Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
TOB, look right here. Here is an example of another drug company sharing ongoing results. You can find one thousand of them. You are not printing the doctor's quotes, you are printing AF.
Results From MD Anderson-Sponsored Trial of Sunesis ‘s AML and High-Risk MDS Treatment Vosaroxin to be Presented at AACR 2014
Posted by: Rafaela Relvas April 7, 2014
md andersonSan Francisco-based Sunesis Pharmaceuticals, a biopharmaceutical company focused on the development and commercialization of new oncology therapeutics for the treatment of solid and hematologic cancers, recently announced that it will present updated data from the ONGOING PHASE 1b/2 University of Texas MD Anderson Cancer Center-sponsored trial of vosaroxin in combination with decitabine in older patients with previously untreated acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (MDS). The data will be presented at the American Association for Cancer Research Annual Meeting 2014 (AACR), that will take place in San Diego, California.
The poster, titled “Phase I/II study of vosaroxin and decitabine in older patients with acute myeloid leukemia (AML) and high risk myelodysplastic syndrome (MDS),” will be presented at the San Diego Convention Center, Hall A-E, Poster Section 38, during the Phase II/III Clinical Trials Poster Session on Tuesday, April 8, 2014 from 8:00 a.m. to 12:00 p.m. Pacific Time (Poster #7).
The abstract (#CT307), which includes preliminary results, can be found on the AACR website
This. Are you going to sticky this TOB?
antihama:
[I]t seems a no brainer that the label for DCVax-L, once its approved, will include all GBM patients (w adequate resectable tumor mass) including those with progression since it wouldn’t be ethical to wait to find out whether they are a pseudo or real progressors. If given earlier, at least pseudo-progressors will have maximum benefit from the drug even if it may not help those that actually progressed since at this time you can’t separate the two. I’m assuming pseudo progressors will show efficacy and be part of the label regardless. Assuming, assuming, assuming.
Both. Plus DCVAX-L is currently being used on many cancers in Israel as we speak. Consequently upon approval for brain cancer, label extension efforts may make L more widely available throughout the world as Direct continues to move into one or more phase II pivotal trials -- imho.
Exactly!
My misread.
As I go off-line for the evening, here is a wiki reference.
Paul Simon would probably look at me and sigh, "why deny the obvious child."
However, I can't help notice that NWBO first brought its miracle to brave patients in Israel 9 years ago.
Now, the first opening for an NWBO trained clinic in Germany is Dresden. I assume you all know why America appropriately fought against Hitler, so here is lesser known Wikihistory on Dresden, for those who are weak on history -- like me.
I pray Israel, Dresden and the world benefit from DCVAX.
The controversial British and American bombing of Dresden in World War II towards the end of the war killed approximately 25,000, many of whom were civilians, and destroyed the entire city center. The bombing gutted the city, as it did for other major German cities. After the war restoration work has helped to reconstruct parts of the historic inner city, including the Katholische Hofkirche, the Semper Oper and the Dresdner Frauenkirche as well as the suburbs.
Before and since German reunification in 1990, Dresden was and is a cultural, educational, political and economic center of Germany and Europe. The Dresden University of Technology is one of the 10 largest universities in Germany and part of the German Universities Excellence Initiative. -- Wiki
It's hard to read emotions on the board. My mistake. Great questions.
[early thought to be progressors] would return at [8] weeks after radiation therapy for a repeat MRI at the base 2 visit. [Some] would not have progress[ion] and would be eligible to enroll. The others would not be eligible to enroll. The[] [eligible] would be randomized by the same ratio (2:1) into the pseudoprogression arm of the study. [They] would follow the same schedule as the other 240 (with the exception of the base 2 visit). -- Sentiment modified by me
It takes some time to train clinics to administer this treatment. "Centers of Excellence" can conduct trials and/or simply provide treatment once authorized by the FDA or other legislation (aka: Right to Try).
Remember when Obama got blamed for not having/distributing enough flu vaccine? I think Linda wants to avoid that type of scenario.
AKA said:
if you needed to find 18 pseudos, you'd have to enroll and randomize nearly 100 new patients.
You need to read the May 2012 PR on upgrade to a phase III trial. You need to look at the historical changes to the trial over the years on clinical trials.gov. There was other info that came and went.
(You're getting angry at the wrong people AKA.)
From my memory -- not exact:
Each interim the DMC is supposed to do a statistical analysis of
1. The Primary Group minus the 33 carry over.
2. The 33 carry over.
3. The primary group plus the 33 carry over.
If and only if they reach Statistical Significance on #3 above, the DMC will then:
4. Separately Statistically Analyze the tertiary pseudo-progression group.
5. Separately Statistically analyze #3 plus #4.
Only # 3 will be used to determine the actual primary and secondary endpoint analysis.
There are/will be 312 in the phase 3 trial (unless this goal is changed).
240 ultimate enrollment in the primary group -- to determine the primary and secondary endpoint.
72 ultimate enrollment in the secondary group -- to determine the tertiary endpoint (and give further scientific background to help determine possible application expansion for other patients).
Cheers!
Agreed.
Exciting times, and let's hope NWBO executes with a sense of urgency. To quote from Les Goldman's recent mail on DCVax-Direct..."While much remains to be seen, these early returns are indeed making this an exciting time over here at NW Bio. We will be working hard to continue and build upon this early progress." -- Red
Great points Red. I think Direct appeals to a lot of factions.
1. Patients -- Personalization, relative ease of administration, lack of side effects, improved well being, affordable and possible lifetime immunity for many individuals.
2. Oncologists -- Ease of administration, safety, efficacy, patient well being, a hybrid transition from their chemotherapy income (not to be cynical), a hybrid transition from their surgical income (not to be cynical).
3. Insurance companies -- Predictability, reduced overall annual cost, reduces surgery and chemotherapy costs, reduced home care, reduced hospital cost.
4. Government -- Reduced work loss time/Increased productivity, eventual reduction in healthcare costs and death benefit costs. Keeps medical infrastructure (jobs) in place with smooth transition. Provides manufacturing jobs.
5. Pharmaceutical companies -- Does not immediately eliminate need for some chemotherapies and other current Big pharma income streams because the tumors often need to be softened up initially. As you mention, ultimately this will allow next generation off-the-shelf-products to provide choices and competition.
6. FDA -- Safety, efficacy, and smooth "hybrid" transition away from chemotherapy.
7. Radiologists -- Image guided injection business (not to be cynical), initial softening up will still be required in many cases.
I think the one thought I'd leave you with is that the primary group involves interim analysis. The tertiary group does not -- it involves a one time look.
LTT, "I Gotch ya a dollar"
You'll have to be quicker than that!
And I think it's important to add that there does not appear to be a required number of events for the pseudo group, so, since the primary group data analysis determines whether there is an early halt or not, why not increase the flexible powering in the pseudo group by simply getting some more events by enlarging their enrollment before the primary group analysis officially stops the trial -- but not increasing the required number of events. This sounds confusing, but when you consider the pseudo group is a tertiary endpoint, it makes sense that there is more flexibility here. Remember, there is an ethics group in there, and if the results in the primary group are strong enough for approval, the ethicists are arguing strenuously against a continuance in the trial.
Personally, I think 240 is enough for the primary group. I think "a little bit" bit for the pseudo group would be 25% or less.
So if they decide to enlarge enrollment, they might add 18 patients to the pseudo group.
However, if they do that, as Pyrr suggests, they might add some to the primary group of 240 -- just to account for screening. My guess would be 30, because that might take one quarter (Q4) with ramped up enrollment.
The next question would be whether they increase the required number of events. To me, this is unlikely, because, despite what Linda states, I think they are simply trying to get more events from the pseudo group in order to start showing separation between the relatively immature trx. group and control group.
Are you asking what will happen if ultimate enrollment size is expanded, or do you mean now that they expanded the trial to 63 clinics according to clinical trials.gov?
1. For the former, it would depend on what a "little" enrollment enlargement means.
2. For the latter, it may mean the current 240 target could be reached closer to July than September.
Simple Math
Pyrr is confident we hit 192 enrollment by late winter.
Ballpark 2 years to enroll 159 patients. (Not including 33 patients from 2008)
159 patients / 2 years = Approx. 80 patients per year.
240 - 192 = 48 left to enroll as of Mid-March.
Without considering ramping, we would reach full enrollment before the end of October.
However, if NWBO is continuing to ramp enrollment (very likely), we should reach full enrollment sometime between July Fourth and Labor Day.
An independent neuropathologist is used to help make enrollment decisions, but I do not know the answer to your question.
Thanks again Hodge. This is very encouraging. I hope all is well for you and your family.
It sounds like he was entered into the expanded access program before it became official on clinical trials.gov.
I think this also shows at least one reason why the expanded access program now exists. I think this also demonstrates why the Germans thought it was still too difficult to distinguish between pseudo progression and true progression. Rico's 6 month wait is akin to control/placebo patients waiting to progress before receiving delayed treatment.
I pray that DCVAX-L will (is) start(ing) to kick in for RICO. Remember, chemo fades and immunotherapy builds.
Thus we may reasonably speculate:
Responders include:
1. Lung
2. colorectal
3. pancreatic and
4. melanoma*
and
5. at least another cancer involving sarcoma.
6.?*
* = not yet confirmed.
I think it is safe to say they have had a response in Melanoma patients as well, since 7 are enrolled with more than one injection each, I think it is reasonable to assume at least one of those patients exceeded 4 injections(aka: included in the 9 of 9 response rate aka: 100% RR).
It looks like they closed the breast cancer with brain metastases at 2 patients and moved the remaining four slots to other. I do not think we can read anything into this yet. It may have more to do with logistics, difficulty regarding administration and need for quick resolution to phase 1.
Here is the poster link:
DCVAX-Direct Poster from ASCO 2014
DCVAX-L
63 clinics. That means it would take 3.8 patients (average of course) per clinic to reach 240.
DCVAX-Direct
Thanks. I'll try to relocate the poster.
Clarification: 36 screened 32 enrolled.
Well said. I will attest that your passage is a work of concise wit, humility and unparalleled board comprehension -- just in case outsiders have no idea what you are talking about.
Welcome back comrade. I hope your Journey to Siberia does not make these small cramped quarters intolerable for your newly acquired worldliness:)
Thanks for getting back to the board!
One must allow that nwbo excluded early true and pseudo progression in the primary group, but those almost wash each other out regarding os.
Just a startling number comparison.
ICT-107 = 124 patients
67 deaths between January 11 to December 2013. = 24 months
DCVAX-L = unknown enrollment (Probably the same or higher by Dec 2013)
67 progressions between 2008 to December 2013 with enrollment pause but not treatment pause = 60 months.
Both have 2:1 ratio enrollment.
I'm with you Sentiment -- looking for any new facts.
I think that is the same information shared in the June 11, 2014 release, unless you are looking at something else.
Afford, Long makes a good point that another specific company Russell listing PPS did not behave similarly. AVII recently cleared up one of those "33" questions -- believe it or not, I think that may also play a part in the price rise.
Les talked about Big Pharma interest at ASCO. I suspect that was not a casual reference.
We are getting very close to full enrollment for phase 1.
The specter of AF waiting to drain The Street's ink barrels to unfairly ambush NWBO is gone for the time being.
Smith wrote an article discussing other catalysts.
Things are afoot Afford.
Long, I agree today's market reaction was not simply based upon Russell listings.
Les was not shy about mentioning interests by big pharma -- this may play into the PPS.
I'm glad things are working out for you. These are very exciting times in science and medicine.
Yes, but not for NWBO. I'm staying completely liquid. 20% maximum capital gains is fine with me. Of course, I have high expectations for this particular stock. Otherwise I'm well diversified. I'm primarily interested in a cure for solid tumor cancer. While NWBO Direct will almost get a perfect batting average (IMHO), other companies will mop up NWBO's few misses; and like antibiotics, once an effective cancer treatment is found, companies and governments must continue finding additional cancer cures -- just in case.
I add from time to time, my core investment is in the 20% C.G. tax bracket.
As you know, I'm just a boring long, but I agree with your sentiment on the strength of this rally.