This week, Resverlogix (RVX) announced its BET protein inhibitor, RVX-208, met the primary endpoint in a Phase 2b clinical trial for patients with high risk of cardiovascular disease. At the end of the day, the company’s stock price had increased by 12.8%.
Patients demonstrated a significant increase in functional HDL that persisted throughout the 24-week long study. In addition, secondary endpoints were also met, with patients showing increases in levels of Apo-AI and large HDL particles, which are both believed to be important factors in enhancing reverse cholesterol transport activity. Additional results evaluating the drug candidate’s ability to reduce plaque regression are expected the first half of 2013.
In addition, the trial showed that previously reported increases in alanine aminotransferase (ALT) were infrequent and transient, supporting chronic use of the drug. The company expects to initiate a Phase 3 trial in late 2013.
RVX-208 is a first-in-class small molecule that inhibits BET, a protein involved in epigenetic regulation of gene expression. RVX-208 functions by removing atherosclerotic plaque via reverse cholesterol transport, the natural process through which atherosclerotic plaque is transported out of the arteries and removed from the body by the liver. This drug candidate also has the potential to treat other indications, including neurodegenerative disorders.
Recently, Russo Partners coordinated the launch of a newly redesigned website for Thrombolytic Science International (TSI). The company is currently developing a new-generation, clot-dissolving therapy, TS01, to treat patients with acute ischemic stroke, an area with a high level of unmet need.
In addition to new web copy, which can be viewed here, the redesigned website also features an illustration demonstrating the mechanism behind TS01’s specificity for only the types of clots that cause strokes and heart attacks (view the graphic here).
Approximately 90% of all strokes are caused by a blood clot, however no satisfactory clot-dissolving treatment exists. TS01 potentially addresses the limitations of the only approved clot-dissolving drug, rtPA, which has a short treatment time window, suboptimal efficacy and carries a risk of intra-cranial hemorrhage. As a result, only about 5% of patients with acute ischemic strokes receive this therapy. TSI plans on initiating a Phase 1 clinical study evaluating TS01 in healthy adults in the third quarter of 2012.
Russo Partners provided recommendations as well as feedback related to the design and development of the 3D graphic illustrating the mechanism TS01’s specificity. In addition, Russo Partners coordinated the redesign of the new site and provided support in the development of the updated web copy.
Adynxx, a newly-formed clinical stage pharmaceutical company developing therapeutics addressing pain at its molecular roots, emerged from stealth mode this week with the announcement that it has completed enrollment in a Phase 1 clinical study of its lead therapeutic for pain, AYX1.
The 30-subject, dose-escalating study is currently evaluating AYX1 in five cohorts of healthy volunteers. Later this year, Adynxx plans to move into a proof-of-concept Phase 2 clinical study assessing the ability of a single administration of AYX1 at the time of surgery to reduce acute pain, prevent the transition to persistent post-surgical pain and consequently improve functional recovery.
In a variety of preclinical pain and functional assessment models, long-term efficacy of AYX1 after a single administration has been demonstrated. In addition to AYX1, Adynxx is advancing a pipeline of therapeutics for the treatment of other indications, including chronic lower back pain and intractable neuropathic and inflammatory pain syndromes.
Russo Partners worked with Adynxx to develop key messages surrounding the announcement and secured coverage of the news in trade as well as regional publications.
Read more about the company and its programs in the articles below from Xconomy and the San Francisco Business Times.
San Francisco Business Times
Last week, StemCells was awarded $20 million from the California Institute for Regenerative Medicine (CIRM) to fund preclinical development of the company’s human neural stem cells as a potential treatment for cervical spinal cord injury. In sum, the agency awarded over $150 million to promising stem cell therapeutics, with StemCells being the only company to receive an award.
Disease advocates speak on July 26, 2012, in Burlingame, Calif., where the California Institute for Regenerative Medicine decided whether to approve more than $100 million in funding. Photo: Liz Hafalia, The Chronicle / SF
Funds from this award will be applied over a four-year period, with the goal of filing an investigational new drug (IND) application in that time. Currently, StemCells is evaluating the same neural stem cells in a Phase 1/2 clinical trial in chronic spinal cord injury, a Phase 1 clinical trial in a rare myelination disorder, Pelizaeus-Merzbacher disease (PMD), which holds applications for multiple sclerosis and cerebral palsy, as well as a Phase 1 trial in dry age-related macular degeneration (AMD).
A decision on an Alzheimer’s disease application submitted by the company was deferred to CIRM’s Grants Working Group for further consideration, and is expected to be reviewed at the next meeting of its governing board currently scheduled for September 6th.
Read more about the StemCells’ award as well as other projects funded by CIRM in the article below from the San Francisco Chronicle.
San Francisco Chronicle