BERLIN–(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. (Read more…) 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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Disclaimer
Certain statements in this communication contain formulations or terms referring to the future or future developments, as well as negations of such formulations or terms, or similar terminology. These are described as forward-looking statements. In addition, all information in this communication regarding planned or future results of business segments, financial indicators, developments of the financial situation or other financial or statistical data contains such forward-looking statements. The company cautions prospective investors not to rely on such forward-looking statements as certain prognoses of actual future events and developments. The company is neither responsible nor liable for updating such information, which only represents the state of affairs on the day of publication.
Contacts
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