Dr. Maurizio Fava, Internationally Renowned Expert in the Field of Depression, Joins VistaGen’s Clinical and Scientific Advisory Board
SAN FRANCISCO, Oct. 7, 2015 /PRNewswire/ — VistaGen Therapeutics, Inc. (OTCQB: VSTA), a clinical-stage biopharmaceutical company committed to developing and commercializing novel medicines to treat depression, cancer and diseases and disorders involving the central nervous system (CNS), today announced that Maurizio Fava, MD, a world renowned expert in depressive disorders and psychopharmacology, has joined the Company’s Clinical and Scientific Advisory Board, effective immediately. Dr. Fava is Director of the Division of Clinical Research of the Massachusetts General Hospital (MGH) Research Institute, Executive Vice Chair, Department of Psychiatry at MGH, and Executive Director of the MGH Clinical Trials Network and Institute (CTNI), as well as Slater Family Professor of Psychiatry at Harvard Medical School. He co-developed, with Dr. David Schoenfeld, Professor of Biostatistics at the Harvard School of Public Health, a novel, patented clinical trial design which increases the probability of detecting a positive drug response, while markedly reducing sample size requirements for the trial, by reducing the potentially high placebo response sometimes found in depression, and other, clinical trials.
“We are honored to welcome Dr. Fava to our Clinical and Scientific Advisory Board,” stated Shawn Singh, Chief Executive Officer of VistaGen. His leading-edge expertise and guidance will make a significant impact on our clinical development of AV-101 as a new generation, orally-available prodrug candidate for the treatment of Major Depressive Disorder (MDD) and other CNS indications with high unmet need.”
Commenting on his appointment, Dr. Fava noted, “I am pleased to join VistaGen’s Clinical and Scientific Advisory Board. MDD is a pervasive, debilitating condition which is growing in incidence and, as a result, is a major global health concern. Given the limitations inherent in currently available medications for MDD, including selective serotonin reuptake inhibitors (SSRIs) and serotonin norepinephrine reuptake inhibitors (SNRIs), there exists an urgent need for development of new, alternative therapies involving a different mechanism of action to treat this patient population.”
Dr. Fava founded and was Director of the MGH Depression Clinical and Research Program (DCRP) from 1990 until 2014. Under his direction, the DCRP became one of the most highly regarded depression programs in the United States. Dr. Fava was co-Principal Investigator, with Dr. A. John Rush, of the largest clinical trial ever conducted in depression, STAR*D, whose findings were published in journals such as the New England Journal of Medicine (NEJM) and the Journal of the American Medical Association (JAMA). Dr. Fava recently served as President of the American Society of Clinical Psychopharmacology (ASCP).
During his career, Dr. Fava has authored or co-authored more than 600 original articles published in medical journals with international circulation. The citation impact of Dr. Fava’s work is extremely high, as his articles have been cited more than 40,000 times in the literature. He has edited eight books, published more than 50 chapters and 600 abstracts, and has given more than 350 presentations at national and international meetings. He is the recipient of several awards, and is on the editorial board of five international medical journals.
About VistaGen Therapeutics
VistaGen Therapeutics, Inc. is a clinical-stage biopharmaceutical company committed to developing and commercializing novel medicines to treat depression, cancer and diseases and disorders involving the central nervous system (CNS). VistaGen’s AV-101 is a new generation orally-available NMDAR GlyB antagonist in Phase 2 clinical development for Major Depressive Disorder. Based on preclinical studies, AV-101 may also have potential as a treatment for other CNS-related conditions, including chronic neuropathic pain and epilepsy, as well as neurodegenerative diseases such as Parkinson’s disease and Huntington’s disease. VistaGen is also using its pluripotent stem cell technology platform for potential commercial applications focused on producing proprietary new chemical entities (NCEs) through drug rescue and regenerative therapies for diseases and conditions related to blood, cartilage, heart and liver cells. For additional information, please visit www.VistaGen.com.
Cautionary Statement Regarding Forward-Looking Statements
The statements in this press release that are not historical facts may constitute forward-looking statements that are based on current expectations and are subject to risks and uncertainties that could cause actual future results to differ materially from those expressed or implied by such statements. Those risks and uncertainties include, but are not limited to, risks related to the VistaGen’s successful Phase 2 clinical development of AV-101 in MDD, its stem cell technology-based drug rescue activities, protection of its intellectual property, and the availability of substantial additional capital to support its operations, including the foregoing activities. These and other risks and uncertainties are identified and described in more detail in VistaGen’s filings with the Securities and Exchange Commission (SEC). These filings are available on the SEC’s website at www.sec.gov. VistaGen undertakes no obligation to publicly update or revise any forward-looking statements.
SOURCE VistaGen Therapeutics, Inc.
MARLBOROUGH, Mass., Oct. 7, 2015 /PRNewswire/ — RXi Pharmaceuticals Corporation (NASDAQ: RXII), a biotechnology company focused on discovering and developing innovative therapies primarily in the areas of dermatology and ophthalmology, today announced that the Company’s President and CEO, Dr. Geert Cauwenbergh, will present at the 14th Annual BIO Investor Forum on Wednesday, October 21, 2015 at 1:30 p.m. PDT in San Francisco, California.
Dr. Cauwenbergh will present an update on advancements within the Company’s research and development programs. In addition, he will provide a corporate overview that includes the Company’s clinical programs and the multiple business development opportunities available based on RXi’s proprietary sd-rxRNA® platform and extensive intellectual property portfolio. The presentation will be webcast and available on the “Investors” section of the Company’s website, www.rxipharma.com.
About the BIO Investor Forum
The 14th Annual BIO Investor Forum is an international investor conference focused on private and emerging public biotech companies. This Forum draws private equity and public investors, research analysts and industry executives from leading global pharmaceutical and established biotechnology companies focused on investment and business development opportunities in the life sciences industry. The meeting will take place October 20-21, 2015 at the Parc 55 Hotel in San Francisco, California.
About RXi Pharmaceuticals Corporation
RXi Pharmaceuticals Corporation (NASDAQ: RXII) is a biotechnology company focused on discovering and developing innovative therapeutics primarily in the areas of dermatology and ophthalmology that address high-unmet medical needs. Our discovery and clinical development programs are based on siRNA technology as well as immunotherapy agents. These compounds include, but are not limited to, our proprietary, self-delivering RNAi (sd-rxRNA®) compounds for the treatment of dermal and ocular scarring. It also includes an immunomodulator, Samcyprone™, a proprietary topical formulation of diphenylcyclopropenone (DPCP), for the treatment of disorders such as warts, alopecia areata, non-malignant skin tumors and cutaneous metastases of melanoma.
RXi’s novel, self-delivering RNAi (sd-rxRNA®) compounds are designed for therapeutic use and have drug-like properties, such as high potency, target specificity, serum stability, reduced immune response activation, and efficient cellular uptake. sd-rxRNAs have been shown, in vitro and in vivo, to achieve efficient spontaneous cellular uptake and potent, long-lasting intracellular activity.
Building on the pioneering work of RXi’s Scientific Advisory Board Chairman and Nobel Laureate Dr. Craig Mello, RXI-109, an sd-rxRNA compound, is the Company’s first clinical development candidate. RXI-109 silences Connective Tissue Growth Factor (CTGF), which plays a key role in tissue regeneration and repair and is initially being developed to reduce or inhibit scar formation in the skin and in the eye. RXI-109 is currently being evaluated in Phase 2a clinical trials in dermatology and a Phase 1/2 trial is planned to initiate this year in ophthalmology. The Company’s sd-rxRNA technology platform is broadly protected by multiple issued patents and numerous patent applications.
RXi’s robust pipeline, coupled with an extensive patent portfolio, provides for product and business development opportunities across a broad spectrum of therapeutic areas. We are committed to being a partner of choice for academia, small companies, and large multinationals. We welcome ideas and proposals for strategic alliances, including in- and out-licensing opportunities, to advance and further develop strategic areas of interest. Additional information may be found on the Company’s website, www.rxipharma.com.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements about: our ability to successfully develop RXI-109, Samcyprone™ and our other product candidates (collectively “our product candidates”); the future success of our clinical trials with our product candidates; the timing for the commencement and completion of clinical trials; our ability to enter into strategic partnerships and the future success of these strategic partnerships; and our ability to deploy our sd-rxRNA® technology through partnerships, as well as the prospects of these partnerships to provide positive returns. Forward-looking statements about expectations and development plans of RXi’s product candidates and partnerships involve significant risks and uncertainties, including the following: risks that we may not be able to successfully develop and commercialize our product candidates; risks that product development and clinical studies may be delayed, not proceed as planned and/or be subject to significant cost over-runs; risks related to the development and commercialization of products by competitors; risks related to our ability to control the timing and terms of collaborations with third parties; and risks that other companies or organizations may assert patent rights preventing us from developing or commercializing our product candidates. Additional risks are detailed in our most recent Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q under the caption “Risk Factors.” Readers are urged to review these risk factors and to not act in reliance on any forward-looking statements, as actual results may differ from those contemplated by our forward-looking statements. RXi does not undertake to update forward-looking statements to reflect a change in its views, events or circumstances that occur after the date of this release.
RXi Pharmaceuticals Corporation
SOURCE RXi Pharmaceuticals Corporation
Astute Medical, Inc. Highlights Upcoming Presentation Of Study Examining Risk Of AKI In Neurologic Patients
SAN DIEGO, Oct. 7, 2015 /PRNewswire/ — Astute Medical, Inc., developer of the NephroCheck® Test, today highlighted an abstract to be presented October 8, 2015 at the 13th Neurocritical Care Society (NCS) Annual Meeting relating to the prediction of acute kidney injury (AKI) in neurologic patients using two urinary cell cycle arrest biomarkers. The meeting will take place October 7 through October 10 in Phoenix.
Dr. Paul McCarthy of the University of Maryland Medical Center will present the abstract “Cell Cycle Arrest Biomarkers Predictive of Early Acute Kidney Injury in Critically Ill Neurologic Patients.”
“Neurologic conditions in critically ill patients are highly complex, and evaluation of a threat as grave as AKI is crucial to managing care,” said Paul McPherson, Astute Medical chief scientific officer. “We are pleased to see research addressing this important disease category.”
Acute kidney injury is increasingly prevalent.1 Fifty percent of patients in the ICU will contract some stage of AKI,2 a condition associated with a 10-fold increase in hospital mortality rates and a higher rate of chronic kidney disease among post-op patients. 3 Unlike other potentially catastrophic events, such as myocardial infarction, AKI often has no signs or symptoms, making risk assessment via traditional methods difficult.4
The NephroCheck® Test is designed to detect the two urinary biomarkers featured in the abstract, TIMP-2 and IGFBP-7. Both biomarkers are involved in a wide array of responses to tissue insult (inflammation, oxidative stress, ultra-violet radiation, drugs and toxins) 5-7 and are thought to be involved in G1 cell-cycle arrest during the earliest phases of injury to the kidney. 8 With results in just 20 minutes, the NephroCheck® Test helps healthcare professionals evaluate intensive care patients’ risk of moderate to severe acute kidney injury in the next 12 hours. The test was created for use alongside clinical evaluation of intensive care patients over 21 who have or have had acute cardiovascular and/or respiratory compromise in the past 24 hours.
Once at-risk patients have been identified and their risk stratified, healthcare professionals can implement kidney-sparing strategies to potentially temper the severe consequences associated with AKI.
About Astute Medical, Inc.
Selected to the 2014 Fierce 15 by Fierce Medical Devices, Astute Medical is dedicated to improving the diagnosis of high-risk medical conditions and diseases through the identification and validation of protein biomarkers that can serve as the basis for novel diagnostic tests.
The Company’s focus is community- and hospital-acquired acute conditions that require rapid diagnosis and risk assessment. Astute Medical’s current areas of interest include abdominal pain, acute coronary syndromes, cerebrovascular injury, kidney injury and sepsis.
Astute Medical is a founding corporate partner of 0by25, a human rights initiative aimed at eliminating preventable and treatable deaths from AKI worldwide by 2025.
Astute Medical’s NephroCheck® Test received 510(k)-clearance through the FDA’s de novo classification process in September 2014. The test was CE-marked in 2012 and is available in Europe.
For additional information, please visit AstuteMedical.com.
For information regarding trademarks and other intellectual property applicable to this product, including international trademarks, please see astutemedical.com/about/intellectual-property. PN0503 Rev A 2015/10/05
- Kam Tao Li P, Burdmann EA, Mehta RL. Acute kidney injury: Global health alert. J Nephropathol. 2013;2(2):90-97.
- Mandelbaum T, Scott DJ, Lee J, et al. Outcome of critically ill patients with acute kidney injury using the AKIN criteria. Crit Care Med. 2011;39(12):2659-2664.
- Hobson C, Ozrazgat-Baslanti T, Kuxhausen A, et al. Cost and mortality associated with postoperative acute kidney injury. Ann Surg. 2014;00:1-8.
- Ronco C, Ricci Z. The concept of risk and the value of novel markers of acute kidney injury. Crit Care. 2013;17:117-118.
- Boonstra J, Post JA. Molecular events associated with reactive oxygen species and cell cycle progression in mammalian cells. Gene. 2004;337:1-13.
- Seo DW, Li H, Qu CK, et al. Shp-1 mediates the antiproliferative activity of tissue inhibitor of metalloproteinase-2 in human microvascular endothelial cells. J Biol Chem. 2006;281:3711-3721.
- Price PN, Safirstein RL, Megyesi J. The cell cycle and acute kidney injury. Kidney Int. 2009;76:604-613.
- Kashani K, Al-Khafaji A, Ardiles T, et al. Discovery and validation of cell cycle arrest biomarkers in human acute kidney injury. Crit Care. 2013;17:R25.
SOURCE Astute Medical, Inc.
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