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SYSTEMIC RADIOTHERAPY FOR METASTATIC MELANOMAS: INNOVATION OF A NOVEL RADIOPHARMA

Award Number: R44CA138041
ORGANIZATION: NATIONAL CANCER INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/16/2008
PERIOD OF PERFORMANCE END DATE: 08/31/2012

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SYSTEMIC RADIOTHERAPY FOR METASTATIC MELANOMAS: INNOVATION OF A NOVEL RADIOPHARMA - DESCRIPTION (provided by applicant): The ultimate goal of this Fast Track Phase I/II SBIR proposal is to develop the novel pharmaceutical agent 131I-MIP-1145, as a molecular targeting radio-therapeutic treatment for metastatic melanoma. Preliminary results with the former lead compound were highly successful in animal tumor models and human melanoma patients. During purity testing for animal safety studies, radiolysis induced degradation at high radioactive concentrations prohibited development of the first generation compound. Chemical and preclinical evaluation identified the compound MIP-1145 to have greater chemical stability with more desirable distribution properties in animals. 131I-MIP-1145 is a radio-iodinated benzamide molecule with extremely high selective binding to melanin expressing melanomas with prolonged retention and low non-target organ accumulation. The molecular target specificity and high tumor accumulation of 131I-MIP-1145 are ideal properties for an agent to effectively treat melanoma metastasis. Preliminary preclinical efficacy studies demonstrated complete tumor remission after two treatments with 131I-MIP-1145 in a SK-Mel-3 human melanoma xenograft mouse model. The first six month phase of this proposal will focus on developing a stable formulation for large doses (150 mCi) of high specific activity 131I-MIP-1145. The formulation composition must be firmly established prior to conducting extensive pre-clinical safety and efficacy studies. The second phase of the proposal will focus on developing a continuous flow production process that will be validated on an automated laboratory synthesis system, to reduce radiation exposure to personnel and provide sufficient levels of activity for therapeutic clinical trials. To produce material for human testing, a GMP production campaign for the critical component precursor and reference standard must be initiated. Radioactive 131I-MIP-1145 material from pre-validation productions will also be used to perform animal safety and toxicity testing. The data on process development chemistry, manufacturing and controls, analytical testing, chemical stability as well as pre-clinical toxicity studies will be the backbone of an application to the FDA. The justification for requesting Fast Track consideration is to have the therapeutic scale production batch ready to treat patients as soon as the imaging / dosimetry study is performed in human melanoma patients. The innovation in this proposal is the exciting promise for a potential curative therapeutic treatment of metastatic melanoma. Following successful completion of the SBIR program, Molecular Insight will develop a clinical protocol for an industry sponsored IND application to the FDA.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2011 ( Subtotal = $722,670 )
2011	2011	MOLECULAR INSIGHT PHARMACEUTICALS INC	160 SECOND STREET	CAMBRIDGE	MA	02142	MIDDLESEX	USA	Cancer Treatment Research	000	4	8/11/2011	NON-COMPETING CONTINUATION	$722,670
														Subtotal = $722,670

Issue Date FY: 2010 ( Subtotal = $0 )
2010	2010	MOLECULAR INSIGHT PHARMACEUTICALS INC	160 SECOND STREET	CAMBRIDGE	MA	02142	MIDDLESEX	USA	Cancer Treatment Research	000	3	9/17/2010	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2009 ( Subtotal = $911,810 )
2009	2009	MOLECULAR INSIGHT PHARMACEUTICALS INC	160 SECOND STREET	CAMBRIDGE	MA	02142	MIDDLESEX	USA	Cancer Treatment Research	001	2	8/18/2009	EXTENSION WITH OR WITHOUT FUNDS	$911,810
2009	2008	MOLECULAR INSIGHT PHARMACEUTICALS INC	160 SECOND STREET	CAMBRIDGE	MA	02142	MIDDLESEX	USA	Cancer Treatment Research	000	1	10/31/2008	NEW	$0
														Subtotal = $911,810

Issue Date FY: 2008 ( Subtotal = $331,449 )
2008	2008	MOLECULAR INSIGHT PHARMACEUTICALS INC	160 SECOND STREET	CAMBRIDGE	MA	02142	MIDDLESEX	USA	Cancer Treatment Research	000	1	9/16/2008	NEW	$331,449
														Subtotal = $331,449

Grand Total All Awards = $1,965,929

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SYSTEMIC RADIOTHERAPY FOR METASTATIC MELANOMAS: INNOVATION OF A NOVEL RADIOPHARMA

Award Number: R44CA138041

ORGANIZATION: NATIONAL CANCER INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 09/16/2008

PERIOD OF PERFORMANCE END DATE: 08/31/2012

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