Commercialization of Safe and Effective Locoregional Head and Neck Cancer Therapy

根据口腔癌症基金会的数据，今年有超过51,000名美国人被诊断出患有口腔和咽癌， 造成1万多人死亡，大约每小时一人。全世界新确诊的口腔癌病例超过64万例， 只有一半的人能在首次诊断后存活5年以上。到2020年，全球年发病率预计将达到 增加到超过84万人，增加30%，每年的死亡率增加到近48万人，大约增加37%。 口腔癌是所有癌症中自杀率最高的癌症之一，因为口腔癌导致永久性肢体残疾 令人难看的手术。这些症状包括永久性言语障碍、吞咽障碍和/或颌骨丧失。 因为手术切除了舌头和其他口腔组织。与治疗相关的长期成本和这些 残疾从100,000美元到250,000美元不等，导致口腔癌持续成为所有癌症中最昂贵的癌症之一 为了治疗。尽管有这些现实情况，口腔癌仍然得不到足够的服务，而且在美国国内的发病率仍在上升 以及世界范围内。晚期口腔鳞癌患者的存活率主要受局部治疗失败/复发的影响。 为了满足这一需求，Privo开发了其主导产品PRV111。这是一种纳米工程的贴片，可以直接放置 转移到肿瘤上。通过将顺铂-化疗纳米粒保留在局部，PRV111已显示出在 对肿瘤和区域淋巴结无任何全身副作用。PRV111‘S局部治疗可解决 超过75%的OC患者在首次诊断时需要治疗。PRV111的目标是减少肿瘤 复发，同时减少面部毁容的数量。PRV111治疗目前处于第二阶段临床试验 结果令人振奋。基于PRV111的S中期数据，FDA已经为这项临床研究提供了200万美元的资金，以支持目前的 完成临床研究。 在这项提案中，Privo要求提供资金，以完成其GMP制造的商业化，扩大其专利 进行市场研究，制定定价和报销策略。 如果获得资金，Privo还从投资者那里获得了300万美元的非SBIR资金，用于PRV111‘S 如果这项提案获得通过，就需要商业化。 Privo认为，PRV111治疗与NIDCR的目标密切一致，即提供更安全、更有效和更少的 口腔癌患者的昂贵治疗。

According to the Oral Cancer Foundation, over 51,000 Americans are diagnosed with oral and pharyngeal cancer this year, causing over 10,000 deaths, roughly one person every hour. Over 640,000 new oral cancer cases were diagnosed worldwide, and only half will live more than 5 years after initial diagnosis. By 2020, the annual worldwide incidence is predicted to increase to over 840,000, a 30% rise, and the annual mortality to increase to nearly 480,000, approximately a 37% increase. Oral cancer has one of the highest suicide rates of all cancers due to permanent physical disabilities resulting from disfiguring surgeries. These include permanent speech impairment, an inability to swallow, and/or the loss of the jawbone due to the surgical removal of the tongue and other oral tissue. The long-term costs associated with the treatment and these disabilities can range from $100,000-$250,000, resulting in oral cancer persisting as one of the most expensive of all cancers to treat. Despite these realities, oral cancer remains underserved and remains on the rise in incidence both within the US and worldwide. Survival in patients with advanced OSCC is driven primarily by locoregional treatment failure/recurrence. To address this need, Privo has developed its lead product, PRV111. It is a nano-engineered patch that can be placed directly onto the tumor. By retaining its cisplatin-chemotherapy nanoparticles local, PRV111has shown to destroy cancer cells in the tumor and regional lymph nodes without any systemic side effects. PRV111’s locoregional treatment can address the treatment needs of over 75% of OC patients at the time of their initial diagnosis. The goal of PRV111 is to reduce tumor recurrence while decreasing the amount of facial disfigurement. PRV111 treatment is currently in a Phase 2 clinical trial with promising results. Based on PRV111’s interim data, the FDA has funded the clinical study $2M to support the current clinical study to completion. In this proposal Privo is requesting funds to complete its commercialization of its GMP manufacturing, to expand its patent portfolio and to conduct market research and develop pricing and reimbursement strategies. If funded, Privo has also secured commitments for $3M non-SBIR funds from investors to be used toward PRV111’s commercialization needs if this proposal is awarded. Privo believes that PRV111 treatment aligns closely with the aims of NIDCR in providing a safer, more effective, and less costly treatment for oral cancer patients.