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I wonder if the plan is to apply for the NASDAQ or NYSE?
Some samples of media coverage of a small company. FWIW
https://tapimmune.com/news-events/media-coverage/?utm_source=getresponse&utm_medium=email&utm_campaign=investor_alerts&utm_content=TapImmune+in+The+News
This constant "pumping" rotation at least keeps anyone new to the board informed one way or another as well as reducing the amount of DD they might have to do to bring them up to speed. We might be surprised the number of possible investors that read the information gathered by long and short posters here and never disclose themselves.
Thanks Flipper.
PT1
Evan
Thank you for your response.
PT1
What would the contents of a publication possibly say that would create attention to DCVax-L if the trial is still blinded? Wouldn't the trial have to be unblinded to garner any information that would be a knock down, drag 'em out publication?
PT1
Just a note to mention (Cytosorbents blood filter) is being used to mitigate the cytokine storm. My father died from a cytokine storm. So, I have been following it very closely.
PT1
Drug Pricing and Alternative Methods of Payment
https://www.cnbc.com/2018/01/03/spark-therapeutics-luxturna-gene-therapy-will-cost-about-850000.html
What would be the advantage/s of Cognate and NWBO merging from a purely business standpoint if any? Not taking to account what the merger would do to benefit stockholders?
TIA for any input
PT1
22 Erwachsene mit neu diagnostiziertem Gliobastom wurden nach
vorausgegangener chirurgischer Tumorentfernung und Bestrahlungstherapie mit
begleitender Chemotherapie mit DCVax-L-Injektionen behandelt. Die mediane
Überlebenszeit der Patienten war 35 Monate. Das mediane progressionsfreie
Überleben (PFS) betrug 23,1 Monate. Die progressionsfreie Überlebensrate nach 36 Monaten lag im Mittel bei 34% (13% - 55%). Diese Ergebnisse sind als explorativ zu betrachten. Nach 2 Jahren waren 70% der mit DCVax-L behandelten Patienten noch am Leben.
22 adults with newly diagnosed glioblastoma were relapsed
previous surgical tumor removal and radiation therapy with
concomitant chemotherapy treated with DCVax-L injections. The median
Survival of the patients was 35 months. The median progression-free
Survival (PFS) was 23.1 months. The progression-free survival rate at 36 months was 34% on average (13% - 55%). These results should be considered exploratory. At 2 years, 70% of DCVax-L treated patients were still alive.
Working fine so far. My spleen was enlarged to the point I could lay on my right side and reach under my ribs and feel it. It's is back to normal after the treatments. I may have to go on a pill regiment to keep the cancer in check.
PT1
I have been given the immunotherapy Rituxin which is made from mouse protein. I was allergic to it at first and encountered rigors (my body shook pretty badly for around 45 minutes before it subsided.) The next time it was given, I felt a cool sensation and a little teeth chattering then it quit. The 3rd time it was administered .........nothing.
PT1
https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm590005.htm?utm_campaign=Oncology%2011%2F13&utm_medium=email&utm_source=Eloqua&elqTrackId=d750c2a07e5e4c3a923a82424bc93597&elq=9455d6a201e143dbac718ec172da28b2&elqaid=1865&elqat=1&elqCampaignId=1243
https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm590004.htm?utm_campaign=Oncology%2011%2F13&utm_medium=email&utm_source=Eloqua&elqTrackId=5eba2e45eedc41c3ad7ee0d0f384d47d&elq=9455d6a201e143dbac718ec172da28b2&elqaid=1865&elqat=1&elqCampaignId=1243
That's something I'm all too familiar with. Caught pneumonia 3 times after chemo all within about 6 months.
Might want to consider sending your letter by registered mail. Might cost a little and would make someone at NWBO sign for it. I suppose once a few letters were sent with similar concerns, they might just pitch them and maybe not. May tick them off or could make them really aware of shareholder concerns that would generate a response. Ya never know.
PT1
Guys, don't worry!
This Week at NEJM.org | November 30, 2017
Listen to the Weekly Audio Summary
Listen to the Weekly Audio Summary
PERSPECTIVE
Chasing Seasonal Influenza — The Need for a Universal Influenza Vaccine Online First
C.I. Paules and Others | November 29, 2017 | DOI: 10.1056/NEJMp1714916
Strengthening the ACA for the Long Term
L.J. Blumberg and J. Holahan | N Engl J Med 2017;377:2105-2107 | Published Online October 18, 2017
Free Full Text Audio Comments
Lessons from the Latest ACA Battle
J.M. Lambrew | N Engl J Med 2017;377:2107-2109 | Published Online October 18, 2017
Free Full Text Audio
My Real Patients
L. Simon | N Engl J Med 2017;377:2109-2111
ORIGINAL ARTICLES
Fremanezumab for the Preventive Treatment of Chronic Migraine
S.D. Silberstein and Others | N Engl J Med 2017;377:2113-2122
CME Exam Quick Take Comments
A Controlled Trial of Erenumab for Episodic Migraine
P.J. Goadsby and Others | N Engl J Med 2017;377:2123-2132
Restrictive or Liberal Red-Cell Transfusion for Cardiac Surgery
C.D. Mazer and Others | N Engl J Med 2017;377:2133-2144 | Published Online November 12, 2017
Simulation of Growth Trajectories of Childhood Obesity into Adulthood
Z.J. Ward and Others | N Engl J Med 2017;377:2145-2153
CME Exam
HIV Prevention Efforts and Incidence of HIV in Uganda
M.K. Grabowski and Others | N Engl J Med 2017;377:2154-2166
Free Full Text
REVIEW ARTICLE
Acute Graft-versus-Host Disease — Biologic Process, Prevention, and Therapy
R. Zeiser and B.R. Blazar | N Engl J Med 2017;377:2167-2179
IMAGES IN CLINICAL MEDICINE
ECG-Induced Koebner Phenomenon
E. Streit and L.E. Vogelgsang | N Engl J Med 2017;377:2180-2180
Free Full Text
Zenker’s Diverticulum
J.-P. Le Mouel and M. Fumery | N Engl J Med 2017;377:e31
Free Full Text
CASE RECORDS OF THE MASSACHUSETTS GENERAL HOSPITAL
Case 37-2017: A 36-Year-Old Man with Unintentional Opioid Overdose
A.S. Raja and Others | N Engl J Med 2017;377:2181-2188
CME Exam
EDITORIAL
CGRP — The Next Frontier for Migraine
A.D. Hershey | N Engl J Med 2017;377:2190-2191
CORRESPONDENCE
An Unconscious Patient with a DNR Tattoo
Emicizumab Prophylaxis in Hemophilia A with Inhibitors
Liraglutide and Renal Outcomes in Type 2 Diabetes
Cost-Effectiveness of Intensive versus Standard Blood-Pressure Control
Recent Developments in Radiotherapy
Thanks Flipper appreciate your comments as well as others.
Vator
Thank you for your response. I was thinking the NASDAQ and the NYSE may have a certain dollar SP before institutions could buy a stock. $5.00 comes to mind when considering the NASDAQ exchange for institutional buyers. NYSE.............don't have any idea.
Thanks again
PT1
When (not if.... IMO) NWBO becomes a player in the biotech world, is it possible they could list on the NYSE rather than listing on the NASDAQ again? I have no idea concerning the hoops they would have to jump through.
PT1
NWBO's Theme Song
Doing some elementary reading on the subject. Thanks again.
https://en.wikipedia.org/wiki/Hematopoietic_stem_cell
PT1
Just never read about using stem cells.
Thanks for the response.
Anyone aware that stem cells are used to make DC-Vax or DCvax-L?
December 7, 2016 ·
Our Christmas Miracle!
We have been quiet over the last few months going through our
journey with some highs and some lows.
Earlier this year we flew to Memphis in America for Kat to have
Stem Cells removed for DCVAX.(Also managed to Pop to Sun Records!)
The parts of Kat's tumour which had been surgically removed in
November 2015 had already been flown over and the team there managed
to create all 11 treatments (3 years’ worth) of DCVAX.
Think Dvax has a shot at metastatic melanoma?
https://content.equisolve.net/oncosec/news/2017-10-10_OncoSec_Initiates_Registration_Directed_Clinical_1916.pdf
http://www.nejm.org/doi/full/10.1056/NEJMoa1709684?query=TOC
ORIGINAL ARTICLE
Overall Survival with Combined Nivolumab and Ipilimumab in Advanced Melanoma
Jedd D. Wolchok, M.D., Ph.D., Vanna Chiarion-Sileni, M.D., Rene Gonzalez, M.D., Piotr Rutkowski, M.D., Ph.D., Jean-Jacques Grob, M.D., C. Lance Cowey, M.D., Christopher D. Lao, M.D., M.P.H., John Wagstaff, M.D., Dirk Schadendorf, M.D., Pier F. Ferrucci, M.D., Michael Smylie, M.D., Reinhard Dummer, M.D., Andrew Hill, M.D., David Hogg, M.D., John Haanen, M.D., Matteo S. Carlino, M.D., Oliver Bechter, M.D., Ph.D., Michele Maio, M.D., Ph.D., Ivan Marquez-Rodas, M.D., Ph.D., Massimo Guidoboni, M.D., Grant McArthur, M.D., Celeste Lebbé, M.D., Ph.D., Paolo A. Ascierto, M.D., Georgina V. Long, M.B., B.S., Ph.D., Jonathan Cebon, M.B., B.S., Ph.D., Jeffrey Sosman, M.D., Michael A. Postow, M.D., Margaret K. Callahan, M.D., Ph.D., Dana Walker, M.D., M.S.C.E., Linda Rollin, Ph.D., Rafia Bhore, Ph.D., F. Stephen Hodi, M.D., and James Larkin, F.R.C.P., Ph.D.
N Engl J Med 2017; 377:1345-1356October 5, 2017DOI: 10.1056/NEJMoa1709684
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BACKGROUND
Nivolumab combined with ipilimumab resulted in longer progression-free survival and a higher objective response rate than ipilimumab alone in a phase 3 trial involving patients with advanced melanoma. We now report 3-year overall survival outcomes in this trial.
METHODS
We randomly assigned, in a 1:1:1 ratio, patients with previously untreated advanced melanoma to receive nivolumab at a dose of 1 mg per kilogram of body weight plus ipilimumab at a dose of 3 mg per kilogram every 3 weeks for four doses, followed by nivolumab at a dose of 3 mg per kilogram every 2 weeks; nivolumab at a dose of 3 mg per kilogram every 2 weeks plus placebo; or ipilimumab at a dose of 3 mg per kilogram every 3 weeks for four doses plus placebo, until progression, the occurrence of unacceptable toxic effects, or withdrawal of consent. Randomization was stratified according to programmed death ligand 1 (PD-L1) status, BRAF mutation status, and metastasis stage. The two primary end points were progression-free survival and overall survival in the nivolumab-plus-ipilimumab group and in the nivolumab group versus the ipilimumab group.
RESULTS
At a minimum follow-up of 36 months, the median overall survival had not been reached in the nivolumab-plus-ipilimumab group and was 37.6 months in the nivolumab group, as compared with 19.9 months in the ipilimumab group (hazard ratio for death with nivolumab plus ipilimumab vs. ipilimumab, 0.55 [P<0.001]; hazard ratio for death with nivolumab vs. ipilimumab, 0.65 [P<0.001]). The overall survival rate at 3 years was 58% in the nivolumab-plus-ipilimumab group and 52% in the nivolumab group, as compared with 34% in the ipilimumab group. The safety profile was unchanged from the initial report. Treatment-related adverse events of grade 3 or 4 occurred in 59% of the patients in the nivolumab-plus-ipilimumab group, in 21% of those in the nivolumab group, and in 28% of those in the ipilimumab group.
CONCLUSIONS
Among patients with advanced melanoma, significantly longer overall survival occurred with combination therapy with nivolumab plus ipilimumab or with nivolumab alone than with ipilimumab alone. (Funded by Bristol-Myers Squibb and others; CheckMate 067 ClinicalTrials.gov number, NCT01844505.)
Supported by Bristol-Myers Squibb, by a grant (P30CA008748, to Dr. Wolchok) from the National Cancer Institute, and by the NIHR Royal Marsden–Institute of Cancer Research Biomedical Research Centre (to Dr. Larkin).
Disclosure forms provided by the authors are available with the full text of this article at NEJM.org.
Drs. Hodi and Larkin contributed equally to this article.
This article was published on September 11, 2017, at NEJM.org.
We thank the patients and investigators who participated in the CheckMate 067 trial, and Ward A. Pedersen, Ph.D., Melissa Kirk, Ph.D., and Cara Hunsberger, M.S., of StemScientific for medical writing and editorial assistance with an earlier version of the manuscript.
Flipper
Yes, I am on top of my of my medical care and what I miss, my wife reminds me. She is very organized and has a mind of an elephant (doesn't forget much).
You may not be aware of the impact you and others have on the silent people on this board with your educated comments that apply to their health in regard to cancer. We read every word and indirectly you guys/gals give us hope.
Be well
PT1
BWIS
Thank you for your concern and prayer. I'm good with my insurance as the cost is minimal compared to what some have to pay.
I'll keep your suggestion concerning the fundraising in mind but I hope my health doesn't warrant doing that.
Be well
PT1
Thank you Flipper and Doingmybest for responding to my post. You guys are the best. I've been thinking about what you both said and the possibilities and roadblocks that may occur.
My question originated relative to my sister passing away 6 years ago. She had 98% of her glioblastoma tumor removed at the Cleveland Clinic but it returned 18 months later in an inoperable area of the brain. I've always wondered about the swelling issue should she had been so lucky to have had the vaccine and her options should the cancer have metastasized to an inoperable area.
It's my hope that the docs can do something about the swelling one day. She did not have the chance to live longer since DVax-L was not administered and we were not aware of its existence just SOC was given.
I have 2 types of cancers (which are under control as I speak) that may be treated with DVax-D or some other form of of DVax that could possibly be offered without the injection directly to the tumor. I've kept my oncologist informed of the Dvax-L and D possibilities with glioblastoma and inoperable tumors as well. He wants to know immediately by phone or fax as soon as the FDA approves either one. He will see that I have a prescription to begin the vaccine/therapy when approved if it applies in my case........... as well as his other patients (Just letting you know what my doctor thinks of the vaccine from what he knows at this point in time.)
Be well
PT1
Any ideas as to a procedure that might be used if a brain tumor has metastasized to another area of the brain that is inoperable regarding swelling? There's got to be some way to mitigate swelling. A shunt?
PT1
News for 'NWBO' - (*DJ NW BIO Announces Registered Direct Offering of $1.75M)
http://www.nejm.org/doi/full/10.1056/NEJMp1711886?query=TOC
Tragedy, Perseverance, and Chance — The Story of CAR-T Therapy
Lisa Rosenbaum, M.D.
September 13, 2017DOI: 10.1056/NEJMp1711886
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ArticleReferencesMetrics
In 2010, 5-year-old Emily Whitehead was diagnosed with acute lymphoblastic leukemia (ALL). Though her parents were told that if you had to have a kid with cancer, ALL was the best one to have, Emily’s course was hardly typical. After two rounds of chemotherapy, necrotizing fasciitis developed in both legs and she barely avoided amputation. Sixteen months later, she had a relapse. Bone marrow transplantation was recommended, but the Whiteheads, concerned about toxic effects, sought a second opinion at Children’s Hospital of Pennsylvania. There they learned about a new therapy, developed by University of Pennsylvania investigators and known as CART-19, which involved genetically engineering the patient’s own T cells to kill tumor cells.
Unfortunately, a clinical trial had not yet been cleared by the Food and Drug Administration (FDA), and Emily’s leukemic cells were doubling daily. So Emily returned to her local hospital and received another round of intensive chemotherapy, which bought her 3 weeks but no remission. Out of options, one oncologist recommended hospice. But “That just didn’t make sense to us,” says Tom Whitehead, Emily’s father. When the Whiteheads said they wanted to return to Children’s Hospital, the oncologist told them that hospice was preferable to entering Emily into an experimental study that wouldn’t help her get better.
But her parents opted to enroll her in a study, and she became the first child to receive CART-19. As a result, not only is she now a thriving 12-year-old, but her survival helped reenergize a line of research that was nearing failure. In August 2017, the FDA approved the first chimeric antigen receptor T-cell (CAR-T) therapy, Novartis’s tisagenlecleucel, which uses the Penn-developed technology, for patients up to 25 years of age with relapsed or refractory ALL. Though the indication is narrow, the results are striking in a patient population with otherwise limited options: 83% of the 63 evaluable children who received tisagenlecleucel in Novartis’s phase 2 trial had complete elimination of malignant cells at 3 months.1
The approval is probably the first of many for CAR-T products. Gilead recently announced its $11.9 billion acquisition of Kite Pharma, whose CAR-T technology, initially developed at the National Institutes of Health (NIH), has shown efficacy in patients with chemorefractory, aggressive B-cell non-Hodgkin’s lymphoma.2 And some 40 other companies, many in partnership with academic institutions, are racing to develop CAR-T technologies for myriad indications. Though early data are most promising for other hematologic cancers, such as relapsed chronic lymphocytic leukemia (CLL),3 similar therapies may eventually prove effective for solid tumors as well.
The emergence of CAR-T therapy, like most scientific advances, reflects the incremental insights of hundreds of scientists over decades — from surgeon William Coley’s recognition of the immune system’s potential for treating cancer when, in 1893, he injected streptococcus into inoperable osteosarcoma and observed the tumor shrink, to the making of the first CAR-T cells by the Israeli immunologist Zelig Eshhar in 1993.4 Indeed, the story of CAR-T therapy says as much about the methodical nature of scientific progress as it does about the passions that sustain it.
As Carl June, the immunologist who led the development of Penn’s CAR-T technology, recalled, “So many times, I almost had to quit.” June spent his early career developing a technique to boost immune function in patients with HIV by modifying their T cells and inducing proliferation ex vivo. Though he and his colleague Bruce Levine would later build on this technique to engineer patients’ T cells to attack leukemia, June might have continued focusing solely on the basic science. But in 1996, his 41-year-old wife was diagnosed with ovarian cancer. June tried unsuccessfully to get a pharmaceutical company to provide the tools he needed to attempt immunotherapy. When his wife died in 2001, June resolved to apply emerging immunologic insights to the development of cancer therapies, even though that meant creating a biotech infrastructure within academia.
The translational hurdles remained formidable. The field had been dogged by skepticism and setbacks, and the NIH wouldn’t fund a clinical trial. Once again, tragedy propelled the research forward. In 2001, Barbara and Edward Netter, having watched their daughter-in-law die of breast cancer, started the Alliance for Cancer Gene Therapy (ACGT), hoping to develop alternative approaches. In 2008, ACGT granted June and his coinvestigator David Porter $1 million, enough to treat their first three patients with relapsed CLL with CART-19. Two of the three patients achieved complete remission, but the investigators ran out of funding. Knowing they couldn’t prove efficacy statistically, they published their findings as case reports.3,5 Soon, the National Cancer Institute offered June a grant, and Novartis licensed Penn’s CAR-T technology. But June acknowledges the tenuous nature of anecdote: “Were we lucky? Were they representative? Would it be durable?”
Indeed, anecdote can easily break a field rather than make it: the death of Jesse Gelsinger in a trial at Penn had set the field of gene therapy back at least a decade. And as both June and Stephan Grupp, the Children’s Hospital oncologist and principal investigator of the CART-19 trial in children, emphasized, had Emily died, the CAR-T field would probably have died with her. But though unexpected toxic effects in phase 1 studies can fell any new therapy, the unfortunate reality is that it often takes time, and human lives, to distinguish fatal toxic effects from those that can be managed. As Grupp explained, “There was no way to predict a great deal of what we learned. The toxicity issues can only be learned from human beings.”
Emily Whitehead was a case in point. After receiving her third dose of CART-19, she developed high fevers, respiratory failure, and shock necessitating the use of three pressors. Though Emily was experiencing what’s now understood to be cytokine-release syndrome, which occurred in 78% of patients in Novartis’s phase 2 trial, it wasn’t clear at the time what was driving this response, much less how to treat it.
That she survived gives new meaning to the adage “Chance favors the prepared mind.” Per protocol, participants’ blood was sent for cytokine analysis, with about a 2-week turnaround time. But as Emily rapidly deteriorated, Grupp called the lab and begged them to run Emily’s blood more quickly. Two hours later, in time for his 3 p.m. lab meeting, Grupp learned that Emily’s level of interleukin-6 was elevated 1000-fold. He recalls the meeting, as everyone pored over the results. “No one thought we should be thinking about this thing, IL6,” Grupp explained. “It isn’t even made by T cells.” That fact, however, made interleukin-6 acceptable for Emily’s doctors to target, since any interference with T-cell function could interfere with the antileukemic activity, without which she would die. But how to quash interleukin-6? As Grupp and his lab members started Googling, June, giving a talk in Seattle, received the results and had an idea. His daughter, who has juvenile rheumatoid arthritis, had recently started taking tocilizumab, a monoclonal antibody that targets interleukin-6. As the investigators converged on a similar conclusion, one hurdle remained: how to get the drug in time for Emily?
Once again, they got lucky. Tocilizumab was on the hospital’s formulary for rheumatologic indications, which meant that rather than having to wait for up to 2 days, by 8 p.m. that evening, Emily received a dose. Within hours, she began to improve, so dramatically that her doctors could barely wean the pressors fast enough. On her seventh birthday, Emily woke up. Eight days later, on the basis of a bone marrow biopsy, Grupp reported that the treatment had worked.
Though the remissions achieved with CAR-T therapy are impressive, much remains unknown. CAR-T products vary in ways that will have implications for both efficacy and toxicity. Some variation arises from the chimeric antigen receptors (CARs) themselves, which are programmed to recognize various antigens and contain various types and numbers of costimulatory domains to induce proliferation. In the case of CART-19, for instance, the engineered T cells bind to lymphocytes displaying the CD19 antigen, a hallmark of leukemic B cells and thus an attractive target because humans can tolerate B-cell aplasia. Identifying antigen targets in solid tumors while preventing destruction of healthy tissue remains challenging, however, especially since the tumor microenvironment can be immunologically hostile to introduction of a CAR. Moreover, toxicities remain formidable. Though tocilizumab is now often used to manage the cytokine-release syndrome, other toxic effects, such as cerebral edema, remain poorly understood and difficult to manage.
Meanwhile, the CAR-T discussion has become dominated by cost concerns. Critics argue that tisagenlecleucel’s $475,000 price tag is unaffordable and unjustifiable given the taxpayer-supported basic research underpinning its development, while manufacturers point to the tremendous investment required to produce the drug and fund trials. With many patients unable to afford their medications and ongoing instances of unconscionable drug-company profiteering, these discussions are both essential and complex. Regardless of the finances, we all hope that these remissions are prolonged or, even better, turn out to be cures. There is no way to know whether they will without prolonged observation, but while we carefully observe each patient, it is important to remember that therapeutic advances are motivated by more than money — that it’s the hope, vision, and perseverance of both patients and investigators that have made this critical conversation possible.
A company involved in cytokine removal. (CTSO)
https://finance.yahoo.com/quote/CTSO?p=CTSO
The U.S. Food and Drug Administration granted regular approval to olaparib tablets (Lynparza, AstraZeneca) for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer, who are in a complete or partial response to platinum-based chemotherapy. August 17, 2017. More Information: https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm572143.htm
FDA approved inotuzumab ozogamicin (BESPONSA,, Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc.) for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). August 17, 2017. More Information: https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm572133.htm
FDA granted regular approval to a liposome-encapsulated combination of daunorubicin and cytarabine (VYXEOS, Jazz Pharmaceuticals, Inc.) for the treatment of adults with newly-diagnosed therapy-related AML (t-AML) or AML with myelodysplasia-related changes (AML-MRC), two types of AML having a poor prognosis.
August 3, 2017.
https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm569950.htm