NASA SBIR 2017 Solicitation

FORM B - PROPOSAL SUMMARY


PROPOSAL NUMBER: 171 H12.01-9189
SUBTOPIC TITLE: Radioprotectors and Mitigators of Space Radiation-induced Health Risks
PROPOSAL TITLE: Protecting cardiomyocytes from mixed fields of radiation by BIO 300

SMALL BUSINESS CONCERN (Firm Name, Mail Address, City/State/Zip, Phone)
Humanetics Corporation
7650 Edinborough Way, Suite 620
Edina, MN 55435 - 6012
(952) 937-7660

PRINCIPAL INVESTIGATOR/PROJECT MANAGER (Name, E-mail, Mail Address, City/State/Zip, Phone)
Michael David Kaytor PhD
mkaytor@humaneticscorp.com
7650 Edinborough Way, Suite 620
Edina, MN 55435 - 6012
(952) 400-0406

CORPORATE/BUSINESS OFFICIAL (Name, E-mail, Mail Address, City/State/Zip, Phone)
Mr. John Dykstra
jdykstra@humaneticscorp.com
7650 Edinborough Way, Suite 620
Edina, MN 55435 - 6012
(952) 400-0404

Estimated Technology Readiness Level (TRL) at beginning and end of contract:
Begin: 5
End: 6

Technology Available (TAV) Subtopics
Radioprotectors and Mitigators of Space Radiation-induced Health Risks is a Technology Available (TAV) subtopic that includes NASA Intellectual Property (IP). Do you plan to use the NASA IP under the award?
No

TECHNICAL ABSTRACT (Limit 2000 characters, approximately 200 words)
The cumulative dose of radiation exposure to our astronauts remains one of the limiting roadblocks to longer duration missions in space. Humanetics Corporation (Humanetics) is developing a novel radioprotectant, BIO 300, for use in both clinical radiotherapy and as a radiation countermeasure. BIO 300 is a safe, shelf-stable pharmaceutical which has been shown to mitigate both the acute and delayed effects of radiation exposure. BIO 300 is in advanced stages of clinical development, and is currently being evaluated as a radioprotectant of healthy lung tissue during radiotherapy treatment for non-small cell lung cancer in a Phase I/II trial. One component of developing radioprotectants for space is understanding if the therapy can protect against broad-spectrums of ionizing radiation, rather than just man-made X-Rays. Thus, the objective of this proposal is to examine BIO 300's radioprotective capabilities against mission-relevant doses of neutron/gamma mixed-fields of radiation. Another component of the work proposed here, is to utilize a novel cellular platform of terminally differentiated human cardiomyocytes to investigate degenerative consequences of radiation exposure in a functional human tissue model. Together, these studies will validate the utility of BIO 300 as a countermeasure for extraterrestrial radiation exposures.

POTENTIAL NASA COMMERCIAL APPLICATIONS (Limit 1500 characters, approximately 150 words)
BIO 300 is intended as a broadly utilized radioprotectant therapy to mitigate the cellular and biological consequences of radiation exposure. In our Phase I/II clinical trial, 7 patients have taken BIO 300 daily for 8 weeks, while undergoing daily fractionated radiation doses of 2Gy, for a total cumulative dose of 60 Gy. Thus, we suggest that BIO 300 could be taken daily for the entire duration of a mission. Yet as chronic dosing for multiple astronauts may become weight limiting (with respect to amount of drug required to be put on a rocket) we also have data suggesting that BIO 300 can be taken acutely (in 1-3 doses) to mitigate larger radiation events, such as Solar Particle Events. As these events can constitute a large percentage of the total radiation dose over the mission, BIO 300 could be administered intermittently to mitigate these larger exposure radiological events.

POTENTIAL NON-NASA COMMERCIAL APPLICATIONS (Limit 1500 characters, approximately 150 words)
Humanetics is aggressively pursuing multiple modes of radioprotection interests for Earth applications. Our interest in the protection of normal tissue during clinical radiotherapy has manifested itself into a clinical trial in lung cancer patients receiving fractionated radiotherapy. Secondly, in preclinical studies, BIO 300 has been shown to mitigate radiation-induced erectile dysfunction following prostate radiation. Hence, a clinical trial in prostate cancer patients is planned to evaluate BIO 300?s ability to prevent radiation-induced erectile dysfunction. Finally, BIO 300 is being developed as a low-dose radioprotectant. For example, there is significant evidence that medical imaging techniques (e.g. CT Scans) which rely on ionizing radiation can pose significant risks, especially in younger patients and those subjected to multiple scans. For example, some traumatic brain injury patients will receive 20 to 50 brain CTs in a single year. Other applications of BIO 300 development include Department of Defense interests in countermeasures for radiation exposure.

TECHNOLOGY TAXONOMY MAPPING (NASA's technology taxonomy has been developed by the SBIR-STTR program to disseminate awareness of proposed and awarded R/R&D in the agency. It is a listing of over 100 technologies, sorted into broad categories, of interest to NASA.)
Physiological/Psychological Countermeasures

Form Generated on 04-19-17 12:59