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Those who have averaged down are either:
1) better at due diligence and/or smarter than you
2) idiots and dumber than you
Obviously I believe I am #1. We will find out soon enough Ready. No hard feelings either way. I believe you are one of the few genuine longs and just frustrated. Even if not I wish you the best. I always kind of liked you (unlike some of the others who are negative whom I despise).
Seconded
we're talking about the UCLA site, not clinicaltrials.gov
I think it was really just a cleanup. Moved from "hold on enrollment" to "closed to recruiting" and removed the consent form.
I don't think it's anything to worry about, just wanted to notify everyone about a change I noticed.
And many of the true diehards are already fully invested having averaged down for over a year. I for one have over 10 times the shares I had 2 years ago.
You’ll be happy tomorrow BSB ??
244,350 accumulated today average price report after close. That's why we moved quite a bit and they dropped it down midday.
The market makers just took us down 11.22% on a trade value of $25,000. This is a game. The trend is up and news is coming. I'm loaded to the gills myself. I haven't sold any in over 2 years and I've bought a ton. And I don't even like grapefruit juice. We'll know soon how this story unfolds.
Beautiful...They are sure putting up a wall here...hopefully it's a fake.
Right on, Smokey.
I like to watch Nite in particular. I've noticed when they back off briefly, we tend to go to where they were momentarily. Like today, they backed off to $0.30. That doesn't mean we get there right away every time, but there is a definite probability.
I actually saw them today remove the $0.26 and sit at $0.40 for about 30 seconds before moving their ask back to $0.30 where they sit now.
I wouldn't be surprised if we get to $0.40 in the next few days.
Here is how the German version looked on October 19, 2016
Summary
EudraCT Number: 2011-001977-13
Sponsor's Protocol Code Number: 020221
National Competent Authority: Germany - PEI
Clinical Trial Type: EEA CTA
Trial Status: Temporarily Halted
Date on which this record was first entered in the EudraCT database: 2013-02-11
Link: https://www.clinicaltrialsregister.eu/ctr-search/trial/2011-001977-13/DE/
A. Protocol Information
A.1 Member State Concerned: Germany - PEI
A.2 EudraCT number: 2011-001977-13
A.3 Full title of the trial: A Phase III clinical trial evaluating DCVax®-L, autologous dendritic cells
(DC) pulsed with tumor lysate antigen for the treatment of glioblastoma
multiforme (GBM)
A.3 Full title of the trial (de): Klinische Phase III Studie zur Evaluierung von DCVax®-L - autologe
dendritische Zellen beladen mit Tumor-Lysat Antigen zur Behandlung von
Glioblastoma multiforme (GBM).
A.3.1 Title of the trial for lay people, in easily understood, i.e. non-technical, language: A Clinical Trial Evaluating DCVax®-L, Self-Derived Dendritic Cells Loaded
with Tumor Proteins for the Treatment of Glioblastoma, a Type of Brain
cancer
A.3.2 Name or abbreviated title of the trial where available: DCVax-L trial for GBM
A.4.1 Sponsor's protocol code number: 020221
A.5.2 US NCT (ClinicalTrials.gov registry) number: NCT00045968
A.7 Trial is part of a Paediatric Investigation Plan: No
A.8 EMA Decision number of Paediatric Investigation Plan:
B. Sponsor Information
Sponsor 1
B.1.1 Name of Sponsor: Northwest Biotherapeutics, Inc
B.1.3.4 Country: United States
B.3.1 and B.3.2 Status of the sponsor: Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1 Name of organisation providing support: Northwest Biotherapeutics, Inc
B.4.2 Country: United States
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1 Name of organisation: Northwest Biotherapeutics GmbH
B.5.2 Functional name of contact point: Dr. Guenter Rosskamp
B.5.3 Address
B.5.3.1 Street Address: Deutscher Platz 5a
B.5.3.2 Town/ city: Leipzig
B.5.3.3 Post code: 04103
B.5.3.4 Country: Germany
B.5.4 Telephone number: 493413929 6480
B.5.5 Fax number: 493413929 6499
B.5.6 E-mail: info@nwbio.de
D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3 IMP Role: Test
D.2 Status of the IMP to be used in the clinical trial
D.2.1 IMP to be used in the trial has a marketing authorisation: No
D.2.5 The IMP has been designated in this indication as an orphan drug in the Community: Yes
D.2.5.1 Orphan drug designation number: EU/3/07/431
D.3 Description of the IMP
D.3.1 Product name: DCVax-L
D.3.4 Pharmaceutical form: Suspension for injection
D.3.4.1 Specific paediatric formulation: No
D.3.7 Routes of administration for this IMP:
Intradermal use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8 INN - Proposed INN: NA
D.3.9.3 Other descriptive name: AUTOLOGOUS DENDRITIC CELLS LOADED WITH AUTOLOGOUS TUMOR CELL LYSATE
D.3.9.4 EV Substance Code: SUB99905
D.3.10 Strength
D.3.10.1 Concentration unit: Other
D.3.10.2 Concentration type: equal
D.3.10.3 Concentration number: 1250000
D.3.11 The IMP contains an
D.3.11.1 Active substance of chemical origin: No
D.3.11.2 Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP): No
D.3.11.3 Advanced Therapy IMP (ATIMP): Yes
D.3.11.3.1 Somatic cell therapy medicinal product: Yes
D.3.11.3.2 Gene therapy medical product: No
D.3.11.3.3 Tissue Engineered Product: No
D.3.11.3.4 Combination ATIMP (i.e. one involving a medical device): No
D.3.11.3.5 Committee on Advanced therapies (CAT) has issued a classification for this product: No
D.3.11.4 Combination product that includes a device, but does not involve an Advanced Therapy: No
D.3.11.5 Radiopharmaceutical medicinal product: No
D.3.11.6 Immunological medicinal product (such as vaccine, allergen, immune serum): No
D.3.11.7 Plasma derived medicinal product: No
D.3.11.8 Extractive medicinal product: No
D.3.11.9 Recombinant medicinal product: No
D.3.11.10 Medicinal product containing genetically modified organisms: No
D.3.11.11 Herbal medicinal product: No
D.3.11.12 Homeopathic medicinal product: No
D.3.11.13 Another type of medicinal product: No
D.8 Information on Placebo
D.8 Placebo: 1
D.8.1 Is a Placebo used in this Trial? Yes
D.8.3 Pharmaceutical form of the placebo: Suspension for injection
D.8.4 Route of administration of the placebo: Intradermal use
E. General Information on the Trial
E.1 Medical condition or disease under investigation
E.1.1 Medical condition(s) being investigated: Glioblastoma multiforme
E.1.1.1 Medical condition in easily understood language: Brain cancer, stage 4
E.1.1.1 Medical condition in easily understood language (de): Gehirnkrebs, Stage 4
E.1.1.2 Therapeutic area: Diseases [C] - Cancer [C04]
MedDRA Classification
E.1.2 Medical condition or disease under investigation:
E.1.2 Version: 18.0
E.1.2 Level: PT
E.1.2 Classification code: 10018337
E.1.2 Term: Glioblastoma multiforme
E.1.2 System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
E.1.3 Condition being studied is a rare disease: Yes
E.2 Objective of the trial
E.2.1 Main objective of the trial: The primary objective of this study is to compare progression free
survival (PFS) between patients in the DCVax-L cohort and patients in
the placebo cohort in patients with no evidence of disease progression at
baseline.
E.2.2 Secondary objectives of the trial: The secondary objective of this study is to compare Overall Survival (OS)
between patients in the DCVax-L group and patients in the placebo
group in patients with no evidence of disease progression at baseline.
E.2.3 Trial contains a sub-study: No
E.3 Principal inclusion criteria: Determined at pre-screening
• Patients ≥18 and ≤70 years of age at time of surgery
• Patients must be able to understand and sign the informed consent indicating that they are aware of the investigational nature of this study. The consent for tumor donation may be signed by a legally authorized representative (LAR) if allowed by the institution.
• Patients must have a life expectancy of ≥8 weeks
Determined at or around surgery, and prior to pre-leukapheresis visit
• Primary therapy must consist of surgical resection with the intent for a gross or near gross total resection of the contrast-enhancing tumor mass as confirmed by central review, followed by external beam radiation therapy and concurrent temozolomide chemotherapy. Patients who have a resection with original intent for gross or near gross total resection where the surgery can be said to be beyond biopsy are eligible. Central confirmation is not required prior to the pre-leukapheresis visit, but is required before the patient can proceed to leukapheresis. Patients having a biopsy only will be excluded. Patients may be screened if they have had a previous biopsy and are scheduled for a subsequent gross or near gross total resection prior to commencement of other therapies.
• Patients with newly diagnosed, unilateral GBM (Grade IV) without metastases are eligible for this protocol. An independent central neuropathologist will review this diagnosis during the enrollment process. This confirmation is not required prior to the pre-leukapheresis visit, but is required before the patient can proceed to leukapheresis.
• All Patients must have sufficient tumor lysate protein that was generated from the surgically obtained tumor material. This determination will be made by the contracted manufacturer and communicated to the clinical site through the Sponsor, or its designee. This confirmation is not required prior to the pre-leukapheresis visit, but is required before the patient can proceed to leukapheresis.
Determined at pre-leukapheresis visit
• Patients must have adequate bone marrow function prior to each leukapheresis procedure (hemoglobin >10 g/dl or >100g/L, white blood count ≥ 3.6x10E3/mm3 or ≥ 3.6x10E9/L, absolute granulocyte count ≥1.5x10E3/mm3 or ≥1.5x10E9/L, absolute lymphocyte count ≥0.5x10E3/mm3 or ≥0.5x10E9/L, and platelet count ≥100x10E3/mm3 or ≥100x10E9/L). Patients for whom a transfusion is clinically indicated may be considered eligible based on post-transfusion Hgb levels. These values are determined by a central laboratory.
• Adequate liver function (SGPT, SGOT, and alkaline phosphatase ≤4.0 times upper limits of normal (ULN) and total bilirubin ≤1.5 mg/dl or <25.7 µmol/L), and adequate renal function (BUN or creatinine ≤1.5 times ULN) prior to starting therapy. These values are determined by a central laboratory.
Determined at baseline visit
• Patients must have a KPS rating of ≥70 at the Baseline Visit (Visit 5)
• Patients may have received steroid therapy as part of their primary treatment. Steroid treatment should preferably be stopped; or if continued steroid use is clinically indicated, be tapered down to no more than 4 mg dexamethasone per day (or equivalent) at least 7 days prior to the first immunization.
• Patients must be willing to forego cytotoxic anti-tumor therapies except temozolomide while being treated with study drug/placebo. DCVax-L and placebo must be given as described and temozolomide must be given essentially according to the Stupp Protocol guidelines. Administration of adjuvant temozolomide is minimally modified from the guidelines to allow for vaccine dose window adherence.
• A minimum of 5 immunizations must be available for treatment as determined by the contracted manufacturer.
E.4 Principal exclusion criteria: Determined at pre-screening
• History of prior malignancy except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer or other cancers that were deemed fully resolved 5 or more years prior to Visit 1 (surgery) of the study. Prior lower grade gliomas are acceptable unless treated with chemotherapy, and provided that all other eligibility criteria are met.
• History of immunodeficiency disease or unresolved autoimmune disease such as rheumatoid arthritis, systemic lupus erythematosus, multiple sclerosis, scleroderma, polymyositis-dermatomyositis, juvenile onset insulin dependent diabetes, or vasculitis.
• Known HIV-1,2, HTLV-1,2 or Hepatitis B, C infection
• Pregnancy
• Inability to obtain informed consent because of psychiatric or complicating medical problems.
• Any known genetic cancer-susceptibility syndromes.
Determined at or around surgery
• Bilateral or metastatic disease detected at diagnosis, during surgery or at post-surgical magnetic resonance imaging (MRI). Tumors may cross into, but not beyond the corpus callosum.
• Positive test(s) for infectious agents (HIV 1 and 2, Anti-HIV-1,2, Hepatitis B, HBsAg, Anti HBc, Hepatitis C, Anti-HCV-Ab, Syphilis) that would preclude eligibility for tumor procurement and processing per applicable manufacturing guidelines (e.g. German manufacturing vendors).
• Post operative MRI scan evidence of biopsy only without significant tumor resection.
• Implantation of Gliadel® wafers (polifeprosan 20 with carmustine implant) at surgery.
Determined at pre-leukapheresis visit
• Positive HIV-1, HIV-2, HTLV-1, 2, hepatitis B surface antigen, or hepatitis C antibody.
• Patients with organ allografts.
• Allergies to reagents used in this study.
• Patients who are unable to stop or taper steroid treatment to no more than 4mg of dexamethasone per day (or equivalent) prior to leukapheresis are excluded from the trial; steroid use should be stopped or tapered down to the lowest clinically acceptable dose approximately 7 days prior to leukapheresis. The Leukapheresis Visit must occur a minimum of 45 days before the projected Baseline Visit.
• Inability or unwillingness to return for required visits and follow-up exams.
• Any previous cytotoxic drug therapies within the last 5 years.
Determined at or prior to baseline visit
• Patients who have evidence of disease progression (including possible pseudoprogression) as determined by central review
• Patients may not be taking medications that might affect immune function and that have documented anti-tumor activity: The following are exceptions: nonprescription strength doses of NSAIDS, acetaminophen (paracetamol) or acetylsalicylic acid (aspirin).
Determined at baseline visit:
• Acute infection: any active viral, bacterial, or fungal infection that requires specific therapy. Antibiotic therapy must be completed at least 7 days prior to the first immunization.
• Active uncontrolled infection. Examples are a sexually transmitted disease (STD), herpes, uncontrolled tuberculosis, malaria, etc.
• Fever ≥101.5°F (38.6 °C). If considered possibly transient, retesting is allowed.
• Unstable or severe intercurrent medical conditions such as unstable angina, uncontrolled arrhythmias, ulcerative colitis etc.
• Females of child-bearing potential who are pregnant or lactating or who are not using adequate contraception (abstinence, surgical, hormonal or double barrier, i.e. condom and diaphragm).
E.5 End points
E.5.1 Primary end point(s): Time to objective demonstration of disease progression or death,
measured from time of randomization (progression free survival, PFS),
in patients with no evidence of disease progression after external beam
radiation therapy with concurrent temozolomide chemotherapy.
E.5.1.1 Timepoint(s) of evaluation of this end point: The primary endpoint will be evaluated when 248 events of progression or death have occurred. in addition, two interim analyses will evaluate the endpoint when approximately 60% and 80% of the events have occurred.
E.5.2 Secondary end point(s): Overall survival: In patients with no evidence of disease progression after external beam radiation therapy with concurrent temozolomide chemotherapy.
E.5.2.1 Timepoint(s) of evaluation of this end point: Overall survival will be assessed when 233 deaths have occurred.
E.6 and E.7 Scope of the trial
E.6 Scope of the Trial
E.6.1 Diagnosis: No
E.6.2 Prophylaxis: No
E.6.3 Therapy: Yes
E.6.4 Safety: Yes
E.6.5 Efficacy: Yes
E.6.6 Pharmacokinetic: No
E.6.7 Pharmacodynamic: No
E.6.8 Bioequivalence: No
E.6.9 Dose response: No
E.6.10 Pharmacogenetic: No
E.6.11 Pharmacogenomic: No
E.6.12 Pharmacoeconomic: No
E.6.13 Others: No
E.7 Trial type and phase
E.7.1 Human pharmacology (Phase I): No
E.7.1.1 First administration to humans: No
E.7.1.2 Bioequivalence study: No
E.7.1.3 Other: No
E.7.1.3.1 Other trial type description:
E.7.2 Therapeutic exploratory (Phase II): No
E.7.3 Therapeutic confirmatory (Phase III): Yes
E.7.4 Therapeutic use (Phase IV): No
E.8 Design of the trial
E.8.1 Controlled: Yes
E.8.1.1 Randomised: Yes
E.8.1.2 Open: No
E.8.1.3 Single blind: No
E.8.1.4 Double blind: Yes
E.8.1.5 Parallel group: No
E.8.1.6 Cross over: Yes
E.8.1.7 Other: No
E.8.2 Comparator of controlled trial
E.8.2.1 Other medicinal product(s): No
E.8.2.2 Placebo: Yes
E.8.2.3 Other: No
E.8.2.4 Number of treatment arms in the trial: 2
E.8.3 The trial involves single site in the Member State concerned: No
E.8.4 The trial involves multiple sites in the Member State concerned: Yes
E.8.4.1 Number of sites anticipated in Member State concerned: 20
E.8.5 The trial involves multiple Member States: Yes
E.8.5.1 Number of sites anticipated in the EEA: 28
E.8.6 Trial involving sites outside the EEA
E.8.6.1 Trial being conducted both within and outside the EEA: Yes
E.8.6.2 Trial being conducted completely outside of the EEA: No
E.8.6.3 If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned:
Germany
United Kingdom
United States
E.8.7 Trial has a data monitoring committee: Yes
E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial: LVLS
E.8.9 Initial estimate of the duration of the trial
E.8.9.1 In the Member State concerned years: 4
E.8.9.1 In the Member State concerned months:
E.8.9.1 In the Member State concerned days:
E.8.9.2 In all countries concerned by the trial years: 4
F. Population of Trial Subjects
F.1 Age Range
F.1.1 Trial has subjects under 18: No
F.1.1.1 In Utero: No
F.1.1.2 Preterm newborn infants (up to gestational age < 37 weeks): No
F.1.1.3 Newborns (0-27 days): No
F.1.1.4 Infants and toddlers (28 days-23 months): No
F.1.1.5 Children (2-11years): No
F.1.1.6 Adolescents (12-17 years): No
F.1.2 Adults (18-64 years): Yes
F.1.2.1 Number of subjects for this age range: 298
F.1.3 Elderly (>=65 years): Yes
F.1.3.1 Number of subjects for this age range: 50
F.2 Gender
F.2.1 Female: Yes
F.2.2 Male: Yes
F.3 Group of trial subjects
F.3.1 Healthy volunteers: No
F.3.2 Patients: Yes
F.3.3 Specific vulnerable populations: Yes
F.3.3.1 Women of childbearing potential not using contraception : No
F.3.3.2 Women of child-bearing potential using contraception: Yes
F.3.3.3 Pregnant women: No
F.3.3.4 Nursing women: No
F.3.3.5 Emergency situation: No
F.3.3.6 Subjects incapable of giving consent personally: No
F.3.3.7 Others: No
F.4 Planned number of subjects to be included
F.4.1 In the member state: 87
F.4.2 For a multinational trial
F.4.2.1 In the EEA: 132
F.4.2.2 In the whole clinical trial: 348
F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition): Current standard of care of that condition by their physcians.
G. Investigator Networks to be involved in the Trial
N. Review by the Competent Authority or Ethics Committee in the country concerned
N. Competent Authority Decision: Authorised
N. Date of Competent Authority Decision: 2013-07-30
N. Ethics Committee Opinion of the trial application: Favourable
N. Ethics Committee Opinion: Reason(s) for unfavourable opinion:
N. Date of Ethics Committee Opinion: 2012-06-04
P. End of Trial
P. End of Trial Status: Temporarily Halted
Longfellow-
Here is a data dump I collected on 10/19/2016.
It looks the same to me then as today.
Summary
EudraCT Number: 2011-001977-13
Sponsor's Protocol Code Number: 020221
National Competent Authority: UK - MHRA
Clinical Trial Type: EEA CTA
Trial Status: Temporarily Halted
Date on which this record was first entered in the EudraCT database: 2012-07-09
Link: https://www.clinicaltrialsregister.eu/ctr-search/trial/2011-001977-13/GB/
A. Protocol Information
A.1 Member State Concerned: UK - MHRA
A.2 EudraCT number: 2011-001977-13
A.3 Full title of the trial: A Phase III clinical trial evaluating DCVax®-L, autologous dendritic cells (DC) pulsed with tumor lysate antigen for the treatment of glioblastoma multiforme (GBM)
A.3.1 Title of the trial for lay people, in easily understood, i.e. non-technical, language: A Clinical Trial Evaluating DCVax®-L, Self-Derived Dendritic Cells Mixed with Tumor Proteins for the Treatment of Glioblastoma, a Type of Brain cancer
A.3.2 Name or abbreviated title of the trial where available: DCVax®-L
A.4.1 Sponsor's protocol code number: 020221
A.5.2 US NCT (ClinicalTrials.gov registry) number: NCT00045968
A.7 Trial is part of a Paediatric Investigation Plan: No
A.8 EMA Decision number of Paediatric Investigation Plan:
B. Sponsor Information
Sponsor 1
B.1.1 Name of Sponsor: Northwest Biotherapeutics Inc
B.1.3.4 Country: United States
B.3.1 and B.3.2 Status of the sponsor: Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1 Name of organisation providing support: Northwest Biotherapeutics Inc
B.4.2 Country: United States
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1 Name of organisation: Northwest Biotherapeutics Inc
B.5.2 Functional name of contact point: Chief Technical Officer
B.5.3 Address
B.5.3.1 Street Address: 4800 Montgomery Lane, Suite 800
B.5.3.2 Town/ city: Bethesda
B.5.3.3 Post code: MD 20814
B.5.3.4 Country: United States
B.5.4 Telephone number: 001240497 9022
B.5.6 E-mail: marnix@nwbio.com
D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3 IMP Role: Test
D.2 Status of the IMP to be used in the clinical trial
D.2.1 IMP to be used in the trial has a marketing authorisation: No
D.2.5 The IMP has been designated in this indication as an orphan drug in the Community: Yes
D.2.5.1 Orphan drug designation number: EU/3/07/431
D.3 Description of the IMP
D.3.1 Product name: DCVax®-L
D.3.4 Pharmaceutical form: Suspension for injection
D.3.4.1 Specific paediatric formulation: No
D.3.7 Routes of administration for this IMP:
Intradermal use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8 INN - Proposed INN: Canpuldencel-T
D.3.9.2 Current sponsor code: DCVax-L
D.3.9.3 Other descriptive name: Tumor lysate loaded DC
D.3.10 Strength
D.3.10.1 Concentration unit: Other
D.3.10.2 Concentration type: equal
D.3.10.3 Concentration number: 1250000
D.3.11 The IMP contains an
D.3.11.1 Active substance of chemical origin: No
D.3.11.2 Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP): Yes
D.3.11.3 Advanced Therapy IMP (ATIMP): Yes
D.3.11.3.1 Somatic cell therapy medicinal product: Yes
D.3.11.3.2 Gene therapy medical product: No
D.3.11.3.3 Tissue Engineered Product: No
D.3.11.3.4 Combination ATIMP (i.e. one involving a medical device): No
D.3.11.3.5 Committee on Advanced therapies (CAT) has issued a classification for this product: No
D.3.11.4 Combination product that includes a device, but does not involve an Advanced Therapy: No
D.3.11.5 Radiopharmaceutical medicinal product: No
D.3.11.6 Immunological medicinal product (such as vaccine, allergen, immune serum): No
D.3.11.7 Plasma derived medicinal product: No
D.3.11.8 Extractive medicinal product: No
D.3.11.9 Recombinant medicinal product: No
D.3.11.10 Medicinal product containing genetically modified organisms: No
D.3.11.11 Herbal medicinal product: No
D.3.11.12 Homeopathic medicinal product: No
D.3.11.13 Another type of medicinal product: No
D.8 Information on Placebo
D.8 Placebo: 1
D.8.1 Is a Placebo used in this Trial? Yes
D.8.3 Pharmaceutical form of the placebo: Suspension for injection
D.8.4 Route of administration of the placebo: Intradermal use
E. General Information on the Trial
E.1 Medical condition or disease under investigation
E.1.1 Medical condition(s) being investigated: Glioblastoma Multiforme
E.1.1.1 Medical condition in easily understood language: Brain cancer
E.1.1.2 Therapeutic area: Diseases [C] - Cancer [C04]
MedDRA Classification
E.1.2 Medical condition or disease under investigation:
E.1.2 Version: 18.0
E.1.2 Level: PT
E.1.2 Classification code: 10018337
E.1.2 Term: Glioblastoma multiforme
E.1.2 System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
E.1.3 Condition being studied is a rare disease: Yes
E.2 Objective of the trial
E.2.1 Main objective of the trial: The primary objective of this study is to compare progression free survival (PFS) between patients in the DCVax-L cohort and patients in the placebo cohort
E.2.2 Secondary objectives of the trial: The secondary objective of this study is to compare Overall Survival (OS) between patients in the DCVax-L group and patients in the placebo group.
E.2.3 Trial contains a sub-study: No
E.3 Principal inclusion criteria: Determined at pre-screening
• Patients ≥18 and ≤70 years of age at surgery
• Patients must be able to understand and sign the informed consent. The consent for tumor donation may be signed by a legally authorized representative (LAR) if allowed by the institution.
• Patients must have a life expectancy of ≥8 weeks determined at or around surgery, and prior to pre-leukapheresis
• Primary therapy must consist of surgical resection with the intent for a gross or near gross total resection of the contrast-enhancing tumor mass as confirmed by central review, followed by external beam radiation therapy and concurrent temozolomide chemotherapy.
• Patients with newly diagnosed, unilateral GBM (Grade IV) without metastases are eligible for this protocol.
• All Patients must have sufficient tumor lysate protein that was generated from the surgically obtained tumor material.
Determined at pre-leukapheresis
• Patients must have adequate bone marrow function (
• Adequate liver function
Determined at baseline (or baseline2 for pseudoprogression patients)
• Patients must have a KPS rating of ≥70 at the Baseline Visit (Visit 5)
• Patients may have received steroid therapy as part of their primary
treatment. Steroid treatment must preferably be stopped; or if continued steroid use is clinically indicated, be tapered down to 2-4 mg dexamethasone qd at least 7 days prior to the first immunization.
• Patients must be willing to forego cytotoxic anti-tumor therapies except temozolomide while being treated with study drug.
• A minimum of 5 immunizations musat be available for treatment as determined by the contracted manufacturer.
E.4 Principal exclusion criteria: Determined at pre-screening
• History of prior malignancy except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer or other cancers that were deemed fully resolved 5 or more years prior to Visit 1 (surgery) of
the study.
• History of immunodeficiency disease or unresolved autoimmune disease
• Known HIV-1,2, HTLV-1,2 or Hepatitis B, C infection
• Pregnancy
• Inability to obtain informed consent because of psychiatric or complicating medical problems.
• Any known genetic cancer-susceptibility syndromes.
Determined at or around surgery
• Bilateral or metastatic disease detected at diagnosis, during surgery or at post-surgical magnetic resonance imaging (MRI). Tumors may cross into, but not beyond the corpus callosum.
• Post operative MRI scan evidence of biopsy only without significant tumor resection.
• Implantation of Gliadel® wafers (polifeprosan 20 with carmustine implant) at surgery.
• Positive test(s) for infectious agents (HIV 1 and 2, Anti-HIV-1,2, Hepatitis B, HBsAg, Anti HBc, Hepatitis C, Anti-HCV-Ab, Syphilis) that would preclude eligibility for tumor procurement and processing per manufacturing guidelines.
Determined at pre-leukapheresis
• Positive HIV-1, HIV-2, HTLV-1, 2, hepatitis B surface antigen, or hepatitis C antibody.
• Patients with organ allografts.
• Allergies to reagents used in this study.
• Patients who are unable to stop or taper steroid treatment to less than 8mg of dexamethasone qd prior to leukapheresis
• Inability or unwillingness to return for required visits and follow-up exams.
• Any previous cytotoxic drug therapies for the current disease. *note, cytotoxic therapy received for previous malignancies (resolved greater than 5 years prior) is not excluded
Determined at or prior to baseline
• Patients who have evidence of disease progression (including possible pseudoprogression) as determined by central review are not eligible for the study
• Patients taking medications that might affect immune function and that have documented anti-tumor activity.
• Acute infection: any active viral, bacterial, or fungal infection that requires specific therapy. Antibiotic therapy must be completed at least 7 days prior to the first immunization.
• Active uncontrolled infection e.g. a sexually transmitted disease (STD), herpes, uncontrolled tuberculosis, malaria, etc.
• Fever ≥101.5oF. If considered possibly transient, retesting is allowed.
• Unstable or severe intercurrent medical conditions e.g., unstable angina, uncontrolled arrhythmias, Crohn's Disease, ulcerative colitis etc.
• Females of child-bearing potential who are pregnant or lactating or
who are not using adequate contraception.
E.5 End points
E.5.1 Primary end point(s): Time to objective demonstration of disease progression or death, measured from time of randomization (progression free survival, PFS),
E.5.1.1 Timepoint(s) of evaluation of this end point: Event related
E.5.2 Secondary end point(s): Overall survival
E.5.2.1 Timepoint(s) of evaluation of this end point: Event related
E.6 and E.7 Scope of the trial
E.6 Scope of the Trial
E.6.1 Diagnosis: No
E.6.2 Prophylaxis: No
E.6.3 Therapy: Yes
E.6.4 Safety: Yes
E.6.5 Efficacy: Yes
E.6.6 Pharmacokinetic: No
E.6.7 Pharmacodynamic: No
E.6.8 Bioequivalence: No
E.6.9 Dose response: No
E.6.10 Pharmacogenetic: No
E.6.11 Pharmacogenomic: No
E.6.12 Pharmacoeconomic: No
E.6.13 Others: No
E.7 Trial type and phase
E.7.1 Human pharmacology (Phase I): No
E.7.1.1 First administration to humans: No
E.7.1.2 Bioequivalence study: No
E.7.1.3 Other: No
E.7.1.3.1 Other trial type description:
E.7.2 Therapeutic exploratory (Phase II): No
E.7.3 Therapeutic confirmatory (Phase III): Yes
E.7.4 Therapeutic use (Phase IV): No
E.8 Design of the trial
E.8.1 Controlled: Yes
E.8.1.1 Randomised: Yes
E.8.1.2 Open: No
E.8.1.3 Single blind: No
E.8.1.4 Double blind: Yes
E.8.1.5 Parallel group: Yes
E.8.1.6 Cross over: Yes
E.8.1.7 Other: No
E.8.2 Comparator of controlled trial
E.8.2.1 Other medicinal product(s): No
E.8.2.2 Placebo: Yes
E.8.2.3 Other: No
E.8.2.4 Number of treatment arms in the trial: 2
E.8.3 The trial involves single site in the Member State concerned: No
E.8.4 The trial involves multiple sites in the Member State concerned: Yes
E.8.4.1 Number of sites anticipated in Member State concerned: 3
E.8.5 The trial involves multiple Member States: Yes
E.8.5.1 Number of sites anticipated in the EEA: 25
E.8.6 Trial involving sites outside the EEA
E.8.6.1 Trial being conducted both within and outside the EEA: Yes
E.8.6.2 Trial being conducted completely outside of the EEA: No
E.8.6.3 If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned:
Germany
United Kingdom
United States
E.8.7 Trial has a data monitoring committee: Yes
E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial: LVLS
E.8.9 Initial estimate of the duration of the trial
E.8.9.1 In the Member State concerned years: 3
E.8.9.1 In the Member State concerned months: 0
E.8.9.1 In the Member State concerned days: 0
E.8.9.2 In all countries concerned by the trial years: 6
E.8.9.2 In all countries concerned by the trial months: 0
E.8.9.2 In all countries concerned by the trial days: 0
F. Population of Trial Subjects
F.1 Age Range
F.1.1 Trial has subjects under 18: No
F.1.1.1 In Utero: No
F.1.1.2 Preterm newborn infants (up to gestational age < 37 weeks): No
F.1.1.3 Newborns (0-27 days): No
F.1.1.4 Infants and toddlers (28 days-23 months): No
F.1.1.5 Children (2-11years): No
F.1.1.6 Adolescents (12-17 years): No
F.1.2 Adults (18-64 years): Yes
F.1.2.1 Number of subjects for this age range: 288
F.1.3 Elderly (>=65 years): Yes
F.1.3.1 Number of subjects for this age range: 60
F.2 Gender
F.2.1 Female: Yes
F.2.2 Male: Yes
F.3 Group of trial subjects
F.3.1 Healthy volunteers: No
F.3.2 Patients: Yes
F.3.3 Specific vulnerable populations: No
F.3.3.1 Women of childbearing potential not using contraception : No
F.3.3.2 Women of child-bearing potential using contraception: Information not present in EudraCT
F.3.3.3 Pregnant women: No
F.3.3.4 Nursing women: No
F.3.3.5 Emergency situation: Information not present in EudraCT
F.3.3.6 Subjects incapable of giving consent personally: No
F.3.3.7 Others: No
F.4 Planned number of subjects to be included
F.4.1 In the member state: 24
F.4.2 For a multinational trial
F.4.2.1 In the EEA: 132
F.4.2.2 In the whole clinical trial: 348
F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition): Patients will be treated by their physicians according to the current standard of care.
G. Investigator Networks to be involved in the Trial
N. Review by the Competent Authority or Ethics Committee in the country concerned
N. Competent Authority Decision: Authorised
N. Date of Competent Authority Decision: 2012-08-01
N. Ethics Committee Opinion of the trial application: Favourable
N. Ethics Committee Opinion: Reason(s) for unfavourable opinion:
N. Date of Ethics Committee Opinion: 2011-10-05
P. End of Trial
P. End of Trial Status: Temporarily Halted
Sure buddy. Good luck.
I prefer 'Bullish Pennant' ;)
Poor Man
I usually agree with your posts but I completely disagree with all of this:
Yes! I am hoping for the start of information flow starting sometime between 4pm today and 9:30am tomorrow. I can't wait much longer! More realistically...sometime this week or next should be doable to start telling us something, right?
Reminder, this is happening today
There are millions and millions available below 50 cents so they'll have no problem. And that's our issue.
Flipper-
Item for the calendar:
Per NWBO Notice of Settlement on their website
“A Settlement Hearing shall be held before the Court on January 3rd, 2018 before the Honorable David A. Boynton, at the Montgomery County Circuit Court, 50 Maryland Avenue, Rockville, Maryland 20850, to determine whether, inter alia, the proposed Settlement is fair, reasonable, and adequate, and should be finally approved by the Court and whether Plaintiffs Counsel's Fee Award and Plaintiffs Service Award should be finally approved” for Kent Wells v Linda F Powers et al. “The proposed Settlement, if approved by the Court, would fully, finally and forever resolve the Action on the terms set forth in the Stipulation and summarized in this Notice, including the dismissal of the Action with prejudice.”
This offering is specifically stated as under rule 506 of Reg D, which has no limit to the amount they can raise.
December 2013
Statement from FDA Commissioner Scott Gottlieb, M.D., on new FDA efforts to support more efficient development of targeted therapies
For Immediate Release
December 15, 2017
Statement
In recent years, the medical community has experienced a shift in the way health care is practiced. Rather than focusing solely on how to treat an overall disease type, medical innovators are now exploring how to tailor treatments that target unique characteristics of an individual’s disease, such as the genetic profile of a person's tumor. Innovation in this modern, targeted approach to medicine has already led to new more targeted medicines and, in some cases, therapies that are tailored to individual patients.
The FDA has an important role to play in advancing this targeted approach to treating disease by building a modern framework that ensures we’re providing the guidance and resources needed to efficiently develop these novel products using new technology. In particular, the FDA needs to clarify and expand an existing pathway that allows innovators to develop products based on the molecular markers that the drug targets, rather than the more traditional approach to drug development, where new medicines were developed based on the disease phenotype that they targeted. In many cases, science is revealing that the driver of disease is really a molecular change in the body. New drugs are being developed based solely on their ability to target these underlying molecular subtypes. Moreover, this same molecular change may be present as the driving factor of many different disease phenotypes. When drugs successfully target these molecular mistakes to reverse the effects of different diseases, we need a development pathway that allows the new drug to pursue approval in each of these novel settings on the basis of the molecular marker that the drug targets. In the setting of oncology, this is often referred to as tissue agnostic drug development.
By providing clear guidance on the regulatory and scientific frameworks for product developers, safe and effective targeted treatments can be identified with scientifically valid tests and ultimately, made available to patients faster. That’s why today we are issuing two draft guidances that will provide medical product developers with greater clarity on the FDA’s recommendations for researching and developing the next generation of individualized therapies.
The first draft guidance, “Developing Targeted Therapies in Low-Frequency Molecular Subsets of a Disease,” addresses the important topic of finding treatments that address the underlying molecular changes (e.g., genetic mutations) that often cause or contribute to diseases, including uncommon molecular changes that are present in a small subset of patients. This draft guidance (which is also in a more concise, streamlined format) proposes an approach for drug developers to enroll patients based on the identification of rare mutations into clinical trials for targeted therapies when reasonable scientific evidence suggests the drug could be effective in patients with these genomic findings. The guidance discusses the evidence needed to demonstrate effectiveness for a variety of molecular subsets within a particular disease, which could lead to more consistent development and approval of targeted therapies for patients who are likely to benefit from them. These scientific principles described in the guidance could also be applied to supporting “tissue agnostic” drug development. This relates to how drugs may be able to gain regulatory approval on the basis of targeting a molecular subtype that is common across different phenotypes, rather than solely on the individual disease states. We think both approaches have the potential to increase the likelihood of finding viable treatment options for those with less common mutations. When finalized, this draft guidance will represent the FDA’s current thinking. The FDA also plans to publish a manuscript early next year that provides a detailed, comprehensive look at this issue.
The second draft guidance, “Investigational IVD Devices Used in Clinical Investigations of Therapeutic Products,” seeks to provide those running clinical trials with a clear framework to reference when determining if an in vitro diagnostic (IVD) device used in a therapeutic product study must undergo its own FDA review, distinct from the drug being studied. To develop new targeted therapies that are safe and effective, clinical trials often use investigational, or unapproved, IVDs to assess biomarkers and guide the selection of therapeutic products or care strategies that are applied to study participants.
When final, this draft guidance will clarify the appropriate regulatory pathway for investigational IVDs used in clinical trials for therapeutic products, which is significant so that trial results for a novel targeted therapy are not undermined just because the diagnostic test to determine a specific biomarker did not meet appropriate regulatory criteria. The aim is to make the process for developing more targeted “drug and diagnostics systems” more efficient and to simplify the proper development of these approaches.
Building on the IVD draft guidance issued today, we are also considering ways to streamline the review of oncology therapeutic products and the IVDs used with these products, and plan to issue draft guidance on this in the near future. The goal is to reduce the burden on sponsors for the development of certain cancer drugs, and on FDA staff as well.
These draft guidances are just a few examples of the FDA’s ongoing efforts to advance the development of innovative, targeted drugs and foster the availability of individualized treatment approaches. For example, earlier this month, the FDA issued draft guidance that describes a potential new approach for companies to collaborate and test multiple drug products in the same clinical trials for rare pediatric diseases, thereby reducing the number of patients treated with placebo. We also outlined how modeling and simulation can be used to reduce the reliance on placebo arms in these rare pediatric settings. Finally, we specifically addressed a more efficient pathway for developing drugs targeted to the rare pediatric disorder Gaucher Disease. We also recently authorized three, novel next generation sequencing-based devices for the detection of multiple cancer markers with the run of a single test – enabling the development of evidence to drive more individualized care management decisions.
By proposing streamlined approaches for our colleagues in the research and development communities, the FDA hopes to enable more efficient access to safe and effective, novel targeted therapies for the patients who need them. We look forward to receiving feedback on the draft guidances issued today and remain committed to assisting the medical community as it further modernizes and individualizes approaches to care, to increase the public health benefit offered by new medical technologies.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm589248.htm?utm_campaign=12152017_Statement_Targeted%20therapies&utm_medium=email&utm_source=Eloqua
Do they have legos in prison?
There was actually a 2 cent spread. Unheard of for us. Shares are becoming scarce. If they could just say something, it could finally blow the lid off.
That would be $45,000 for every dime it goes up.
You may want a new service for your charting. We closed at 0.2488 yesterday on 1.591 vol.
There was another document posted to the Chardan case on December 4th. I was busy the past couple days but don't think it was ever posted here.
https://www.pacermonitor.com/public/case/21771510/Chardan_Capital_Markets,_LLC_v_Northwest_Biotherapeutics,_Inc
I will have doubled my investment, thanks Ready4GreySky
Barcode-
There are a lot of new documents in the Chardan Case, if you would be so kind...it would make you a boss in my opinion. I know that probably means a lot to you :)
https://www.pacermonitor.com/public/case/21771510/Chardan_Capital_Markets,_LLC_v_Northwest_Biotherapeutics,_Inc
Marzan that is not an after hours trade. It is an average price report of many trades throughout the day consolidated into one price. If you notice the past 10 days, on the days we run up and close near the high, that report is lower than the close. Yesterday Algorithm mentioned that it was the first day (like today) that it was higher than the closing price. It is because we had down days and closed near the low of the day.
It's been listed in Germany for years
It went from NBY to NBYA to NBYB
And the domain name has been abandoned by the cowards
Canaccord looks like they're trying to buy up the float since about 11/13. Baiting sellers by entering large asks and then pulling them once some people sell down to the bid to keep the price from rising too quickly.