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with NWBO Trial Information On Individual Patient Survival At NY Cancer Immunotherapy. this is HUGE!! look like a buyout going to happen very SOOOON!!
GO LONG!
NWBO Bio Presents Further DCVax®-Direct Phase I Trial Information On Individual Patient Survival At NY Cancer Immunotherapy
NW Bio Presents Further DCVax®-Direct Phase I Trial Information On Individual Patient Survival At NY Cancer Immunotherapy Co...
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Northwest Biotherapeutics, Inc. (MM) (NASDAQ:NWBO)
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Today : Thursday 29 September 2016
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BETHESDA, Md., Sept. 29, 2016 /PRNewswire/ -- Northwest Biotherapeutics (NASDAQ: NWBO) ("NW Bio"), a U.S. biotechnology company developing DCVax® personalized immune therapies for solid tumor cancers, announced that Dr. Marnix Bosch, Chief Technical Officer of NW Bio, presented additional information relating to the DCVax®-Direct Phase I Trial in a poster presentation at the Second CRI-CIMT-EATI-AACR International Cancer Immunotherapy Conference: Translating Science into Survival, being held from September 25th through September 28th in New York City.
Northwest Biotherapeutics Logo. (PRNewsFoto/Northwest Biotherapeutics, Inc.)
Dr. Bosch's New York presentation, as well as his presentation at a cancer vaccines conference in London last week, included information about estimated life expectancies for individual patients (not for types of cancers or medians of groups of patients) based on a system developed and published by Dr. Jennifer Wheler at MD Anderson Cancer Center. The Wheler system was based upon clinical experience with 1,181 patients with diverse cancers at the MD Anderson Phase I Cancer Clinic (where most of the DCVax-Direct Trial was conducted). Wheler validated and enhanced (with additional risk factors) a system for prediction of individual-patient life expectancies previously developed by the Royal Marsden Hospital in the UK and well established in the field.
A fundamental purpose of early stage exploratory trials, such as the DCVax-Direct Phase I trial, is to evaluate both product characteristics and patient characteristics – and especially to identify which patients show the best responses to the experimental product. Such evaluations enable later stage trials to be designed with more precision, to focus on the patients who are the best fit for the experimental product and to potentially best demonstrate the performance of the experimental product.
Exploratory trials typically involve diverse patient populations, as did the DCVax-Direct Phase I Trial. In evaluating the results of such trials, it is especially helpful to be able to identify life expectancies for individual patients, and compare those expectations to the actual results obtained in those individual patients. Patient-specific assessments are still estimates, but are more precise than general assessments relating to types of cancer or medians of groups of patients. Patient-specific assessments also can be more relevant, taking account of diversity among the patients.
The DCVax-Direct Phase I Trial included more than a dozen different types of cancers, as well as sub-types (e.g., several different types of sarcoma), patients with varying numbers of inoperable and locally advanced or metastatic tumors, and varying numbers and types of prior treatment regimens that had all failed. This diversity enabled demonstration, in a wide range of settings, of the safety and feasibility of DCVax-Direct (including feasibility of the novel intra-tumoral injections) as well as an initial signal or indication of potential results.
As explained in Dr. Bosch's poster presentation, under the Wheler methodology individual life expectancy is determined through measurements of 5 key risk factors: serum albumin, serum LDH, number of metastases, GI tumor, and ECOG (Eastern Cooperative Oncology Group) performance status. The expected survival is 24.0, 15.2, 8.4, 6.2 or 4.1 months for patients with 0, 1, 2, 3 or 4-5 of the above risk factors, respectively.
Dr. Bosch's New York and London presentations applied the Wheler system to determine estimated individual-patient life expectancies, and compare those to the actual clinical results in each patient in the top 30% of patients in the DCVax-Direct Phase I Trial. Dr. Bosch's poster will be available on the Company's website starting today.
The top 20% of the patients in the DCVax-Direct Phase I Trial have each exceeded 2 years of survival so far, and are still alive. The longest survivor to date has reached nearly 3 years.
The top 30% of the patients in the DCVax-Direct Phase I Trial (including pancreatic, melanoma, lung, ovarian, sarcoma and other cancers) have average actual individual survival to date of 26.7 months, compared with average expected individual survival of 12.3 months.
The Wheler system for assessing individual patient life expectancies can be found at Wheler, et al.; Survival of 1,181 Patients in a Phase I Clinic: The MD Anderson Clinical Center for Targeted Therapy Experience. Clin. Cancer Res. 2012 May 15; 18(10): 2922–2929.
Dr. Bosch's presentation also included assessments of dendritic cell quality and their relationship with patient outcomes, such as stabilization of disease and overall survival. The encouraging survival results correlate with underlying mechanisms of action and cellular and immune profiles, including phenotype analyses, and relative production of a wide range of cytokines by the dendritic cells. Additional positive observations include T-cell infiltration, and PD-L1 expression, with 64% of the patients evaluable for PD-L1 checkpoint expression (14 of 22) showing either de novo or significantly increased expression of PD-L1 following DCVax-Direct treatment, indicating potential for combination of DCVax-Direct and checkpoint inhibitors. Such information will also be helpful in shaping later stage trials.
About Northwest Biotherapeutics
NWBO- let blast off out of this channel!!! what's are BULL waiting for? HERE?
Bullish $$ Signal @techrightpicks $GLRI - expect an announcement today on Fed deal victory.
News leak likely here. Stock will be $0.30 a/h today.
NWBO-look like seller won! and all the buyer have left with profits.
look like the leg just broke, $BAS
vfin move back to 01 cent. and ISBG ready to move soon.
I google S-8 and I still dont get it, beside it for S-8 registration statement can be used by Issuers to register securities to be offered to employees under certain employee benefit plans.
-how that going to effect the market.
nice pop on $BDR.
not in, still just to see what going on.. SFOR today doesnt looking that good. and I think this might going lower with all the drama, flowing around.
note or R/S? since today sell off very scary.
I know, same here been buying all the 0003 I can get. easy money here.
ISBG news coming next week.
Chapter 11 bankruptcy can also be called rehabilitation bankruptcy. It's much more involved than chapter 7 as it allows the firm the opportunity to reorganize its debt and to try to re-emerge as a healthy organization. What this means is that the firm will contact its creditors in an attempt to change the terms on loans such as the interest rate and dollar value of payments. Like its cousin, chapter 11 requires that a trustee be appointed; however, rather than selling off all assets to pay back creditors, the trustee supervises the assets of the debtor and allows business to continue. It's important to note that debt is not absolved in chapter 11: the restructuring only changes the terms of the debt, and the firm must continue to pay it back through future earnings.
Read more: What are the differences between chapter 7 and chapter 11 bankruptcy? | Investopedia http://www.investopedia.com/ask/answers/190.asp#ixzz4FxscPluK
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TALK-iTalk, Inc. 2016 Letter to Shareholders
DELRAY BEACH, FL -- (Marketwired) -- 07/26/16 -- iTalk, Inc. (OTC PINK: TALK) ("iTalk").
Dear Shareholders,
Management wishes to clarify and explain to the iTalk shareholders its decision to file Chapter 11 reorganization of its indirect subsidiary, United Mobile Solutions, LLC. I understand the concerns expressed by our shareholders regarding this action. I want to assure the Company's shareholders that this tactical maneuver, in this context, is a legitimate strategy to recapitalize debt. Chapter 11 is often inaccurately equated to Chapter 7, which administers the liquidation and demise of failed enterprises. On the contrary, Chapter 11 is a reorganization process that permits otherwise viable companies, overburdened with debt and other liabilities, to streamline their operations and continue forward. It is an efficient interim process that provides a period of time for the company to maintain normal operations and, with the assistance of creditors, guide management in decisions to maximize future value.
sell sell sell share #CEO
no download, can you send a picture?
took a position here. very small let see if this baby bounce back to where it is. or got leg for tomorrow. $BIND