FDA Removes Clinical Hold On Inovio Pharma's VGX-3100, Its First Drug To Enter A Pivotal Study

Inovio Pharmaceuticals IncINO
announced Thursday morning it has commenced a Phase III clinical program (called REVEAL) to evaluate the efficacy of its DNA-based immunotherapy, VGX-3100, to treat cervical dysplasia caused by human papillomavirus.

Inovio's study will assess the efficacy of VGX-3100 in regressing cervical high-grade squamous intraepithelial lesions, a direct precursor to cervical cancer, and eliminating the HPV infection that causes these lesions.

The company suffered a setback when the U.S. Food and Drug Administration placed a clinical hold on the phase 3 trial but after satisfying the agency's request for information the clinical hold has since been removed. The announcement helped boost Inovio's stock higher by around 1.35 percent ahead of Thursday's market open.

H.C. Wainwright Maintains At Buy

Related Links: 22 Stocks Moving In Thursday's Pre-Market Session A Peek Into The Markets: U.S. Stock Futures Rise Ahead Of Jobless Claims

Raghuram Selvaraju of H.C. Wainwright & Co maintains a Buy rating and $13 price target after Inovio's announcement.

VGX-3100 happens to be the first candidate within the company's extensive pipeline to proceed with a pivotal study, the analyst noted. In fact, it also happens to be the first immunotherapy and non-surgical treatment for HSIL.

"We note that the design of the REVEAL studies is similar to the design of the Phase 2b trial, in which VGX-3100 was given intramuscularly at 0, 4, and 12 weeks," the analyst said. "The primary endpoint in the Phase 2b trial was regression to CIN 1 or normal pathology at 36 weeks."

The analyst added:

    "Importantly, overall HPV-specific T cell levels in VGX-3100 recipients in the Phase 2b trial were greater than those in placebo recipients at all observation periods. CD8+ T cells were generated in the blood and had substantial infiltration in the cervical tissue of VGX-3100 recipients. This clearly demonstrates the correlation of antigen-specific CD8+ T cells to clinical efficacy, in our view."

At time of publication, shares of Inovio were up 4.8 percent at $7.74.

Posted In: HC WainwrightInovio PharmaceuticalsRaghuram SelvarajuVGX 3100Analyst ColorBiotechLong IdeasNewsReiterationFDAAnalyst RatingsMoversTrading IdeasGeneral

Ad Disclosure: The rate information is obtained by Bankrate from the listed institutions. Bankrate cannot guaranty the accuracy or availability of any rates shown above. Institutions may have different rates on their own websites than those posted on Bankrate.com. The listings that appear on this page are from companies from which this website receives compensation, which may impact how, where, and in what order products appear. This table does not include all companies or all available products.

All rates are subject to change without notice and may vary depending on location. These quotes are from banks, thrifts, and credit unions, some of whom have paid for a link to their own Web site where you can find additional information. Those with a paid link are our Advertisers. Those without a paid link are listings we obtain to improve the consumer shopping experience and are not Advertisers. To receive the Bankrate.com rate from an Advertiser, please identify yourself as a Bankrate customer. Bank and thrift deposits are insured by the Federal Deposit Insurance Corp. Credit union deposits are insured by the National Credit Union Administration.

Consumer Satisfaction: Bankrate attempts to verify the accuracy and availability of its Advertisers' terms through its quality assurance process and requires Advertisers to agree to our Terms and Conditions and to adhere to our Quality Control Program. If you believe that you have received an inaccurate quote or are otherwise not satisfied with the services provided to you by the institution you choose, please click here.

Rate collection and criteria: Click here for more information on rate collection and criteria.