Close

RXI Pharma (RXII) Issues Update from Rodman & Renshaw Conference

September 11, 2014 7:07 AM EDT
Get Alerts RXII Hot Sheet
Price: $0.33 --0%

Today's EPS Names:
SHIM, KOD, HEWA, More
Join SI Premium – FREE

RXI Pharma (Nasdaq: RXII) announced that the Company's President & CEO, Dr. Geert Cauwenbergh, presented at the Rodman & Renshaw 16th Annual Global Investment Conference on Wednesday, September 10, 2014. Dr. Cauwenbergh provided early interim data from their first Phase 2a clinical trial (RXI-109-1301) as well as other advancements in the Company's dermatology and ophthalmology franchises.

Clinical Trial Update

In the Company's first Phase 2a trial (RXI-109-1301), eight patients in each of two cohorts were enrolled and have reached the one month post-surgery observation point. Because this trial was designed with an adaptive protocol, it provides the ability to review early data and optimize future cohorts and/or trials. While one month is an early time point to evaluate scar formation, assessments of 1-month post surgery photographs by 11 blinded evaluators suggest that delayed treatment with RXI-109 (Cohort 2) is better than immediate treatment (Cohort 1). In Cohort 2 only, there was a statistical preference for RXI-109 treated scars by both comparative observations (RXI-109 treated- vs. placebo-treated scars) and by evaluation of the scars using a visual analog scale. Based on these early observations, the dosing regimen in this study can be fine-tuned and we can more rapidly move forward to an optimized treatment for prevention of scarring after surgery. Additional results to date show that RXI-109 is well tolerated with no systemic side effects. Local effects are mild and similar to those seen in the Company's prior Phase 1 clinical trial (erythema, occasional burning or stinging sensation). Evaluation of the 3, 6 and 9 month time points in this and the other ongoing Phase 2a trials will provide continued insight into dosing regimen, and give further guidance for future study design.

"Our progress in the past few months has been remarkable, both in advancing our RXI-109 clinical program and in expanding the development potential within our dermatology and ophthalmology franchises," said Dr. Geert Cauwenbergh, President and CEO. He added that, "The interim findings in the first Phase 2a trial with RXI-109 are of significant help in accelerating the evaluation of the best treatment regimen for patients with hypertrophic scars, allowing for additional patients to be included in cohorts with a more effective dosing regimen and saving time and costs by eliminating less optimal treatment schedules."

New Targets for sd-rxRNA® in Dermatology

The Company also announced that collagenase and tyrosinase were selected as new discovery stage targets for their self-delivering platform. For each of these two targets, we have identified potent sd-rxRNA compounds for further evaluation. These two targets are important for various diseases in skin. e.g., photo aging, wound healing, hyperpigmentation as well as in other disease areas (including osteo- and rheumatoid arthritis, acne scarring, blistering skin disorders, corneal erosions and endometriosis and certain neurological cancers).

Ophthalmology Franchise Update

As part of the ongoing ophthalmology program, the Company filed a request for a pre-IND meeting with the FDA in advance of filing an IND for RXI-109 for diseases in the eye. IND-supporting toxicology studies are in progress to support RXI-109 being developed as a treatment for ocular scarring.

In addition, the Company announced that a potent anti-VEGF sd-rxRNA has been identified, which may be considered for development in age-related macular degeneration (AMD) alone or in combination with RXI-109 to block both the neovascular and the scarring component of AMD. The VEGF compound is based in part on the target sequence of Bevasiranib, the siRNA compound acquired along with additional RNAi assets from OPKO Health, Inc.



Serious News for Serious Traders! Try StreetInsider.com Premium Free!

You May Also Be Interested In





Related Categories

Corporate News, FDA, Guidance, Hot Corp. News, Management Comments

Related Entities

Rodman & Renshaw