learningcurve2020
4 hours ago
Yup…Still up there!
DCVax® – L Phase III for GBM Brain Cancer
Status: Enrollment Completed in 2015
For a complete listing of clinical trial sites, details, and contact information please Click Here.
Our lead product is DCVax-L for Glioblastoma multiforme (“GBM”), the most lethal form of primary brain cancer. We have completed two Phase I/II trials and are now well under way with a large Phase III trial, as described below.
With full standard of care treatment for GBM today, including surgery, radiation and chemotherapy, the median time from surgery to remove the initial tumor to the time of tumor recurrence is just 6.9 months, and median survival is just 14.6 months. There has been very little improvement in clinical outcomes for GBM patients in the last 30 years. The incidence of GBM appears to be on the rise, for unknown reasons, and there is an urgent need for new and better treatments.
XMaster2023
5 hours ago
Flipper, along with some specialized lab freezers the only thing one would need is a procedure room with a comfortable chair.
Procedure rooms are positive and have a higher air turn over as described below.
ASHRAE Standard 170, "Ventilation of Health Care Facilities," is indeed the key standard for ventilation requirements in healthcare settings. While it may not explicitly have a section labeled "leukapheresis unit," it does provide the framework for appropriate ventilation in areas where procedures involving blood and potentially vulnerable patients are performed.
Here's how ASHRAE 170 applies:
* General Healthcare Requirements:
* ASHRAE 170 sets standards for air changes per hour (ACH), filtration, and pressure relationships in various healthcare spaces.
* Leukapheresis procedures, because they involve blood handling and patient vulnerability, would fall under the general requirements for procedure rooms or similar spaces where infection control is crucial.
* Procedure Room Considerations:
* Depending on the specific leukapheresis procedure and the patient's condition, the ventilation requirements might align with those for procedure rooms that require careful control of airborne contaminants.
* This could involve HEPA filtration and positive pressure to protect the patient.
* Infection Control:
* A key aspect of ASHRAE 170 is minimizing the risk of airborne infections. Leukapheresis, like other procedures involving blood, requires a clean environment. Therefore, the standard's guidelines on filtration and air changes are highly relevant.
So it would be like a Dialysis clinic with separate rooms and an upgraded HVAC system. Naturally the machines are different and you would need specialized staff.
I believe this space could be an outpatient facility similar to a dialysis clinic but slightly more advanced.
manibiotech
5 hours ago
This is entire page 27
“Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
The following discussion and analysis of our financial condition and results of operations should be read in conjunction with our unaudited condensed consolidated financial statements and the notes to those statements included with this report. In addition to historical information, this report contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). Such forward-looking statements are subject to certain risks and uncertainties that could cause actual results to differ materially from those projected. The words “believe,” “expect,” “intend,” “anticipate,” and similar expressions are used to identify forward-looking statements, but some forward-looking statements are expressed differently. Many factors could affect our actual results, including those factors described under “Risk Factors” in our Form 10-K for the year ended December 31, 2023 and in Part II Item 1A of this report. These factors, among others, could cause results to differ materially from those presently anticipated by us. You should not rely upon on these forward-looking statements.
Overview
We are a biotechnology company focused on developing personalized immune therapies for cancer. We have developed a platform technology, DCVax®, which uses activated dendritic cells to mobilize a patient’s own immune system to attack their cancer.
Our lead product, DCVax®-L, is designed to treat solid tumor cancers in which the tumor can be surgically removed. We have completed a 331-patient international Phase III trial of DCVax-L for Glioblastoma multiforme brain cancer (GBM), published the results in the JAMA Oncology peer reviewed journal, and on December 20, 2023 we submitted a Marketing Authorization Application (MAA) for commercial approval in the U.K. We plan to conduct clinical trials of DCVax-L for other solid tumor cancers in the future, when resources permit. Our second product, DCVax®-Direct, is designed to treat inoperable solid tumors. A 40-patient Phase I trial has been completed, and included treatment of a diverse range of more than a dozen types of cancers. We plan to work on preparations for Phase II trials of DCVax-Direct as resources permit.
During the first nine months of 2024, the Company continued its progress on multiple fronts, including the following.
MAA Application and Inspections. The Company has continued to work with multiple teams of expert consultants, the trial’s CRO (contract research organization) and Advent BioServices on the MAA process. The review of the application is ongoing, and inspections are being conducted in the U.K and the U.S. Each inspection involves pre-inspection requests from the inspectors for production of extensive documents and information, weeklong onsite inspections (including review of further documents, interviews of personnel, checking of facilities and procedures, etc.), and ongoing follow-up document and information requests after the onsite inspection. The inspections cover the sponsor, the CRO, the independent experts involved in the trial (such as the independent clinical database company, independent statisticians and others), selected trial site hospitals and their pharmacies, and others. As is typical, and as the Company has previously stated, the Company does not plan to make any interim announcements while its MAA is going through the regulatory process. The Company plans to announce the results when the regulatory review and decision-making is finished.
Reimbursement. The Company has evaluated and selected specialized, highly experienced consultants with whom to undertake preparations for a potential reimbursement review and evaluation process. The Company has executed the relevant contracts and is under way with the first stage of the process with the consultants. The preparations for the reimbursement process will involve several stages and include health economics and outcomes (HEO) analyses, analyses of the relevant clinical landscape, engagement with experts and stakeholders, and other steps.
Collaborations: Private Clinics. As previously reported, the Company has been working over the last couple of years and during this year to develop certain clinical collaborations. These include joint efforts by the Company and Advent BioServices to establish collaborations with several private clinics in the U.K. The collaborations with private clinics are designed to achieve several goals. One goal is to establish dedicated leukapheresis units which will be available for NWBio patients at all times. This is quite important for scale-up of the numbers of patients who can be handled for NWBio’s treatments, because there is a country-wide shortage of leukapheresis capacity in the U.K.
Another goal of the clinic collaborations is to potentially be able to conduct clinical trials with these private clinics as trial sites and be able to treat compassionate use patients – patients with diverse types of solid tumors, in addition to patients with brain cancer. The joint efforts have now reached or are reaching fruition. A contract has been executed with one private clinic for a dedicated leukapheresis unit there, and the focus is now on arrangements for the medical personnel and training. A Letter of Intent has been completed with a second private clinic, and the full contract is in process, for both a dedicated leukapheresis unit and treatment of patients. Arrangements have been made with a third private clinic for treatment of patients, and the first such patient is in process.
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