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Re GERN
Pretty obvious. President and CEO of Moffitt didn't have a hard time spotting this.
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I asked two top experts in the field, Gary Gilliland, the former head of cancer research at Merck and the Vice President for Precision Medicine at Penn Medicine, and Alan List, the President and CEO of Moffit Cancer Center, for their thoughts on the data.
“It’s very interesting data but it’s very early, they have small numbers of patients with modest follow up,” says Gilliland. “I hate the hype that comes out around this because these patients are so desperate for treatments.”
In the exciting column: Four of 18 patients had blood test results consistent with a complete remission of disease, and one more with a partial remission and three with clinical improvement.
Gilliland says he’d want to know more about how sick they were at the beginning of the study – healthier patients are more likely to look like they’ve gone into remission based on a blood test. Myelofibrosis can be spotty, he says, so it’s useful to have long-term biopsies to make sure the bone marrow is improving. “Three months is different from two years.”
List notes that a blood test result is not enough to judge a complete remission. “These are not true CRs,” he says. But he’s encouraged by the fact that there was reversal of fibrosis, the bone marrow scarring, in the four patients whose blood tests showed signs of the cancer disappearing. “At least it’s evidence of activity,” he says. “The JAK inhibitors have no effect on fibrosis at all.”
But List does see a “major problem” for the Geron drug. Even for high-risk myelofibrosis patients, the condition is chronic. Imetelstat is likely to be given intravenously once a week for three weeks, followed by once every three weeks. With that dosing schedule, it’s going to be very difficult to get patients to stick to the regimen. “If you can get to a more extended schedule it makes a lot more sense,” List says.
http://www.forbes.com/sites/matthewherper/2013/11/07/independent-researchers-hopeful-but-cautious-about-geron-drug/?partner=yahootix
Onslaught? How many active programs left? Seen mostly cancelled plans.
Re CLDX
CDX-1127 looked like a flop to me. Don't get the mutual fund managers who are buying into this. Sat in the clinic for 2 years, little interest.
Read the sub note.
"4 patients received incorrect RBV doses (3 received <50% of the prescribed dose:1 given RBV in the RBV-free arm); all achieved HCV-RNA <25 IU/mL at FU12
3 patients discontinued early:1 patient at Day 3 (violated protocol inclusion criterion), and 2 patients at Day 22 and Day 35 (withdrew consent – patients had undetectable HCV RNA at the time of discontinuation)"
Re 5172
Tolerability/AEs seemed to be an issue at the higher doses(400/800mg). They're moving forward with 100mg.
http://www.natap.org/2013/EASL/EASL_27.htm
http://clinicaltrials.gov/ct2/show/NCT01717326?term=mk-5172&rank=10
I would guess drug wont be back for 6-12 months, if things go well.
This trial likely has a very good shot of hitting, using PD-L1 as inclusion requirement.
"Histologically- or cytologically-confirmed diagnosis of non-small cell lung cancer (NSCLC) that is PD-L1 positive per central laboratory review"
Thanks for pointing these out. Today's move did seem a bit dramatic.
Transcript here
http://seekingalpha.com/article/1778792-merck-amp-co-inc-s-ceo-discusses-q3-2013-results-earnings-call-transcript
Jacobus also has about 20yrs of patient data on top of that Phase 2 trial. LEMs patients and KOLs have pushed patients towards Jacobus trial, explains why Biomarin could never get it fully enrolled. See the Wikipedia page for 3,4-DAP.
LEMS is also smaller than CPRX has said. I heard that since Jacobus has been giving 3,4-DAP out over 20 years, only treated about 500+ patients.
This is very true. They do a lot of interviews with KOLs in particular.
No question, they are building an oncology force to be reckoned with on the cheap.
What's your thinking on RNA? They go back and try IV dosing? Certainly more compelling at these levels if you think they can sort of the issues.
It applies to them as well. It had more immediate read thru to Idenix though, given their previous relationship with Jannsen.
Achillion news was disappointing, underestimated how weak of a PI that sova was and the FDA. I do think that Merck will do well though with their PI+NS5A given how potent 5172 is.
IDIX - This morning's news can't be good for this collaboration
Janssen acquires investigational NS5A inhibitor for the treatment of Hep C from $GSK
TITUSVILLE, N.J., Oct. 8, 2013 /PRNewswire/ -- Janssen Pharmaceuticals, Inc. (Janssen) announced today the acquisition of the investigational compound GSK2336805, an NS5a replication complex inhibitor in Phase 2 development for the treatment of chronic hepatitis C, from an affiliate of GlaxoSmithKline plc. Janssen has acquired all rights to develop and commercialize GSK2336805, including in combination with other drugs. Financial details of the agreement have not been disclosed.
Janssen plans to initiate Phase 2 studies to evaluate the use of GSK2336805 in interferon-free combinations with the investigational protease inhibitor simeprevir (TMC435) and TMC647055, Janssen's non-nucleoside polymerase inhibitor, for the treatment of chronic hepatitis C in adult patients with compensated liver disease.
"We're excited to add GSK2336805 to our existing portfolio of direct-acting antivirals (DAAs). This addition will broaden our clinical development program as we continue to look for new investigational interferon-free treatment combinations to combat the hepatitis C virus," said Gaston Picchio, Hepatitis Disease Area Leader, Janssen. "Janssen is dedicated to working with the hepatitis C community to investigate our portfolio of DAAs in a number of different treatment combinations and hepatitis C patient populations."
I think they are still working with EMiS GLP1 candidate. Haven't heard much recently though.
They seem reasonable based on the AVIATOR data, nice breakdown of the performance in these slides.
http://www.chronicliverdisease.org/disease_focus/ppts/ch/Emerging_Therapies_AASLD_2012_Part1.pdf
What are your expectations for the SVR data from these trials?
No PRs seen and 1202 going over 1000mg. Drug has poor bioavailability it seems. Disappointing.
Rolapitant isn't all that different from Emend and Helsinn/Eisai will launch NEPA, an all oral 5HT3+NK-1, likely ahead of them. Phase 2 data were not spectacular.
Their ALK drug is likely much too far back to hold much hope for.
PARPs haven't really differentiated themselves yet, but company moving to Phase 3 with limited data in Phase 1/2.
Executives used to be head of MGI pharma
You are trying to rationalize why it could go higher instead of whether where its at now makes any sense. Comparing it to PCYC Ibrutinib is absurd; patient testimonials littered the web before a lot of their data was presented. You're also ignoring they arent being honest with the CDX-011 program.
Glad youve done well in CLDX, but you are obviously a bit blinded by it.
1127 has shown no data, so we should believe it is next PD1? It's not. PD1 generated an incredible amount of buzz before data was known on the patient forums. Zilch so far for CD27.
Sorry if another explanation for constant harping on "potential" doesn't sound suspicious. If CLDX so great, I'd love to know why Baker Bros /RA Capital/ Orbimed/ etc never got involved.
Company also acting shady. Refuses to share the HR's from the Phase 2 trial with CDx-011
Just look at who the top holders are: all mutual funds. These guys are on the phone with the sellside constantly trying to get their stocks upgrade. They drive the volume.
BRUSSELS (Reuters) - Belgian biotech firm Ablynx (ABLX.BR) has signed a licensing agreement with U.S. group AbbVie for its antibody ALX-0061 which treats inflammatory diseases such as rheumatoid arthritis and lupus.
Under the terms of the deal, Ablynx will receive an upfront payment of $175 million and may receive additional payments of up to $665 million, the group said on Monday.
You don't think PRAN is a 'scam'?
Really?
Their ability to burn cash at such high rates without making strides forward is astounding.
Not really, whisper number was close to $100m+ amongst buy siders.
PPHM - I think Bavituximab isn't a placebo... more like a virtual neural virus. It somehow infects people into believing it works.
This is just annoying. This has already been disclosed.
Obviously this might be reading too much into a preliminary PR, but my only caution is previously they said, "FDA will consider AA" and today we get "Regulatory Update". Although last time they held CC immediately after and all major data been released in morning.
It could be this is just a primer PR.
Doubt it would be that high. CRTh2's have had about 4-5% placebo adjusted if my memory serves me , none have gone to Phase 3 for asthma. Actelion scrapped their asthma plans.
More like 4.5M now
Main reason stocks holding up other than QE.
Can you clarify this?
No one with a PD1 or PD-L1 is interested in running a combo study with Bavi nor does PPHM have the money to run one themselves once these are approved.
It's not just moving up lines, but moving into the least robust subpop and a very difficult to treat form of BrCa. Also, why isnt the company disclosing the hazard ratios? I've asked and they have never answered.
Where are you assigning most of today's current value? I think '011 occupies significant portion, followed by Rindo, 1127 then 1135.
'1127 could be promising, but hope they chose their path forward carefully. Although melanoma might be quickest path forward, it is also way too crowded with BMY, MRK many years ahead. I also view the proposition of combining with PD1 as risky from a safety perspective.
I think $1.7B is speculative at this juncture and price needs correction. There is such thing as a stock getting ahead of itself.
re CLDX
With a number of parties going after TNBC (PD1's included), CLDX should've went for all high GPNMB 3rd/4th line BrCa patients vs high GPNMB TNBC patients. It will take quite some time to screen enough patients(likely 700+ pts) to fully enroll the trial(think they said 2:1 randomization wit n=300), when you consider TNBC is like 10-15% of all BrCa and high GPNMB isn't likely 50% of these(maybe 25%). Not to mention, this subset had very few patients.
If the company was so confident, they would have enrolled more patients. Sample size much too small to reach any sort of conclusions.
Do you think ENTA is a compelling play at these levels? What's their royalty and payouts on the HCV deal with ABBV?
Thanks for this. Probably will suck for my June options(had the $15 calls and $13 puts) unless they say something tomorrow.
This may confirm your rumor
"Open-Label Study of GS-7977+ Ribavirin With or Without Peginterferon Alfa-2a in Subjects With Chronic HCV Infection Who Participated in Prior Gilead HCV Studies"
http://clinicaltrials.gov/ct2/show/NCT01625338