NOXXON Announces Successful Completion of Patient Recruitment for Second Dose Cohort in Phase 1/2 Brain Cancer Study of NOX-A...
14 Ottobre 2020 - 8:00AM
Business Wire
Regulatory News:
NOXXON Pharma N.V. (Euronext Growth Paris: ALNOX),
a biotechnology company focused on improving cancer treatments by
targeting the tumor microenvironment (TME), announced today that
all three patients of the second dose cohort have been enrolled
into the brain cancer clinical trial testing CXCL12 inhibitor,
NOX-A12, and have already received the planned initial treatment.
The Phase 1/2 clinical study investigates three dose regimens of
NOX-A12 (200, 400 and 600 mg/week), each combined with external
beam radiotherapy in newly diagnosed brain cancer patients.
Once the last patient in the second cohort completes four weeks
of therapy of NOX-A12 and radiotherapy, the independent Data Safety
Monitoring Board (DSMB) will determine whether it is safe to
proceed from the middle to the highest dose level of NOX-A12. The
approved protocol plans for each patient to be treated with NOX-A12
for up to six months.
“The combination of NOX-A12, at both low and middle doses, and
radiotherapy has been well tolerated by the patients participating
in this clinical trial. Recruitment of the last cohort could start
as early as November once the next safety analysis confirms benign
safety profile of NOX-A12,” said Dr. Frank Giordano, Chairman of
the Department of Radiation Oncology at the University Hospital
Bonn.
“Completing patient recruitment is an important step in the
continued clinical assessment of this novel therapy for patients
with difficult-to-treat and highly aggressive brain cancer. As a
measure to ensure the timely completion of the study under the
current challenging conditions posed by the COVID-19 pandemic, we
will soon open additional clinical sites in Germany to increase
recruitment capacity,” commented Aram Mangasarian, CEO of
NOXXON.
About NOXXON
NOXXON’s oncology-focused pipeline acts on the tumor
microenvironment (TME) and the cancer immunity cycle by breaking
the tumor protection barrier and blocking tumor repair. By
neutralizing chemokines in the tumor microenvironment, NOXXON’s
approach works in combination with other forms of treatment to
weaken tumor defenses against the immune system and enable greater
therapeutic impact. Building on extensive clinical experience and
safety data, the lead program NOX-A12 has delivered top-line data
from a Keytruda® combination trial in metastatic colorectal and
pancreatic cancer patients and further studies are being planned in
these indications. In September 2019 the company initiated an
additional trial with NOX-A12 in brain cancer in combination with
radiotherapy. The combination of NOX-A12 and radiotherapy has been
granted orphan drug status in the US and EU for the treatment of
certain brain cancers. The company’s second clinical-stage asset
NOX-E36 is a Phase 2 TME asset targeting the innate immune system.
NOXXON plans to test NOX-E36 in patients with solid tumors both as
a monotherapy and in combination. Further information can be found
at: www.noxxon.com
Keytruda® is a registered trademark of Merck Sharp & Dohme
Corp
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information in this communication regarding planned or future
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updating such information, which only represents the state of
affairs on the day of publication.
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NOXXON Pharma N.V. Aram Mangasarian, Ph.D., Chief
Executive Officer Tel. +49 (0) 30 726247 0
amangasarian@noxxon.com
Trophic Communications Gretchen Schweitzer or Valeria
Fisher Tel. +49 (0) 172 861 8540 or +49 (0) 175 804 1816
noxxon@trophic.eu
NewCap Arthur Rouillé Tel. +33 (0) 1 44 71 00 15
arouille@newcap.fr