Fidest – Agenzia giornalistica/press agency

Quotidiano di informazione – Anno 33 n° 244

Posts Tagged ‘aura biosciences’

American Academy of Ophthalmology 2019 Annual Meeting

Posted by fidest press agency su giovedì, 17 ottobre 2019

Aura Biosciences, a leader in the development of novel targeted therapies in ocular oncology, today announced the presentation of updated clinical data from its ongoing Phase 1b/2 clinical trial evaluating the safety and efficacy of light-activated AU-011, the Company’s lead product candidate for the first line treatment of primary choroidal melanoma, at the American Academy of Ophthalmology (AAO) 2019 Annual Meeting, being held October 12-15, 2019 in San Francisco, CA.“With its ability to provide tumor control and vision preservation, AU-011 holds significant potential as a new targeted therapy for the primary treatment of choroidal melanoma,” said Cadmus Rich, MD, Chief Medical Officer and Head of Research and Development of Aura Biosciences. “The data presented this year by Dr. Duker provided information on Aura’s proprietary technology platform and key insights that will inform the design and conduct of our pivotal Phase 3 program for AU-011, which we expect to commence in the second half of 2020. Dr. Schefler’s presentation included an update on ongoing research we are conducting into suprachoroidal delivery which, may allow us to increase the range of tumor sizes that AU-011 can treat. Both of these presentations underscore our long-term vision and commitment to bringing this first-in-class technology to patients for this rare and life-threatening disease.”

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Aura Biosciences to Present at Upcoming Investor Conferences

Posted by fidest press agency su sabato, 9 marzo 2019

Aura Biosciences, a leader in the development of novel targeted therapies in ocular oncology, today announced that management will present a company overview at the following investor conferences: Cowen and Company 39th Annual Health Care Conference on Tuesday, March 12, 2019, at 10:00 a.m. Eastern Time in Boston, MA
Oppenheimer’s 29th Annual Healthcare Conference on Tuesday, March 19, 2019, at 9:10 a.m. Eastern Time in New York, NY.
Aura Biosciences is developing a new class of therapies to selectively target and destroy cancer cells. Its lead program, AU-011 in primary choroidal melanoma, is being developed under a CRADA with the National Cancer Institute (NCI), part of the National Institutes of Health. For more information, visit http://www.aurabiosciences.com.

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Aura Biosciences Announces Update of Clinical Safety and Efficacy Data on Lead Candidate AU-011 for Choroidal Melanoma

Posted by fidest press agency su martedì, 19 giugno 2018

Aura Biosciences, a biotechnology company developing a new class of therapies to target and selectively destroy cancer cells using viral capsid conjugates, today announced new interim safety and efficacy data from an open-label Phase 1b/2 study of its lead program, light-activated AU-011 for the treatment of primary choroidal melanoma. The findings were presented by Ivana Kim, M.D., Co-Director of the Ocular Melanoma Center at Massachusetts Eye and Ear, at the 2018 World Ophthalmology Congress in Barcelona.AU-011 is an investigational, first-in-class targeted therapy in development for the treatment of primary choroidal melanoma. FDA has already granted Fast Track Designation and orphan drug designation, recognizing that there are no FDA-approved therapies and that the disease is serious and life-threatening.AU-011 is being evaluated in a Phase 1b/2 open-label, multicenter trial designed to evaluate the safety and efficacy of single and multiple ascending doses in 30 adult subjects with clinically diagnosed small to medium primary choroidal melanoma.Interim data presented today show that AU-011 has been generally well-tolerated with no related serious adverse events, no severe adverse events and no dose-limiting toxicities observed. Adverse events were manageable with standard of care treatments and had no further clinical sequelae. Pre-treatment visual acuity was maintained in all subjects that have been followed for 6 to 12 months.Early efficacy results are very promising with two subjects in the first multiple-ascending-dose cohort showing evidence of reduction in tumor height at 3 months. Further evidence of preliminary efficacy has also been demonstrated with subtherapeutic doses in the single-ascending-dose cohorts providing stable disease with vision preservation up to 12 months.“We are excited by these preliminary findings showing AU-011 provided local tumor control without loss of visual acuity for a majority of subjects dosed to date,” said Dr. Kim. “That is an encouraging sign of progress toward developing a new treatment for this cancer that could preserve much more vision than radiotherapy, which is the current standard of care but not FDA approved for this indication.”

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