Avacta Announces AVA6000 Receives Orphan Drug Designation From the US Food and Drug Administration
September 05 2022 - 4:56AM
Business Wire
Avacta Group plc (AIM: AVCT), a clinical stage oncology drug
company and developer of powerful diagnostics based on its
innovative Affimer® and pre|CISION™ platforms, announces that the
US Food and Drug Administration (FDA) has granted Orphan Drug
Designation (ODD) to the company’s lead pre|CISION drug candidate,
AVA6000, for treatment of soft tissue sarcoma.
AVA6000 is a form of the generic chemotherapy doxorubicin that
has been modified using the pre|CISION technology so that it is
activated predominantly in the tumour with the aim of sparing
healthy tissue from exposure and improving the safety, tolerability
and efficacy of the drug. Doxorubicin has a market size that is
expected to grow to $1.38bn by 2024, and is widely used as part of
the standard of care in several cancer types. Avacta has an ongoing
Phase 1 clinical trial to assess the safety and pharmacokinetics of
AVA6000 which has potential as a treatment for patients with a
range of cancer types, including soft tissue sarcoma.
The FDA can grant ODD based on a review of preclinical data from
investigational treatments for rare diseases, such as soft tissue
sarcoma, which are defined as conditions affecting fewer than
200,000 people in the US. This designation qualifies the developer
of the drug for certain incentives, including, seven years of
market exclusivity upon drug approval from the FDA.
Soft-tissue sarcoma is a rare mesenchymal malignancy which
accounts for less than 1% of all adult tumours. Despite the
successful advancement of localised therapies, such as surgery and
radiotherapy, these tumours can recur, often with metastatic
disease. The American Cancer Society estimates that, in 2022
approximately 13,190 new soft tissue sarcomas will be diagnosed,
and about 5,130 people are expected to die of the disease in the
US.
Dr Alastair Smith, Chief Executive Officer of Avacta,
commented: “We are delighted to receive Orphan Drug Designation
from the FDA for AVA6000, which is a reflection of the high quality
of the preclinical data and the potential benefit the pre|CISION
platform can bring to cancer patients.”
“This designation provides tax credits and other incentives for
drug developers addressing rare diseases. Most notably the Orphan
Drug Designation will give Avacta, if AVA6000 is approved for
treatment of soft tissue sarcoma, seven years of market exclusivity
in the US, which is a significant commercial advantage.”
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Media Contact: Zyme Communications Lily Jeffery
lily.jeffery@zymecommunications.com +44 (0)7891 477 378
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