Independent Data Monitoring Committee Recommends Discontinuation of the ADAPT Phase 3 Clinical Trial of Rocapuldencel-T in Me...
February 22 2017 - 08:00AM
-Company to host conference call today, February
22, 2017 at 8:30am EST-
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 announced that the
Independent Data Monitoring Committee (IDMC) for the company’s
pivotal
Phase 3 ADAPT clinical trial of
rocapuldencel-T in combination with
sunitinib/standard-of-care for the treatment of metastatic renal
cell carcinoma (mRCC) has recommended that the study be
discontinued for futility based on its planned interim data
analysis. The IDMC concluded that the study was unlikely to
demonstrate a statistically significant improvement in overall
survival in the combination treatment arm, utilizing the
intent-to-treat population, the primary endpoint of the study. The
IDMC noted that
rocapuldencel-T was generally
well-tolerated in the trial.
In conjunction with its clinical and scientific advisors, the
company is analyzing the preliminary ADAPT trial
data set and plans to discuss the data with the U.S. Food and Drug
Administration (FDA). The company plans to leave the
ADAPT trial open while the company conducts its
ongoing data review and discussions with FDA. Based on these
analyses and discussions, the company will make a determination as
to the next steps for the rocapuldencel-T clinical
program.
"We are extremely disappointed with these results, which
included seventy-five percent of the targeted events needed to
permit the primary analysis and assessment of overall survival in
the study," said Jeff Abbey, president and chief executive officer
of Argos Therapeutics. “We sincerely appreciate the patients and
investigators who have participated in the ADAPT
Phase 3 trial, and remain convinced in the ability of precision
immunotherapy to improve the lives of patients.”
Rocapuldencel-T is an individualized
immunotherapy that is designed to capture mutated and variant
antigens that are specific to each patient's tumor and induce an
immune response targeting that patient’s tumor antigens. The
randomized Phase 3 ADAPT trial evaluating
rocapuldencel-T plus sunitinib/standard-of-care
therapy versus standard-of-care therapy alone in newly diagnosed
mRCC patients was opened in January 2013 and completed enrollment
in July 2015. A total of 462 mRCC patients were randomized to
the trial. The primary endpoint of the trial is a
statistically significant improvement in overall survival.
Conference Call and Webcast Details
Argos executive management will host a conference call today
beginning at 8:30am EST.
To participate by telephone, please dial (855) 433-0930
(Domestic) or (484) 756-4271 (International). The conference ID
number is 77486645. A live and archived audio webcast can be
accessed through the Investors section of the Company's website at
www.argostherapeutics.com. The archived webcast will remain
available on the Company's website for 12 months following the
call.
About the Arcelis® Technology
PlatformArcelis® is a precision
immunotherapy technology that captures both mutated and variant
antigens that are specific to each patient’s individual disease. It
is designed to overcome immunosuppression by producing a
specifically targeted, durable memory T-cell response without
adjuvants that may be associated with toxicity. The technology is
potentially applicable to the treatment of a wide range of
different cancers and infectious diseases, and is designed to
overcome many of the manufacturing and commercialization challenges
that have impeded other personalized immunotherapies. The
Arcelis® process uses only a small disease sample
or biopsy as the source of disease-specific antigens, and the
patient’s own dendritic cells, which are optimized from cells
collected by a single leukapheresis procedure. The proprietary
process uses RNA isolated from the patient's disease sample to
program dendritic cells to target disease-specific antigens. These
activated, antigen-loaded dendritic cells are then formulated with
the patient’s plasma, and administered via intradermal injection as
an individualized immunotherapy.
About Argos TherapeuticsArgos 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' most advanced
product candidate, rocapuldencel-T, is being
evaluated in the pivotal ADAPT Phase 3 clinical
trial for the treatment of metastatic renal cell carcinoma (mRCC).
In addition, rocapuldencel-T is being studied in
Phase 2 investigator-initiated clinical trials as
neoadjuvant therapy for renal cell carcinoma (RCC) and bladder?.
Argos is also developing a separate 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.
Forward Looking StatementsAny statements in
this press release about Argos’ future expectations, plans and
prospects, including statements about the Argos’s planned analysis
of the data from the ADAPT trial, Argos’ anticipated meeting with
the FDA, clinical development of Argos’ product candidates 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
periods anticipated; the impact of the planned analysis of
the data and discussions with the FDA on the development of
rocapuldencel-T; the impact of the recommendation of the IDMC on
the continuation of the ADAPT 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 United States Food and Drug Administration 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-Q for the quarter ended
September 30, 2016, 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 contact:
Adam Daley
Berry & Company Public Relations
212-253-8881
adaley@berrypr.com
Investor contact:
John Menditto
Argos Therapeutics, Inc.
919-908-0687
jmenditto@argostherapeutics.com