Uncategorized – Page 15339 – 1stOncology™: Cancer Intelligence Service

10-Q – Quarterly report [Sections 13 or 15(d)]

Rich Pharmaceuticals has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing 10-Q , Rich Pharmaceuticals, FEB 23, 2015, View Source [SID1234501840]).

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10-K – Annual report [Section 13 and 15(d), not S-K Item 405]

Ligand has filed a 10-K – Annual report [Section 13 and 15(d), not S-K Item 405] with the U.S. Securities and Exchange Commission (Filing 10-K , Ligand, FEB 23, 2015, View Source [SID1234501847]).

10-K – Annual report [Section 13 and 15(d), not S-K Item 405]

PDL BioPharma has filed a 10-K – Annual report [Section 13 and 15(d), not S-K Item 405] with the U.S. Securities and Exchange Commission (Filing 10-K , PDL BioPharma, FEB 23, 2015, View Source [SID1234501849]).

Taiho Pharmaceutical Announces TAS-102 (brand name in Japan: "Lonsurf®") New Drug Application for Refractory Metastatic Colorectal Cancer Accepted for Review by FDA

On February 23, 2015 Taiho Pharmaceutical reported that the U.S. Food and Drug Administration (FDA) has accepted the Company’s submission of a New Drug Application (NDA) for TAS-102 (nonproprietary names: trifluridine and tipiracil hydrochloride, brand name in Japan: "Lonsurf combination tablet T15, T20"). TAS-102 is an oral combination investigational anticancer drug for the treatment of refractory metastatic colorectal cancer (mCRC). The PDUFA goal date is December 19, 2015 (Press release, Taiho, FEB 23, 2015, View Source [SID:1234502140]).

Results from the Phase III RECOURSE trial of TAS-102 in 800 mCRC patients, whose disease had progressed after or who were intolerant to standard therapies, form the foundation for the NDA. The TAS-102 RECOURSE trial met the primary efficacy endpoint of statistically significant improvement in overall survival versus placebo (HR = 0.68, p < 0.0001) and demonstrated a safety profile consistent with that observed in earlier clinical trials.

About TAS-102
TAS-102 is an oral combination investigational anticancer drug of trifluridine (FTD) and tipiracil hydrochloride (TPI). FTD is an antineoplastic nucleoside analog, which is incorporated directly into DNA, thereby interfering with the function of DNA. The blood concentration of FTD is maintained via TPI, which is an inhibitor of the FTD-degrading enzyme, thymidine phosphorylase. TAS-102 was approved initially in Japan in March 2014 for the indications of "unresectable advanced or recurrent colorectal cancer (only if refractory to standard therapies)," based on the results of the Phase II clinical trial conducted in Japan, and launched in Japan in May 2014 under the brand name "Lonsurf combination tablet T15, T20".

The fucosylation inhibitor, 2-fluorofucose, inhibits vaso-occlusion, leukocyte-endothelium interactions and NF-ĸB activation in transgenic sickle mice.

2-Fluorofucose (2FF) blocks the fucosylation and the tethering of sialyl-Lewisx tetrasaccharide and structural variants on leukocytes and red blood cells to P- and E-selectins on activated endothelial cell surfaces. Because P- and E-selectin are required for vaso-occlusion in murine sickle cell disease (SCD), we investigated whether 2FF would inhibit vaso-occlusion in SCD mice. Microvascular stasis was measured in subcutaneous venules in NY1DD and HbSS-Townes SCD mice with dorsal skin-fold chambers after infusion of hemoglobin or exposure to hypoxia/reoxygenation. 2FF in drinking water or administered by gavage inhibited stasis in sickle mice in a dose-responsive manner. Significant inhibitory effects on stasis were seen 1 day post-treatment. 2FF treatment of SCD mice also significantly reduced leukocyte rolling and adhesion along the vessel walls of SCD mice and the static adhesion of neutrophils and sickle red blood cells isolated from 2FF-treated SCD mice to resting and activated endothelial cells. Total white blood cell counts increased in response to 2FF. NF-ĸB activation and VCAM-1 and E-selectin expression were inhibited in the livers of SCD mice consistent with an overall decrease in vascular inflammation and ischemia-reperfusion physiology. Pretreatment with 2FF completely eliminated heme-induced lethality in HbSS-Townes mice, consistent with the observed anti-inflammatory and anti-adhesive properties of 2FF in SCD mice. These data suggest that 2FF may be beneficial for preventing or treating vaso-occlusive crises in SCD patients.

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Category: Uncategorized

10-Q – Quarterly report [Sections 13 or 15(d)]

10-K – Annual report [Section 13 and 15(d), not S-K Item 405]

10-K – Annual report [Section 13 and 15(d), not S-K Item 405]

Taiho Pharmaceutical Announces TAS-102 (brand name in Japan: "Lonsurf®") New Drug Application for Refractory Metastatic Colorectal Cancer Accepted for Review by FDA

The fucosylation inhibitor, 2-fluorofucose, inhibits vaso-occlusion, leukocyte-endothelium interactions and NF-ĸB activation in transgenic sickle mice.