Farmas USA

SUPN
No comentada por aquí ¿posible adquisición por parte de hznp?
http://seekingalpha.com/article/3223006-supernus-growth-on-track-upside-potential-still-significant?ifp=0

SNTA

Presentaciones ASCO. (Información del jueves, creo)

Feasibility of Ganetespib Combination Therapy Demonstrated in Three Investigator-Sponsored Trials

STA-12-8666 Results in Pediatric Sarcoma Models Highlighted in Poster Discussion Session

Synta Pharmaceuticals Corp. (NASDAQ: SNTA) today announced that Phase 1 clinical results from three investigator-sponsored trials evaluating ganetespib combination therapy in ALK-positive lung cancer, platinum-resistant ovarian cancer, and rectal cancer will be presented at the 2015 American Society of Clinical Oncology (ASCO) Annual Meeting taking place May 29-June 2 in Chicago. Ganetespib, a next-generation inhibitor of the chaperone protein Hsp90 critical for the activation of numerous proteins that control malignant tumor growth, is currently in Phase 3 evaluation in non-small cell lung cancer.

The Company also announced that preclinical results for its lead HDC candidate, STA-12-8666, in pediatric sarcoma will be presented at the ASCO Annual Meeting. STA-12-8666 is a conjugate of an Hsp90 inhibitor and SN-38, the active metabolite of the widely used drug irinotecan.

Details of the poster presentations are provided below:

Part I of GANNET53: A multicenter phase I/II trial of the Hsp90 inhibitor ganetespib combined with weekly paclitaxel in women with high-grade serous, high-grade endometrioid, or undifferentiated, platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal cancer.

Abstract #: 5578
Date and Time: Saturday, May 30, 1:15-4:45 PM CT
Location: S Hall A2
Presenter: Isabelle Ray-Coquard, M.D., Centre Léon Bérard, Lyon, France

Activity of Hsp90 inhibitor drug conjugate (HDC) STA-12-8666 in preclinical models of pediatric sarcoma.

Abstract #: 10025
Date and Time: Sunday, May 31, 8:00-11:30 AM CT (Poster); 11:30AM-12:45PM CT (Discussion)
Location: S Hall A2 (Poster); S504 (Discussion)
Presenter: Christine Heske, M.D., Pediatric Oncology Branch, National Cancer Institute, Bethesda, MD

Phase I study of ganetespib, capecitabine, and radiation in rectal cancer.

Abstract #: 3596
Date and Time: Monday, June 1, 8:00-11:30 AM CT
Location: S Hall A2
Presenter: Bassel F. El-Rayes, M.D., Winship Cancer Institute of Emory University, Atlanta, GA

A phase 1 study of crizotinib and ganetespib (STA-9090) in ALK positive lung cancers.

Abstract #: 8064
Date and Time: Monday, June 1, 8:00-11:30 AM CT
Location: S Hall A2
Presenter: Gregory J. Riely, M.D., Memorial Sloan Kettering Cancer Center, New York, NY

Soy sanitario, trabajo en atención primaria, y los equipos de protección individual para ébola ante sospecha de pcte infectado, que nos suministraron en su día,son de risa. Pero eso, en Ejjjpaňa la culpa nunca es de los políticos. Si tuvimos una ministra de sanidad que tenía confeti hasta en las bragas...

THLD

Threshold Pharmaceuticals Presents Encouraging Preliminary Phase 2 Data in Multiple Myeloma at ASCO

VRX
Imparables y la dire compra por valor de $1.760.000, también anda en cree y snta
http://www.openinsider.com/insider/Whitaker-Anne-Clem/1593283

Ampliación de la noticia (de barbacoa modo móvil)
.

CHICAGO, IL--(Marketwired - May 31, 2015) - Threshold Pharmaceuticals, Inc. (NASDAQ: THLD) today announced new preliminary data from the Phase 2 component of an ongoing Phase 1/2 trial of evofosfamide (an investigational compound formerly known as TH-302) in combination with the proteasome inhibitor Velcade® (bortezomib) and low-dose dexamethasone ("EBorD") in patients with relapsed/refractory multiple myeloma. A clinical benefit rate of 29% (one complete response, two partial responses, and one minimal response) was observed in patients treated at the recommended Phase 2 dose of evofosfamide (340 mg/m2) in EBorD. Objective responses were observed in heavily pretreated patients (median of 8 prior systemic therapy regimens) including prior treatment with bortezomib (median of 3 prior bortezomib-containing regimens). Evofosfamide, an investigational hypoxia-activated prodrug currently in Phase 3 clinical trials in locally advanced or metastatic pancreatic cancer and advanced soft tissue sarcoma, is being developed in collaboration with Merck KGaA, Darmstadt, Germany. The data are being presented today at American Society of Clinical Oncology (ASCO) meeting in Chicago, Illinois (Abstract #8579).

"New treatment options are greatly needed for patients with multiple myeloma whose disease has progressed despite having received multiple previous therapies," said Tillman Pearce, M.D., Chief Medical Officer of Threshold. "Research suggests that hypoxia may play an important role in treatment resistance in multiple myeloma and supports the investigation of hypoxia-activated therapeutics in patients with relapsed/refractory multiple myeloma. As such, we are encouraged by the initial responses observed with EBorD therapy, particularly given that the patients in our trial had already received multiple types of treatment prior to enrollment including a median of 3 prior bortezomib-containing regimens."

"While the two pivotal Phase 3 trials of evofosfamide in patients with advanced soft tissue sarcoma and advanced pancreatic cancer remain our top priority, we are actively investigating evofosfamide in other cancers where hypoxia is implicated, preclinical data are supportive, and there is a high unmet medical need for new treatment options," said Barry Selick, Ph.D., Chief Executive Officer of Threshold. "We are encouraged by results seen to date suggesting activity of evofosfamide plus dexamethasone with or without bortezomib in patients with treatment-resistant multiple myeloma and are working with clinical experts in the field to help determine the most viable clinical and regulatory paths forward."

The ongoing Phase 1/2 trial is investigating evofosfamide and dexamethasone with or without bortezomib with respect to safety and tolerability, dose-limiting toxicities and the maximum-tolerated dose of evofosfamide, and preliminary efficacy in patients with relapsed/refractory multiple myeloma. The recommended Phase 2 dose of evofosfamide in EBorD was previously established at 340 mg/m2.1 A total of 25 patients with relapsed/refractory multiple myeloma have been enrolled in the EBorD component of the study as of May 1, 2015. At the ASCO meeting, preliminary safety and efficacy analyses were presented from 18 patients who initiated therapy prior to December 1, 2014, with presented analyses reflecting data in the clinical database as of May 2015.

Key preliminary data from EBorD dosing cohorts presented at ASCO include:

Preliminary assessment of safety and tolerability

Preliminary safety and tolerability results from the 18 patients included in the ASCO presentation support further investigation of evofosfamide in patients with relapsed/refractory multiple myeloma. The most common Grade 3/4 hematological adverse events were thrombocytopenia (reported in 11 patients), anemia (reported in 6 patients), and neutropenia (reported in 4 patients). Nausea (reported in 8 patients; one Grade 3/4) and fatigue (reported in 7 patients; one Grade 3/4) were the most common non-hematological adverse events. Eleven serious adverse events (SAEs) were reported in 9 patients. The only SAE occurring in more than one patient were two events of colitis. Neither event was considered related to evofosfamide. Five SAEs were considered as related to evofosfamide: bronchiolitis, melena, pneumonia, thrombocytopenia and viral infection. Skin toxicity and mucosal toxicities were not dose limiting. Rash was reported in five patients; stomatitis, skin lesion, pruritus and skin hyperpigmentation were each reported in one patient; none of these were Grade 3 or higher. No patients discontinued treatment due to an adverse event. There were no deaths related to study drug.

Preliminary assessment of clinical activity

Preliminary results from the 18 patients included in the ASCO presentation suggested anti-myeloma activity of EBorD therapy. According to modified International Myeloma Working Group (IMWG) criteria,2,3 responses included one complete response (CR), two partial responses (PRs), one minimal response (MR) and eleven stable disease (SD) assessments; three patients had progressive disease (PD). The patients with the CR and PRs had all previously undergone autologous transplantations and had received prior current standard treatment including IMiDs (a class of immunomodulators), proteasome inhibitors (including bortezomib), dexamethasone, and at least one conventional alkylating agent.

About Multiple Myeloma

Multiple myeloma, a hematologic cancer resulting from abnormal plasma cells typically found in the bone marrow, affects nearly 230,000 people worldwide with approximately 114,000 new cases diagnosed per year.4 An estimated 96,000 people in the U.S. are living with, or in remission from, multiple myeloma.5 The number of new cases that will be diagnosed in the U.S. in 2015 is estimated to be almost 27,000, and the estimated number of deaths is approximately 11,000.6

About Evofosfamide

Evofosfamide (previously known as TH-302), an investigational hypoxia-activated prodrug, is designed to be activated under tumor hypoxic conditions, a hallmark of many cancers. Areas of low oxygen levels (hypoxia) in solid tumors are due to insufficient blood supply as a result of aberrant vasculature. Similarly, the bone marrow of patients with hematological malignancies has also been shown, in some cases, to be severely hypoxic.

Evofosfamide is currently under evaluation in two Phase 3 trials: one in combination with doxorubicin versus doxorubicin alone in patients with locally advanced unresectable or metastatic soft tissue sarcoma (STS), and the other in combination with gemcitabine versus gemcitabine and placebo in patients with locally advanced unresectable or metastatic pancreatic cancer (the MAESTRO trial). Both Phase 3 trials are being conducted under Special Protocol Assessment (SPA) agreements with the FDA. The FDA and the European Commission have granted evofosfamide Orphan Drug Designation for the treatment of STS and pancreatic cancer. The FDA has also granted Fast Track designation for the development of evofosfamide for both STS and pancreatic cancer. Evofosfamide is also being investigated in a Phase 2 trial designed to support registration for the treatment of non-squamous non-small cell lung cancer, and in earlier-stage clinical trials of other solid tumors and hematological malignancies.

Threshold has a global license and co-development agreement for evofosfamide with Merck KGaA, Darmstadt, Germany, which includes an option for Threshold to co-commercialize in the U.

THLD

Ay madre, eso es que el ASCO ha sido hoy, y ha sido bueno para THLD ¿no?

THLD

Voy a leer sus foros, a ver qué dicen. Madre mía, estoy con el ansia viva ya.