Close

Oxford BioMedica Announces US IND Approval for Novel Ocular Product

Note* - All images used are for editorial and illustrative purposes only and may not originate from the original news provider or associated company.

Subscribe

- Never miss a story with notifications

- Gain full access to our premium content

- Browse free from any location or device.

Media Packs

Expand Your Reach With Our Customized Solutions Empowering Your Campaigns To Maximize Your Reach & Drive Real Results!

– Access the Media Pack Now

– Book a Conference Call

– Leave Message for Us to Get Back

Related stories

Ensuring optimal product integrity with pharmaceutical preservation strategies

Preserving the potency of pharmaceutical products is paramount in...

How Stem Cell Therapy Works for the Individual

Stem cell therapy has emerged as one of the...

Tjoapack Expands Injectable Packaging Capabilities Globally

Increased Capabilities in the United States Tjoapack is finishing up...

Oxford BioMedica plc, the leading gene-based biopharmaceutical company, announces that the US Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) application for the Phase I/IIa clinical development of UshStat®, a novel gene-based treatment for Usher syndrome type 1B.  UshStat® was designed and developed by Oxford BioMedica using the Company’s proprietary LentiVector® platform technology and is the third programme to enter clinical development under the Phase I/II ocular collaboration agreement signed with Sanofi in April 2009.

The approval of the IND follows the decision by the US Recombinant DNA Advisory Committee (RAC) to approve the UshStat® Phase I/IIa protocol in May 2011.  The open label, dose escalation Phase I/IIa study will enrol up to 18 patients with Usher syndrome type 1B at the Oregon Health and Science University’s Casey Eye Institute, Portland, Oregon.  The study, led by Professor Richard Weleber, will evaluate three dose levels for safety, tolerability and aspects of biological activity and is expected to be initiated by the end of 2011.

Latest stories

Related stories

Ensuring optimal product integrity with pharmaceutical preservation strategies

Preserving the potency of pharmaceutical products is paramount in...

How Stem Cell Therapy Works for the Individual

Stem cell therapy has emerged as one of the...

Tjoapack Expands Injectable Packaging Capabilities Globally

Increased Capabilities in the United States Tjoapack is finishing up...

Subscribe

- Never miss a story with notifications

- Gain full access to our premium content

- Browse free from any location or device.

Media Packs

Expand Your Reach With Our Customized Solutions Empowering Your Campaigns To Maximize Your Reach & Drive Real Results!

– Access the Media Pack Now

– Book a Conference Call

– Leave Message for Us to Get Back