Benatar M.,University of Miami |
Sanders D.B.,Duke University |
Burns T.M.,University of Virginia |
Cutter G.R.,University of Alabama at Birmingham |
And 17 more authors.
Muscle and Nerve | Year: 2012
The recommendations for clinical research standards published in 2000 by a task force of the Medical Scientific Advisory Board (MSAB) of the Myasthenia Gravis Foundation of America (MGFA) were largely successful in introducing greater uniformity in the recording and reporting of MG clinical trials. Recognizing that changes in clinical trial design and implementation may increase the likelihood that new therapies are developed for MG, the MGFA MSAB Task Force here presents updated recommendations for the design and implementation of clinical trials in MG, including (a) the use of a quantitative measure, such as the MG-Composite, that is weighted for clinical significance and incorporates patient reported outcomes; (b) consideration of nontrial strategies; and (c) development of biomarkers that support mechanistic studies of pharmacotherapies. The hope is that these updated task force recommendations will expedite the development and acceptance of more effective and less noxious therapies for MG. © 2012 Wiley Periodicals, Inc.
Bayhill Therapeutics | Date: 2006-02-21
Therapeutic preparations for treatment of autoimmune diseases and neurodegenerative diseases. Research and development services in the fields of autoimmune disease therapeutics and neurodegenerative disease therapeutics and consultation therefore; and technical consultation services for manufacturing and production in the fields of autoimmune disease therapeutics and neurodegenerative disease therapeutics.
Bayhill Therapeutics | Date: 2007-11-16
News Article | January 23, 2009
Venture capital firms tightened their purse strings in the fourth quarter of 2008, according to the latest MoneyTree Report released by the National Venture Capital Association and PricewaterhouseCoopers. The total dollar amount invested in venture financings was $5.4 billion, down 33 percent from the fourth quarter of 2007 (when it was $8.09 billion) and down 26 percent from the third quarter of 2008 (when it was $7.3 billion). For the entire year, the total venture capital invested into startups was $28.3 billion, down 8 percent. The decline in investing mapped the decrease in exit options, even though VCs are supposed to have a 5 to 7 year investment horizon. More money continued to flow into later stage deals. And broken down by sector, venture dollars going into Internet deals fell 26 percent quarter over quarter as well to $787 million across 170 deals (a 20 percent decline from the third quarter). Even investments in clean tech startups dipped 14 percent sequentially to $909 million across 62 deals. For the year, Internet financings were pretty much flat at $4.9 billion, while the dollars going into clean tech deals increased 52 percent to $4.1 billion. The ten largest venture fundings in the quarter were: Interactive iCharts and the entire slide deck is embedded below:
Sarikonda G.,La Jolla Institute for Allergy and Immunology |
Sachithanantham S.,La Jolla Institute for Allergy and Immunology |
Manenkova Y.,La Jolla Institute for Allergy and Immunology |
Kupfer T.,University of Colorado at Denver |
And 19 more authors.
PLoS ONE | Year: 2013
A recent type 1 diabetes (T1D) clinical trial of rituximab (a B cell-depleting anti-CD20 antibody) achieved some therapeutic benefit in preserving C-peptide for a period of approximately nine months in patients with recently diagnosed diabetes. Our previous data in the NOD mouse demonstrated that co-administration of antigen (insulin) with anti-CD3 antibody (a T cell-directed immunomodulator) offers better protection than either entity alone, indicating that novel combination therapies that include a T1D-related autoantigen are possible. To accelerate the identification and development of novel combination therapies that can be advanced into the clinic, we have evaluated the combination of a mouse anti-CD20 antibody with either oral insulin or a proinsulin-expressing DNA vaccine. Anti-CD20 alone, given once or on 4 consecutive days, produced transient B cell depletion but did not prevent or reverse T1D in the NOD mouse. Oral insulin alone (twice weekly for 6 weeks) was also ineffective, while proinsulin DNA (weekly for up to 12 weeks) showed a trend toward modest efficacy. Combination of anti-CD20 with oral insulin was ineffective in reversing diabetes in NOD mice whose glycemia was controlled with SC insulin pellets; these experiments were performed in three independent labs. Combination of anti-CD20 with proinsulin DNA was also ineffective in diabetes reversal, but did show modest efficacy in diabetes prevention (p = 0.04). In the prevention studies, anti-CD20 plus proinsulin resulted in modest increases in Tregs in pancreatic lymph nodes and elevated levels of proinsulin-specific CD4+ T-cells that produced IL-4. Thus, combination therapy with anti-CD20 and either oral insulin or proinsulin does not protect hyperglycemic NOD mice, but the combination with proinsulin offers limited efficacy in T1D prevention, potentially by augmentation of proinsulin-specific IL-4 production. © 2013 Sarikonda et al.