Commercialization of Safe and Effective Locoregional Head and Neck Cancer Therapy

根据口腔癌基金会的数据，今年有超过51,000名美国人被诊断出患有口腔癌和咽癌， 造成一万多人死亡，大约每小时一人全世界诊断出超过64万例新的口腔癌病例， 只有一半的人在初次诊断后能活5年以上。到2020年，预计全球每年的发病率将 增加到超过八十四万人，上升百分之三十，每年死亡人数增加到将近四十八万人，大约上升百分之三十七。 口腔癌是所有癌症中自杀率最高的癌症之一，这是由于口腔癌导致的永久性身体残疾。 毁容手术这些包括永久性语言障碍，无法吞咽，和/或颌骨的损失 因为手术切除了舌头和其他口腔组织。与治疗相关的长期费用以及 残疾的范围可以从100，000美元到250，000美元，导致口腔癌持续成为所有癌症中最昂贵的癌症之一。 尽管存在这些现实，口腔癌仍然得不到充分的治疗，并且在美国的发病率仍在上升， 和世界各地。晚期OSCC患者的生存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PRV 111。它是一种纳米工程贴片， 转移到肿瘤上通过将其顺铂化疗纳米颗粒保留在局部，PRV 111已被证明可以破坏癌细胞， 肿瘤和局部淋巴结无任何全身副作用。PRV 111的局部治疗可以解决 超过75%的OC患者在首次诊断时需要治疗。PRV 111的目标是减少肿瘤 复发，同时减少面部毁容的数量。PRV 111治疗目前处于2期临床试验中 取得了可喜的成果。根据PRV 111的中期数据，FDA已经资助了200万美元的临床研究，以支持目前的 完成临床研究。 在这份提案中，Privo要求获得资金，以完成其GMP生产的商业化， 投资组合，并进行市场研究，制定定价和报销策略。 如果获得资助，Privo还从投资者那里获得了300万美元非SBIR资金的承诺，用于PRV 111的 商业化的需要，如果这个建议被授予。 Privo认为，PRV 111治疗与NIDCR的目标密切相关，提供了一种更安全，更有效，更少 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.