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In re Lupron ® Marketing and Sales Practices Litigation

United States District Court, D. Massachusetts

December 22, 2015

IN RE LUPRON ® MARKETING AND SALES PRACTICES LITIGATION, M.D.L. No. 1430

MEMORANDUM ACKNOWLEDGING THE RECEIPT AND REVIEW OF THE A. DAVID MAZZONE RESEARCH PROGRAM’S ANNUAL PROGRESS REPORT FOR 2014-2015

RICHARD G. STEARNS UNITED STATES DISTRICT JUDGE

On November 2, 2015, Dr. Philip Kantoff of the Dana-Farber/Harvard Cancer Center (DF/HCC), the principal investigator for the A. David Mazzone Research Awards Program (Program), [1] and co-principal investigator, Dr. Jonathan Simon, President of the Prostate Cancer Foundation (PCF), submitted the 2014-2015 Report on the progress of the Mazzone Program grantees supported through DF/HCC and PCF. This Report notes the medical and scientific achievements of the grantees and their accounting of expenditures on the twenty-two current Program projects, the DF/HCC student training project, and the CURE Mazzone award all for the period August 1, 2014 to July 31, 2015.

Prior to the previous 2014 reporting period, the court allocated an additional $140, 000 of Program monies to fund two Disparities Research grants of $90, 000 and $50, 000 each, and another $20, 000 to support student training through the DF/HCC Cure Program. PCF also awarded its final $500, 000 matching grant.[2]

As of July 2015, year 2012 DF/HCC and PCF research award recipients had completed the maximum three year funding cycle; year 2013 grantees had completed the second year; and year 2014 grantees the first. Each award recipient has submitted annual scientific progress and financial reports for review and approval by Dr. Kantoff and Dr. Simon, where appropriate members of the Scientific Advisory Board (SAB).[3] Grantee institutions have also submitted the required reports.

The cumulative reports paint a picture of solid progress in achieving the Program’s goal of finding a cure for prostate cancer and related diseases. Some highlights portrayed in Dr. Kantoff’s and Dr. Simon’s Report include:

High Impact Projects 2012

Defining the Spectrum of Resistance to Androgen Ablation Therapy in Prostate Cancer, Levi A. Garraway In completing this high impact grant, researchers:

1. Identified loss of INPP5A as a candidate of resistance to androgen-deprivation;
2. Discovered that INPP5A genomic loss is enriched in CRCP clinical tumor samples;
3. Revealed lower INPP5A mRNA expression in PDx derived from patients with poor or no response to castration therapy;
4. Performed molecular characterization of the mechanism of resistance driven by INPP5A silencing, suggesting a role for CamKII signaling; and
5. Initiated optimization work to perform gain-of-function CRISPRA screens with LNCaP cells to study castration-resistance.

Dr. Garraway’s team plans to continue intensive mechanistic studies of INPP5A-silencing-driven resistance to castration. Members will also initiate the CRISPRA-gain-of-function pooled screen in LNCaP cells to study resistance to CSS enzalutamide or ARN-509. Dr. Garraway reports that the results achieved through the shRNA screening supported by a Mazzone Award have enabled him and members of his team, including Ginevra Botta, the ...


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