|Data From New Studies of VIBATIV; CytRx Announces the Publication of its Positive Global Phase 2b Clinical Trial|
|By William Kent|
|Monday, 21 September 2015 18:49|
Below is a look at some of the headlines for companies that made news in the healthcare sector on September 21, 2015.
Theravance Biopharma, Inc. (NASDAQ: TBPH), announced new positive data from several studies of VIBATIV® (telavancin) confirming the product's in vitro potency against isolates from a range of difficult-to-treat infections. The findings further supplement the extensive and well-documented evidence demonstrating greater in vitro activity for VIBATIV against methicillin-resistant Staphylococcus aureus (MRSA) and other difficult-to-treat clinical pathogens as compared to antibiotics such as vancomycin, daptomycin and linezolid. Results from these studies were presented at the Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) held in San Diego, CA, on September 17 - 21, 2015.
"The new VIBATIV data presented at ICAAC provides additional important support for the product's profile as one of the industry's most potent antibiotics against susceptible Gram-positive pathogens," said Frank Pasqualone, Senior Vice President, Development and Operations at Theravance Biopharma. "These study findings confirm the in vitro activity of VIBATIV and highlight the promise of the antibiotic in difficult-to-treat infections for which there is a significant medical need, particularly in light of the growing epidemic of antibiotic resistance."
Highlights from data presentations include: Researchers showed that VIBATIV possessed the greatest in vitro activity of all antibiotics evaluated against a broad collection of contemporary Gram-positive clinical isolates that caused complicated skin and skin structure infections (cSSSIs) in U.S. hospitals. Data showed that the minimum inhibitory concentrations (MICs) for VIBATIV were eight-fold lower than for daptomycin and 16-fold lower than for vancomycin and linezolid against all Staphylococcus aureus (S. aureus) strains, including MRSA and methicillin-susceptible Staphylococcus aureus (MSSA) subsets. MICs are a common measure used to express an antibiotic's in vitro potency.
Data from a second study demonstrated that VIBATIV possessed the greatest in vitro activity of all antibiotics evaluated against a broad collection of contemporary Gram-positive cocci from Canadian hospitals. VIBATIV showed greater in vitro potency than vancomycin, daptomycin and linezolid against such pathogens as MRSA, vancomycin-intermediate Staphylococcus aureus (VISA) and heterogeneous vancomycin-intermediate Staphylococcus aureus (hVISA).
Data from additional studies highlighted the potential of VIBATIV in addressing serious infection types with significant unmet medical need and critical treatment challenges. For example, VIBATIV demonstrated greater in vitro activity against biofilm-producing MRSA, as compared to vancomycin, daptomycin, teicoplanin, and ceftaroline. Furthermore, results showed VIBATIV to be significantly more effective than vancomycin and daptomycin in animal models of infective endocarditis (IE) caused by MRSA. In these IE models, VIBATIV was significantly better than daptomycin at reducing the levels of MRSA found in target tissues and producing a significantly higher percentage of target tissues that were classified as culture-negative. Vancomycin was relatively ineffective in both of these areas.
"This collection of new, compelling data provides additional support for our belief that VIBATIV represents a critically important antibiotic option for physicians as a range of life-threatening, Gram-positive infections continue to become more difficult to treat," stated Jon Bruss, M.D., Vice President Clinical Development & Medical Affairs at Theravance Biopharma. "By continuing to demonstrate greater in vitro potency against such challenging pathogens, as compared vancomycin, daptomycin and linezolid, we are further supplementing our extensive collection of data that support the competitive profile of the product."
VIBATIV is a bactericidal, once-daily, injectable lipoglycopeptide antibiotic with in vitro potency and a dual mechanism of action whereby telavancin both inhibits bacterial cell wall synthesis and disrupts bacterial cell membrane function. The drug's proven efficacy against difficult-to-treat Gram-positive infections has been demonstrated in several large, multinational registrational studies, which involved one of the largest cohorts of patients with MRSA infections studied to date. Additionally, there is extensive and well-documented evidence of the drug's in vitro potency and in vivo activity against a broad collection of Gram-positive bacterial pathogens, including those that are considered difficult-to-treat and multidrug-resistant.
CytRx Corporation (NASDAQ: CYTR), a biopharmaceutical research and development company specializing in oncology, today announced that JAMA Oncology, the prestigious peer-reviewed Journal of the American Medical Association (JAMA), has published a paper on September 17, 2015 entitled "First-Line Aldoxorubicin vs Doxorubicin in Metastatic or Locally Advanced Unresectable Soft-Tissue Sarcoma: A Phase 2b Randomized Clinical Trial."
This paper discusses the design, methodology and results from CytRx's completed multicenter, randomized, open-label global Phase 2b clinical trial investigating the efficacy and safety of aldoxorubicin compared with doxorubicin as first-line therapy in patients with metastatic or locally advanced unresectable soft tissue sarcomas (STS). It concludes that aldoxorubicin is the first single-agent therapy that has shown significantly superior efficacy over doxorubicin in the primary and secondary endpoints of progression-free survival and overall tumor response rate. Additionally, patients treated with aldoxorubicin exhibited manageable adverse effects, had no unexpected events, and did not exhibit evidence of acute cardiotoxicity.
"The publication of our global Phase 2b clinical trial results in JAMA Oncology underscores the significance of aldoxorubicin as a potential new therapy for STS as we make progress on our global, pivotal Phase 3 clinical trial for this indication," said Steven A. Kriegsman, CytRx's Chairman and CEO. "The fact that aldoxorubicin is the first single chemotherapy to demonstrate statistically significant improvement in progression-free survival, progression-free survival at 6 months and tumor response underscores our confidence in the potential of this drug to benefit patients with advanced STS. We are confident that the publication of these results in a major, peer-reviewed journal will increase aldoxorubicin's awareness in the STS community."
About the Aldoxorubicin Phase 2b Trial Design -- In this international, open-label, 123-patient, 31-center Phase 2b trial, patients with advanced soft tissue sarcomas were randomized 2:1 to receive either 350 mg/m2 of aldoxorubicin (83 patients) or 75 mg/m2 of doxorubicin (40 patients) every 3 weeks for up to 6 cycles. Patients were then followed every 6 weeks with CT scans to monitor tumor size. Two approaches were used to evaluate efficacy of aldoxorubicin: assessment by the study investigators, as well as assessment by a blinded central laboratory review. The primary endpoint was progression-free survival (PFS) and secondary endpoints include PFS at 6 months for each group, overall response (complete and partial) rate (ORR) and overall survival (OS). A 2:1 randomization scheme was chosen to extend safety information for aldoxorubicin; because doxorubicin has well-documented safety and efficacy data, the doxorubicin arm served to demonstrate patient responses to the drug similar to those evaluated in other studies.
Summarization of Trial Results --- An analysis of the trial data revealed the following results, as previously reported: Primary endpoint results, as determined by both the trial investigators and by blinded central radiology review, found that subjects treated with aldoxorubicin demonstrated highly statistically significantly better clinical outcomes than subjects that received standard doxorubicin therapy for their soft tissue sarcomas. In scans read by trial investigators, PFS results demonstrated that treatment with aldoxorubicin increased median PFS approximately 80% to 8.3 months, compared to 4.6 months with doxorubicin, meeting the study's primary endpoint (HR=0.419; p=0.0007). In the blinded central radiology review, PFS results demonstrated that treatment with aldoxorubicin increased median PFS approximately 107% to 5.6 months, compared to 2.7 months with doxorubicin, also meeting the study's primary endpoint (HR=0.60; p=0.0228).
Progression-free survival at 6 months effectively doubled for those receiving aldoxorubicin compared to doxorubicin. By blinded central radiology review, the PFS at 6 months was 45.7% for aldoxorubicin-treated patients compared to 22.9% for those receiving doxorubicin. As evaluated by investigators, PFS at 6 months was 68% and 33% for patients receiving aldoxorubicin or doxorubicin respectively.
Overall survival (OS) was assessed as a prospectively planned secondary endpoint although the trial was not powered to show a statistically significant outcome. Aldoxorubicin-treated patients demonstrated a 27 percent reduction in the risk of death compared to patients treated with doxorubicin (HR 0.73: 95% confidence interval 0.44-1.20), the current standard-of-care in this indication. In addition, aldoxorubicin-treated patients demonstrated a 41% likelihood of surviving more than 2 years, a 2-fold increase, compared to a 20% probability for doxorubicin-treated patients. Median OS was 15.8 months (95% CI, 13.1-NR) for aldoxorubicin-treated patients versus 14.3 months (95% CI, 8.6-20.6) for doxorubicin treated patients (p=0.21). For treatment-naïve patients, representing 90% of the patients in the clinical trial, median OS was 16.0 months (95% CI, 13.1-NR) for aldoxorubicin-treated patients versus 14.0 months (95% confidence interval 8.7-20.1) for doxorubicin treated patients (p=0.14).
ORR as determined by the investigators was 23% for aldoxorubicin subjects (2% complete response) versus 5.0% for doxorubicin subjects (0% complete response). As assessed by blinded central lab review, 25% of aldoxorubicin subjects had a partial response while 0.0% of doxorubicin subjects exhibited any objective response. In addition, a higher percentage of aldoxorubicin-treated subjects demonstrated tumor shrinkage compared to patients treated with doxorubicin, regardless of whether the scans were evaluated by investigators (66% vs. 44%) or by blinded reviewers (63% vs. 41%).
Adverse events were of a type consistent with known doxorubicin toxicities. The majority of adverse events resolved prior to the following cycle with no treatment discontinuation. Aldoxorubicin-treated subjects did experience a higher percentage of Grade 3 or 4 treatment emergent adverse events (TEAEs) of neutropenia (29% vs. 12%).
No clinically significant cardiotoxicity was seen with aldoxorubicin while approximately 10% of doxorubicin patients had clinically significant cardiotoxicity. Most importantly, there was no clinically significant reduction in cardiac function in the aldoxorubicin patients despite receiving doses up to 4 times the standard dose of doxorubicin.
About Soft Tissue Sarcoma --- Soft tissue sarcoma is a cancer occurring in muscle, fat, blood vessels, tendons, fibrous tissues and connective tissue, and can arise anywhere in the body at any age. According to the American Cancer Society, there are approximately 50 types of soft tissue sarcomas. In 2013 more than 11,400 new cases were diagnosed in the U.S. and approximately 4,400 Americans died from this disease. In addition, approximately 40,000 new cases and 13,000 deaths in the U.S. and Europe are part of a growing underserved market.
ADMA Biologics, Inc. (Nasdaq:ADMA), a late-stage biopharmaceutical company that develops, manufactures, and intends to commercialize specialty plasma-based biologics, announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Company's Biologics License Application (BLA) for RI-002 intended for the primary immunodeficiency (PI) population. PI is a class of inherited genetic disorders that causes an individual to have a deficient or absent immune system due to either a lack of necessary antibodies or a failure of these antibodies to function properly, affecting approximately 250,000 people in the United States. The PDUFA date for the FDA to complete the review is scheduled for the second half of 2016.
Akari Therapeutics (formerly known as Celsus Therapeutics plc) (NASDAQ:AKTX), an emerging growth, development-stage biopharmaceutical company, announced today that it has closed a previously announced private placement financing with a select group of investors, led by Deerfield, and including Venrock, Vivo Capital, Foresite Capital, New Enterprise Associates, QVT Financial, RA Capital Management and certain other institutional investors. The private placement, which follows the Company’s completion of its acquisition of Volution Immuno Pharmaceuticals SA announced on September 18, 2015, valued the combined entity at $150 million on a fully-diluted basis prior to the completion of the private placement. With the closing of the transaction, Akari received gross proceeds of approximately $75 million from the sale of 3,958,811 restricted American Depositary Shares (ADSs), representing an aggregate of 395,881,100 ordinary shares, at a price of $18.945 per restricted ADS, which represents approximately 33.3% of the outstanding Ordinary Shares of the Company after giving effect to the acquisition and the financing. The Company’s ADSs, each representing 100 Ordinary Shares (giving effect to the previously announced ADS ratio change, trade on The NASDAQ Capital Market under the symbol “AKTX” commencing on the date hereof.
Akorn, Inc. (Nasdaq:AKRX), a leading specialty pharmaceutical company, today announced that it has launched Doxercalciferol Injection Solution, 4 mcg/2 mL in 2mL single-use vials. The launch follows an approval of an abbreviated new drug application for the product from the U.S. Food and Drug Administration on May 7, 2015. Akorn's product is therapeutically equivalent to Hectorol® injection, marketed by Genzyme Corporation.
Anavex Life Sciences Corp. (OTCQX:AVXL), a clinical-stage biopharmaceutical company developing drug candidates to treat Alzheimer’s disease, other central nervous system (CNS) diseases, pain, and various types of cancer, today announced the appointment of Harald Hampel, MD, MA, PhD, MSc, to the Company’s Scientific Advisory Board. An internationally recognized expert on Alzheimer’s and related neurodegenerative diseases, Dr. Hampel is Professor and AXA Research Fund Chair at Sorbonne Universities’ Pierre and Marie Curie University (UPMC) in Paris, the leading university in science, technology and medicine in France. The AXA-UPMC Chair is hosted within the highly specialized Institute for Memory and Alzheimer’s Disease (IM2A), a reference center for Alzheimer’s and other neurodegenerative diseases, and affiliated with a leading neuroscience institution, the Brain and Spine Institute (ICM), as well as the Department of Neurology at the Pitié-Salpétrière University Hospital.
Atlanta fertility specialist and robotic surgeon Dr. Edward Dourron of Servy Massey Fertility Institute performs Essure removal using minimally invasive robotic surgery, not hysterectomy, and will present his experiences with this method to the U.S. Food and Drug Administration (FDA). On September 24, the FDA is reviewing the mounting complaints about Essure, which has been under attack by healthcare advocates because of the risks from side effects. An allergic reaction to nickel, one of the side effects, has resulted in a backlash of women anxious to have Essure, the only non-surgical method of sterilization for women, removed from their bodies. Removal should end any Essure side effects the woman experiences.
athenahealth, Inc. (Nasdaq:ATHN), a leading provider of cloud-based services and mobile applications for medical groups and health systems, today announced that approximately 9 percent of patients who are over the age of 50 may be candidates for more aggressive treatment of hypertension based on electronic health record (EHR) information obtained from athenahealth's cloud-based national network, as further described below. This announcement follows preliminary study findings made public last week by the National Institute of Health (NIH) from the Systolic Blood Pressure Intervention Trial (SPRINT), which suggest that lowering the systolic blood pressure (SBP) guidelines from 140 and 150 to 120 could be lifesaving.
Applied Genetic Technologies Corporation (Nasdaq:AGTC), a biotechnology company conducting human clinical trials of adeno-associated virus (AAV)-based gene therapies for the treatment of rare eye diseases, today announced that company management and collaborators will be participating in seven upcoming scientific and investor conferences: Discovery on Target – Boston, Mass. (September 21-24); Cell & Gene Therapy Europe – Barcelona, Spain (September 29-30); Leerink Rare Disease Roundtable – New York, N.Y. (September 30); Stem Cell Meeting on the Mesa – La Jolla, Calif. (October 7-9); The Retina Society 48th Annual Scientific Meeting – Paris, France (October 7-11); BioFlorida Annual Conference – Orlando, Fla. (October 11-13); ROTH Gene Therapy Corporate Access Day – New York, N.Y. (October 27);
Aquinox Pharmaceuticals, Inc. (NASDAQ:AQXP), a clinical-stage pharmaceutical company discovering and developing targeted therapeutics in disease areas of inflammation and immuno-oncology, announced that it will host an R&D Day in New York City on Wednesday, October 7th from 8:30 AM to 10:00 AM Eastern Time. This event will provide an opportunity to hear from a distinguished clinical expert on bladder pain syndrome/interstitial cystitis (BPS/IC), a debilitating disease affecting millions in the U.S. Aquinox will also be reviewing the full data from its recently completed LEADERSHIP trial and provide an update on the clinical development plans for AQX-1125 in BPS/IC.
Authentidate Holding Corp. (Nasdaq:ADAT), a provider of secure web-based revenue cycle management applications and telehealth products and services for healthcare organizations, today announced its receipt of a positive decision from the NASDAQ Hearings Panel, which has granted the company's request for the continued listing of its common stock on NASDAQ, subject to the conditions that the company complete the proposed business combination with Peachstate Health Management, LLC (d/b/a AEON Clinical Laboratories) and that the NASDAQ Listing Qualifications Staff approve the combined company's application for initial listing on NASDAQ on or before January 25, 2016. "I am pleased to see that the Panel recognized the opportunities available to the company and its stockholders through our prospective business combination and gave us the opportunity to remain listed on NASDAQ," said Ian C. Bonnet, the company's President and Chief Executive Officer.
Chimerix, Inc. (NASDAQ:CMRX), a biopharmaceutical company developing novel, oral antivirals in areas of high unmet medical need, presented findings from a new study that show hospital readmissions related to opportunistic infections are common among patients following autologous and allogeneic hematopoietic cell transplant (HCT), also known as bone marrow or stem cell transplant. The study showed that of hospital readmissions related to opportunistic infections (25.8 percent of all readmissions), approximately 1 in 3 readmissions were due to double-stranded DNA (dsDNA) viral infections. Among dsDNA viral infections diagnosed after hospital discharge, almost half occurred within the first month after discharge. The study also showed that the majority of hospital readmissions among HCT recipients were major or extreme in severity. These data were presented during the 55th Annual Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in San Diego.
CytoDyn Inc. (OTCQB:CYDY), a biotechnology company focused on the development of new therapies for combating human immunodeficiency virus (HIV) infection, today announced that the first group of patients receiving weekly PRO 140 monotherapy have now reached one year of viral load suppression in an extension study. CytoDyn's PRO 140 Phase 2b study was concluded in January 2015. Following the initial 13-week treatment period, patients with viral load suppression could continue receiving weekly PRO 140 monotherapy in an extension study. Patients enrolled in this study are infected with strains of HIV that utilize the CCR5 co-receptor. The PRO 140 monoclonal antibody targets CCR5 with high affinity and potently blocks HIV infection. These patients substituted their daily Highly Active Antiretroviral Therapy (HAART) regimen with weekly subcutaneous injections (one 350mg dose) of PRO 140 monotherapy throughout the trial and extension study.
Endocyte, Inc. (NASDAQ:ECYT), a leader in developing targeted small molecule drug conjugates (SMDCs) and companion imaging agents for personalized therapy, today announced that data from ongoing phase 1 trials of Endocyte's SMDC EC1456 will be presented at the European Cancer Congress 2015, being held Sept. 25 - 29, 2015, in Vienna, Austria.
Genticel (Euronext Paris & Brussels: FR00011790542 – GTCL), a clinical-stage biotechnology company and developer of innovative immunotherapies to prevent cancers caused by the human papillomavirus (HPV), presents today its financial results for the six-month period ending June 30, 2015 prepared in accordance with IFRS as endorsed by the European Union. The full interim financial report (regulated information) is available on Genticel's website under Investors. In accordance with applicable law, the Half Year 2015 financial statements were subject to a limited review by the company's statutory auditors and were approved by the Executive Board (Directoire) on September 10, 2015.
HealthEquity, Inc. (NASDAQ:HQY) announced today the commencement of a secondary offering of shares of its common stock. Certain of HealthEquity's stockholders are offering 3,000,000 shares of the company's common stock for sale. Additionally, the selling stockholders intend to grant the underwriter a 30-day option to purchase up to an additional 450,000 shares of the company's common stock. HealthEquity will not receive any proceeds from the sale of the shares offered by the selling stockholders. Wells Fargo Securities, LLC is acting as the sole underwriter for the offering. A registration statement relating to these securities was filed with the Securities and Exchange Commission (SEC) and became automatically effective on September 9, 2015. The offering is being made only by means of a prospectus supplement and accompanying prospectus. A preliminary prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and will be available on the SEC's website located at http://www.sec.gov. Copies of the preliminary prospectus supplement and accompanying prospectus relating to the offering, when available, may be obtained from Wells Fargo Securities, LLC, Attention: Equity Syndicate Department, 375 Park Avenue, New York, New York 10152, or by email at [email protected], or by telephone at (800) 326-5897.
Hemispherx Biopharma (NYSE MKT:HEB) announces the publication of an online peer reviewed research article of an analysis of clinical data on its investigational therapeutic, Ampligen, entitled, "Chronic Fatigue Syndrome/Myalgic Encephalomyelitis (CFS/ME); Characteristics of Responders to Rintatolimod" in the current issue of Journal of Drug Research and Development. The team of authors is composed of Hemispherx staff, consultants and leading independent clinical experts in CFS/ME in the United States. Data from a previous Phase III clinical trial of Ampligen in patients with CFS/ME were retrospectively analyzed to determine whether baseline exercise tolerance (ET) could be used to predict responses to Ampligen (rintatolimod) vs. placebo. A modified Bruce ET treadmill test was used because of the severe physical exercise intolerance of CFS patients.
Intra-Cellular Therapies, Inc. (Nasdaq:ITCI) a biopharmaceutical company focused on the development of therapeutics for central nervous system (CNS) disorders, announced today that it is assuming sponsorship of the Investigational New Drug Application (IND) for studies related to ITI-214. ITI-214 is a novel, potent phosphodiesterase type 1 (PDE1) inhibitor. Multiple human clinical Phase 1 studies have been completed. In these studies, ITI-214 demonstrated a favorable safety profile and was generally well-tolerated across a broad range of doses both in healthy volunteers and in patients with schizophrenia with a pharmacokinetic profile that supports once daily dosing.
HTG Molecular Diagnostics, Inc. (Nasdaq:HTGM), a provider of instruments and reagents for molecular profiling applications, announced it has formed a technology partnership with The Centre of Excellence for the Prevention of Organ Failure (PROOF Centre) for an RNA-based liquid biopsy from peripheral blood, utilizing the NGS-based HTG EdgeSeq system. The heart transplant rejection blood test is intended to provide early indication of organ rejection in heart transplant patients, allowing doctors to better monitor and treat patients post-transplant. PROOF Centre is preparing to initiate clinical validation studies for their HTG EdgeSeq-based blood test, beginning at St. Paul's Hospital in Vancouver, Canada. "The development of this blood test was driven by demand from patients who typically have to undergo at least 12 invasive biopsies per year in the first year post-transplant. Currently, there is no globally accepted, affordable blood test available for monitoring heart transplant patients," says Dr. Bruce McManus, PROOF Centre CEO. "The heart transplant rejection blood test developed by PROOF Centre and deployed on the HTG platform will allow doctors to test patients during this crucial period."
India Globalization Capital, Inc. (IGC) announces that the company applied for a provisional patent based on a novel therapy that uses cannabinoid extracts from the cannabis plant for the treatment of cachexia. Cachexia is a condition that accompanies severe illness such as cancer and results in the weakness and wasting away of the body. In the U.S. it is estimated that a population of approximately 1.3 million are experiencing cachexia associated with cancer, multiple sclerosis, Parkinson's disease, HIV/AIDS and other progressive illnesses. Cancer induced anorexia cachexia is responsible for about 20% of all cancer deaths.
Lumenis Ltd. (NASDAQ:LMNS), the world's largest energy-based medical company for surgical, ophthalmology and aesthetic applications, and XIO Group jointly announced today that the merger transaction under which XIO Group will acquire Lumenis for $14.00 per share in cash, is expected to close by October 18, 2015.
Medigus Ltd. (NASDAQ:MDGS) (TASE:MDGS), a medical device company developing minimally invasive endosurgical tools and a leader in direct visualization technology, announced today that Chris Rowland, CEO, and Gilad Mamlok, CFO of Medigus, will present at the Ladenburg Thalmann 2015 Healthcare Conference on Tuesday, September 29 at 10:00 a.m. ET, Track 3 – St. Germain Room. The conference will be held at the Sofitel Hotel in New York City. A live webcast of the presentation will be available to the public at http://wsw.com/webcast/ladenburg/mdgs. The webcast will be archived for 90 days following the live presentation. Medigus management will be also available during the conference on September 29 for one-on-one meetings. To schedule a meeting, please contact your Ladenburg Thalmann representative or Miri Segal at [email protected]
MEDTECH (Euronext, FR0010892950 – ROSA), a company specialized in designing, developing and marketing innovative surgical assistance robots, is pleased to announce a new sale of its ROSA™ robot to Frankfurt University Hospital in Germany. Frankfurt University Hospital is one of the largest health establishments in Germany with more than 3,000 patients treated for neurological disorders per year. The neurosurgery department is of international renown and offers new approaches for the treatment of brain and spine diseases due to its commitment to equipping its patient care unit with the latest technology.
Merge Healthcare Incorporated (NASDAQ:MRGE), a leading provider of clinical systems and innovations that seek to transform healthcare, today announced a collaboration with ifa Systems AG to deliver high quality, affordable eye care technology services to the Singapore National Eye Center (SNEC), which manages more than 300,000 outpatient visits and 26,000 day surgeries annually. This collaboration will improve ophthalmologists' ability to review and digitize patient documentation leading to greater productivity and efficiency. Current and new clients using ifa Systems' EMR ophthalmology platform will have access to Merge PACS™ and Merge Eye Care PACS™. Integrating these tools within ifa Systems' EMR will ensure SNEC has access to comprehensive eye care instruments and diagnostic devices enhancing overall patient care.
Neothetics, Inc. (NASDAQ:NEOT), a clinical-stage specialty pharmaceutical company developing therapeutics for the aesthetic market, today announced that George Mahaffey, president and chief executive officer, was selected to present at the Orange County Summit on Aesthetics and Dermatology on September 26th at 4:30PM PT. The conference will be held at the Hyatt Regency Newport Beach.
Novavax, Inc. (Nasdaq:NVAX), a clinical-stage vaccine company focused on the discovery, development and commercialization of recombinant nanoparticle vaccines and adjuvants, today announced that Stanley C. Erck, President and CEO, will present at the Ladenburg Thalmann Healthcare 2015 Conference. Conference details are as follows: Date: Tuesday, September 29, 2015; Time: 1:30 – 1:55 p.m. US Eastern Time; Location: Sofitel Hotel, New York City. Live webcast: http://wsw.com/webcast/ladenburg/nvax. The webcast and a replay of the presentation will also be accessible under the “Investors/Events” section of the Novavax website at novavax.com.
Pain Therapeutics, Inc. (Nasdaq:PTIE) today reported that the National Institutes of Health (NIH) has awarded the Company a $1.7 million innovation grant. This grant award provides a path forward for the Company to develop a small molecule drug, called PTI-125, that offers a promising new approach to treat Alzheimer's Disease. "We are grateful to the National Institutes of Health for its support of our research program," said Remi Barbier, Chairman, President & CEO of Pain Therapeutics. "NIH has long been a supporter of innovative technologies that stand up to rigorous, peer reviewed scientific evaluation and that have the potential to benefit human health in areas of unmet needs, such as Alzheimer's Disease."
Pineapple Express, Inc. (OTC Pink:PNPL), formerly Globestar Industries and ticker symbol OTC Pink: GSTI, a Wyoming corporation engaged in cannabis industry consulting, announced that effective September 22, 2015, FINRA approved the Company's corporate actions changing its name to Pineapple Express, Inc. and its trading symbol to PNPL. "We are elated that we can finally begin our market awareness and branding initiatives for the company now that our name and symbol have been adopted on a regulatory basis," stated Matthew Feinstein, CEO and Chairman for the Company. "Branding is the number one priority that all public companies in the cannabis sector should focus on. We feel that our Pineapple Express brand gives us a key advantage and allows us a head-start on our business development initiatives and market awareness objectives."
Provista Diagnostics, Inc., a privately-held molecular diagnostics company developing and commercializing a new generation of proprietary blood-based diagnostic, prognostic, and monitoring tests designed to address the unmet needs in cancers affecting women including breast and gynecologic cancers, today announced the reelection of the company's Board of Directors. "The reelection of the Board of Directors demonstrates the ongoing commitment to our business, product, and development in women's health," said David E Reese, Ph.D., President and CEO of Provista.
SAGE Therapeutics (NASDAQ:SAGE), a clinical-stage biopharmaceutical company developing novel medicines to treat life-altering central nervous system (CNS) disorders, today announced the following appointments: Anne Marie Cook joins SAGE as Senior Vice President, General Counsel; Jim Doherty, Ph.D., is promoted to Senior Vice President of Research; Heinrich Schlieker, Ph.D., joins SAGE as Senior Vice President of Technical Operations; Ryan Arnold, D.O., joins SAGE as Vice President of Medical Affairs.
Simavita (ASX:SVA) (TSXV:SV), developer of the Smart Incontinence Management (SIM™) medical device, the world's first wearable integrated digital technology solution for continence care assessment and management, is pleased to recognize the National Fall Prevention Awareness Week 2015 by making its first U.S. pilot study available for healthcare providers at www.simavita.com. The association between incontinence and falls in people over the age of 70 has been widely established in the scientific literature. Results from a large retrospective study confirmed the correlation between incontinence and falls for people over the age of 70 and demonstrated that a higher degree of incontinence is associated with a higher risk of falls.i Research also indicates that up to 50 percent of all falls in long term care facilities are incontinence-related.ii
Sonendo®, Inc., the developer of a transformative technology for the endodontic marketplace, today announced that the Company has appointed Christopher Rabbitt as Chief Commercial Officer. Mr. Rabbitt will be responsible for driving the commercialization strategy for Sonendo's GentleWave™ System and future technologies. "Chris brings considerable sales and marketing leadership experience and a strong track record of driving sustained sales growth leveraging highly differentiated technologies with compelling value propositions, making him a great fit for Sonendo," stated Bjarne Bergheim, President and Chief Executive Officer of Sonendo. "His expertise will be crucial as we look to transform the endodontic therapy market, improve the patient experience, increase procedural success rates, and improve practice economics for our customers." Drug discovery and development company SCYNEXIS, Inc. (Nasdaq:SCYX) announced today that results of three nonclinical studies of the company's lead clinical drug candidate, SCY-078, were presented in podium and poster presentations at the 55th Annual Interscience Conference of Antimicrobial Agents and Chemotherapy (ICAAC) and the International Congress of Chemotherapy (ICC) joint meeting in San Diego, California.
Stereotaxis, Inc. (NASDAQ:STXS), a global leader in innovative technologies for the treatment of cardiac arrhythmias, today announced that J. David Burkhardt, M.D. of the Texas Cardiac Arrhythmia Institute (TCAI) at St. David's Medical Center in Austin, TX has surpassed 1,000 electrophysiology (EP) procedures performed with the Niobe® remote magnetic navigation system. Dr. Burkhardt is the first in the U.S. to achieve this significant milestone and one of the top five Niobe system users globally. More than 82,000 procedures have been conducted worldwide with the Niobe system.
TESARO, Inc. (NASDAQ:TSRO), an oncology-focused biopharmaceutical company, today announced the appointment of Martin Huber, M.D., to the position of Senior Vice President and Chief Medical Officer. Dr. Huber will report to Mary Lynne Hedley, Ph.D., President and COO of TESARO, and will lead the global medical development, medical affairs and pharmacovigilance & safety functions at TESARO. Dr. Huber most recently served as Vice President, Oncology Clinical Research, at Merck Research Laboratories. "I am pleased to welcome Marty to TESARO at such a pivotal time for the company as we launch VARUBI™, expand the development of our lead anticancer product candidate, niraparib, and advance our first immunology-oncology agents into the clinic," said Mary Lynne Hedley. "Marty's deep oncology drug development experience and strong leadership skills will be invaluable to us as we work to provide transformative therapies to people facing cancer."
Xenon Pharmaceuticals Inc. (Nasdaq:XENE), a clinical-stage biopharmaceutical company, today announced that the Company has achieved a milestone in its pain genetics discovery collaboration with Genentech, a member of the Roche Group, triggering a milestone payment. Xenon and Genentech have successfully discovered and identified a novel pain target by leveraging Xenon's Extreme Genetics™ platform based on the study of rare phenotypes of individuals who have either an inability to perceive pain or have non-precipitated spontaneous severe pain. "We are proud of our progress in our discovery collaboration with Genentech, which underscores the potential of our Extreme Genetics discovery platform and our ability to identify novel targets and pathways that may play a causal role in the sensation of pain," said Dr. Simon Pimstone, President and Chief Executive Officer of Xenon. "There is a critical need for non-opioid alternatives for patients with chronic pain. We look forward to working further with Genentech to discover additional targets that could yield novel therapeutics."