St Helier, Jersey – IQ-AI Ltd, a medical services firm specializing in cancer treatment, announced on Wednesday that its wholly-owned subsidiary, Imaging Biometrics LLC, has submitted a request to the US Food & Drug Administration (FDA) for a Pediatric Rare Disease (PRD) designation for its gallium maltolate therapy. The request is aimed at facilitating the approval process for gallium maltolate as an oral treatment for pediatric brain tumors.
Focusing on pediatric brain tumors
Imaging Biometrics, headquartered in Elm Grove, Wisconsin, is dedicated to the development of advanced imaging platforms and therapeutics designed to enhance the diagnosis and treatment of various medical conditions. In this case, the company is concentrating its efforts on addressing pediatric brain tumors, a serious and often life-threatening condition.
The PRD designation, as granted by the FDA, is reserved for rare diseases that affect fewer than 200,000 individuals under the age of 18 in the United States. This designation is intended to encourage the development of novel drugs and therapies specifically tailored to treat such rare pediatric diseases.
One significant advantage of PRD designation is eligibility for a priority review voucher, which can be redeemed for a marketing application. This voucher has the potential to expedite the FDA’s review process for new drug approvals or can be sold to another pharmaceutical company.
Market reaction
Following the announcement of this development, shares of IQ-AI surged by 7.4% to reach 4.19 pence each around midday on Wednesday in London. If granted PRD designation by the FDA, gallium maltolate therapy could offer a ray of hope for pediatric brain tumor patients and their families. Rare diseases often pose significant challenges in terms of treatment development and accessibility, making the designation particularly crucial for addressing this unmet medical need.
The submission to the FDA marks a crucial step forward in the journey of gallium maltolate therapy towards potential approval for pediatric brain tumor treatment. While there are no guarantees in the complex and rigorous drug approval process, obtaining PRD designation is a positive sign for both IQ-AI and Imaging Biometrics.
Looking to the Future
IQ-AI and Imaging Biometrics will be eagerly awaiting the FDA’s response to their PRD designation request. If granted, it could pave the way for further clinical trials and research to determine the therapy’s effectiveness in treating pediatric brain tumors. Ultimately, this development has the potential to transform the lives of children and families affected by this devastating disease.
