DRUG DEVELOPMENT DECONSTRUCTOR MANIFESTO: : “Tell me how you read and I'll tell you who you are.” ― Martin Heidegger
Monday, March 31, 2014
Sunday, March 30, 2014
Saturday, March 29, 2014
Friday, March 28, 2014
Thursday, March 27, 2014
Targeted failure of the week. Post No 141-142. Cabozantinib and amikacin
Exelixis Inc. (NASDAQ:EXEL) fell $2.54 (39%) to $3.90 on Wednesday after an independent DMC said the Phase III COMET-1 trial evaluating Cometriq cabozantinib for metastatic castration-resistant prostate cancer (CRPC) did not meet criteria to support early trial unblinding. The DMC recommended continuing the trial based on a planned interim analysis of the primary overall survival (OS) endpoint. A final analysis is scheduled when there are 578 events, with data expected this year. The trial enrolled 960 patients and is comparing Cometriq vs. prednisone in patients who have progressed following treatment with docetaxel, Zytiga abiraterone from Johnson & Johnson (NYSE:JNJ) or Xtandi enzalutamide from Medivation Inc. (NASDAQ:MDVN) and partner Astellas Pharma Inc. (Tokyo:4503).
Insmed Inc. (NASDAQ:INSM) fell $2.39 (13%) to $15.90 on Wednesday after reporting that once-daily Arikayce amikacin plus standard of care (SOC) missed the primary endpoint vs. placebo plus SOC in 89 evaluable patients in the Phase II TARGET NTM (TR02-112) trial to treat treatment-resistant non-tuberculosis mycobacterial (NTM) lung infection. The primary endpoint was a reduction in mycobacterial density as measured by a seven-point scale from baseline to day 84. Arikayce plus SOC did meet the secondary endpoint of a greater proportion of patients with culture conversion to negative by day 84 vs. placebo plus SOC (25% vs. 7%, p=0.01). Additional data are slated to be presented at the American Thoracic Society meeting in May.Insmed plans to meet with FDA and EMA to determine next steps for Arikayce in the indication, for which the product has Qualified Infectious Disease Product (QIDP) designation in the U.S. The company said it also plans to apply for breakthrough therapy designation in the U.S. based on the culture conversion data in TARGET NTM.
This half, Insmed plans to submit regulatory applications to EMA and Health Canada for Arikayce to treat Pseudomonas aeruginosa infection in cystic fibrosis (CF) patients. Insmed gained the inhaled liposomal amikacin through its 2010 acquisition of Transave Inc. Arikayce is administered with the eFlow Nebulizer System from Pari GmbH (Starnberg, Germany).
Wednesday, March 26, 2014
Targeted failure of the week. Post No 140. Afinitor/Aromasin combo
A combination of Novartis' Afinitor and Pfizer's Aromasin failed to reach
statistical significance in a trial’s secondary endpoint of overall
survival.Eagerly-awaited results from the BOLERO-2 trial looking at the mTOR inhibitor Afinitor (everolimus) plus the aromatase inhibitor Aromasin (exemestane) were presented at the European Breast Cancer Conference in Glasgow and proved disappointing. In the study of women with advanced oestrogen receptor-positive breast cancer, median survival was 31 months for the combo versus 26.6 months for those on Aromasin monotherapy.
Previously reported results had shown the primary endpoint of progression-free survival to be clinically meaningful and statistically significant. Slightly fewer patients (10%) in the everolimus arm had received salvage chemotherapy after cancer progression and no new safety concerns were identified.
Presenting the results, Martine Piccart of the Jules Bordet Institute in Brussels said she hoped ongoing studies would identify breast cancer patients most likely to benefit from mTOR inhibition. However, “so far we have not been very successful,” she added.
Read more at: http://www.pharmatimes.com/Article/14-03-25/Afinitor_Aromasin_combo_disappoints_in_breast_cancer_trial.aspx#ixzz2x2osg4xV
AZ: very cheap trick to fool innovators.
The website also includes a route for interested parties to submit proposals to AZ for grants of up to $100,000 for target validation partnerships; and an "R&D Challenges" section where the pharma plans to crowd-source solutions to problems. In May, AstraZeneca plans to post more information about a discovery program that will provide screening assays and other assistance to external investigators while allowing the external partner to retain IP to discovered compounds.
From here:http://www.biocentury.com/dailynews/company/2014-03-25/astrazeneca-puts-programs-for-partnering-online
Tuesday, March 25, 2014
Cancer Vaccines: Doomed to Fail!
From here: http://www.fool.com/investing/general/2014/03/24/cancer-vaccines-doomed-to-fail.aspx
Monday, March 24, 2014
Sunday, March 23, 2014
Saturday, March 22, 2014
Friday, March 21, 2014
Targeted failure of the week. Post No 139. MAGE-A3 antigen
Prospects for GlaxoSmithKline's therapeutic cancer vaccine MAGE-A3 are looking increasingly shaky after a second negative phase III trial, this time in lung cancer.
The MAGRIT study showed that the vaccine was unable to improve disease-free survival (DFS) compared to placebo in patients with non-small cell lung cancer (NSCLC) whose tumours carried the MAGE-A3 antigen, regardless of whether or not they were receiving chemotherapy.
From here: http://www.pmlive.com/pharma_news/gsks_cancer_vaccine_flunks_another_trial_554491
Thursday, March 20, 2014
Wednesday, March 19, 2014
Monday, March 17, 2014
Sunday, March 16, 2014
Saturday, March 15, 2014
Friday, March 14, 2014
Thursday, March 13, 2014
Targeted failure of the week. Post No 138. Imetelstat
Geron Corp. (NASDAQ:GERN) fell $2.71 (62%) to $1.69 on Wednesday after FDA placed a full clinical hold on company-sponsored trials of imetelstat (GRN163L). According to Geron, FDA said the hold is due to "persistent" low-grade liver function test abnormalities seen in patients in a Phase II trial in essential thrombocythemia (ET)/polycythemia vera (PV) and the potential risk of chronic liver injury. On a conference call to discuss the hold, the company said at least one abnormal liver function test has been observed in all of the patients in the trial, which completed enrollment of 20 patients in December 2012. Geron said the hold will affect eight patients in the ET/PV trial and two patients in a Phase II trial evaluating imetelstat for multiple myeloma (MM).
FDA requested information on the incidence of abnormalities in investigator-sponsored trials and the reversibility of abnormalities in all imetelstat trials. Geron said it plans to provide the information in the coming weeks. Imetelstat is an oligonucleotide that competitively inhibits telomerase activity.
Wednesday, March 12, 2014
Tuesday, March 11, 2014
Monday, March 10, 2014
Friday, March 7, 2014
Thursday, March 6, 2014
Wednesday, March 5, 2014
Tuesday, March 4, 2014
Targeted failure of the week. Post No 137. Onartuzumab
A late-stage trial of a combination of an experimental cancer-fighting drug from Genentech and the already-marketed drug Tarceva didn’t help patients with a type of advanced lung cancer live longer.An independent data monitoring committee recommended that the 499-patient, Phase III study of onartuzumab and Tarceva be stopped, South San Francisco-based Genentech said Sunday night. The study indicated that the combination did not help previously treated advanced non-small cell lung cancer patients live longer than those treated with only Tarceva.
From here: http://www.bizjournals.com/sanfrancisco/blog/biotech/2014/03/genentech-onartuzumab-roche-lung-cancer.html
Monday, March 3, 2014
Sunday, March 2, 2014
Saturday, March 1, 2014
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