RXi Pharmaceuticals (Nasdaq: RXII) is a biopharmaceutical company pursuing the development and commercialization of novel treatments for human diseases using a technology called RNA interference (RNAi). RNAi was discovered by our co-founder, Dr. Craig Mello, who was awarded the 2006 Nobel Prize for his groundbreaking work in this area. By harnessing the power of RNAi, we believe that RXi Pharmaceuticals may be able to develop a new class of therapeutic products that could have a number of distinct advantages over today’s drugs.
US FDA lifts clinical hold on RXi Pharmaceuticals cancer drug NeuVax
Biotech company RXi Pharmaceuticals (NASDAQ:RXII) reported on Monday that the Food and Drug Administration lifted its hold on the company’s cancer drug NeuVax as it plans to carry-out phase 3 clinical trials in first half of 2012.
Worcester, Massachusetts-based RXi Pharmaceuticals’ stock traded at $1.15 Monday on the Nasdaq market.
RXi said the U.S. FDA lifted its clinical hold as RXi has met all requirements set out by the FDA. The company has started a clinical trial material manufacturing plan to remain on schedule to meet its planned trial start date for NeuVax.
The drug, taken once a month for six months followed by booster injections once every six months, stimulates cytotoxic T cells that seek out and terminate levels of Human Epidermal Growth Factor Receptor 2 (HER2) antigens, while not harming healthy cells.
The HER2 gene produces a protein found in certain breast cancers. When the HER2 gene is altered or duplicated it can lead to an over production of the HER2 protein and can stimulate cancer cell growth.
NeuVax targets 50% of HER2 positive patients who achieve remission with current standard care, but have no available HER2 treatment options to maintain their disease free status.
According to the National Cancer Institute, more than 200,000 women in the U.S. are diagnosed with breast cancer each year.
RXi said Prof. Beth Mittendorf, who brings over 10 years of experience in cancer vaccine research, will be the principal investigator for the trial.
It is expected the clinical trial will encompass about 100 trial sites in the U.S., Canada and Europe. RXi has hired Aptiv Solutions to manage the trial and clinical operations are on track for the study to start inside the first half of next year.
In Monday’s press release, Chief Executive Mark Ahn said this “is testament to the team's operational excellence and its commitment to meeting program timelines."
"NeuVax is now the cornerstone for building a strong oncology pipeline as we continue to build momentum within the oncology community and look forward to presenting additional NeuVax data at key clinical meetings this fall."
RXi Pharmaceuticals is a biotechnology company focused on developing and commercializing innovative therapies that address major unmet medical needs using RNAi-targeted and immunotherapy technologies.