Topic 346: Targeted Radionuclide Therapy of Neuroendocrine Tumors Using 212Pb-octreotate Analogs

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 75N91018C00048-0-0-0
Agency Tracking Number: N44CA180048
Amount: $1,994,002.00
Phase: Phase II
Program: SBIR
Solicitation Topic Code: NCI
Solicitation Number: N/A
Solicitation Year: 2017
Award Year: 2018
Award Start Date (Proposal Award Date): N/A
Award End Date (Contract End Date): N/A
Small Business Information
9701 Richmond Ave, HOUSTON, TX, 77042
DUNS: 782281302
HUBZone Owned: N
Woman Owned: N
Socially and Economically Disadvantaged: N
Principal Investigator
 Izabela Tworowska
 (832) 868-2812
Business Contact
 Izabela Tworowska
Phone: (832) 868-2812
Research Institution
A peptide receptor radionuclide therapy (PRRT) using [177Lu]/[90Y]-labeled somatostatin analogs has been proven to induce objective response in 30-45% of patients with advanced/progressive neuroendocrine tumors (NETs). The complete response to beta-emitter PRRT is rare. This is due to the fact that NETs are diagnosed at late stage of disease; the NETs patients with remissions could develop resistance to beta-radiation therapy that could be overcome by alpha-emitter-targeted-therapy (TAT). The commercial potential of TAT has been confirmed by recent introduction of Xofigo for therapy of bone metastasis in prostate cancer; and remissions of NETs in patients undergoing therapy with [213Bi]DOTATOC and [225Ac]DOTA-TATOC. The TAT has a potential to revolutionize treatment of NETs whether applied alone or supported by beta-emitter PRRT. It can significantly enhance therapeutic efficacy of PRRT without side effects on non-targeted normal tissues. Our Phase I Contract produced favorable results of the pre-clinical efficacy, long term-toxicity and dosimetry studies [212Pb]-octreotate. These results together with the safety, and dosimetry of 203Pb-octreotate in human allow us to propose the following objectives for the Phase II Contract: 1) Manufacturing of the clinical doses of [212Pb]-octreotate; (2) Initiation of Phase I dose escalation clinical studies of [212Pb]-octreotate in NETs patients. With success in these aims, we expect to a) evaluate our bussiness model of centralized production of clinical doses of [212Pb]-octreotate; b) assess the safety, and dose limiting toxicity of ascending doses of agent used for TAT of subjects with somatostatin receptor expressing NETs; c) determine the PK and the preliminary effectiveness of ascending doses of this drug.

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

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