Aerosolized platinum nanoparticle chemotherapy for lung cancer

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R43CA203142-01A1
Agency Tracking Number: R43CA203142
Amount: $298,065.00
Phase: Phase I
Program: SBIR
Solicitation Topic Code: 102
Solicitation Number: PA15-269
Solicitation Year: 2015
Award Year: 2017
Award Start Date (Proposal Award Date): 2017-02-01
Award End Date (Contract End Date): 2019-07-31
Small Business Information
2029 BECKER DR, Lawrence, KS, 66047-1620
DUNS: 020057359
HUBZone Owned: N
Woman Owned: N
Socially and Economically Disadvantaged: N
Principal Investigator
 (724) 480-5850
Business Contact
Phone: (785) 813-1331
Research Institution
Significance Lung cancer is the leading cause of cancer deaths with over new diagnoses annually Survival rate of lung cancer patients is correlated with the extent of lymph node metastasis Standard care includes chemotherapy radiation and or surgery Cisplatin is a first line chemotherapy for lung cancer but systemic intravenous IV delivery is confounded by various toxicities renal toxicity is dose limiting poor penetration into tumors and lymph nodes organ damage and resistance Solution Delivery of high dose targeted cisplatin directly to lung cancers can increase the therapeutic window increasing efficacy and renal safety even in platinum resistant patients Product The product of this SBIR will be pulmonary delivery of an aerosolized chemotherapeutic HylaPlat that delivers high dose targeted cisplatin directly to the lungs targeting primary lung cancers and lymphatic metastases to replace IV cisplatin therapy for locally advanced CD non small cell lung cancers Innovation Formulation HylaPlatandapos s formulation is a hyaluronan HA cisplatin conjugate Innovation Aerosol Delivery Directly to Lungs Direct administration to the lungs deposits HylaPlat at the site of action The innovation of HylaPlat which is the combination of its formulation and aerosolized delivery has four major advantages HA targets CD tumor cells CD expression is associated with metastasis and poor prognosis High drug levels in lungs High drug levels in lymph nodes targets metastases Improved PK Collectively these advantages are expected to result in significantly increased efficacy and renal safety over standard of care IV cisplatin Unlike many targeted cancer therapies in development that are limited to specific types of cancers HylaPlat has demonstrated efficacy in models of several cancer types Most strikingly or fewer doses of peri tumoral HylaPlat achieved a complete response in of dogs presenting at a veterinary hospital with naturally occurring age related head and neck squamous cell carcinomas significantly better than a success rate with IV cisplatin Therefore the major unanswered question is whether pulmonary delivery of aerosolized HylaPlat is safe and effective for targeting lung cancers Hypothesis Pulmonary delivery of aerosolized HylaPlat will be more efficacious and more tolerable than IV cisplatin in rodent models of lung cancer Preliminary results indicate that a single dose of aerosolized HylaPlat significantly attenuates the growth of lung cancer allografts in immunocompetent mice In this project we will establish feasibility of pulmonary delivery of aerosolized HylaPlat for lung cancer by demonstrating increased efficacy and preferential target tissue distribution and pharmacokinetics over standard of care IV cisplatin in rodent models This Phase I SBIR will position aerosolized HylaPlat for IND enabling studies SBIR Phase II award after which Hylapharm will seek partnerships for human phase I clinical trials PROJECT NARRATIVE In this Phase I SBIR HylaPharm LLC plans to develop an aerosolized chemotherapeutic HylaPlat that is administered directly to the lungs targeting primary lung cancers and potential lymphatic metastases This is relevant to public health because the local and targeted delivery of HylaPlat will prevent the spread of metastatic cancer reduce the toxicity of chemotherapy and lessen the need for extensive surgical resection and radiotherapy all of which cause irreversible harm to patientsandapos health and quality of life Thus the proposed research is relevant to the NIHandapos s mission to develop knowledge that will help reduce the burdens of human illness

* Information listed above is at the time of submission. *

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