U.S. FDA gives nod to Inovio to start Phase ½ trial for INO-3107
Category: #health  By Pankaj Singh  Date: 2020-02-12
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U.S. FDA gives nod to Inovio to start Phase ½ trial for INO-3107

Inovio Pharmaceuticals, Inc. has received green signal from the U.S. FDA to assess its Phase ½ trial for DNA medicine INO-3107 aimed at treating RRP (Recurrent Respiratory Papillomatosis). For the uninitiated, a rare disease inflicted by the HPV (human papillomavirus) type 6 and 11 infections, RRP, is incurable and it is usually treated by surgery that fleetingly restores the airway.

It is widely believed that the surgery should be repeated given the fact that the tumor always recurs. RRP can have a toll on the quality of the life for people living with the disease.  It is worth noting that the HPV virus leads to noncancerous tumor growth that tends to invite lethal airway obstructions, and often it can lead to cancer.

The introduction of the multicenter, open-label Phase ½ trial will witness enrollment of around 63 American and will assess the INO-3107’s safety, efficacy, immunogenicity, tolerability in studies with 11-associated RRP and/or HPV 6 who have warranted at least two surgical interventions a year in the span of last three years for the outcast of associated papilloma. Reportedly, adult subjects are expected to get one-every-three-week four doses of INO-3107 following the surgical removal of their papillomas.

Along with kicking off the efficacy trial, the company is also contemplating plans to get Orphan Disease designation with the Office of Orphan Products Development (OOPD) of FDA. For the record, the FDA tends to grant orphan status to biological and drugs products which are meant for impactful diagnosis, prevention and treatment of rare disorders or diseases which inflict fewer than 200,000 Americans. OOPD offers a drug developer with some incentives and upsides, such as marketing exclusivity period provided regulatory nod is attained for the designation indication.

The company is of the opinion that INO-3107—an investigational DNA medicine—is innately designed to decimate and ward off tumors inflicted by HPV 6 and 11 infections from the body.

Source credit:

http://ir.inovio.com/news-and-media/news/press-release-details/2020/Inovio-Receives-Authorization-from-the-US-FDA-To-Begin-Phase-12-Clinical-Trial-for-INO-3107-a-DNA-Medicine-To-Treat-a-Rare-Disease----Recurrent-Respiratory-Papillomatosis-RRP/default.aspx



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Pankaj Singh

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Pankaj Singh

Pankaj Singh Develops content for Market Size Forecasters, Algosonline, and a couple of other platforms. A Post Graduate in Management by qualification, he worked as an underwriter in the UK insurance domain before deciding to switch his field of profession. With exp...

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