To balance years in the past talking positively about DCVax-L, I need to point out a few things that most, but maybe not all of you already know.
You are now hoping that the DCVax-L applied to GBM is much more effective than other DC therapies applied to other indications.
Although I remain somewhat optimistic that NWBIO has reason to be optimistic, I have to point out two things that weigh on me.
1) ARGS recently announced final failure of their DC therapy. About a year ago they announced failure, then came back to life later saying that they saw a tail in the data, so wanted to give the tail a little more time to grow. Based on their relatively recent PR pasted below, I believe they collected another year's worth of data, and in the end concluded that their DC therapy did more harm than good. That announcement about a tail forming made me feel good about DCVax-L with the view that NWBIO was being wise to let that tail form before data lock, unlike ARGS. But ARG's final result is worrisome.
2) I was very loud with my criticism of AF when he touted the single bullet approach over the shotgun approach (just before Celdex's limpit extract failed). His analogy, as presented, was ridiculous, however, in retrospect, the DCVax-L shot-gun pellets are predominantly self-antigens, not neo-antigens. That huge excess of self-antigens likely has no good effect, however, it may have a bad effect. Those self-antigens do not excite any T-Cells, but do they excite anything else in the immune system? Do they create any elevation of the immune system that might provoke a defensive response with tumor cells responding by raising checkpoint flags, as other cells would do? Almost certainly 30 neo-antigens is better than just one neo-antigen, but what about one neo-antigen vs (30 neo-antigens + 10,000 self-antigens)? I don't know.
It is in everyone's interest for the DCVax-L trial to finish. I still applaud and admire those that have done what retail individuals can do to keep the company afloat long enough to get to that point. At this point, assuming the trial really is about to finish, negativity may be a rotten thing, so, I will not be repeating my concerns. In fact I might still buy shares if I dig out of my unrelated financial mess in time.
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DURHAM, N.C., April 19, 2018 (GLOBE NEWSWIRE) -- Argos Therapeutics, Inc. (Nasdaq:ARGS), an immuno-oncology company focused on the development and commercialization of individualized immunotherapies based on the Arcelis® precision immunotherapy technology platform, today reported interim results from its randomized, active controlled, open-label, multi-center Phase 3 ADAPT trial of Rocapuldencel-T in combination with sunitinib/standard-of-care for the treatment of newly diagnosed metastatic renal cell carcinoma. Based on these results, the Company has decided to discontinue the trial.
As previously reported, a total of 462 patients with previously untreated advanced or metastatic renal cell carcinoma were enrolled in the ADAPT trial and randomized 2:1 between combination treatment with Rocapuldencel-T and sunitinib (combination arm) vs. sunitinib monotherapy (control arm) after undergoing cytoreductive nephrectomy. The Company recently submitted a protocol amendment to the U.S. Food and Drug Administration providing for four co-primary endpoints focused on various measures of survival. Based upon review of the interim data, the Company does not believe that it would achieve these endpoints if the trial were to be continued. After consulting with the principal investigators of the trial, the Company has therefore decided to discontinue the trial and has informed the FDA of its decision.
The most recent interim analysis was conducted after 51 new events (deaths) had occurred since the time of the February 2017 interim analysis. Median overall survival for the intent-to-treat patient population, one of the four co-primary endpoints, was estimated using the Kaplan-Meier method. The estimated median overall survival for the combination arm was 28.2 months (95% Confidence Interval (CI): 23.4, 35.2) compared to 31.2 months (95% CI: 23.0, 44.5) for the control arm. The hazard ratio was 1.10 (95% CI: 0.85, 1.42). The two other co-primary endpoints that were evaluated at this time, including overall survival for the patients who remained alive at the time of the February 2017 interim analysis and overall survival for all patients for whom at least 12 months of follow-up was available, also did not demonstrate a favorable result. A fourth endpoint, five-year survival, was not evaluated because there was insufficient data at this time to perform this analysis.
Based on a review of the status of its internal programs, resources and capabilities, Argos plans to explore a wide range of strategic alternatives that may include a potential merger or sale of the Company, among other potential alternatives that could maximize both near and long-term value for our shareholders. The Company has retained Stifel, Nicolaus & Company, Incorporated to serve as its financial advisor in the process.
Argos does not have a defined timeline for the exploration of strategic alternatives and is not confirming that the process will result in any strategic alternative being announced or consummated. Argos does not intend to discuss or disclose further developments during this process unless and until its Board of Directors has approved a specific action or otherwise determined that further disclosure is appropriate.
Argos also today reported that it does not expect to regain compliance with The Nasdaq Capital Market continued listing requirements by the April 24, 2018 deadline. As a result, Argos expects that its common stock will be delisted from The Nasdaq Capital Market and that trading in the Company's common stock on The Nasdaq Capital Market will be suspended effective at the open of business on April 23, 2018. The Company has filed an application to transfer trading and quotation of its common stock to the OTCQB® Venture Market, operated by OTC Markets Group Inc., under its current trading symbol "ARGS," effective as of April 23, 2018. Quotation and trading information for the common stock will be available on www.otcmarkets.com.
About Argos Therapeutics
Argos Therapeutics is an immuno-oncology company focused on the development and commercialization of individualized immunotherapies for the treatment of cancer and infectious diseases using its Arcelis® technology platform. Argos is developing an Arcelis®-based product candidate, AGS-004, for the treatment of human immunodeficiency virus (HIV), which is currently being evaluated in an investigator-initiated Phase 2 clinical trial aimed at HIV eradication in adult patients. Funding for the development of AGS-004 has been provided by the National Institutes of Health, the National Institute of Allergy and Infectious Diseases, and the Collaboratory of Research for AIDS Eradication.
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