Farmas USA

ARRY

Más info de la conference call de hoy a las 9h00 ET... no parece que vayan a soltar ninguna gran novedad, pero he puesto una orden a $10 por si suena la faluta..

Data from these trials will be presented at the European Society of Medical Oncology's (ESMO) annual European Cancer Conference (ECC) or were presented at the 2015 ESMO World Congress of Gastrointestinal Cancer. The trials include a Phase 2 combination trial of binimetinib and encorafenib in BRAF-mutant melanoma patients (LOGIC2), a Phase 1b/2 combination trial of binimetinib and a CDK4/6 inhibitor in NRAS-mutant melanoma patients and a Phase 2 combination trial of encorafenib and an EGFR inhibitor with or without the addition of a PI3K inhibitor in patients with BRAF-mutant colorectal cancer.

no entiendo, no hay previstas grandes news segun dices,... y pones venta 10$ que no los ha visto en ... 7 y 8 años??

eres un cachondo

ARRY

 

ARRY

Me refería a que no espero nada de la conference call de hoy (aunque cuando habla el CEO de una empresa siempre existe la posibilidad de que el valor "responda"); sí que habrá presentación de resultados de clinical trials mañana en el congreso europeo. En cualquier caso, dejar puesta una orden con vencimiento 30/9 no me cuesta nada... mi idea era aguantarla todo el curso escolar, pero si por lo que fuera se fuese a $10, ahí está mi orden... ¿qué pierdo poniéndola?

Edito: de hecho, tengo puestas órdenes de venta tipo "wishful thinking" en casi toda mi cartera de valores... la de NVAX está en $30; la de THLD, en $14.

tu perfil pone que eres de Barcelona ... pero yo creo que naciste en Bilbao ... :)))))

 

Ja ja... pues mira, casi casi... soy de Barcelona, pero he trabajado muchos años para una empresa con la sede central en Bilbao, así que iba muy a menudo.

GALE

Segura y parece que efectiva en el grupo de 1000 mcg. En el resto de grupos no es significativo.

Galena Biopharma Presents Positive GALE-301 Phase 2a Clinical Trial Data at the European Cancer Congress 2015

GALE-301 is well-tolerated and elicits a strong and dose-dependent in vivo immune response; 1000 mcg identified as optimal dose

In the 1000 mcg vaccine dose group (VG), the clinical recurrence rate is 13.3% versus 55% in the control group (CG) (p=0.02), providing for a two-year Disease Free Survival estimate of 85.7% (VG) versus 33.6% (CG), p < 0.02

ORTLAND, Ore., Sept. 28, 2015 (GLOBE NEWSWIRE) -- Galena Biopharma, Inc. (NASDAQ:GALE), a biopharmaceutical company developing and commercializing innovative, targeted oncology therapeutics that address major medical needs across the full spectrum of cancer care, today announced that data from the GALE-301 Phase 2a portion of the Phase 1/2a clinical trial was presented at the European Cancer Congress 2015 in Vienna, Austria. GALE-301 is Galena's cancer immunotherapy that consists of a peptide (E39) derived from Folate Binding Protein (FBP). GALE-301 is combined with the immune adjuvant, granulocyte macrophage-colony stimulating factor (GM-CSF) and administered via intradermal injection for the prevention of recurrence in ovarian and endometrial cancers.

Poster #P427 (abstract #2764), entitled "Preliminary results of the phase I/IIa dose finding trial of a folate binding protein vaccine GALE-301 (E39) + GM-CSF in ovarian and endometrial cancer patients to prevent recurrence," provided updated data for all patients who have received at least twelve months of treatment. As presented, the clinical recurrence rate based on all treatment cohorts was 41% in the Vaccine Group (VG) (n=29) versus 55% in the Control Group (CG) (n=22), p=0.41. However, in the 1000 mcg VG cohort (n=15), there have only been two clinical recurrences (13.3% versus 55% CG, p=0.02), and the two-year Disease Free Survival (DFS) estimate is 85.7% (1000 mcg patients) versus 33.6% (CG), p < 0.02, as compared by Kaplan-Meir and Log rank tests.

"This one-year data from our GALE-301 trial is extremely encouraging as it has established the optimal dose while demonstrating clear signs of improvement in the disease free status of women with endometrial and ovarian cancer in the 1000 mcg cohort," said Mark W. Schwartz, Ph.D., President and Chief Executive Officer. "More than 70,000 women will be diagnosed with ovarian or endometrial cancer this year, and we are focused on preventing their cancer from returning once they receive their initial treatments. Based on the data presented today, we expect to meet with the FDA to discuss a potential path forward to move GALE-301 into a prospective, randomized trial in ovarian and endometrial cancer patients to prevent recurrence."

The clinical trial program for GALE-301 began as a Phase 1 3x3, safety and dose-escalation (100, 500, 1000 mcg of E39) trial and transitioned to a Phase 2a, expanding the optimal dose cohort. Disease-free endometrial and ovarian cancer patients were enrolled after receiving their standard of care therapy. HLA-A2+ patients were vaccinated (VG), and HLA-A2- patients followed prospectively as a CG. Six monthly intradermal inoculations of GALE-301 (E39) + 250 mcg GM-CSF were administered followed by two boosters, one every six months. A total of 51 patients were enrolled: 29 VG and 22 CG. Of the 29 VG patients, 15 received the optimal dose of 1000 mcg, and 14 patients received a suboptimal dose of less than 1000 mcg.

"The data presented at the European Cancer Congress reveal that E39 + GM-CSF is well tolerated and elicits a strong and dose-dependent in vivo immune response. Early efficacy results are promising in the optimally dosed 1000 mcg cohort, with the vaccine exhibiting a very favorable safety profile with primarily Grade 1 and 2 toxicities and no differences in toxicities based on dose," commented Julia Greene, M.D., post-doctoral fellow with the Cancer Vaccine Development Program, and the poster presenter.

Demographic, safety, immunologic, and clinical recurrence data are continuing to be collected. There have been no observable differences in age, grade, stage, or histology between groups (all p≥0.1). In vivo immunologic response is being measured by the delayed type hypersensitivity reaction (DTH) to the E39 peptide. DTH increased pre- to post-vaccination, and the DTH increase was larger in the patients who received the 1000 mcg dose.

ARRY

Pues mira, sí que han soltado news. Pego la "press release". No me la he leído todavía, pero los titulares pintan bien...

Clinical Data Presented On Binimetinib And Encorafenib In Melanoma

-Binimetinib and encorafenib combination shows an emerging differentiated tolerability profile while maintaining expected levels of activity in BRAF-mutant melanoma-
-Binimetinib and CDK4/6 inhibitor combination shows promising activity in NRAS-mutant melanoma-

BOULDER, Colo., Sept. 28, 2015 /PRNewswire/ -- Clinical trial results from Array BioPharma's (Nasdaq: ARRY) wholly-owned MEK inhibitor, binimetinib, and BRAF inhibitor, encorafenib, were presented this weekend at the European Society of Medical Oncology's (ESMO) annual European Cancer Conference (ECC). At the meeting, preliminary data were shared from both a Phase 2 combination trial of binimetinib and encorafenib in BRAF-mutant melanoma patients (LOGIC2) and a Phase 1b/2 combination trial of binimetinib and ribociclib (Novartis, LEE011), a CDK4/6 inhibitor in NRAS-mutant melanoma patients.

LOGIC2 is an ongoing 140-patient, two-part study designed to explore the safety and activity of novel triplet combinations in BRAF-mutant melanoma. In part 1, patients are treated with the combination of binimetinib and encorafenib until disease progression. Based on the results of molecular profiling at that time, each patient is assigned to one of four arms containing a triplet combination of binimetinib, encorafenib and a third targeted therapy. Results from part 1 of the study are reported separately for patients who have previously received a BRAF and/or MEK inhibitor versus those who were initially naive to BRAF and MEK inhibitor treatment.

In part 1, patients are treated with binimetinib 45 mg twice daily (BID) and encorafenib 450 mg once daily (QD), the same doses evaluated in the ongoing Phase 3 COLUMBUS trial. In the BRAF/MEK-naive group (n=40), the interim overall response rate (confirmed and unconfirmed complete response or partial response) was 68%, with a 6-month progression-free survival estimate of 79%. Of note, 96% of patients in this group continued to receive study treatment as of the data cutoff. Preliminary data from all patients in the study (n=89) also indicate that the combination of binimetinib and encorafenib showed good tolerability with a 12% incidence of pyrexia and little to no rash or photosensitivity. These results indicate that the combination of binimetinib and encorafenib show encouraging clinical activity and an emerging differentiated tolerability profile relative to other MEK/BRAF inhibitor combinations.

"MEK and BRAF combination therapy is now established as the optimal molecularly targeted approach for BRAF mutant melanoma patients," said Reinhard Dummer, M.D., investigator, University Hospital Zurich. "In this study, the combination of encorafenib and binimetinib demonstrated robust clinical activity, consistent with results from other BRAF/MEK inhibitor combinations, but with a potentially improved and differentiated safety profile."

NRAS-mutant Melanoma Interim Results

A Phase 1b/2 study of binimetinib in combination with ribociclib showed promising preliminary antitumor activity in NRAS-mutant melanoma patients. Results were shared from 45 patients enrolled in the dose escalation portion of the study, which included two dosing schedules (28-day or 21-day cycles). For the 28-day dosing schedule, patients received continuous twice daily dosing of binimetinib while receiving ribociclib for 21 days per 28 day cycle. For the 21-day schedule, both agents were delivered for 14 days of a 21 day cycle.

For patients receiving the combination on a 28-day cycle (n=22), the Objective Response Rate (ORR, confirmed and unconfirmed complete or partial responses) was 41%, the Disease Control Rate (DCR, confirmed and unconfirmed complete or partial responses and stable disease) was 82% with a median Progression Free Survival (mPFS) of 6.7 months. Furthermore, the ORR was 56% (n=9) for patients receiving dose level 1 of the 28-day schedule consisting of binimetinib 45 mg BID and the lowest dose of ribociclib (200 mg QD), indicating that robust activity can be achieved with this dose and schedule. Common treatment-related adverse events included elevated creatine phosphokinase (CPK), skin and gastrointestinal events. Investigation of an alternative 21-day schedule is ongoing.

"Among metastatic melanoma patients, the presence of an NRAS-mutation is a predictor of poor prognosis, and for this subgroup of patients, there are currently no approved targeted therapies," said Carla van Herpen, M.D., Ph.D., Radboud University Medical Center, Nijmegen, The Netherlands. "Simultaneous inhibition of MEK and CDK4/6 protein kinases could suppress the activation of two major signaling pathways associated with NRAS mutations and may provide additive, or synergistic, activity versus single-agent therapy."

About Melanoma

Melanoma is the fifth most common cancer among men and the seventh most common cancer among women in the United States, with almost 74,000 new cases and nearly 10,000 deaths from the disease projected in 2015. BRAF and NRAS mutations occur in approximately 40% to 60% and 15% to 20%, respectively, of patients with melanoma. When melanoma is diagnosed early, it is generally a curable disease. However, when it spreads to other parts of the body, it is the deadliest and most aggressive form of skin cancer. A person with metastatic melanoma typically has a short life expectancy with only approximately 15% of patients surviving for five years following diagnosis of metastatic disease.

About BRAF, MEK, Binimetinib and Encorafenib

Raf and MEK are key protein kinases in the RAS/RAF/MEK/ERK pathway, which regulates several key cellular activities including proliferation, differentiation, migration, survival and angiogenesis. Inappropriate activation of this pathway has been shown to occur in many cancers, such as non-small cell lung cancer, melanoma, colorectal and thyroid cancers. Binimetinib is a small molecule MEK inhibitor and encorafenib is a small molecule BRAF inhibitor, both of which target key enzymes in this pathway. Three Phase 3 trials in advanced cancer patients continue to advance: NRAS-mutant melanoma (NEMO, with binimetinib), low-grade serous ovarian cancer (MILO, with binimetinib) and BRAF-mutant melanoma (COLUMBUS, with binimetinib and encorafenib). The NEMO and COLUMBUS Part 1 studies completed enrollment in April 2015. NRAS-mutant melanoma represents the first potential indication for binimetinib, with a projected regulatory filing estimated in the first half of 2016. Array also projects a regulatory filing of binimetinib in combination with encorafenib in BRAF melanoma in 2016.

http://investor.arraybiopharma.com/phoenix.zhtml?c=123810&p=irol-newsArticle&ID=2090805

flojo premarket de GILD por debajo del minimo del Viernes.

Venga, vamos a ver si es hoy ese dia de envolventes alcistas.