Navidea Bioparmaceuticals (NAVB) Stock Rockets On Data

Navidea Biopharmaceuticals NAVB Stock News

Navidea Biopharmaceuticals Inc (NYSEAMERICAN: NAVB) is screaming for the top in the market this morning, trading on gains that are better said in multiples than percentages. The gains come after the company announced positive data from a Phase 2 clinical trial. Here’s what’s going on:

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NAVB Stock Screams For The Top On Positive Data

In the press release, Navidea Biopharmaceuticals announced positive preliminary data from a second analysis of its ongoing NAV3-31 Phase 2B study. Importantly, the daa demonstraes that the company’s Tc99m tilmanocept imaging can provide robust, quantitative imaging in healthy controls and in patients with active rheumatoid arthritis. Moreover, the imaging can provide an early indicator of treatment efficacy in patiens with active RA.

The study has three arms. The first of these arms consists of healthy subjecs, the second is patients with active, moderate-to-severe RA who are on stable therapy, and the third is a pilot arm of the upcoming Phase 3 trial assessing the ability of Tc99m tilmanocept to provide an early indicator of efficacy of anti-tumor necrosis factor alpha treatment in RA patients.

NAVB said that this is the second analysis, designed to examine data from Arm 3 of the study. The goal of the analysis was to evaluate the magnitude of change of Tc99m tilmanocept signal localized to RA-involved joints in patients before and after treatment with anti-TNF alpha therapy. The analysis also examined whether the change in localization, if any, can serve as an early, quantifiable predictor of treatment efficacy.

In the release, the comapny said that the wide dynamic range of global Tc99m tilmanocept signal readout combined with the low variability of imaging signal quantification established in Arms 1 and 2 of the trial are supportive of the idea that clinically meaningful changes in signal localization can be detected.

In a statement, Michael Rosol, CMO at NAVB, had the following to offer:

We are encouraged by these interim results, which are in line with our hypotheses, support the continuation of the current Phase 2B study, and will be fundamental to speaking with the FDA about moving forward into the Phase 3 trial later this year. We are excited that we are on track to possibly providing rheumatologists and those suffering with RA a noninvasive, quantifiable, early indicator of whether or not an anti-TNF alpha treatment is working. This could bring enormous benefit to these patients by assisting physicians in putting them on the right course of treatment earlier than would otherwise be possible today.

The above statement was followed up by Jed Latkin, CEO at NAVB. Here’s what he had to say:

I am once again very pleased that the interim results of our ongoing Phase 2B study are so encouraging. These data support our belief that Tc99m tilmanocept imaging has the potential to provide an early and accurate indication of treatment effectiveness to rheumatologists, allowing them to tailor effective treatment regimens for RA patients. We are looking forward to continuing our progress into a Phase 3 study.

This Is Big News

This positive data is great news for Navidea Biopharmaceuticals and its investors. Ultimately, the company’s imaging is proving to be a great early indicator of efficacy as physicians treat RA patients. Should the data continue to be the same in the upcoming Phase 3 trial, this would be a major breakthrough in the field of RA treatment.

With RA affecting about one percent of the global population, should all continue to go well, this imaging product is likely to be approved and met with strong demand in the market. All in all, NAVB is a stock that’s well worth watching closely.

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