Phase 1/2a study, our first clinical study with ORCA-010," said Kees Groen, ORCA Therapeutics' CEO. "We are grateful for the continuous support from our investors. The generous contributions enable ORCA Therapeutics to progress ORCA-010's development for treating prostate cancer." ORCA Therapeutics B.V.'s two-part Phase 1/2a study is a multi-center, open-label, dose-escalation study of ORCA-010 in approximately 24 treatment-naïve patients with localized prostate cancer: Part A: Dose-escalation phase to define the safety, tolerability, and optimal dose level of ORCA-010 in treatment-naïve patients with localized prostate cancer. This phase is expected to enroll up to 12 patients in three dose cohorts. Part B: A subsequent extension of the optimal dose level, as defined in the dose escalation phase, and given as two doses with 2 weeks interval. This phase is expected to enroll approximately 12 additional patients. For more information, please visit http://www.orca-therapeutics.nl/ View original content:http://www.prnewswire.com/news-releases/orca-therapeutics-to-start-highest-dose-in-treatment-naive-prostate-cancer-301243554.html