It has been a long 13-year wait for shareholders of Northwest Bio, but top-line data is imminent. The database for the Phase 3 trial of DCVax-L for Glioblastoma has been locked, which means that only the firms managing the trial have access to the data for analyses and to prepare summaries of the trial results. Here is what we expect this month:
- The primary endpoint of this study is overall survival (OS) compared between patients randomized to DCVax-L and control patients from comparable, contemporaneous trials who received standard of care therapy only, in patients with newly diagnosed glioblastoma.
- The first secondary endpoint is overall survival (OS) compared between patients randomized to placebo who received DCVax-L treatment following disease recurrence, and control patients from comparable, contemporaneous clinical trials, in patients with recurrent GBM.
- The second secondary endpoint, confirmed progression-free survival (cPFS), is confirmed disease progression (cPD) compared between subjects randomized to DCVax®-L and those randomized to Placebo within Study 020221.
- The third secondary endpoint, PFS, is progression-free survival compared between subjects randomized to DCVax®-L and those randomized to Placebo within Study 020221.
- The fourth secondary objective, OS, is overall survival compared between subjects randomized to DCVax®-L and those randomized to Placebo within Study 020221.
- The fifth secondary objective is tumor response compared between subjects randomized to DCVax®-L and those randomized to Placebo within Study 020221.
What is significant here is that the original trial design called for the primary endpoint to be progression-free survival between patients in the DCVax-L cohort and patients in the placebo cohort.
This is a huge win for Northwest Bio and its shareholders. This particular pathway presents a way to more easily achieve statistical significance with the data.
What The Bears Are Saying About Northwest Bio?
The bears are trying to claim a battle victory by saying that by having the main objective of the trial changed from progression-free survival to overall survival, the endpoints failed. They are trying to say that PFS failed, when that data has not even be released yet. Their entire campaign has been about spreading Fear, Uncertainty, and Doubt (FUD) for 13 years now.
This vendetta against Northwest Bio has been lead by the so-called “Night King of Biotech” Adam Feuerstein, a wanna-be journalist at Stat News. He may write under Stat News, but he is really employed by Big Pharma that wants to maintain their monopolies and quash any hopes a small-cap bio can bring a drug to market. By employing Feuerstein, they can depress the share price, prevent them from raising funds, and either drives them into bankruptcy or buy them on the cheap.
If NWBO stock can be successful with DCVax-L, we should encourage and embrace what they are doing, not attack them. However, when you understand that Merck & Co.’s temozolomide is the preferred FDA-approved chemotherapeutic agent for glioblastoma, you realize that sinister forces are at work. Unfortunately, this is the underbelly of the biotech world, and more need to understand what is happening.
Why The Bulls Are About To Win The War
The overall ability to show statistical significance on Overall Survival appears easy to prove statistically, given the presentations already given over the years.
According to Dr. Linda M. Liau, the blinded interim data is consistent with an extended survival tail. For example, among the patients (n = 182) who were ≥ 36 months past their surgery date as of the date of this analysis, 24.2% (n = 44) were alive for ≥ 36 months and have a KM estimated median survival time of 88.2 months. Thus, it appears that patients who survive past certain threshold time points may continue onwards to unusually long survival times, similar to the findings in the prior Phase I/II studies of this DC-based vaccine.
DCVax-L has shown a benign safety profile in the Phase 3 study, as it has consistently done in prior early-stage trials, and in a large group of patients treated on a compassionate use basis. The fact that only 7 of the 331 ITT patients (2.1%) experienced any grade 3 or 4 adverse events that were at least possibly related to the treatment makes this DC vaccine an especially well-tolerated treatment.
Dr. Liau’s conclusion is the addition of DCVax-L autologous dendritic cell vaccine to SOC is feasible and safe. Collectively, the blinded interim survival data suggest that the patients in this Phase 3 trial are living longer than expected.
Northwest Bio Bottom Line
The recent data is that brain and other nervous system cancers are the 10th leading cause of death for men and women. Globally, over 241,000 people die each year as a result of brain or nervous system cancer, with GBM being the most common form of the disease. GBM has an incidence of two to three per 100,000 adults per year and accounts for 52 percent of all primary brain tumors.
Glioblastoma is the most common primary malignant form of brain cancer. Despite technological advances in surgery and radio-chemotherapy, glioblastoma remains largely resistant to treatment. The standard treatment for glioblastoma is surgery. The choice of drug therapy for glioblastoma is still limited to a handful of compounds.
An effective treatment is needed and that treatment is DCVax-L. The past 13 years have been a long road, but the payoff is just around the corner for Northwest Bio and its shareholders. Congratulations to all as TLD is imminent!
As always, good luck to all (except the shorts)!
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Disclosure: We have no position in OTCMKTS:NWBO or any of the securities mentioned. We wrote this article ourselves and it expresses our own opinions. We are not receiving compensation for it. We have no business relationship with any company whose stock is mentioned in this article. Insider Financial is not an investment advisor and does not provide investment advice. Always do your own research and make your own investment decisions. This article is not a solicitation or recommendation to buy, sell, or hold securities. This article is meant for informational and educational purposes only and does not provide investment advice.