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Me as well!!
This scientific data PR from CLDX today could bode well for DCVax-L on Phase III interim. NWBO's data presented this summer on the 55 Information Arm on recurrent glioblastoma was also impressive.
Celldex Therapeutics Reports Promising Long-term Survival Data from Phase 2 ReACT Study of RINTEGA
MIDNIGHT TRADER 3:08 PM ET 11/20/2015
CLDX 16.65down +2.14 (+14.75%)
QUOTES AS OF 03:21:32 PM ET 11/20/2015
03:08 PM EST, 11/20/2015 (MT Newswires) -- Celldex Therapeutics(CLDX) rose in Friday afternoon trade after the biopharmaceutical company reported promising data from its randomized, double-blind Phase 2 study of RINTEGA (rindopepimut) in patients with EGFRvIII-positive, recurrent glioblastoma (GBM).
Shares were up 16.4% at $16.81, with a 52-week range of $10.11 - $32.82.
RINTEGA is an investigational EGFRvIII specific therapeutic vaccine and was granted Breakthrough Therapy Designation in February 2014. Patients with recurrent glioblastoma that express the EGFRvIII mutation typically have a worse prognosis than the overall glioblastoma population, including poor long-term survival (median time from recurrence to death for EGFRvIII-positive patients is 8.7 months). As previously reported, the primary endpoint of the study, progression-free survival at six months (PFS6) has been met.
The company said promising results, among others, include: mature overall survival (OS) data continue to show a marked benefit with a long-term survival benefit clearly seen in the RINTEGA arm; nine of 10 patients (one patient lost to follow up) on the RINTEGA arm remain alive since the company last presented data in May compared to only two out of five patients on the control arm; and, at two years, the survival rate for RINTEGA patients is 25% versus 0% for control patients in the intent to treat (ITT) population, with five patients extending beyond two years.
Results were presented at the 20th Annual Scientific Meeting of the Society for Neuro-Oncology (SNO).
Nice find astavakra! NWBO also noted in a PR when DCVax-L trial resumed recruitment a couple of years ago that they had a detailed collaboration with the FDA for DCVax-L and reached agreement on Primary Endpoint of PFS and Secondary Endpoint of OS.
I get the feeling the "shoe can drop at any moment" with a major PR from NWBO on multiple topics, interim for efficacy, PIM, Hospital Exemption reimbursement agreement, Direct Phase II, partnering deal. JMHO
I remember it well..I think it opened pre-market at $175 and ran to almost $400 next day! Very well could happen to NWBO...
Agree with you Flip as that is how I looked at this as well!
I came across this link to a Russian Immunotherapy site regarding brain cancers and found this very interesting as they are referred to Israel for treatment. Click testimonials from Russian patients and there some encouraging stories but does not specify which immunotherapy they received. It really shows how fast immunotherapy is being recognized as a "cutting edge" treatment for aggressive brain cancer.
http://www.rak-mozga.ru/immunoterapiya/
In the early stages of the cancer tumor immunotherapy is typically used as an additional treatment after surgery as well as chemotherapy or radiation therapy. In the treatment of malignant tumors in the third and fourth stages of the surgical intervention, generally can not completely remove the tumor, therefore, immunotherapy of cancer can be the main treatment.
Immunotherapy of brain cancer
Some variants of brain tumor immunotherapy have shown high effectiveness, so go in-depth clinical studies. These medications include:
? DCVax-L (dendritic cell vaccine). The drug made from the patient's tumor cells. The vaccine passes the third phase of research for the treatment of secondary gliomas (including ordinary and glioblastoma multiforme, astrocytoma).
? Rindopepimut is a directed mutant peptide showed a high efficacy in the treatment of glioblastomas third of cases. Currently under the third phase of research of the drug in people with primary glioblastoma and a second phase of the study in patients with repeated (recurring) tumor.
? HSPPC-96 - a new drug, passing the second stage of testing in people with glioma appears again, not amenable to surgical treatment.
? ICT-107 (dendritic cell vaccine) involves the use of synthetic materials and is aimed at the destruction of tumor antigens for the treatment of glioblastoma. Successfully conducted the second phase of tests, were obtained very encouraging results of therapy. Scientists plan a third, international, phase studies.
? Indoximod (IDO inhibitor) used for the treatment of recurrent glioma, and the first stage of trials.
? Ipilimumab Nivolumab and successfully used in the treatment of glioblastoma, also carried out the second phase of research for the treatment of secondary glioblastomas.
? Anti-EGFRvIII chimeric antigen receptor - a method based on the possibility of destruction of abnormal cells by T cells. This method of therapy was developed several decades ago, but, unfortunately, today there is no universal treatment that would suit a large number of patients. This method of brain tumor immunotherapy the first stage of research for the treatment of glioma.
? ADU-623 antigen is an expression passing the first stage of studies in humans with primary and secondary astrocytoma.
? AMG 595 - a drug targeted therapy, based on the action of the antibody and used with chemotherapy. The drug is the first stage of clinical trials.
Researchers and scientists are working to find a vaccine that would allow to effectively treat various types of cancer of the brain in children and adults. Most of the preparations based on immunotherapy of cancer of the brain, show the high effectiveness in slowing down or complete growth arrest and dividing blast cells.
Immunotherapy of tumors: especially the method
Immunotherapy of tumors comprising administering to a subject of biologically active substances with anti-tumor activity, which include cytokines and monoclonal antibodies. These substances are introduced into the patient, overlapping feeding mechanisms cancerous tumor, whereby growth of tumors is stopped.
This method of treatment has no side effects - this is because the healthy tissues and organs are not damaged, as it happens as a result of chemo- and radiotherapy.
In most cases, anti-cancer drugs are produced from biomass which contains human tumor cells or other human (donor). The resulting material undergoes special handling and preparation, and then by injections or infusions administered to a patient.
Immuntoterapiya cancer - a long-term treatment, which is carried out for months. During therapy, the patient is under medical supervision. Forecast full recovery of people with brain cancer with the cancer immunotherapy currently stands at 60-80%, but these figures may change as research and implementation of innovative forms of treatment.
The cost of immunotherapy
Due to the complexity of producing biological agents, and the use of innovation in the field of genetic engineering and molecular chemistry, cancer immunotherapy is an expensive treatment. In determining the cost of brain tumor immunotherapy takes into account such factors as:
? Stage Oncology
? Type of tumor
? The presence of metastatic foci,
? Grade blasts.
The exact cost of treating a patient may ask the physician.
Get detailed information
Center for brain cancer treatment
Treatment of brain cancer
Wow, great find Kap10jak! Thanks for sharing this!
Bear....this search from Google.com and search for DCVax and select Past 24 hours has brought the FDA site I posted prior in each days search results. I could find DCVax in the FDA site via search and the following link comes up:
Search Results
Showing 1 - 1 of about 1 for dcvax
Did you mean: divx
MS EXCEL List of Orphan Products Designa FOR INDUSTRY
2014-10-23 | www.fda.gov/.../howtoapplyfororphanproductdesignation/ucm162066.xls
List of Orphan Products Designa. A, B, C, D, E, F, G, H, I, J, K. 1, Cumulative List of all Products that have received Orphan Designation ...
Text Version
Google DCvax and this result has been showing up in my search results for the last 7 days I have done this when you select Past 24 hours . Thoughts?
Recently Updated Advisory Committee Materials
www.fda.gov › Advisory Committees
Food and Drug Administration
5 hours ago - Antimicrobial Drugs Advisory Committee (formerly known as the Anti-Infective Drugs Advisory Committee). Webcast Information for the November 5, 2015 Joint ...
Amazing story with another Immune therapy....
New kind of "designer" immune cells clear baby's leukaemia
REUTERS 9:54 AM ET 11/6/2015
By Kate Kelland, Health and Science Correspondent
LONDON, Nov 5 (Reuters) - A baby whom doctors thought almost certain to die has been cleared of a previously incurable leukaemia in the first human use of an "off-the-shelf" cell therapy from Cellectis(CLLS) that creates designer immune cells.
One-year-old Layla had run out of all other treatment options when doctors at Britain's Great Ormond Street Hospital (GOSH) gave her the highly experimental, genetically edited cells in a tiny 1-millilitre intravenous infusion.
Two months later, she was cancer-free and she is now home from hospital, the doctors said at a briefing about her case in London on Wednesday.
"Her leukaemia was so aggressive that such a response is almost a miracle," said Paul Veys, a professor and director of bone marrow transplant at GOSH who led the team treating Layla.
"As this was the first time that the treatment had been used, we didn't know if or when it would work, so we were over the moon when it did."
The gene-edited cell treatment was prepared by scientists at GOSH and University College London (UCL) together with the French biotech firm Cellectis(CLLS), which is now funding full clinical trials of the therapy due to start next year.
When do you think we will begin to see the market reaction in PPS and valuation in line with results to their progress being made?
Senti,thanks for your time putting an important portion of Dr. Bosch's ASCO presentation in a transcript. NWBO management should have this down as there is software that can do this type of transation.
Very impressive presentation by Dr. Bosch. I prefer him doing this more than Linda IMO.
GLTA
We should also be receiving some update from Elliot on Pfizer's Ponezumab as Primary Endpoint was September 2015.
I agree with you as this change on clinical trial site mirrors exactly what happened with Pfizer's Ponezumab trial enrollment complete as well as Shire's trial for Friedreich's ataxia.
https://www.clinicaltrials.gov/ct2/show/NCT01821118?term=Ponezumab&rank=5
Principles of immunology and its nuances in the central nervous system
Neuro-Oncology, Nov 2015
Gavin P. Dunn
Hideho Okada
http://paperity.org/p/74652320/principles-of-immunology-and-its-nuances-in-the-central-nervous-system
Someone just picked up 40k shares at the ask of $.09!
I noticed it as well...looks like it can move up quickly on some news!
I read the disclaimer and summary as of page 3 and stopped because it was not well done never realizing Jim and I were in the report...pretty funny!
Amazing that anyone would take this report seriously by placing people posting on message board in the report. Obviously someone who follows this board is involved....
TC....all I had to get through was page 2 Disclaimer and page 3 Summary and could easily see how poorly this was written and even "claiming Phd's and analysts with medical backgrounds" even though they list not one phd or analyst on their web site.
Something is brewing as shorts pulling out all the stops IMO!
I would never take anything in this report seriously especially after Neil Woodford's massive investment in NWBO.
Absolutely a scam! Go to the following link and they do not even list any individual research analysts, track record of 3 companies and no business address or phone numbers!
http://www.phasefiveresearch.com/track-record/
Troy Rohn Appointed to Help with Antibody Program
By: Kathleen Tuck Published 8:06 am / October 27, 2015
Link to article at bottom
Biology professor Troy Rohn has been appointed lead scientific consultant for Intellect Neurosciences Inc. Intellect is a biopharmaceutical company engaged in the discovery and development of disease-modifying therapeutic agents for the treatment and prevention of rare neurodegenerative conditions.
Rohn, who is well known for his research on Alzheimer’s, Parkinson’s, Pick’s and other neurodegenerative diseases, will assist the company in shaping and guiding its Tau-C3 antibody program.
In 2012, Intellect licensed a Tau-C3 antibody from Northwestern University, acquiring exclusive global rights to develop and commercialize the antibody. In January 2014, they announced top-line data showing initial proof of concept in a preclinical Alzheimer’s disease model indicating the antibody’s potential to be disease modifying. The data showed that the TauC3 monoclonal antibody effectively engaged the target and is potentially disease modifying.
Rohn will help Intellect identify one or more orphan diseases where the Tau-C3 antibody may be an effective therapeutic agent and help guide potential clinical trials. Orphan diseases are those that affect fewer than 200,000 people nationwide.
https://news.boisestate.edu/update/2015/10/27/troy-rohn-appointed-to-help-with-antibody-program/
http://www.octafinance.com/hyman-charles-d-just-filed-13f-positions-for-q3-2015/242302/
Increased Positions
According to this filing the investment professional lifted its stakes in Exxon Mobil Corp (XOM) by 13% to $11.06 million, Boeing (BA) by 21% to $10.96 million, Goldman Sachs Group Floating R (GS PR J) by 7% to $9.35 million, Walt Disney (DIS) by 21% to $4.33 million and Amerigas Partners Lp (APU) by 7% to $3.59 million. Hyman Charles D also acquired smaller stakes in Travelers Companies Inc (TRV) by 6.90% to $2.62 million, Northwest Biotherapeutics Inc (NWBO) by 35.96% to $284,000 and Matinas Biopharma Holdings In by 201.34% to $74,000. Building positions gradually is normal for many hedge funds.
Read more: http://www.octafinance.com/hyman-charles-d-just-filed-13f-positions-for-q3-2015/242302/#ixzz3prCo8cCd
Nice purchase of 84,621 shares @ $4.96 of NWBO After Hours at 16:56!
Nice find DrillaHill!
Very encouraging update in this information you provided. Thanks for sharing!
Cellceutix Responds to Rosen Law Firm.....wonder if NWBO takes this approach at some point! Good read!
http://www.marketwired.com/press-release/cellceutix-responds-to-rosen-law-firm-otc-ctix-2066335.htm
I noticed that as well and felt the same way as you. This $30M financing from Woodford just shows how far along NWBO is to the finish line!
Great job Papa Tweek1 on this email to Sen Warren! Thanks for sharing your personal experience with cancer and we all wish you the best going forward.
I agree with your post Flip. Today's trading was mostly tutes as the volume at 2:45pm was 1.79M @ PPS of $4.835 and finished at 2.008M at close with 43K shares traded in last minute and closing price of $4.82 seems a bit odd no PPS movement with the volume traded which included many large block trades.
Great find Buck! I like this noted in this abstract you posted regarding ILNS monoclonal antibody with Pfizer and with an acceptable safety profile already determined as noted below!
Beach...I agree with you 100%!
longterm was on this board a couple of years ago and only appears during this type of trading day to spread FUD!
I found the following interesting from the 10K beyond OS count which was a surprise.
Good news this finally closed and HRTPY receives cash for this transaction.
MATERIAL FACT
PETRORIO CONCLUDES THE SALE OF ASSETS IN SOLIMÕES
Rio de Janeiro, October 13, 2015 - Petro Rio S.A. ("PetroRio" or the "Company") (BM&FBovespa: PRIO3, TSX-V: PRJ), hereby announces the closing of the transaction for the sale and transfer of all of its interest, and respective rights and obligations, in the Concession Contracts of Oil and Gas located in the Solimões Sedimentary Basin, to Rosneft Brasil E&P Ltda. ("Rosneft"), subsidiary of Rosneft Oil Company, becoming the holder of 100% of these Concession Contracts.
The Brazilian National Agency of Petroleum, Natural Gas and Biofuels (Agência Nacional do Petróleo, Gás Natural e Biocombustíveis - ANP) granted the approval of the Assignment of Rights in these Concession Contracts of Oil and Gas on July 1st, 2015.
The divestiture of the Solimões operations is entirely adherent to the PetroRio's strategy of focusing on production assets and minimizing the exposure to the exploration risks.
I saw that as well and a very good point! She is very well connected on a global basis plus I also like the following in her bio. Ms. Powers taught for more than six years at the National Institutes of Health, on medical product development and commercialization, and at Georgetown Law School as an adjunct professor
Another view on NWBO Funds and Institutions
http://quotes.wsj.com/NWBO/company-people
Link below on Nasdaq is very interesting data on Ownership Summary, Active Positions and New and Sold Out Positions. Nice trend on NWBO!
http://www.nasdaq.com/symbol/nwbo/institutional-holdings
If you google DCVax and set search within hours I found the following information appears. It is something about DCVax on the FDA site but could not locate it. Maybe somebody with more experience can find this somewhere. It may be or not be of value but thought I would share this.
Recently Updated Advisory Committee Material
www.fda.gov › Advisory Committees
Food and Drug Administration
4 hours ago - Cardiovascular and Renal Drugs Advisory Committee. Briefing Information for the March 27, 2014 Meeting of the Cardiovascular and Renal Drugs Advisory ...
Great find Flip! Thanks for sharing this!