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Is Roche's RG7421 the partnered drug with EXEL? I dont know if it EXEL's drug after all. On their site, it says RG7421 is partnered with EXEL, but I saw a brochure they made from 2012 that says differently(lists GDC-0623 as the other name for RG7421). Very confusing.
How long did they say they expected to wait to hear back about the request?
I've already heard from a few sources that folks at JNJ; they are thrilled with the pricing. Imagine it will definitely throttle MDVN sales.
SRPT - Another kid comes forward about his improvements; 2/4 kids on 50mg dose have had great responses
http://www.kfvs12.com/story/19411932/clinical-trial-shows-promise-for-jackson-12-year-old-with-duchenne-muscular-dystrophy#.UD7aZ2U5h7o.twitter
http://abcnews.go.com/Health/vermont-brothers-deadly-disease-healing-drug/story?id=17040089&page=2
ArQule, Inc. (ArQule) has been informed by Kyowa Hakko Kirin Co., Ltd. (Kyowa), which has exclusive development rights to tivantinib in Japan and certain parts of Asia, of Kyowa's decision to temporarily suspend patient enrollment in its ongoing Phase 3 ATTENTION (Asian Trial of Tivantinib plus Erlotinib for NSCLC without EGFR Mutation) trial. The ATTENTION trial investigates the use of tivantinib and erlotinib versus erlotinib and placebo in second line non-squamous non-small cell lung cancer (NSCLC). This trial is being conducted by Kyowa in Japan, South Korea and Taiwan.
Kyowa has taken this action following the recommendation of an independent Safety Review Committee (SRC) in Japan after the reporting of suspected cases of interstitial lung disease (ILD) in the study. The SRC has requested additional information and analyses regarding these cases of ILD which showed an imbalance between the arms of the trial.
During review of the additional information, treatment of patients already enrolled in the study is continuing pursuant to the protocol for the study. Updates on the status of this review and a determination regarding whether to restart patient enrollment will be provided as warranted.
Daiichi Sankyo, Inc. (Daiichi Sankyo) and ArQule are developing tivantinib in the Americas, Europe and certain other regions of the world. The partners are conducting in those regions the Phase 3 MARQUEE trial (Met Inhibitor ARQ 197 plus Erlotinib vs Erlotinib plus Placebo in NSCLC) that completed recruitment of approximately 1,000 patients in May 2012. Kyowa's decision regarding the ATTENTION trial is unrelated to the MARQUEE trial.
GILD - FDA approves "Quad" HIV pill. Brand name is Stribild
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm317004.htm
See BiotechStockResearch tweet
"Subscribers: Why ONCY REO-018 pivotal Reolysin study is taking so long to report efficacy data"
https://twitter.com/BiotechStockRsr
I've also heard similar from big investors that met with the company recently.
Hearing data delayed because of issues at EU clinical sites
Maybe we should revisit all of your nonsense posts on PPHM dating back to 2004 and compare with the stock chart. Been an utter disaster and terrible call.
I think good data would be seeing improvement in the 50mg group. You'd also like to see some improvement treatment delayed group. Also continued dystrophin production.
I suspect the melanoma data will come at ESMO or AACR in Nov.
Troubling bit at the end. He said "a read out on our new formulation of 614 early next year". What gives?
This is really quite embarrassing for someone Sanofi's size.
Idenix Pharmaceuticals, Inc. (IDIX), a biopharmaceutical company engaged in the discovery and development of drugs for the treatment of human viral diseases, today announced that the Company received verbal notice from the U.S. Food and Drug Administration (FDA) that a clinical hold has been placed on IDX19368, the Company's next-generation nucleotide polymerase inhibitor under development for the treatment of hepatitis C virus (HCV) infection. This news follows an announcement that Idenix made on August 16, 2012 related to a partial clinical hold placed on IDX184, the Company's lead nucleotide polymerase inhibitor also under development for the treatment of HCV.
The FDA verbally informed Idenix that it placed IDX19368 on clinical hold due to concerns related to the serious cardiac-related adverse events reported for HCV patients treated with BMS-986094, a nucleotide polymerase inhibitor previously under development by Bristol-Myers Squibb Company. To date, no patients have been exposed to IDX19368.
"Based on our discussions with the FDA, we understand the clinical hold is a precautionary decision made by the FDA in light of the adverse events seen with BMS-986094," said Ron Renaud, President and CEO. "Both IDX184 and IDX19368 fall into the same broader class of NS5B inhibitors, and share the same active metabolite as BMS-986094. However, there are many attributes of our compounds, particularly the prodrug approach, that we believe favorably differentiate the toxicity profiles from that of BMS-986094. We recently learned that Bristol-Myers Squibb has agreed to share relevant information on BMS-986094 with us and hope this helps us to resolve this issue quickly."
As part of the partial clinical hold placed on IDX184, the FDA has requested additional cardiac testing of patients in the ongoing phase IIb clinical trial of IDX184. More than 50 patients have been scheduled for echocardiograms, and the Company is on track to submit these data to the FDA in the coming weeks. To date, echocardiograms have been performed on a small number of these patients, and the results are normal. Idenix's primary concern is patient safety and it will work diligently to expedite this review process and continue its discussions with the FDA with the goal of further advancing its drug candidates, IDX184 and IDX19368, in clinical development.
I really disagree here. Risk/reward makes it worth going long a small(3-4%) amount. Worth $450M+ with good data. I believe that accelerated approval might be possible.
Sorry, but NME does not imply NCE.
I will email him to get an idea.
Quote,"The US H+N results were presented last November by Monica Mita and Anand Kardad at the AACR/EORTC Molecular Targets meeting in San Francisco."
Yes, but they were notably missing PFS and OS data. Still no sign of it either...I actually contacted Dr. Mita; asked if she thought Reolysin was the most promising viral therapy in HNSCC... No response.
HNSCC is so heterogeneous just have a hard time believing it can succeed
BMY discontinues INX-189 program , 9 patients hospitalized
PRINCETON, N.J.--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE: BMY) announced today that the Company has discontinued development of BMS-986094 (formerly known as INX-189), a nucleotide polymerase (NS5B) inhibitor that was in Phase II development for the treatment of hepatitis C. This decision was made in the interest of patient safety, based on a rapid, thorough and ongoing assessment of patients in a Phase II study that the Company voluntarily suspended on August 1, 2012. The U.S. Food and Drug Administration (FDA) subsequently placed the compound on clinical hold.
The initial case of heart failure, which was the basis for halting the study, subsequently resulted in death. The Company is working in close collaboration with the FDA and clinical study investigators to conduct ongoing, comprehensive assessments and close follow-up of all BMS-986094 study patients. To date, nine patients have been hospitalized, including the initial patient; two patients remain hospitalized. While the cause of these unexpected events, which involve heart and kidney toxicity, has not been definitively established, the Company has determined that it is in the best interest of patients to halt development of BMS-986094.
“The decision to halt development of BMS-986094 has been guided by our overriding interest in protecting patients,” said Elliott Sigal, M.D., Ph.D., Executive Vice President and Chief Scientific Officer, Bristol-Myers Squibb. “In the interest of all patients participating in hepatitis C clinical studies, and in cooperation with the FDA, we will make relevant information on BMS-986094 available to inform the development of other investigational compounds to treat hepatitis C. We will also work expeditiously to share the results of our further investigations more broadly in the medical and scientific community.”
I agree on OS/PFS being rather low in HNSCC and the agreement in OS/PFS when this happens. Just curious if anyone has seen hard numbers for this particular indication.
Just trying to figure out what the heck ONCY is doing with the "predictive probability of success" nonsense.
Also, where are the results of the REO 015 study in the US?
http://clinicaltrials.gov/ct2/show/NCT00753038?term=REOLYSIN+neck&rank=2
Re ONCY
What do you make of part 2? This seems very odd to me. How are they calculating predictive success in OS when theyre only looking at the PFS curves? What is the cutoff? I have heard they want to see 70% predictive probability and ~50% increase in PFS.
Have you seen any such data showing a tight correlation with PFS and OS in HNSCC? Have you ever seen a company do such an analysis?
From this morning.... NeoGenomics initiated with a Buy at Craig-Hallum : Target $5.
Re AMRN
JP Morgan put out a note today: worst case scenario- generics in 2018 with a $9 PT (highly unlikely). Informal $39 PT and formal PT of $27.
Singh talked a mighty big game. He was bad for the reputation of the company.
Can you post those links? I live in LA and want to follow up with some of the trial investigators from Cedars Sinai.
From the company’s June 20th DMC safety review,
“The study design stipulates that the study will proceed to full enrollment in Stage 2 (ranging from 100 to 400 additional patients) provided that the DMC concludes that safety data in Stage 1 is acceptable for continuation to Stage 2, and an independent statistical analysis of Progression-Free Survival (PFS, a measure of efficacy) in Stage 1 predicts probability of success in Stage 2. The data collection for this analysis is currently being performed.
The safety analysis was performed on the 80 patients enrolled in Stage 1 of the study, once every patient had sufficient follow up after starting treatment on the study (six weeks). The statistical analysis will be performed once every patient has had sufficient follow up after starting treatment (12 weeks) to determine potential differences in PFS between the control and test arms of the study.”
ONCY does not plan to release OS data from this.
IMUC CEO resigns (finally the pumper goes)
re SNY/Lemtrada
Where did you get the PDUFA date? I dont believe it has been announced that their NDA was accepted.
UPDATE: Nevermind, I see it was announced on their CC.
http://seekingalpha.com/article/753911-sanofi-management-discusses-q2-2012-results-earnings-call-transcript?part=single
Thanks for that explanation. Data must be coming soon I guess. Trial seems to have taken a really long time to enroll just 80 patients, that's why I think it is a little unusual how long it has taken; trial began in late May 2010, finished enrollment in April 2012(almost 2 years). A friend also spoke with execs at the company who seemed to indicate the data should be ready in early/mid August.
It is the stage 1 portion of their 2 stage Phase 3 trial of Reolysin in combination with paclitaxel and carboplatin in patients with platinum-refractory head and neck cancers(REO 018).
http://www.oncolyticsbiotech.com/clinical-trials/8
ONCY been ~8 weeks since trial completed the 12-week efficacy window. how does it take that long to collect/analyze data on 80 patients?? Seems a little long to me. Massaging the data?
JQ already addressed this. When no p-values or hazard ratios are reported, you can assume they did not achieve statistical significance.
Stop posting all of this nonsense on this board.
(1) You keep touting some long forgotten biotech exec who ended up at Peregrine.
(2) You all fail to acknowledge who slimy Peregrine has been. Not reporting p-values, hazard ratios,
Also Adam Feuerstein's account of how sneaky Peregrine has been with heavily diluting shareholders thru ATMs. Real quality guys at Peregrine.
http://www.thestreet.com/story/11627155/1/biotech-stock-mailbag-peregrine-pharma.html
(3) Their trials are not gold standard by any means. Maybe if Peregrine had pre-specified the analysis of overall survival, done this with about 3 times as many patients and not used 50% of patients from Russia/India/Ukraine.
(4) IMO, Peregrine has been dishonest about the control arm. Something is up with the baseline levels across arms. PPHM reporting < 6 months strikes me as too unusual. Even the slide below you posted shows 9 months!
Herbst 2010 ("Vandetanib plus docetaxel versus docetaxel as second-line treatment for patients with advanced non-small-cell lung cancer (ZODIAC): a double-blind, randomised, phase 3 trial")
"However, in the present study, the median overall survival of 10 months for patients receiving placebo plus docetaxel is longer than that reported in the earlier studies. This difference might be explained by differences in the availability or use of first-line and post-progression therapies, as well as general improvements in standards of care over time."
http://www.sciencedirect.com/science/article/pii/S1470204510701327
Hanna 2004 - 7.9 months
http://bit.ly/Pwt26S
Kim 2008 - 8 months
http://bit.ly/P29m71
(5) You can call me Patrick or Pcrutch. My opinion changed because I eventually caught on to their BS after some conversations with the CEO and further digging. We all can make lapses in judgement on certain companies, since then I have thought quite poorly of the company.
re PPHM
This is certainly very strange, given the trial has been unblinded and has no protocol that I know of which would interfere with placebo arm crossover. If this OS benefit were as great as claimed, you would suspect that they would have crossed placebo patients over by now.
Biased? No, I think you meant not blind with greed and pumping. So far, I am 2 for 3 on that prediction. The primary endpoint in both studies is objective response rate, is it not? Both trials did not hit stat sig on ORR or PFS. PPHM admitted the 2nd line study didnt hit on PFS or ORR by leaving off the pvalues and hazard ratios.
http://clinicaltrials.gov/ct2/show/NCT01160601?term=Bavituximab&rank=5
http://clinicaltrials.gov/ct2/show/NCT01138163?term=Bavituximab&rank=6
Thanks for the table. There are some glaring problems.
- Need to know patient baseline levels in each trial(% stage IIIB / IV , mutation status, etc)
- you should also take the median of these results, not the average
- which are Phase 3 trials?
Hard to take those numbers too serious without checking out patient baseline levels between trials.
Still stands out as unusual against MOS of ~5.2 in the ARRY randomized trial in 2L KRAS+ NSCLC. KRAS mutation status confers signif worse treatment prognosis.
It would confirm their DTIC arm MOS is too short for some reason. Baseline levels must not be equal
Agree 100%. ARRY recently reported OS in 2L NSCLC (stage IIIB and IV) who are KRAS positive: Overall survival was longer for selumetinib in combination with docetaxel compared to docetaxel alone (9.4 mo vs 5.2 mo; 56 events, median follow-up 219 days).
KRAS+ have notably shorter OS, so for PPHM to have a median OS<6 months, they must have stacked the deck. Baseline levels of patients must not be the same across arms.