Argos Therapeutics Reports Results of Interim Analysis of the ADAPT Trial and Announces Review of Strategic Alternatives
April 19 2018 - 8:00AM
- Company to terminate the ADAPT study –
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.
Forward Looking Statements
Any statements in this press release about
Argos' future expectations, plans and prospects, including
statements about Argos' financial prospects, future operations and
sufficiency of funds for future operations, clinical development of
Argos' product candidates, expectations regarding future clinical
trials and FDA activities and future expectations and plans and
prospects for Argos and other statements containing the words
"believes," "anticipates," "estimates," "expects," "intends,"
"plans," "predicts," "projects," "targets," "may," "potential,"
"will," "would," "could," "should," "continue," and similar
expressions, constitute forward-looking statements within the
meaning of The Private Securities Litigation Reform Act of
1995. Actual results may differ materially from those
indicated by such forward-looking statements as a result of various
important factors, including whether Argos' cash resources will be
sufficient to fund its continuing operations for the period
anticipated; what the impact of the transfer of Argos’ common stock
to the OTCQB® will have on the trading of Argos’ common stock and
ability to raise funds; whether preliminary or interim clinical
data will be indicative of the final data from a clinical
trial; whether results obtained in clinical trials will be
indicative of results obtained in future clinical trials; whether
Argos' product candidates will advance through the clinical trial
process on a timely basis; whether the results of such trials will
warrant submission for approval from the FDA or equivalent foreign
regulatory agencies; whether Argos' product candidates will
receive approval from regulatory agencies on a timely basis or at
all; whether, if product candidates obtain approval, they will be
successfully distributed and marketed; whether Argos can
successfully establish commercial manufacturing operations on a
timely basis or at all; and other factors discussed in the "Risk
Factors" section of Argos' Form 10-K for the year ended December
31, 2017, which is on file with the SEC, and in other filings Argos
makes with the SEC from time to time. In addition, the
forward-looking statements included in this press release represent
Argos' views as of the date hereof. Argos anticipates that
subsequent events and developments will cause Argos' views to
change. However, while Argos may elect to update these
forward-looking statements at some point in the future, Argos
specifically disclaims any obligation to do so. These
forward-looking statements should not be relied upon as
representing Argos' views as of any date subsequent to the date
hereof.
Media and investor contact:
Richard Katz, MD, MBAChief Financial Officer
Argos Therapeutics, Inc.
919-287-6315 rkatz@argostherapeutics.com