Epstein Files Search

EFTA00810576Set 9

2018-04-0526p9,385w

substrate for multiple drug resistance mechanisms that plague the chemo therapy drugs like docetaxel (taxotere) which is an important first-line chemotherapy drug for Prostate cancer. Also. as a novel ... indication expansion Preclinical studies presented by Veru, showed a few advantages compared to Docetaxel. Oral administration of VERU-111 shows comparable tumor inhibition with IV administered Docetaxel in PC3 prostate ... cells was seen at 5.2 nM of VERU-111. comparable inhibition with Docetaxel was better at 1.2 nM, however, much better in vitro tumor inhibition was seen when taxol-resistant

https://www.justice.gov/epstein/files/DataSet%209/EFTA00810576.pdf

EFTA00857649Set 9

2018-03-164p1,957w

novel oral alpha and beta tubulin inhibitor, VERU-111, compared with IV docetaxel in a resistant prostate cancer model. IV docetaxel had no impact on tumor growth whereas oral VERU ... Microtubules are critical for cancer cell replication to stimulate genes for cancer cell proliferation. Docetaxel and cabazitaxel are examples of FDA-approved chemotherapy drugs that are given intravenously (IV) that ... billion annual market for IV-given taxanes and vinca alkaloids chemotherapies (docetaxel $1 billion and cabazitaxel $500 million in prostate cancer) per Decision Resources Group and Allied Market Research. Second

https://www.justice.gov/epstein/files/DataSet%209/EFTA00857649.pdf

EFTA00810552Set 9

24p3,148w

vinca alkaloid, doxorubicin, enzalutarnide, and abiraterone resistant cancers • Favorable safety profile (less neurotoxicity than docetaxel and unlike taxanes and vinca alkaloids -no neutropenia or myelosuppression)4 Chen ... VERU• Ill enZaklarrele CO ralenCee. Ondageteleeide --.—± t CO:nutan ten:tent rennet AD agent DOCetaXel (lanCetel latale rentlent trek.. ute ettneate ractent metcaolic tenGlant rneneelata mole:tale latettatn ... greater than $5 billion for prostate and other cancer types • TAXANES: TAXOL (PACLITAXEL); TAXOTERE (DOCETAXEL): JEVTANA (CABA/ITAXEL): ABRAXANE (PROTEIN BOUND PACLITAXEL) ~only used for said tumors such as breast, ovarian

https://www.justice.gov/epstein/files/DataSet%209/EFTA00810552.pdf

EFTA01113739Set 9

37p2,922w

chemotherapy + platinum: survival —12 months; 1 year survival at 50% (i.e. erlotinib, permetrexed, gemcitabine, docetaxel..) Aggressive disease after first line failure: survival —8 months; 1 year survival ... line) TKI or chemotherapy (i.e erlotinib, docetaxel, permetrexed..) ALK Inhibitors Crizotinib Xalkory® registered in ALK+ NSCLC pts (3-5% NSCLC pts) OSE EFTA01113747 OSE 2101:Phase Ill Protocol & Objectives

https://www.justice.gov/epstein/files/DataSet%209/EFTA01113739.pdf