On October 18, 2021 Avelas Biosciences, Inc. ("Avelas" or "the Company"), a clinical-stage drug-device company pioneering the field of fluorescence imaging for real-time cancer detection, reported that additions to its senior management team and Board of Directors and provides an update on the pegloprastide Phase III clinical program, due to start in 1H22 (Press release, Avelas Biosciences, OCT 18, 2021, View Source [SID1234591424]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
Corporate Update
Avelas is pleased to announce it has strengthened its management team with the appointment of Ambareen "Amber" Sheriff as Vice President, Regulatory and Quality and further bolstered its Board of Directors with the appointment of Robin Stevens as a Non-Executive Director of the Company.
Ms. Sheriff is an expert in global regulatory strategies with more than 32 years of regulatory affairs and product development experience. Throughout her career, Ms. Sheriff has led US, EMEA and rest of the world regulatory and quality strategies supporting development and preparation of drug products, investigational studies and marketing authorisations. Prior to joining Avelas, Ms. Sheriff was the VP, Regulatory Affairs and Quality Assurance at Celerity Pharmaceuticals, where she obtained ten regulatory approvals in over six years in the role. Ms. Sheriff previously held roles at Marathon Pharmaceuticals, Winston Laboratories, Akorn, and Baxter Healthcare. Ms. Sheriff holds a B.S. in Pharmacy from the University of Karachi and a B.S. in Chemistry from Northeastern Illinois University.
Mr. Stevens has over 30 years’ experience advising private and public companies in a variety of functions, including corporate finance, capital markets and previously as an international audit partner, in a wide range of industries, operating in the UK and overseas. In addition to his role at Avelas, he is a Senior Advisor and Capital Markets Lead at MHA MacIntyre Hudson.
Jay Lichter, Ph.D., Chairman, President, and Chief Executive Officer of Avelas, added: "As Avelas accelerates towards commencement of our Phase III clinical study for pegloprastide, I am delighted to be strengthening our team both at the management and Board level with the addition of Amber and Robin. We look forward to working closely with them."
Clinical Update
Avelas also announces that it is the Company’s intent to commence its registrational confirmatory Phase III trial for pegloprastide, its novel, best-in-class agent for visualizing breast cancer margins, in the first half of 2022, having received constructive and helpful feedback from the US Food and Drug Administration (the "FDA").
Avelas is developing pegloprastide (AVB-620), a novel fluorescent imaging agent used in combination with a fluorescence camera system, which has FDA Breakthrough Therapy Designation, for the intraoperative detection and visualization of positive margins during breast cancer surgery.
The goal of intraoperative image-guided surgery with pegloprastide is to increase the precision of cancer surgery and improve treatment outcomes for patients by fluorescently identifying cancer, in real-time during surgery, on the surfaces of excised tissue or residual cancer in the tumour bed not otherwise detected by surgeons and potentially left behind in a patient during an operation. Avelas has already demonstrated in prior studies that the use of pegloprastide, a fluorescent cancer marker, during surgery correctly identified cancer in up to 75% of patients who may have otherwise been candidates for a repeat (re-excision) surgery.
Through the benefits of Breakthrough Therapy Designation, Avelas has continued to collaborate with the FDA on the design of the Company’s registrational confirmatory Phase III trial. The design and protocol of the Phase III study will now be finalized in preparation for commencement of patient enrolment in the first half of 2022. Jay Lichter, Ph.D., Chairman, President, and Chief Executive Officer of Avelas said "We believe that pegloprastide is a best-in-class novel agent for visualising breast cancer margins in real time during surgery. Following this constructive dialogue with the FDA, we are excited to continue the clinical development of this exciting candidate."