Noxopharm ASX:NOX Stock Report

No independent directors

Following the recent departure of a director, there are no independent directors on the board. The company's board is composed of: No independent directors. 4 non-independent directors. Non-Executive Chairman Fred Bart was the last director to join the board, commencing their role in 2020. The company's lack of independent directors is a risk according to the Simply Wall St Risk Model.

FDA Grants Orphan Drug Designation to Noxopharm for Sarcoma Treatment

Noxopharm has announced the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation (ODD) to Veyonda®, its lead oncology drug candidate, for use in the treatment of soft tissue sarcoma. The ODD program was established by the FDA to encourage development of safe and effective treatments of rare diseases and disorders that affect fewer than 200,000 people in the U.S. annually. Soft tissue sarcomas are rare but often fatal cancers — up to 50% of high-grade sarcoma patients develop metastases and die within 12 months. Noxopharmrecently began its Phase 1 CEP-2 trial [4] at City of Hope in Los Angeles for Veyonda, in combination with the chemotherapy drug doxorubicin, for first-line treatment of soft tissue sarcoma. The ODD program provides a number of significant benefits, including: A seven-year period of market exclusivity — the FDA will not approve a subsequent drug for the same use within this timeframe; Waiver of new drug application fees, valued at approximately $2.9 million in 2021; Opportunities for grant funding from the Office of Orphan Products Development; Regulatory guidance and assistance from the FDA for the drug development process.

Noxopharm Limited Announces Phase 1 CEP-2 Sarcoma Trial is Underway with a First Patient Enrolled and Dosed At City of Hope in Los Angeles, California

Noxopharm Limited Announces First Patient Dosed in CEP-2 Sarcoma Trial at the US City of Hope Cancer Center

Noxopharm Limited announced the first patient in its phase 1 CEP-2 trial has been enrolled and dosed at the City of Hope Cancer Center, California. Patient recruitment is ongoing, and the Company expects to open further US trial sites in due course. The first safety results will be reported once patient cohort 1 has completed the first cycle of combination therapy. The City of Hope Cancer Center is an influential medical institution and is considered one of the most world-renowned cancer hospitals in the USA according to the US News & World Report. It is consistently ranked as a top cancer treatment centre in the US and is also a founding member of the National Comprehensive Cancer Network, a non-profit alliance of 21 US cancer centres that publishes clinical practice guidelines for cancer treatment. The CEP-2 study builds on the findings from CEP-1, as published in the peer-reviewed journal Current Therapeutic Research (announced 30 April 2021).