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Biomatrica Announces Patent Award For Novel Method Of Stabilizing And Storing Biological Materials To Improve Downstream Testing
SAN DIEGO, Jan. 6, 2015 /PRNewswire/ –Biomatrica, Inc. announced today that the United States Patent and Trademark Office (USPTO) has issued the company a patent for Biomatrica’s invention of its core technology for stabilizing biological materials dry at ambient temperatures. The technology covered by this…
SAN DIEGO, Jan. 6, 2015 /PRNewswire/ –Halozyme Therapeutics, Inc. (NASDAQ: HALO) will be presenting at the 33rd Annual J.P. Morgan Healthcare Conference in San Francisco on Tuesday, January 13, 2015 at 4:00 p.m. PT …
TALLAHASSEE, Fla., Jan. 5, 2015 /PRNewswire/ — Prevacus, Inc. today announced that Jake VanLandingham, Ph.D., President and Chairman of the Board of Prevacus, Inc., will make the inaugural corporate presentation on Wednesday, January 14, at 9:30am (pacific time) at the Biotech Showcase 2015 conference being held in San Francisco, CA.
Details of Prevacus’s presentation are as follows:
Biotech Showcase 2015
Wednesday, January 14, 2015
9:30am (pacific time)
Wyndham Parc 55 Hotel, Hearst Room
About Prevacus, Inc.
Prevacus, Inc. is a biopharmaceutical company developing drug candidates with the potential to advance treatment in the fields of traumatic brain injury and other neurological disorders. The Company’s first development candidate (PRV-002) represents a breakthrough strategy for treating concussion (mild traumatic brain injury or mTBI).
A concussion is a type of traumatic brain injury (TBI) caused by a traumatic force to the head or upper body causing the brain to shake inside the skull. The injury is defined as a concussion when it causes a change in mental status such as amnesia, disorientation, mental fogginess, confusion, nausea/vomiting, blurred vision or loss of consciousness. There are 21 symptoms demonstrated to be associated with concussion. Loss of consciousness does not indicate injury severity. Because no two concussions are exactly alike, and symptoms are not always definite, the injury’s severity, effects and recovery are sometimes difficult to determine.
PRV-002 is a fully synthetic non-naturally occurring neurosteroid administered through the nasal cavity. PRV-002 carries with it equivalent, if not superior, neuroprotective effects compared to related neurosteroids. Animal models of concussion demonstrated that PRV-002 reduces the behavioral pathology associated with brain injury symptoms such as memory impairment, anxiety, and motor/sensory performance. Additionally, PRV-002 is lipophilic and can easily cross the blood-brain barrier to rapidly eliminate swelling, oxidative stress and inflammation in the brain.
Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, future financial results, including operating expenses and cash position, pursuit of strategic options and pursuit of research and clinical development programs. Risks that contribute to the uncertain nature of the forward-looking statements include: we expect to incur losses for the foreseeable future and will need additional funds to finance our operations; our operating results fluctuate significantly; our estimates regarding our ability to initiate and/or complete our clinical trials and the timing and expense of these trials may not be accurate; enrollment in our clinical trials may be delayed; our clinical trials may not demonstrate the efficacy and safety of our product candidates; we may not be able to manufacture our product candidates on a commercial scale in a timely or cost-efficient manner; our estimates regarding expenses and capital requirements may not be accurate; regulatory developments in the United States and foreign countries may adversely affect our operations or prospects; we must obtain and maintain intellectual property protection for our product candidates; the loss of key scientific or management personnel could adversely affect our operations. All forward-looking statements contained in this press release speak only as of the date on which they were made. We undertake no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.
SOURCE Prevacus, Inc.
– EPIC Study More Than One-Third Complete– Enrollment On Track to Complete in 2015– Top Line Data Anticipated in the First Quarter of 2016– Conference Call Scheduled for 8:00am ET / 5:00am PT on Tuesday January 6, 2015
SAN DIEGO, Jan. 5, 2015 /PRNewswire/ — Mast Therapeutics, Inc. (NYSE MKT: MSTX), a clinical-stage biopharmaceutical company, today reported that enrollment in its pivotal EPIC study of its lead product candidate vepoloxamer (MST-188) in sickle cell disease surpassed the one-third enrollment milestone, ahead of internal projections. The Company remains on-track to complete enrollment by the end of 2015 and, consistent with prior guidance, anticipates reporting top line results in the first quarter of 2016.
“We are extremely pleased to report that, as of today, 130 patients have been randomized to the EPIC study, which is ahead of the enrollment projections we set for ourselves more than a year ago,” stated Brian M. Culley, Chief Executive Officer. “We now have opened almost 70 sites in ten countries, with more than 50 of those sites located in the U.S. I am pleased to affirm that we remain on-track to complete enrollment this year, which means we expect to announce top line data in the first quarter of 2016. As there has never been a drug approved for sickle cell patients to treat an ongoing crisis, we are both hopeful and excited for a positive outcome from the EPIC study.”
“We have built a sense of camaraderie with the sickle cell medical community and are enjoying a groundswell of momentum that is helping to drive enrollment,” added Edwin L. Parsley, D.O., Chief Medical Officer. “Of note, approximately 60% of the sites we have opened in EPIC have enrolled at least one subject and two-thirds of those sites have enrolled two or more subjects. This broad activity indicates that investigators worldwide are excited about the study and are encouraging their patients to participate.”
“I am also pleased to highlight that the EPIC study’s independent Data and Safety Monitoring Board (“DSMB”) has held multiple pre-planned meetings and recommended that the study proceed without any changes,” added Dr. Parsley.
Additional milestones anticipated from the Company in 2015 include:
- Reporting data from a repeat-dose nonclinical study of vepoloxamer in heart failure;
- Initiating a Phase 2 clinical study of vepoloxamer in acute decompensated heart failure;
- Initiating enrollment in an open-label EPIC extension study, referred to as EPIC-E, to expand the Company’s existing safety database regarding repeat exposure to vepoloxamer;
- Reporting data from a nonclinical study of vepoloxamer in embolic stroke; and
- Reporting data from one or more of the Phase 2a studies of AIR001 in patients suffering heart failure with preserved ejection fraction (HFpEF).
Conference Call Information
Interested parties may access the conference call on Tuesday, January 6, 2015 by dialing (877) 870-4263 from the U.S. and (412) 317-0790 from outside the U.S. and should request the Mast Therapeutics, Inc. Corporate Update Call. The webcast will be available live via the Internet by accessing the Investors section of Mast’s website at http://www.masttherapeutics.com/investors/events/. Replays of the webcast will be available on the Company’s website for 30 days and a phone replay will be available through January 15, 2015 by dialing (877) 344-7529 from the U.S. and (412) 317-0088 from outside the U.S. and entering conference reference number 10057420.
In March 2014, the Company announced that the United States Adopted Names (USAN) Council assigned “vepoloxamer” as the unique non-proprietary (generic) name for the active pharmaceutical ingredient (API) in MST-188. The Company sought a unique name for its API to clearly identify it as different from non-purified poloxamers. In support of its application, the Company submitted proprietary data showing that drug products containing non-purified poloxamers may have serious toxicity consequences and should not be substituted for or confused with MST-188.
About Mast Therapeutics
Mast Therapeutics, Inc. is a publicly traded biopharmaceutical company headquartered in San Diego, California. The Company is leveraging the MAST (Molecular Adhesion and Sealant Technology) platform, derived from over two decades of clinical, nonclinical and manufacturing experience with purified and non-purified poloxamers, to develop vepoloxamer (MST-188), its lead product candidate, for serious or life-threatening diseases and conditions typically characterized by impaired microvascular blood flow and damaged cell membranes.
The Company is enrolling subjects in EPIC, a pivotal Phase 3 study of vepoloxamer in sickle cell disease, and in a Phase 2 study to evaluate whether vepoloxamer improves the effectiveness of recombinant tissue plasminogen activator therapy in patients with acute limb ischemia. The Company also is planning to initiate a Phase 2 study of vepoloxamer in patients with acute decompensated heart failure in the first half of 2015. More information can be found on the Company’s web site at www.masttherapeutics.com. (Twitter: @MastThera)
Mast Therapeutics™ and the corporate logo are trademarks of Mast Therapeutics, Inc.
Forward Looking Statements
Mast Therapeutics cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements that are based on the Company’s current expectations and assumptions. Such forward-looking statements include, but are not limited to, statements regarding the EPIC study, including timing of completion of patient enrollment and announcement of data, and relating to anticipated milestones for the Company’s other development programs. Among the factors that could cause or contribute to material differences between the Company’s actual results and the expectations indicated by the forward-looking statements are risks and uncertainties that include, but are not limited to: delays in the commencement or completion of clinical studies, including as a result of difficulties in obtaining regulatory agency agreement on clinical development plans or clinical study design, opening trial sites, enrolling study subjects, manufacturing sufficient quantities of clinical trial material, being subject to a “clinical hold,” and/or suspension or termination of a clinical study, including due to patient safety concerns or lack of funding; the uncertainty of outcomes in ongoing and future studies of the Company’s product candidates and the risk that its product candidates, including vepoloxamer, may not demonstrate adequate safety, efficacy or tolerability in one or more such studies; the potential for institutional review boards or the FDA or other regulatory agencies to require additional nonclinical or clinical studies prior to initiation of a planned clinical study of a product candidate; the risk that, even if clinical studies are successful, the FDA or other regulatory agencies may determine they are not sufficient to support a new drug application; the potential that, even if clinical studies of a product candidate in one indication are successful, clinical studies in another indication may not be successful; the Company’s reliance on contract research organizations (CROs), contract manufacturing organizations (CMOs), and other third parties to assist in the conduct of important aspects of development of its product candidates, including clinical studies, manufacturing, and regulatory activities for its product candidates, and that such third parties may fail to perform as expected; the Company’s ability to obtain additional funding as needed on a timely basis or on acceptable terms, or at all; the potential for the Company to delay, reduce or discontinue current and/or planned development activities, including clinical studies, partner its product candidates at inopportune times or pursue less expensive but higher-risk and/or lower return development paths if it is unable to raise sufficient additional capital as needed; the risk that, even if the Company successfully develops a product candidate in one or more indications, it may not realize commercial success with its products and may never generate revenue sufficient to achieve profitability; the risk that the Company is not able to adequately protect its intellectual property rights relating to the MAST platform and vepoloxamer or AIR001 and prevent competitors from duplicating or developing equivalent versions of its product candidates; and other risks and uncertainties more fully described in the Company’s press releases and periodic filings with the Securities and Exchange Commission. The Company’s public filings with the Securities and Exchange Commission are available at www.sec.gov.
You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date when made. Mast Therapeutics does not intend to revise or update any forward-looking statement set forth in this press release to reflect events or circumstances arising after the date hereof, except as may be required by law.
SOURCE Mast Therapeutics, Inc.
The protein LC3 is indespensible for the cellular recycling process of autophagy. Loss of phosphorylation of LC3 blocks autophagy and compromises cellular health.
The protein LC3 is indespensible for the cellular recycling process of autophagy. Loss of phosphorylation of LC3 blocks autophagy and compromises cellular health.
SAN DIEGO, CA–(Marketwired – Jan 5, 2015) – Quidel Corporation ( NASDAQ : QDEL ), a provider of rapid diagnostic testing solutions, cell-based virology assays and molecular diagnostic systems, announced today that it will present at the 33rd Annual J.P. Morgan Healthcare Conference to be held at The Westin St. Francis hotel in San Francisco, California on Wednesday, January 14, 2015.
SAN DIEGO, CA–(Marketwired – Jan 5, 2015) – NuVasive, Inc. ( NASDAQ : NUVA ), a medical device company focused on developing minimally disruptive surgical products and procedures for the spine, announced today that management will participate in the following investor event in January 2015:
DUBLIN, Jan. 5, 2015 /PRNewswire/ — Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced that the company will be webcasting its corporate presentation at the 33rd Annual J.P. Morgan Healthcare Conference in San Francisco, CA.
Bruce C. Cozadd, chairman and chief executive officer, will provide an overview of the company and provide a business and financial update at the conference on Monday, January 12, 2015 at 10:00 a.m. PST / 6:00 p.m. GMT.
A live audio webcast of the presentation may be accessed from the Investors section of the Jazz Pharmaceuticals website at www.jazzpharmaceuticals.com. Please connect to the website prior to the start of the presentation to ensure adequate time for any software downloads that may be necessary to listen to the webcast.
An archive of the webcast will be available for at least one week following the presentation on the Investors section of the company’s website at www.jazzpharmaceuticals.com.
About Jazz Pharmaceuticals plc
Jazz Pharmaceuticals plc (Nasdaq: JAZZ) is an international biopharmaceutical company focused on improving patients’ lives by identifying, developing and commercializing meaningful products that address unmet medical needs. The company has a diverse portfolio of products and/or product candidates with a focus in the areas of sleep and hematology/oncology. In these areas, Jazz Pharmaceuticals markets Xyrem® (sodium oxybate) oral solution and Erwinaze® (asparaginase Erwinia chrysanthemi) in the U.S., and markets Erwinase® and Defitelio® (defibrotide) in Europe and other countries outside the U.S. For more information, please visit www.jazzpharmaceuticals.com.
SOURCE Jazz Pharmaceuticals plc
When it comes to skin infections, a healthy and robust immune response may depend greatly upon what lies beneath. In a new paper published in the January 2, 2015 issue of Science, researchers at the University of California, San Diego School of Medicine report the surprising discovery that fat cells below the skin help protect us from bacteria.