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VBL Therapeutics to Present Company Overview at Upcoming Conferences in May
TEL AVIV, Israel, April 29, 2015 (GLOBE NEWSWIRE) -- VBL Therapeutics (Nasdaq:VBLT) a clinical-stage biotechnology company focused on the discovery, development and commercialization of first-in-class treatments for cancer, today announced that management will present a company overview at the following conferences in May:
Deutsche Bank 40th Annual Health Care Conference in Boston, MA on Wednesday, May 6, 2015, at 2:50 p.m. ET. A live webcast will be available by visiting the investor relations section of VBL's website at www.vblrx.com. An archived replay of the webcast will be available on the Company's website for 90 days after the conference.
Oppenheimer 16th Annual Israeli Conference, in Tel-Aviv, Israel on Sunday, May 10, 2015, at 1:10 p.m. IST (6:10 am ET).
IATI Biomed 2015 Conference in Tel Aviv, Israel on Wednesday, May 13, 2015, at 2:20 p.m. IST (7:20 a.m. ET).
http://ir.vblrx.com/phoenix.zhtml?c=253311&p=irol-newsArticle&ID=2041760
VBLT at ASCO with link
https://iplanner.asco.org/am2015/AM2015.aspx
Saturday, May 30 | 1:15 PM - 4:45 PM
Gynecologic Cancer
Session Type: Poster Session
Track(s): Gynecologic Cancer
Presentation(s):
Abstract #5542
A phase I/II trial of multiple dose VB-111 and weekly paclitaxel in recurrent platinum-resistant Müllerian cancer.
Richard T. Penson, MD, MRCP
Massachusetts General Hospital and Harvard Medical School
Monday, Jun 1 | 1:15 PM - 4:45 PM
Central Nervous System Tumors
Session Type: Poster Session
Track(s): Central Nervous System Tumors
Presentation(s):
Abstract #2015
Onartuzumab plus bevacizumab versus placebo plus bevacizumab in recurrent glioblastoma (GBM): HGF and MGMT biomarker data.
Timothy Francis Cloughesy, MD
UCLA
Tuesday, Jun 2 | 8:00 AM - 11:00 AM
Central Nervous System Tumors
Session Type: Oral Abstract Session
Track(s): Central Nervous System Tumors
Presentation(s):
9:36 AM - 9:48 AM
Bevacizumab for Glioblastoma: Selection, Dose, and Schedule
Timothy F. Cloughesy, MD
University of California, Los Angeles
VBLT at ASCO
Gynecologic Cancer
Session Type: Poster Session
Track(s): Gynecologic Cancer
Presentation(s):
Abstract #5542
A phase I/II trial of multiple dose VB-111 and weekly paclitaxel in recurrent platinum-resistant Müllerian cancer.
Richard T. Penson, MD, MRCP
Massachusetts General Hospital and Harvard Medical School
Up over 10% today -- good day finally!
New patent filed
Confidential Treatment Order approved
It's going down on low volume. For example, today down 10% on just 300K shares. Not a lot of resistance if/when good news come out.
I would wait until a reversal is confirmed. $4.77 seems cheap but $4.50 (if it goes there) is cheaper. You never know. I'm waiting to add when reversal happens. Right now, it's being pulled down on very low volume.
I don't think they abandoned VB-201. They only terminated it for the two indications: UC and psoriasis. They are still testing it for other indications: http://www.vblrx.com/inflammatory-disease-programs/inflammatory-pipline/
But I don't think investors are putting much (if any) value on VB-201 at the moment due to its recent failures. It would have to go to pIII before people take it seriously.
VB-111 is it for now. Thankfully it has fast track and orphan status in the US and Europe.
Nice research, Mjmillions!
Nice day, overall. Market was bloody but VBLT held strong on 30% gain.
Agree mjm. If the employees think the stock is undervalued then they will hold.
Great news! Glad I'm holding. :)
"VBL has also received fast track designation for VB-111 in the United States for prolongation of survival in patients with recurrent rGBM and orphan drug designation in both the United States and Europe."
@BR "they ignore the clinical staff at the EPIC trial that complain of serious, in some cases deadly AE's??"
That's a serious accusation. Are you accusing them of criminal activities?
New TKI touted as potentially best in class. When I see "best in class" I think "frontline". Ariad has not been one to pump/over market their products. I wonder if they have news coming out with data that will support such a bold proclamation. I hope so!
@dubstock the 5% drop is the total short interest as seen in here: http://www.nasdaq.com/symbol/aria/short-interest
The short analytics / % fluctuations you're referencing is the daily stock trading % of shorts. They're related but not the same. The 5% drop in over short % is significant but there are still close to 50 mil shares short.
@zuize Bosulif is expected to reach peak global sales of $341 million in 2016.
http://www.thepharmaletter.com/article/fda-nod-for-pfizer-s-rare-leukemia-drug-bosulif
BR said, "Ariad is a terrific research and discovery company, but really have no clue on how to bring a compound to the market."
I agree with this. It is actually a reflection of its leader, HB. He is an intelligent guy but he has his limitations when it comes to being a CEO and taking the company's products to market.
Interesting PII trail research going on for Pona:
Sameek Roychowdhury, a researcher at the OSUCCC – James, has led the design of a phase II clinical trial to test a new drug, called ponatinib, that inhibits one of these genes, called the fibroblast growth factor receptor (FGFR).
One problem is that cancer cells often develop resistance to the drugs that are used to treat them. Anticipating that resistance might develop in some patients during the ponatinib trial, the researchers have received a Pelotonia grant that will enable them to collect biopsy samples from each trial participant’s tumor before and after treatment.
The grant also will enable the researchers to sequence 20,000 genes in each sample and look for new gene changes that could cause ponatinib resistance. The findings will provide a foundation for further research on how cancer cells become resistant to FGFR inhibitors and for the development of drugs to counter the resistant cells.
http://oncampus.osu.edu/a-cancer-free-world-begins-here/
@vidpok45 re pursuing alz: I think the bigger issue is that the company is running out of money and time. Not sure if the company has the resources (people/time/money) to go after this on its own.
What do you think? Just saw this on stocktwit. Looks very promising for Ponatinib. Good, no?
Comparative Efficacy of Tyrosine Kinase Inhibitor Treatments in the Third-Line Setting, for Chronic-Phase Chronic Myelogenous Leukemia after Failure of Second-Generation Tyrosine Kinase Inhibitors
J.H. Liptona, P. Brydenb, M.K. Sidhuc, , , H. Huangd, L.J. McGarryd, S. Lustgartend, S. Mealingb, B. Woodsb, J. Whelanb, N. Hawkinsb
a Princess Margaret Cancer Centre, University Health Network, Toronto, ON, Canada
b CON Health Economics; Oxford, UK
c CON Health Economics; Morristown, NJ, USA
d ARIAD Pharmaceuticals, Inc.; Cambridge MA, USA
Received 12 May 2014, Revised 15 October 2014, Accepted 24 October 2014, Available online 1 November 2014
Highlights
•
We compared the efficacy of ponatinib and 2G-TKIs in CP-CML after =1 prior 2G-TKI.
•
Relevant studies were identified by systematic review.
•
Estimated response to 2G-TKI was 22-26% vs 60% (95%CrI 52-68%) with ponatinib.
•
Probability of response was greater with ponatinib than with a further 2G-TKI.
Abstract
We compared the efficacy of ponatinib and second-generation tyrosine kinase inhibitors (2G-TKIs: bosutinib, dasatinib, and nilotinib) in chronic phase CML resistant/intolerant to =1 prior 2G-TKI. Estimated probabilities of CCyR with 2G-TKI ranged from 22% to 26%, compared with 60% (95% CrI 52-68%) with ponatinib. The estimated probability of ponatinib providing higher response rate than all other included treatments was 99% (CCyR) and 97% (MCyR). Use of further 2G-TKI may provide limited benefit in CP-CML patients resistant/intolerant to prior 2G-TKI treatment. Compared with 2G-TKIs, ponatinib is estimated to provide substantially higher probability of achieving CCyR and MCyR; safety was not compared.
http://www.sciencedirect.com/science/article/pii/S0145212614003270
Article: Where Exactly Does Ponatinib Fit in Chronic Myelogenous Leukemia?
http://www.jnccn.org/content/12/11/1615.abstract
The free version:
Abstract
Ponatinib holds a unique place in the spectrum of drugs in use for the treatment of chronic myelogenous leukemia. It is perhaps the most active tyrosine kinase inhibitor (TKI) among those currently licensed; 51% of patients resistant to or intolerant of second-generation TKIs experienced a major cytogenetic response and 70% of patients with the highly resistant T315I BCR-ABL1 mutation experienced a major cytogenetic response. However, 1 year after its accelerated approval by the FDA, and midway through its phase III pivotal trial, a high number of vascular occlusive events began to be reported. The FDA put a partial clinical hold on the drug and the phase III trial was halted. Dose-reduction recommendations were made, and the drug is now used in patients for whom no alternative TKI is available and those who have the T315I mutation. Currently, the substantial and durable responses that this drug provides are difficult to balance against the late-in-course vascular occlusive events. The hope is that ongoing research into the mechanism of presumed endothelial damage will provide a better understanding of how to position this drug for optimal use.
When ARIA goes to 25, I'll take you up on that beer. :)
@Sikmarson she is postponing it because she is still feeling ok. Wonder what she's taking.
http://www.kgw.com/story/news/local/2014/10/30/brittany-maynard-postpones-oregon-assisted-suicide/18167099/
BR said "Assuming zero growth, our forecast model predicts 4Q14 sales of $9–$12MM (vs. $23MM consensus). As this leaks out next week, it won't be pretty."
BR: It's still early but do you still believe in this statement?
@pom looks like it's immunotherapy. Maybe it could complement the TKIs? Like what TC was referencing in combo treatments. But for now, it looks like Keytruda (pembrolizumab) is in PI and used when nothing else works.
@trading_cyclist are you talking about combo drugs like Lirilumab/Nivolumab (http://clinicaltrials.gov/show/NCT01714739)? Not that common, imo.
Most patients will take additional meds to reduce side effects like nausea, diarrhea, rashes, etc ... but I don't think you're talking about that, right?
The next step in their research was to identify next-generation ALK inhibitors able to overcome alectinib resistance caused by the newly identified mutations. From these studies, they found that ceritinib, approved by the FDA in April 2014 for the treatment of ALK-positive NSCLC resistant to crizotinib, can overcome resistance to alectinib. AP26113, an investigational drug currently in clinical trials, was also able to overcome alectinib resistance.
Shaw and colleagues took this knowledge back to the bedside, to a patient whose cancer relapsed on crizotinib first, and then on alectinib. They treated this patient with ceritinib, and this patient had a partial response lasting for seven months.
“For patients like Rocky, the inevitable question is, ‘What do we do after ceritinib?’” said Shaw in an interview. “Fortunately, our study suggests that you may be able to use another next-generation ALK inhibitor <my response: like AP26113?> as the next treatment. Depending on the resistance mechanisms the patients’ tumors develop, it may be possible for them to derive clinical benefit from a series of different ALK inhibitors.”
http://blog.aacr.org/findings-open-doors-rational-lung-cancer-treatment-strategies/
@LUMA14 using the numbers in the article. Assume ARIA takes 50% of the WW customers of the lower number in the range: 3000. 1500 patients at $9200 per month = $165 million. That's not too bad.
Re: Denner, my guess/speculation is that he came to Ariad for AP26113; not Iclusig ... unless you have a sales/mktg power of J&J, it's too much effort to turn the Iclusig ship around. AP26113 is the crown jewel of Ariad.
With Iclusig, patients have some weird side effects that really negatively impact their quality of life. Maybe starting off at 15mg will help but many drs start off at 15 only to get the patient's system used to the med. They ultimately want to go to 30 mg or higher. The other TKIs have severe side effects as well and Iclusig is no different.
With AP26113, it's superior vs the competition. Not only on its effectiveness but also on its (lower/minimal) side effects. The quality of life improvement is very significant. Wouldn't surprise me if Denner heard about this, saw the huge opportunity and went hard after the company.
@2damoon1 I agree that "The market turned on Ariad". Yes ... after Gleevec, Sprycel and Tasigna .. or Bosulif .. or T315i mutation .. Pona is seen as the last resort. The negative results/press was a kiss of death. Folks avoid it even and are scared to take it even when all other options run out and even when they're staring off at 15 mg.
Certainly, Ariad has its work cut out going forward to improve Pona's perception/image ...
But information is now slowly coming out (from patients that have used G, S and/or T) that Pona is effective (very effective) for some patients that have no/little other option. Thus, the lower scripts #s are not surprising.
@zuize spot on ... especially the list of competitors. AP26113 has a long road ahead but current indications (from actual patients) are that it is very effective and has minimal side effects. The question they all want to learn is ... for how long? since they're all used to seeing/experiencing eventual resistance/mutations.
@Jesspro exactly. Patients have been praising AP26113 for crossing BBB. After chemo, crizo, etc ... they start on AP26113 and ... short of NED, other patients have had tumor shrinkage, little side effects (skin rash), "spots" disappeared ... some could return back to their active lives (jogging, working out)
Would not surprise me if it moves to frontline. "miracle" is a word often used. Knock-on-wood and hoping AP26113 continues to save lives and doesn't develop any serious side effects.
AP26113 and Ponatinib saving lives. These are real stories, which may come out one day ...
Quotes like: I was on Crizotinib ... I was on Xalkori ... now AP26113 and then ... NED!
NO WAY does this company ever go BK. BO perhaps but never BK.
@BR .. what did they order for lunch?
"ability of dasatinib and nilotinib to achieve a very deep molecular remission (= 4.5 logs) is encouraging, in light of evolving data that a proportion of patients who achieve and maintain such remissions for at least 1-2 years can discontinue TKI therapy and remain in molecular remission for at least several years."
Until pona can show its effectiveness, dasa and nilo will continue to take the spotlight.
http://www.medscape.com/viewarticle/833129#vp_2
Relying on analysts is the lazy way to invest. But ask yourself this question: Would you trust an analyst more than Denner? He has a track record and "puts his (Sarissa) money (lots of it) where his mouth is".
As they say, everyone should do their own DD.
Re HB: He's not CEO material. He's not good with the public/stockholders.
But I think he's an intelligent guy and is an asset to ARIA. I doubt he'd take a backseat/lesser role though. But ARIA would be better off if he did.
@rum re "decision to not allow Denner to purchase more shares"
I think this speaks volume about what going on between HB/his pals and Denner/Sarissa. Sarissa is not the largest shareholder, so why decline the waiver? There is just no reason, unless ...
@TC Re "per FDA regulations, this could advance to market at any point (even phase 1 can can advance to market)"
I didn't realize this. Do you know when the FDA would likely pull the trigger and allow something like this? ORR=, AE= ..? Can you provide a link?
Is there enough money to conduct/finish the AP26113 trials? It seems like -- at the current burn rate & revs -- the company needs sales to ramp up significantly to fund the trials.
@BR ... re "they do not live very long". Says here CML AP "4-year survival was 53%". If that's what you mean by not very long, then that's not bad at all. http://www.cancer.gov/cancertopics/pdq/treatment/CML/HealthProfessional/page5