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VBLT at Key Opinion Leader Meeting in New York City
The presentation is a must see:
http://lifesci.rampard.com/20160504/reg.jsp
No debt. Plenty of cash to do phase 3.
VBL Therapeutics Announces Clinical Data to be Presented at 2016 ASCO Annual Meeting
TEL AVIV, Israel, May 03, 2016 (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 data from two Phase 2 clinical studies of VB-111 will be presented at the 2016 American Society of Clinical Oncology (ASCO) Annual Meeting, which will take place June 3 to June 7, 2016 in Chicago.
The ASCO presentation details are as follows:
Title: Ofranogene obadenovec (VB-111), an anti-cancer gene therapy in combination with bevacizumab to improve overall survival compared to bevacizumab monotherapy in patients with rGBM: A phase 2 historically controlled trial.
Abstract: #2074
Session Type: Poster Session
Session Title: Central Nervous System Tumors
Date: Saturday, June 4, 2016
Time: 1:00 PM – 4:30 PM
Location: Hall A
Poster Board: # 261
Presenter: Andrew Jacob Brenner, MD, PhD, The University of Texas Health Science Center at San Antonio
Title: Tumor responses and preliminary survival data in a phase 2 trial of ofranergene obadenovec (VB-111) combined with paclitaxel in patients with recurrent platinum resistant ovarian cancer.
Abstract: #5551
Session Type: Poster Session
Session Title: Gynecologic Cancer
Date: Monday, June 6, 2016
Time: 1:00 PM – 4:30 PM
Location: Hall A
Poster Board: # 374
Presenter: Richard T. Penson, MD, MRCP, Massachusetts General Hospital
VBL Therapeutics Q1 2016 Financial Results
May 13, 2016 8:30 a.m. ET
Webcast Presentation
http://ir.vblrx.com/phoenix.zhtml?c=253311&p=irol-EventDetails&EventId=5226829
March Events
March 09, 2016
BD Boston
March 13, 2016 through March 16, 2016
28th Annual ROTH Conference
March 22, 2016
The Cell & Gene Therapy Investor Day
Upcoming Events
February 08, 2016 through February 09, 2016
BIO 2016 BIO CEO & Investor Conference
March 09, 2016
BD Boston
March 13, 2016 through March 16, 2016
28th Annual ROTH Conference
Now 4 recruiting sites for rGBM
TX, NY, MO and KY
https://clinicaltrials.gov/ct2/show/NCT02511405
VB-111 demonstrates a clear 2-fold efficacy benefit over Avastin alone
http://ir.vblrx.com/phoenix.zhtml?c=253311&p=irol-newsArticle&ID=2113957
VBL Therapeutics Announces Significant Improvement of 12 Month Overall Survival With VB-111 Compared to Pooled Data From Four Avastin(R) Studies at the Annual Meeting of the Society for Neuro-Oncology
TEL AVIV, Israel, Nov. 19, 2015 (GLOBE NEWSWIRE) -- VBL Therapeutics (NASDAQ:VBLT), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of first-in-class treatments for cancer, today announced the presentation of new data on its lead oncology product VB-111, a first-in-class, targeted, anti-angiogenic gene-therapy agent with applicability for multiple solid tumor indications, at the 20th Annual Scientific Meeting and Education Day of the Society for Neuro-Oncology (SNO), being held in San Antonio, Texas, showing significant improvement of 12 month overall survival (OS) with VB-111 in recurrent Glioblastoma multiforme (rGBM) compared to pooled data from four different Avastin® studies.
VB-111 is being featured in a poster presentation at SNO as well as in a satellite symposium sponsored by the company, both taking place Friday, November 20. New data are being presented that compare the 12 month overall survival achieved with VB-111 in rGBM to the results from four different trials of bevacizumab (Avastin®)1 in this disease setting (n=233). In the recently completed Phase 2 study, the overall survival rate for patients treated with VB-111 in combination with bevacizumab upon disease progression (continuous exposure cohort) was 57% at 12 months. This compares with an overall 12 month survival of 28% (range 16% to 38%) in the pooled data from the 4 Avastin™ studies (p = 0.007).
"This new analysis comparing our VB-111 results with multiple historical studies in rGBM demonstrates a clear 2-fold efficacy benefit," stated Yael Cohen, M.D., Vice President, Clinical Development of VBL Therapeutics. "While there are limitations with comparing results across different clinical trials, this comparison gives us additional confidence in the treatment benefit of VB-111 in this patient population."
"We are now actively recruiting patients in the Phase 3 GLOBE study of VB-111 in combination with bevacizumab and our goal is to have interim data in the first quarter of 2017," continued Dr. Cohen. "We believe that VB-111 has the potential to change the treatment paradigm for rGBM patients, who are at great need for an effective therapy."
VBL's pivotal Phase 3 GLOBE study in rGBM which started in August 2015, is comparing VB-111 in combination with bevacizumab to bevacizumab alone and is recruiting about 252 patients in the US, Canada and Israel. The study is proceeding under a Special Protocol Assessment (SPA) granted by the FDA, with full endorsement by the Canadian Brain Tumor Consortium (CBTC). VB-111 has received orphan drug designation in the United States and Europe and was granted Fast Track designation by the FDA for prolongation of survival in patients with glioblastoma that has recurred following treatment with standard chemotherapy and radiation.
GBM AGILE is groundbreaking in so many ways,” said Timothy Cloughesy, MD, the trial’s principal investigator
Cloughesy is also leading phase 3 for VB-111
Here's the whole article:
http://www.targetedonc.com/conference/2015-sno-annual-meeting/innovative-global-trial-planned-for-gbm-treatments
An international team of experts is planning an innovative clinical trial, AGILE, to speed up development of new treatments for glioblastoma multiforme (GBM).
One of the goals of the coalition is to put into motion a biomarker-driven approach that has been employed in other malignancies.
“It’s a brave new world,” said Donald A. Berry, PhD, professor of Biostatistics, University of Texas MD Anderson Cancer Center, co-principal investigator on the trial. “We’re experimenting ... and we’re experimenting with clinical trials.”
Berry said with the way GBM AGILE is designed, investigators would be able to conduct multiple phase II trials simultaneously due to patients being randomized within their subtype versus standard-of-care treatments. Approximately 150 patients will be in each arm of the study and overall survival will be an endpoint.
He said the design would allow for testing combination and sequential therapies.
Researchers would calculate the probability that an experimental therapy might offer an improvement over the standard by analyzing patient data in the study. Based on those results, promising agents would then “graduate” to phase III trials, Berry said. Studies into agents that reach a futility mark would be halted, while new novel agents could be continuously cycled into the protocol.
GBM AGILE will employ an adaptive clinical trial design with a master protocol. This means patients will be screened for preselected molecular biomarkers and then funneled into randomized studies of novel agents with matching signatures, one of the architects of the trial explained in a presentation at the 2015 Society for Neuro-Oncology Annual Meeting.
Hopes are high for GBM AGILE as the complex planning process for the trial gets into full swing. “As a neuro-oncologist taking care of GBM patients every day, GBM AGILE is groundbreaking in so many ways,” said Timothy Cloughesy, MD, the trial’s principal investigator.
“The adaptive design will allow us to modify the trial as it proceeds based on the data collected—and to test many drugs and combinations versus single agents—and to do it faster,” said Cloughesy, who is director of the Neuro-Oncology Program at UCLA. “It's an opportunity for patients to benefit from precision medicine, and a real source of hope for patients and their families.”
GBM AGILE is in the planning and design phase. The organizers hope to begin enrolling patients by mid-2016. No specific drug candidates for inclusion in the trial have been disclosed, and the group is still seeking to raise funds for the study.
“Crowdsourcing” Effort
Through the trial, researchers hope to leverage recent advances in the understanding of the molecular drivers of GBM and the cooperation of scientists throughout the world. The trial will be conducted in the United States, China, Europe, and Australia, organizers said in announcing plans for the initiative in mid-November.
GBM AGILE grew out of a “scientific crowdsourcing” effort that has brought together more than 100 neurosurgeons, neuro-oncologists, pathologists, imagers, neuroscientists, and patient advocates to plan the study. Leading the effort is the National Biomarker Development Alliance (NBDA), a nonprofit organization created as part of the Research Collaboratory at Arizona State University.
The research initiative was announced with a sense or urgency in light of the aggressive nature of GBM, the most common adult brain tumor. Organizers said 50% of patients with GBM survive for 1 year or less and that the 5-year survival rate is less than 2%.
Moreover, despite hundreds of clinical trials, the most notable therapeutic advance in GBM occurred more than 10 years ago when the combination of temozolomide and radiation therapy demonstrated the ability to extend survival by about 2 months, according to the NBDA.
"We have to do something more—something different—something that brings the best science and innovative clinical trials together to identify therapies that work," Mitchel S. Berger, MD, a GBM AGILE co-investigator who chairs the Department of Neurological Surgery at the University of California, San Francisco, said in a statement. "GBM AGILE is the best path to achieve those goals that I have seen for decades."
Modeled on the I-SPY 2 Study
Berry, who is the founding head of the Division of Quantitative Services at MD Anderson, is a leader in the development of innovative statistical methodology for the improvement of clinical trial design and analysis, especially the Bayesian methods used in the I-SPY breast cancer clinical trials. The GBM AGILE trial also would use the Bayesian methodology.
During his presentation, Berry said the FDA recognized a decade ago that adaptive trial design and Bayesian methods could help improve upon the high costs and low success rate of phase III clinical trials. He also said the FDA has acknowledged that the clinical trial paradigm must be changed in order to speed the progress of personalized drugs to market.
Berry described GBM AGILE as a platform trial that would be modeled after I-SPY 2, which was launched in 2010. In the breast cancer trial, 8 pharmaceutical companies have “put aside their differences” to participate in the phase II trials, in which more than 900 patients have been randomized to studies evaluating 10 experimental therapies, Berry indicated.
Thus far, 3 drugs that were tested in combination regimens have met the standards for graduation from I-SPY 2, according to ClinicalTrials.gov website records, which were last updated in mid-July (NCT01042379). Those drugs are veliparib, neratinib, and MK-2206.
Berry said I-SPY 2 has inspired researchers in other areas of medicine to pursue similar trials. Europe’s Innovative Medicines Initiative collaborative efforts include biomarker-driven studies into Alzheimer disease and a wide-ranging Ebola research program.
In oncology, master protocol trials also have been utilized in melanoma with the MICAT trials and in lung cancer with the BATTLE and ongoing Lung-MAP studies.
VBL Therapeutics Presents Positive Data on VB-111 in Advanced Radioactive Iodine Refractory Differentiated Thyroid Cancer at the ITC 2015 Conference
Multi-Cohort Phase 2 Trial Met Its Primary Endpoint of 6-Month PFS
TEL AVIV, Israel, Oct. 21, 2015 (GLOBE NEWSWIRE) --
VBL Therapeutics (NASDAQ:VBLT), today announced positive results from its multi-cohort Phase 2 trial of VB-111 in advanced radioiodine-refractory differentiated thyroid cancer (RAIR-DTC). The pre-specified primary trial endpoint of 6-month Progression Free Survival (PFS) for at least 25% of enrolled patients was met, showing a dose response for VB-111. In the trial, which was conducted at the Mayo Clinic and Massachusetts General Hospital, VB-111 also demonstrated favorable safety and survival data, and a potential for dose-dependent disease stabilization. The results were presented today at the 15th International Thyroid Congress held in Orlando, FL.
The trial, which was designed to assess the safety and efficacy of VB-111, enrolled 29 patients with metastatic radioiodine resistant differentiated thyroid Cancer (RAIR-DTC), whose disease had progressed within the 6 months prior to enrollment. Most of the patients' cancers had previously not responded to various therapeutic interventions including radiation, tyrosine kinase inhibitors and cytotoxic agents. The primary endpoint required at least 25% of enrolled patients to achieve 6 month PFS.
The patients in this open-label, dose-escalating trial, were treated in two cohorts. In the first cohort, 12 patients received a single intravenous infusion of VB-111 at a low dose of 3X1012 viral particles (VPs). The second cohort included 17 patients who received VB-111 at a high dose of 1013 VPs every two months, until disease progression. Six patients (35%) in the high-dose cohort (n=17) met the primary endpoint of 6-month PFS using Response Evaluation Criteria in Solid Tumors (RECIST), compared to three patients (25%) in the low-dose cohort (n=12). PFS at 12 months was 25% in the VB-111 high-dose cohort, versus 0% in the low-dose cohort, potentially indicating dose-dependent disease stabilization. Several patients also had lesional objective responses, such as complete or partially resolved metastatic lesion or metastatic lymph node. To this point, patients in the trial have a median overall survival (OS) of 20 months: 18 months in the low-dose cohort and 22 months in the high-dose cohort. Nine patients remain alive – one in the low-dose cohort (8%) and eight in the high-dose cohort (47%), all of whom are beyond 18 months and still being followed.
"This Phase 2 trial was initiated following our Phase 1 'all comers' trial for VB-111, in which we noticed that the two patients enrolled with late-stage thyroid cancer each responded to treatment with VB-111," said Dror Harats, MD, CEO of VBL Therapeutics. "Meeting the primary endpoint of 6-month PFS in the current Phase 2 trial, along with the favorable overall survival data to date, further support the potential efficacy of VB-111 in patients with RAIR-DTC."
VB-111 was well tolerated in the majority of RAIR-DTC patients, consistent with the favorable safety and tolerability across more than 170 cancer patients in the VB-111 program. Adverse effects seen in the trial were generally modest, and mainly consisted of flu-like symptoms developing shortly after infusion. Severe adverse events were rare.
This positive efficacy signal is in line with the recently reported Phase 2 results of VB-111 for rGBM, which showed statistically significant overall survival benefit in patients treated with VB-111 continued with VB-111 in combination with Avastin™ upon disease progression, compared to patients treated with VB-111 followed by Avastin™ alone, upon disease progression. Similarly, in June, VBL Therapeutics reported positive results of VB-111 in recurrent ovarian cancer in combination with paclitaxel, showing encouraging response rates in heavily pre-treated platinum-resistant patients.
"VB-111 is an innovative, targeted anti-angiogenic agent that has shown efficacy results in clinical trials of three different cancer indications, as well as robust data in various animal models, including thyroid cancer. Together, we believe these data suggest that VB-111 may be an effective cancer therapy with a broad therapeutic potential," said Yael Cohen, MD, VP Clinical Development at VBL.
"Differentiated Thyroid Cancer is a prevalent cancer, with increasing incidence. While most patients respond favorably to surgery and radioactive iodine (RAI) therapy, a subset of patients develop resistant disease which is progressive, symptomatic and fatal. Kinase inhibitors have emerged as a new standard of care for such patients, but there remains a clear need for additional effective therapies. VB-111 represents a novel approach distinct from those otherwise available that may offer hope for these patients. In the present trial, the primary endpoint target for 6-month progression free survival was met, and several lesional responses were observed. A randomized controlled trial is required to more fully assess the efficacy and role of VB-111 in patients with RAI-refractory thyroid cancer," said Dr. Keith Bible, MD, PhD, of the Mayo Clinic Cancer center.
Thyroid news run up?
We returned VBL Therapeutics' (VBLT:NASDAQ) rating to "Market Outperform" recently, after lowering it in Q1/15 because of a failure in the company's inflammatory program.
Our "Market Outperform" rating is based on VB-111, a viral, vector-based, tumor necrosis factor (TNF) smart bomb that tracks to the vasculature in the tumor. It is designed for glioblastoma.
VBL is approaching a very interesting time. Updated data presented at the European Society for Medical Oncology Conference suggests that the improved survival rates it has seen are the direct result of VB-111.
Glioblastoma--and particularly relapsed glioblastoma--is a deadly disease. The type of patients who participate in the VBL trial would be expected to survive only a very brief time, yet many are surviving 16 to 18 months. Therefore, it appears VB-111 has a very real effect.
Updated data will be presented in October at the 15th International Thyroid Congress in Florida. In November, additional data to be presented at the Society for Neuro-Oncology meeting will compare the results of the angiogenesis inhibitor Avastin (bevacizumab; Genentech/Roche Holding AG [RHHBY:OTCQX]) to results achieved from combining Avastin with VB-111. That, I believe, will drive home the message that the benefit is coming from the addition of VB-111 on top of Avastin.
In early 2016, the company plans to petition the FDA to submit regulatory filings based on data it will have to date, and to use the ongoing Phase 3 trial as supportive data for full approval. While I think the chances of that occurring are fairly low, if it does happen, it would be a big upside surprise for VBL. It could enable VBL to shave a year off its launch estimate, which currently is expected in 2018.
News leaked for thyroid? Tomorrow will tell ..
VBLT filed a shelf registration for $100 million
VBLT can now issue securities at any time within three years of the date of filing. Up to $100 million.
At their current burn rate they have enough cash for 5 quarters - 3rd qtr 2016 - so this is a smart move for various reasons, including:
1) Financing VB-111 ph3 for rGBM: this will be much more expensive than ph2. The patient population will be about 5X.
2) Financing VB-111 ph3 for thyroid: ph3 won't be initiated until 2016 (if ph2 is successful) so the company will need funds in place to get this going
3) It's smart to have $100 million available if you're at the negotiation table with a Roche/Novartis/GSK. It can then negotiate from a position of strength. It has the money to be self sufficient and doesn't need a bigger company to help with trials/sales/mktg.
Shelf registration:
http://ir.vblrx.com/phoenix.zhtml?c=253311&p=irol-sec
Upcoming Events and Presentations:
International Thyroid Congress (ITC), October 18-23, 2015 in Lake Buena Vista, Florida
Society for Neurooncology (SNO), November 19-22, 2015 in San Antonio, Texas
Phase 2 study of VB-111, an anti-cancer gene therapy, as monotherapy followed by combination of VB-111 with bevacizumab, in patients with recurrent glioblastoma
Background: VB-111 is an anti-angiogenic agent consisting of a non-replicating adenovirus vector (Ad-5) with a modified murine pre-proendothelin promoter leading to apoptosis of tumor vasculature by expressing a fas-chimera transgene in angiogenic endothelial cells. Safety and efficacy of VB-111 alone and in combination with bevacizumab (BEV) were evaluated for patients with recurrent Glioblastoma (rGBM) in this phase 1–2 dose-escalation study.
Methods: VB-111 was administered at doses of 3x1012 or 1x1013 every 2 months until progression, followed by bevacizumab as standard of care. The protocol was amended to add-on Bevacizumab 10mg/Kg every 2 weeks combined with VB-111 every 2 months, upon further progression. Assessments included safety, pharmacokinetics, overall survival (OS) based on Kaplan Meyer analysis and tumor response (RANO criteria).
Results: Forty-six patients at 4 recruiting medical centers in the US and Israel received up to 13 repeat doses of VB-111. Upon further progression, 24 received combination of VB-111 with bevacizumab, and 22 were treated with standard of care bevacizumab (SOC). There were 26 grade 3–4 adverse events. VB-111 was safe and well tolerated as monotherapy and in combination with BEV in patients with rGBM. The median OS was 15 months for patients who received combination therapy at progression versus 8 months for those who received SOC (p=0.05). OS of the study combination therapy cohort was superior to that reported in the historical controls BELOB trial bevacizumab arm, 15 versus 8 months (p=0.0278).
Conclusions: VB-111 was safe and well tolerated as monotherapy and in combination with BEV in patients with rGBM. Overall survival of patients who received VB-111 followed by VB-111 bevacizumab combination was almost doubled compared to historical rGBM bevacizumab data, and compared to patients who received VB-111 monotherapy. Toxicities were as expected in this patient population. A phase 3 randomized controlled trial is currently underway.
Abstract will be out Sunday (early a.m. here) so news will be out Sunday.
VB-111 to become first line treatment for rGBM
Avastin is the first approved angiogenesis inhibitor. It has been a blockbuster drug for Roche and has been approved for various kinds of cancer including glioblastoma (GBM). Vascular Biogenics is targeting recurrent GBM or rGBM. Interim results from Phase 2 trial of VB-111 in rGBM has already shown that the drug has a better safety and efficacy profile compared to Avastin. The interim results were reported at the Drug Discovery and Therapy World Congress (DDTWC) in July this year and showed a "strengthened, statistically significant overall survival in patients treated with VB-111 followed by VB-111 in combination with bevacizumab upon disease progression, compared to patients treated with VB-111 followed by bevacizumab alone.
VBLT is aiming to make VB-111 a first-line treatment for rGBM. Avastin is a second-line treatment. VB-111 has already shown to have a better safety profile than Avastin so if approved, VB-111 could become a first-line treatment in rGBM. The data on Sunday could further establish the case for making VB-111 a first-line treatment.
In the U.S. alone, VBLT's addressable market would be worth around $1.3 billion to $1.4 billion based on the number of rGBM cases and treatment cost of around $100,000.
http://seekingalpha.com/article/3530976-premarket-biotech-digest-essure-future-vascular-biogenics-data-oncogenexs-apatorsen-fails
UPGRADES from JPM and Chardan Capital !!!
Big days ahead
VBL Therapeutics to Present Complete Phase 2 Data on VB-111 in Combination With Bevacizumab in Recurrent GBM at the European Cancer Conference
TEL AVIV, Israel, Sept. 17, 2015 (GLOBE NEWSWIRE) -- VBL Therapeutics (NASDAQ:VBLT), a late-stage clinical biotechnology company focused on the discovery, development and commercialization of first-in-class treatments for cancer, today announced that complete Phase 2 data on VB-111 in combination with Bevacizumab (Avastin™) will be presented at the European Society for Medical Oncology's (ESMO) European Cancer Congress 2015, being held September 25th-29th in Vienna, Austria.
Presentation Details:
Date: Sunday, September 27th at 9:15am (CET)
Section: Proffered Paper Session: Central Nervous System, LEHAR 3
Title: Phase 2 study of VB-111, an anti-cancer gene therapy, as monotherapy followed by combination of VB-111 with bevacizumab, in patients with recurrent Glioblastoma
Presenter: Andrew J. Brenner, MD, PhD
Cancer Therapy and Research Center
University of Texas Health Science Center
Department of Medicine
San Antonio, Texas
Location: LEHAR 3
"We look forward to this opportunity at ECC 2015 to present complete results from this important Phase 2 trial of VB-111 in rGBM," stated Professor Dror Harats, CEO of VBL Therapeutics. "The presentation will include response rates in patients, as well as updated results on overall survival and response rate. We are excited to move forward with development of this first-in-class biologic agent and continue recruiting to our recently launched pivotal Phase 3 study in rGBM."
Some key points, including the first patient has been dosed in the Company's GLOBE Study:
1) (most promising) "FDA encouraged VBL to launch this single needed pivotal Phase 3 trial for registration even prior to the completion of an ongoing Phase 2 trial ... FDA decision in 2014 was derived from the promising data of an early interim analysis from our ongoing Phase 2 study of VB-111 in rGBM. Later analyses demonstrated even longer overall survival benefit along with statistical significance"
2) Overall survival has increased from 414 days to 480 days in Phase 2
3) "studied VB-111 in over 170 patients" -- Phase 3 is for 252 patients - only 80 more than what has been studied.
You put this all together and VB-111 on its own is a very promising drug. Let's see what it does in Thyroid and Ovarian.
References:
1) http://ir.vblrx.com/phoenix.zhtml?c=253311&p=irol-newsArticle&ID=2080921
2) http://ir.vblrx.com/phoenix.zhtml?c=253311&p=irol-newsArticle&ID=2079383
3) http://www.vblrx.com/cancer-programs/overview/
About VB-111 Phase 2 and Phase 3
In the conference call Dror Harats said:
"We still have patients on the drug and we still have patients that we’re following at are alive on the arm that’s treated with VB-111 and then with the combination of VB-111 and Avastin. By the way on VB-111 alone all the patients are dead now or there is one patient left to follow up, so it has to be considered as dead."
1) "we still have patients that we’re following at are alive on the arm that’s treated with VB-111 and then with the combination of VB-111 and Avastin" .. This means that the overall survival (OS) rate -- last reported at 414 days -- will be greater when presented on 9/27. As it was reported, the OS rate was already statistically significant so the increased OS rate only makes it better but it doesn't change anything. This is why they are moving to Phase 3 already.
2) "on VB-111 alone all the patients are dead now or there is one patient left to follow up, so it has to be considered as dead" .. "VB-111 alone" really means "VB-111 monotherapy followed by bevacizumab monotherapy". All patients (except 1) have died and OS rate was 235 days. The 1 lone survivor is treated as an exception / outlier.
Phase 3: VB-111 Plus Bevacizumab vs. Bevacizumab in Patients With Recurrent Glioblastoma (GLOBE)
1) Instead of 46 patients (Phase 2), Phase 3 will be recruiting 252 patients with rGBM
2) Because the OS rate for Bevacizumab mono and combo therapies were established as 235 and 414 days, respectively, expect to hear an update in 4 to 7 quarters (365 to 455 days). So end of 2017 or beginning of 2018.
3) Phase 3 will either confirm / deny the results of Phase 2.
Upcoming Events and Presentations:
European Cancer Congress (ECCO/ESMO), September 25-29, 2015 in Vienna, Austria
International Thyroid Congress (ITC), October 18-23, 2015 in Lake Buena Vista, Florida
Society for Neurooncology (SNO), November 19-22, 2015 in San Antonio, Texas
Earnings: We'll find out soon enough!
It is active now and they are recruiting this month. See link: https://clinicaltrials.gov/ct2/show/NCT02511405
In September, I think they will announce the final Ph 2 results at the ECC2015. http://www.europeancancercongress.org/Vienna2015/
A Phase 3, Pivotal Trial of VB-111 Plus Bevacizumab vs. Bevacizumab in Patients With rGBM (GLOBE)
This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified July 2015 by Vascular Biogenics Ltd. operating as VBL Therapeutics
Sponsor:
Vascular Biogenics Ltd. operating as VBL Therapeutics
Information provided by (Responsible Party):
Vascular Biogenics Ltd. operating as VBL Therapeutics
ClinicalTrials.gov Identifier:
NCT02511405
First received: July 29, 2015
Last updated: NA
Last verified: July 2015
History: No changes posted
Full Text View Tabular ViewNo Study Results PostedDisclaimerHow to Read a Study Record
Purpose
The purpose of this pivotal, phase 3, randomized, multicenter study is to compare VB-111 plus bevacizumab to bevacizumab in adult patients with recurrent GBM.
Condition Intervention Phase
Recurrent Glioblastoma
Drug: VB-111 + bevacizumab
Drug: Bevacizumab
Phase 3
Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized, Controlled, Double-Arm, Open-Label, Multi-center Study of VB-111 Combined With Bevacizumab vs. Bevacizumab Monotherapy in Patients With Recurrent Glioblastoma
Resource links provided by NLM:
Drug Information available for: Bevacizumab
Genetic and Rare Diseases Information Center resources: Anaplastic Astrocytoma Glioblastoma Glioma Gliosarcoma Neuroepithelioma
U.S. FDA Resources
Further study details as provided by Vascular Biogenics Ltd. operating as VBL Therapeutics:
Primary Outcome Measures:
Overall survival [ Time Frame: From date of study entry until the date of death from any cause (up to 10 years) ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
Progression Free Survival [ Time Frame: To be assessed every 2 months ] [ Designated as safety issue: No ]
Tumor response as measured by RANO Criteria [ Time Frame: To be assessed every 2 months ] [ Designated as safety issue: No ]
Estimated Enrollment: 252
Study Start Date: August 2015
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
VB-111 + Bevacizumab
Drug: VB-111 + bevacizumab
VB-111 will be administered intravenously at a dose of 1x10e13 VPs every 2 months Bevacizumab will be administered intravenously at a dose of 10mg/kg every 2 weeks
Active Comparator: Arm 2
Bevacizumab
Drug: Bevacizumab
Bevacizumab will be administered intravenously at a dose of 10mg/kg every 2 weeks
Eligibility
Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Criteria
Inclusion Criteria:
First or second progression of Glioblastoma;
Measurable disease by RANO criteria at progression;
Patients =18 years of age;
Patient may have been operated for recurrence. If operated: residual and measurable disease after surgery is required;
Surgery completed at least 28 days before randomization;
An interval of at least 12 weeks between prior radiotherapy or at least 23 days from prior chemotherapy, 42 days from nitrosoureas and enrollment in this study;
Adequate performance, i.e."Karnofsky Performance Score" of at least 70%;
Adequate renal, liver, and bone marrow function according to the following criteria:
Absolute neutrophil count =1500 cells/ml,
Platelets = 100,000 cells/ml,
Total bilirubin within upper limit of normal (ULN),
Aspartate aminotransferase (AST) = 2.0 X ULN,
Serum creatinine level = ULN or creatinine clearance = 50 ml/min for patients with creatinine levels above normal limits (creatinine clearance calculated by the Cockcroft-Gault formula, see Appendix II),
PT, PTT (in seconds) not to be prolonged beyond >20% of the upper limits of normal.
Exclusion Criteria:
Prior anti-angiogenic therapy including VEGF sequestering agents (i.e. bevacizumab, aflibercept, etc.) or VEGFR inhibitors (cedirinib, pazopanib, sunitinib, sorafenib, etc.);
Prior stereotactic radiotherapy;
Pregnant or breastfeeding patients;
Concomitant medication that may interfere with study results; e.g. immunosuppressive agents other than corticosteroids;
Active infection;
Evidence of significant CNS haemorrhage i.e. CTCAE grade 2 or above;
Expected to have surgery during study period;
Patients with active vascular disease, either myocardial or peripheral (i.e. acute coronary syndrome, cerebral stroke, transient ischemic attack or arterial thrombosis or symptomatic peripheral vascular disease within the past 3 months);
Patients with known proliferative and/or vascular retinopathy;
Patients with known liver disease (alcoholic, drug/toxin induced, genetic, or autoimmune);
Patients with known active second malignancy other than non-melanoma skin cancers, non-metastatic prostate cancer, in situ cervical cancer, and ductal or lobular carcinoma in situ of the breast. Patients are not considered to have a currently active malignancy if they have completed anticancer therapy and have been disease free for greater than 2 years prior to screening;
Patients testing positive to one of the following viruses: HIV, HBV and HCV within the last 6 months;
Patients that have undergone major surgery within the last 4 weeks before enrollment;
Patients who have received treatment with any other investigational agent within 4 weeks before enrollment.
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.
No Contacts or Locations Provided
More Information
Additional Information:
GLOBE Study Website This link exits the ClinicalTrials.gov site
VBL Therapeutics Company Website This link exits the ClinicalTrials.gov site
No publications provided
Responsible Party: Vascular Biogenics Ltd. operating as VBL Therapeutics
ClinicalTrials.gov Identifier: NCT02511405 History of Changes
Other Study ID Numbers: VB-111-215
Study First Received: July 29, 2015
Last Updated: July 29, 2015
Health Authority: United States: Food and Drug Administration
Keywords provided by Vascular Biogenics Ltd. operating as VBL Therapeutics:
rGBM
Recurrent GBM
Additional relevant MeSH terms:
Glioblastoma
Astrocytoma
Glioma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Antineoplastic Agents
Growth Inhibitors
Growth Substances
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Phase 3 will be next news item.
VBL Therapeutics to Present Data on Proprietary Gene Therapy Vascular Targeting System(TM) and Lead Product VB-111 - at Drug Discovery and Therapy World Congress 2015
TEL AVIV, Israel, July 14, 2015 (GLOBE NEWSWIRE) -- VBL Therapeutics (NASDAQ:VBLT), a late-stage clinical biotechnology company focused on the discovery, development and commercialization of first-in-class treatments for cancer, today announced that Chief Executive Officer, Dror Harats, M.D., will present data regarding the Company's Vascular Targeting System™ (VTS) and its lead product VB-111 in an oral presentation on Wednesday, July 22, 2015 at the Drug Discovery and Therapy World Congress 2015 in Boston, Massachusetts.
VBL recently reported interim Phase 2 data evaluating VB-111 in patients with rGBM, which showed a statistically significant overall survival benefit in patients treated with VB-111 followed by VB-111 in combination with bevacizumab (Avastin™) upon disease progression, compared to patients treated with VB-111 followed by bevacizumab alone (median overall survival of 16 vs. 8 months, respectively; p=0.05). VBL expects to initiate a pivotal Phase 3 study in rGBM under a Special Protocol Assessment with the U.S. Food and Drug Administration in mid-2015. At the American Society of Clinical Oncology (ASCO) Annual Meeting in June, the Company reported promising Phase 1/2 data in a second solid tumor indication evaluating VB-111 for the treatment of platinum-resistant Müllerian cancer, demonstrating evidence of clinical benefit even in patients who previously failed on bevacizumab.
VB-111 is the Company's lead product based on the innovative VTS platform gene therapy technology, which enables targeted and specific expression of a gene of choice in angiogenic blood vessels through unique "super enhancer" DNA regulatory sequences. VTS is comprised of three elements: a viral vector as a delivery tool, VBL's proprietary, semi-artificial PPE-1-3x promoter, and a transgene of choice. The technology can be employed for various purposes, including detecting, promoting or destroying newly-formed blood vessels in various pathological conditions.
As the first highly targeted anti-angiogenic agent for the specific inhibition of tumor vascular growth to use VBL's VTS for cancer therapy, VB-111 has the potential to treat a range of solid tumor indications by selectively targeting the blood vessels required for tumor growth. Since VB-111 causes apoptosis of cells that turn on its proprietary endothelial promoter due to angiogenesis, whether stimulated by VEGF or other signals, we believe it has the potential to be effective whatever the mechanism driving new tumor vascular growth. VB-111's activity is not limited to a certain tumor type or a subset of cells carrying a specific mutation and, because it works through the vasculature, VB-111 is also able to target brain tumors without crossing the blood-brain barrier. Furthermore, VB-111 may induce an immune response that potentiates its anti-angiogenic effect.
Details of the presentation are as follows:
Abstract: SL-33
Title: Vascular Targeting System – a Proprietary Gene Therapy Platform Technology
Time: Wednesday, July 22, 2015, 12:20 – 12:40 p.m. ET
Track: Cancer Targeted Drug Discovery
http://globenewswire.com/news-release/2015/07/14/751830/10141551/en/VBL-Therapeutics-to-Present-Data-on-Proprietary-Gene-Therapy-Vascular-Targeting-System-TM-and-Lead-Product-VB-111-at-Drug-Discovery-and-Therapy-World-Congress-2015.html
VB-111 for brain cancer
Glioblastoma (GBM, WHO grade IV) is the most common and aggressive of the primary brain tumors in adults, with poor prognosis despite intervention with surgery, radiation and chemotherapy. Annually, 5 in 100,000 people are diagnosed with GBM, with a median survival of approximately 14 months. The low survival is attributed partly to the nature of the tumor. GBMs are highly vascularized tumors and display markedly disorganized vascular structures with conspicuous endothelial cell proliferation, pericyte and basement membrane abnormalities resulting in permeability with heterogeneous leakiness and abnormal blood flow. The location of the tumor also makes drug delivery difficult with only small or lipophilic molecules able to cross the blood brain barrier. Of those agents that are able to reach the tumor, GBMs have shown to be resistant to most cytotoxic agents and quickly develop resistance when initially sensitive.
Antiangiogenic therapy has rapidly evolved into an integral component of standard therapy for many malignancies. As an example, bevacizumab, a humanized monoclonal antibody against vascular endothelial growth factor (VEGF), was the first antiangiogenic drug to receive approval and is now considered a component of standard of care for ovarian, lung, kidney, colon and brain cancers. Yet, while antiangiogenics have improved the practice of clinical oncology, clinical outcomes suggest that these therapeutics only prolong overall survival of cancer patients by several months, without offering enduring cure. This may be in part due to tumor cells evading angiogenic inhibitors through modulation of collateral pathways. To overcome the limitations of existing antiangiogenic drug therapies, which ultimately fail, we assessed the efficacy of using VB-111 to target newly formed blood vessels. VB-111 is a nonreplicating adenovirus 5 (Ad-5, El-deleted) carrying a proapoptotic human Fas-chimera transgene (Fas and human TNF receptor 1) under the control of a modified murine pre-proendothelin promoter (PPE-I-3x). This modified murine promoter is able to specifically target the expression of the Fas-chimera transgene to angiogenic blood vessels, leading to targeted apoptosis of these vessels. Because the transgene specifically targets the endothelial cells on the luminal wall of the neovasculature, penetration through the blood brain barrier is not required.
We have recently published a phase I, open-label, multisite, sequenial dose-escalation clinical trial with a single dose of VB-111 showing that VB-111 is safe and well tolerated in patients with advanced metastatic cancer at a single infusion of up to 1E13 viral particles (VPs), with evidence of transgene expression in tumor tissue and tumor responses observed. In addition, a phase II open-label multicenter study is being condicted to determine the efficacy of VB-111 in treating patients with GBM. Here we confirm in two independent pre-clinical models of GBM that VB-111 significantly extends survival, inhibits tumor growth and decreases the volume of angiogenic vessels within the tumor. Given the data presented herein, coupled with human trials, we conclude that VB-111 displays efficacy as a new antiangiogenic agent for the treatment of glioblastoma.
http://link.springer.com/article/10.1007/s11060-015-1853-7
VB-111 GBM indication coming?
Glioblastoma multiforme (GBM) is among the most highly vascularized of solid tumors, contributing to the infiltrative nature of the disease, and conferring poor outcome. Due to the critical dependency of GBM on growth of new endothelial vasculature, we evaluated the preclinical activity of a novel adenoviral gene therapy that targets the endothelium within newly formed blood vessels for apoptosis. VB-111, currently in phase II clinical trials, consists of a non-replicating Adenovirus 5 (El deleted) carrying a proapoptotic human Fas-chimera (transgene) under the control of a modified murine promoter (PPE-1-3×) which specifically targets endothelial cells within the tumor vasculature. Here we report that a single intravenous dose of 2.5 × 1011 or 1 × 1011 VPs was sufficient to extend survival in nude rats bearing U87MG-luc2 or nude mice bearing U251-luc, respectively. Bioluminescence imaging of nude rats showed that VB-111 effectively inhibited tumor growth within four weeks of treatment. This was confirmed in a select group of animals by MRI. In our mouse model we observed that 3 of 10 nude mice treated with VB-111 completely lost U251 luciferase signal and were considered long term survivors. To assess the antiangiogenic effects of VB-111, we evaluated the tumor-associated microvaculature by CD31, a common marker of neovascularization, and found a significant decrease in the microvessel density by IHC. We further assessed the neovasculature by confocal microscopy and found that VB-111 inhibits vascular density in two separate mouse models bearing U251-RFP xenografts. Collectively, this study supports the clinical development of VB-111 as a treatment for GBM.
http://www.ncbi.nlm.nih.gov/pubmed/26108658
9% pop today...news coming?
Great read about VBLT's future
Biomed companies provide "a dream" for investors: will - the stock will fly to heaven fail - the stock will collapse. VBL's story is similar: Biomed company-Yehuda develops drugs for cancer and traded at a value of $ 130 million. CEO, Dror sealed, several Bizportal an exclusive interview with the company.
Prof. Dror incision, is an internist and lung specialist metabolism. In 1995 he returned to Israel from the United States with a lot of experience and ideas. In 2000 he founded the Vascular Biogenics with a series of venture capital funds (such as Pitango) and private investors (like Morris Kahn and a group of former Goldman Sachs). The Nasdaq IPO came only at the end 2014 under the ticker VBLT.
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Where did the idea for a cure for cancer? "I worked at UCSF of California San Francisco, and while working in a pharmaceutical company named Syntex. Although the idea was developed in a foreign company was under a scholarship (post-doctoral work) and rights are mine too. I developed a mouse trans-gardens (living or plant containing DNA modified) - Thus the first patent, and with him went back to Israel to the Tel Hashomer hospital. "
15 years have passed since the establishment of the company and it already has several hundred patents, 32 employees and a team of executives with impressive experience in the world. "We recruited employees by way of a bounty hunter, and they agreed to return to Israel. It also includes Chairman Ben Shapiro, who directed the MRL Merck - Position No. 3 pharmaceutical giant led to the development of several drugs," explains Professor sealed.
Prof. decreed: "The drug is for infusion given over 10 minutes and contains a virus (viral vector). The virus inserts genes into human cells and affect them. In fact, we were able to prevent cancer cells the ability to share with genetic modification of the virus. In other words we use mechanical nature -It's an imitation of what works in nature ".
What makes engineered virus? "The virus enters every cell - even healthy (but not the gene will be expressed there.) In the blood vessels of the tumor is trying all the time to share the cancer cells 'call' the engine and then the gene is expressed, destroys the blood vessels and allows cells to create new cells of the tumor. So we 'choke' the tumor that the cancer can not spread. Protect a zoo creates an increase in immune response that affects the war and so this increase is reflected in prolonging the patient's life. When the tumor is trying to grow it destroys itself - as a 'ticking bomb' within the tumor - it Beautiful imitation of nature. I do not believe in forever the nature but to develop a drug depending on the mechanism of blood. "
The drug has been given to over 170 people, and the results are positive, although it is important to emphasize that this is not yet curative treatment, but treatment prolongs life. In the cruel world of cancer - extended life by a large weight to get a little note proportioned existing drugs, Avastin, sold every year by 8 billion dollars and it does not cure.
As part of the trials GBM disease - a fatal brain cancer, can be treated initially to 16 patients a lower dose or one time. Then we examined two groups of 46 patients in total who started treatment with VB-111 and then: first - received Avastin alone; the second group - received the drug every two months of the VBL parallel Avastin.
Professor sealed "at oncology latest (ASCO) held recently in Chicago were first presented results showing life extension. Survival curves between the two groups separated from the outset Significantly, 30% of patients exposed to the drug lived a relatively long period of two years, and we have doubled median life span ".
The FDA asked the Israeli society to compare the results with Avastin studies carried out previously. Here, too, the results show the advantage of VBL.
What a job? "The next step is to submit by August the Phaze 3 - includes 252 patients and will be conducted by first class US doctors. Let's start in August: 126 patients will receive Avastin Avastin patients and -126 and our drug (85% of patients will be from North America). All patients in the experiment are such that the disease back to them. This is basically the end of the trial the patients' survival and we remain with them until they die. At the same time available late summer the full report on the Phaze - 2 ".
Off-label for brain cancer you develop additional indications of ovarian cancer and thyroid cancer. "You never take one egg there in one basket - the development of drugs has its ups and downs and therefore should always be in a position if forced to take time out there another program that progresses in parallel. There is great history fallen companies that are working on one product."
VBL company now has two technologies:
1 - a cure for cancer.
2 - small molecules that take oral developed atherosclerosis (heart attack and stroke). "At the moment it did not work but it does not end," says Prof. sealed the experiment failed defining psoriasis and ulcerative colitis.
The company's first platform called VB-111 designed for solid tumors and brain cancer, are currently developed (GBM disease). "We have shown in Phaze - 2 we significantly extend life and received recognition as an orphan drug in Europe and the United States (including accelerated development) and SPA protocol. Because the FDA understands the need for the drug and its benefits, we have built together a special program to write the protocol in advance that the FDA commits to certain conditions to approve the drug for marketing if it meets the goals ".
FDA seen positive results in 12 patients and said the company continue to Phaze - 2 with 46 patients and immediately start Phaze 3 - the trials are such different treatment failed them and they are the end of their what? So it is customary to drug development and regulation easier. VBL's drug for cancer is a biological drug that dissolves the tumor but stops its growth rate and thus extends the life of new biological medicines similar to working on the immune system. "
With respect to the note of ovarian cancer trials conducted at Harvard (the two major hospitals thereof) initially with a low dose 3 Sands to prove safety and then with 16 full-dose sands. 12 Sands received a full dose of chemotherapy drug and the VBL and 6 sands still alive.
The results look promising - what their issue shares in September 2014? "My approach was to wait for data and only then talk and now we feel much more comfortable: we develop drugs and we have money ($ 34 million) could be sufficient until the first quarter of 2017".
Here are a few hospitals in the US have three cancer indications: brain - 10 thousand patients, thyroid - 60 thousand and ovaries - 22 thousand. If the platform will prove itself and receive marketing approval - it is quite possible that the technology will be effective in other types of cancer (tumors solids).
google translated from: http://www.bizportal.co.il/biomed/news/article/409537
VBLT at 2015 BIO International Convention
June 15, 2015 through Thursday, June 18, 2015
http://ir.vblrx.com/phoenix.zhtml?c=253311&p=irol-EventDetails&EventId=5195342
VBL Therapeutics Analyst and Investor Event at American Society of Clinical Oncology (ASCO) Annual Meeting, June 01, 2015 7:30 a.m. ET
http://ir.vblrx.com/phoenix.zhtml?c=253311&p=irol-EventDetails&EventId=5194909
Vascular Biogenics (VBLT: Nasdaq) By Roth Capital Partners ($5.05, May 22, 2015)
We are initiating coverage of Vascular Biogenics with a Buy rating and a $13 price target.
Vascular Biogenics (ticker: VBLT) is a clinical-stage-biotechnology company with two technology platforms targeting oncology and immunology indications.
The first platform is Vascular Targeting System (VTS), which is a multi-component gene-therapy design targeting vascular endothelial cells. The second platform is comprised of lecinoxoids, which are synthetic oxidized phospholipid small molecules mimicking naturally occurring anti-inflammatory agents in the body.
Lead focus is on VB-111 with potential for survival benefit in recurrent Glioblastoma (rGBM). Using the VTS platform, VBLT developed VB-111, an anti-angiogenic gene-therapy product specifically targeting angiogenic endothelial cells, thereby leading to their apoptosis such that angiogenesis is impaired. An added benefit of VB-111 is that alongside its anti-angiogenic function, the fusion gene it encodes along with the viral vector, induces a long-term immune reaction. Recent data from a Phase II study in rGBM showed that combination of VB-111 and standard of care, bevacizumab, achieved a statistically significant higher median overall survival (mOS) benefit of 414 days compared to a sequential treatment of VB-111 followed by bevacizumab at 235 days.
Up next: Phase III in rGBM under Special Protocol Assessment (SPA). Vascular Biogenics expects to initiate a Phase III study under SPA in mid-2015. This will be a randomized, placebo-controlled study comparing VB-111 in combination with bevacizumab to bevacizumab alone and the primary endpoint is overall survival.
Additional opportunities: VB-111 is being assessed in a Phase I/II study in platinum-resistant recurrence epithelial ovarian cancer and advanced differentiated radioiodine-resistant thyroid cancer.
Upcoming catalysts: At the upcoming American Society of Clinical Oncology (ASCO) 2015 meeting, investors will receive two updates from the company: 1) Vascular Biogenics will present mature overall survival (OS) data from the Phase II study in rGBM; and 2) Dana-Farber Cancer Institute investigators will present data on the first 14 patients from the Phase I/II study in ovarian cancer. Following ASCO additional catalysts include full data from the ovarian cancer study in the second half and full data from the Phase II study in thyroid cancer in first-half 2016. Interim analysis in the Phase III rGBM study is expected in second-half 2016 with data in second-half 2017.
-- Joseph Pantginis
-- Assaf Vestin
VBL Therapeutics to Webcast Analyst and Investor Event at American Society of Clinical Oncology (ASCO) Annual Meeting on June 1, 2015
TEL AVIV, Israel, May 26, 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 it will host a live audio webcast of its discussion of the Company's clinical programs and pipeline at the ASCO Annual Meeting on Monday, June 1, 2015 at 6:30 a.m. CT (7:30 a.m. ET).
The webcast will be available in the Events and Presentations section under the Investor Relations section of the Company's website at www.vblrx.com, and an archived replay of the webcast will be available for 30 days after the presentation.
http://globenewswire.com/news-release/2015/05/26/739016/10135713/en/VBL-Therapeutics-to-Webcast-Analyst-and-Investor-Event-at-American-Society-of-Clinical-Oncology-ASCO-Annual-Meeting-on-June-1-2015.html
Hope you added :)
ROTH starts Vascular Biogenics at buy
ROTH Capital Partners has initiated coverage of Vascular Biogenics (NASDAQ:VBLT) with a “buy” rating and a $13 price target. The stock closed at $5.05 on Thursday.
Vascular has two technology platforms targeting oncology and immunology indications. The first platform is Vascular Targeting System (VTS), which is a multi-component gene therapy design targeting vascular endothelial cells. The second platform is comprised of lecinoxoids, which are synthetic oxidized phospholipid small molecules mimicking naturally occurring anti-inflammatory agents in the body.
Analyst Joseph Pantginis writes that using the VTS platform, Vascular has developed VB-111, an anti-angiogenic gene therapy product specifically targeting angiogenic endothelial cells, leading to their apoptosis.
Recent data from a Phase 2 study in recurrent glioblastoma (GBM) showed that combination of VB-111, and standard of care, bevacizumab, achieved a statistically significant higher median overall survival benefit of 414 days, compared with a sequential treatment of VB-111 followed by bevacizumab of 235 days.
The company expects to initiate a Phase 3 study in recurrent GBM under a special protocol assessment in mid-2015. The randomized, placebo-controlled study will compare VB-111 in combination with bevacizumab against bevacizumab alone, with the primary endpoint as overall survival.
http://biotuesdays.com/2015/05/22/roth-starts-vascular-biogenics-at-buy/
It is not a well followed stock yet. Give it time.
VBL Therapeutics to Present Positive Phase 1/2 Data for VB-111 in Recurrent Platinum-Resistant Mullerian Cancer at ASCO Annual Meeting
TEL AVIV, Israel, May 13, 2015 (GLOBE NEWSWIRE) -- VBL Therapeutics (VBLT), a late-stage clinical biotechnology company focused on the discovery, development and commercialization of first-in-class treatments for cancer, today announced that principal investigator, Richard Penson, M.D., M.R.C.P., will present interim data from the ongoing Phase 1/2 clinical trial of lead product candidate, VB-111, for the treatment of platinum-resistant Mullerian cancer, in a poster presentation on Saturday, May 30, 2015 at the American Society for Clinical Oncology (ASCO) 2015 Annual Meeting. The reported data will include results in patients with recurrent platinum-resistant Mullerian cancer treated with multiple doses of VB-111 and weekly paclitaxel.
As the first highly targeted anti-angiogenic agent for the specific inhibition of tumor vascular growth to use VBL's Vascular Targeting System(TM) for cancer therapy, VB-111 has the potential to treat a range of solid tumor indications by selectively targeting the blood vessels required for tumor growth and inducing apoptosis of cells in those blood vessels. VBL recently reported positive, statistically significant data evaluating the efficacy of VB-111 for the treatment of recurrent glioblastoma (rGBM), and expects to initiate a pivotal Phase 3 study in rGBM under a Special Protocol Assessment with the U.S. Food and Drug Administration in mid-2015.
Details of the presentation are as follows:
Abstract:#5542
Title: A phase 1/2 trial of multiple dose VB-111 and weekly paclitaxel in recurrent platinum-resistant Mullerian cancer
Time: Saturday, May 30, 2015, 1:15 PM -- 4:45 PM CT
Session: Poster Session: Gynecologic Cancer
Authors: Richard T Penson MD MRCP (Massachusetts General Hospital), Allison J Ambrosio BA (Massachusetts General Hospital), Daphne Suzin BA BSc (Massachusetts General Hospital), Siobhan A. Collins BA (Dana Farber Cancer Institute), Michael J Birrer PhD (Massachusetts General Hospital), Suzanne Berlin DO (Dana Farber Cancer Institute), Yael Cohen MD (VBL Therapeutics).
Potential for VB-201 in Atherosclerosis
Although based on the clinical results described above we have discontinued development of VB-201 for psoriasis and ulcerative colitis, based on the early clinical work described below, we believe VB-201 may have potential for the treatment of atherosclerosis.
We are currently evaluating whether to develop VB-201 in atherosclerosis or other indications, and we continue to investigate other potential Lecinoxoids for development as well, but in the near term we intend to focus substantially all of our efforts and resources on advancing our oncology program.