|Celator Announces Positive Results from R&D Programs; Keryx Receives European Approval for Fexericx|
|By Marilyn Mullen|
|Thursday, 24 September 2015 19:36|
Below is a look at some of the headlines for companies that made news in the healthcare sector on September 24, 2015.
Celator Pharmaceuticals, Inc. (NASDAQ: CPXX), a biopharmaceutical company that is transforming the science of combination therapy and developing products to improve patient outcomes in cancer, announced their successful R&D efforts to apply the CombiPlex® technology platform to optimize the efficacy of anticancer drug combinations incorporating molecularly targeted agents (MTAs).
CombiPlex is Celator's proprietary technology that aims to address several of the fundamental shortcomings of conventional combination regimens, as well as the inherent challenges in combination drug development. Celator is applying this technology to create new drug combinations that target pathways associated with tumor cell growth and/or resistance to treatment. Such MTAs are being widely pursued with an increasing focus on combining agents that target multiple cellular pathways in order to improve therapeutic responses.
"While there have been promising signs of activity for certain molecularly targeted agents, it is clear that combinations will be required for optimal efficacy," said Dr. Joseph Bertino, chief scientific officer at Rutgers Cancer Institute of New Jersey and chairman of Celator's Scientific Advisory Board. "In addition, many combinations will require simultaneous exposure and attempts to accomplish this to date have often led to toxicity problems."
CombiPlex is well positioned to address the challenges with the development of combination drug candidates. Nano-scale delivery systems coordinate the pharmacokinetics (PK) of drug combinations after administration so that the optimal ratio of the two drugs is exposed to tumor cells for prolonged times while reducing drug exposure and toxicity to normal tissues.
Recent results from preclinical studies conducted by Celator suggest the technology may significantly improve the therapeutic index of combinations containing MTAs. Celator's efforts have focused on two combinations: the heat shock protein 90 inhibitor AUY922 combined with docetaxel and the MEK inhibitor selumetinib combined with the Akt inhibitor ipatasertib. In both cases, the drug combinations were stably co-formulated in Celator's proprietary hydrophobic prodrug nanoparticle delivery systems which provided well-coordinated plasma concentrations over 24 hours that were orders of magnitude higher than observed for the free drug combinations. Free drug combinations refer to the drugs as they are currently administered; individual drugs administered in combination without regard to their ratio dependent interaction. In addition, whereas combined treatment with the free drugs required marked dose reductions due to toxicity, the nanoparticle formulations could be administered at higher doses.
For both combinations, the CombiPlex formulations provided significant improvements in efficacy over the free drugs in human xenograft tumor models including breast, colorectal and ovarian. Furthermore, there was evidence of strong drug ratio-dependent efficacy and in vivo synergy.
Another benefit observed during this research was the versatility and modular nature of the nanoparticle technology. Once formulation conditions were optimized for the two initial combinations, the drug components could be "mixed and matched," rapidly generating additional CombiPlex products with coordinated PK. This versatility was then taken one step further by generating a 3-drug combination, co-formulating selumetinib, AUY922 and docetaxel into a single hydrophobic prodrug nanoparticle.
The data have been accepted for presentation at the 2015 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics being held in Boston, MA November 5-9.
"We are very pleased with the data packages generated on the CombiPlex formulations containing molecularly targeted agents," said Dr. Lawrence Mayer, president and chief scientific officer at Celator. "CombiPlex appears to address difficulties associated with the free drugs, resulting in important efficacy improvements. We achieved this milestone on time, and believe these data may help Celator establish collaborative R&D programs with pharma partners where CombiPlex can provide a strategic advantage for their agents."
Keryx Biopharmaceuticals, Inc. (NASDAQ: KERX), announced the European Commission has approved Fexeric® (ferric citrate coordination complex) for the control of elevated serum phosphorus levels, or hyperphosphatemia, in adults with chronic kidney disease (CKD), including both dialysis and pre-dialysis patients. The European Commission considered ferric citrate coordination complex a New Active Substance, which provides 10 years of data and marketing exclusivity in Europe.
"We are pleased that this medicine was approved for broad use, in both the pre-dialysis and dialysis settings, to control hyperphosphatemia in adults with chronic kidney disease," said John Neylan, M.D., chief medical officer of Keryx. "Importantly, the EU product information contains data that is reflective of Fexeric's full clinical profile, including all of the primary and secondary endpoint data from the Phase 3 study. With Fexeric's broad label, nephrologists have a new, well tolerated and effective phosphate binder to control hyperphosphatemia as the patient progresses through the late stages of CKD and into dialysis."
"The differentiated profile of ferric citrate will be a new treatment option for our patients on dialysis and pre-dialysis," said Gilbert Deray, MD, Professor of Nephrology at Université Paris 6 Pierre et Marie Curie in Paris.
Aduro Biotech, Inc. (Nasdaq:ADRO) and BioNovion Holding B.V. announced today that they have entered into a definitive agreement for Aduro to acquire BioNovion, a privately held monoclonal antibody discovery and development company based in The Netherlands. The acquisition will further strengthen and expand Aduro's immunotherapy capabilities to now encompass monoclonal antibodies, including preclinical assets that inhibit clinically validated immune checkpoint pathways. Such immune checkpoint inhibitors could potentially be used alone or in combination with Aduro's LADD and CDN platforms to increase immunotherapy potency and durability. In addition, BioNovion has a rich pipeline of novel preclinical monoclonal antibodies which inhibit or activate unique immune response pathways that have a role in controlling the progression of diverse malignancies. BioNovion has developed a proprietary technology to rapidly produce a broad library of therapeutic antibodies against validated targets, including PD1 and CTLA-4, as well as several undisclosed novel targets. Also, BioNovion's pipeline includes an APRIL antagonist and five bispecific antibody programs against immune-oncology targets under collaboration with Genmab using Genmab's proprietary DuoBody Technology.
Alphatec Holdings, Inc. (Nasdaq:ATEC), the parent company of Alphatec Spine, Inc., a global provider of spinal fusion technologies, announced today that the Company’s Arsenal Cortical Bone Fixation system, Arsenal CBx, has successfully been used in over fifty patients during its limited market release, which began in the second quarter of 2015. The Arsenal CBx system provides surgeons with an alternative procedure to traditional pedicle screw placement, by utilizing a midline approach and cortical bone trajectory to achieve maximum fixation through a less-invasive procedure. The Company will be showcasing the Arsenal CBx implants and instrumentation, as well as its portfolio of products at the upcoming North American Spine Society (NASS) Annual Meeting being held at McCormick Place West, Chicago, Illinois, from October 14th - 16th, 2015. Alphatec Spine will be located in booth number 1147.
athenahealth, Inc.(NASDAQ:ATHN), a leading provider of cloud-based services and mobile applications for medical groups and health systems, and Summit Medical Group, PLLC (SMG), East Tennessee's leading primary care organization, today announced that SMG has selected athenahealth's cloud-based population health service, athenaCommunicator Enterprise, to enhance care coordination and advance its population health management initiatives. athenahealth's services will be provided by Summit Strategic Solutions, LLC (SSS), a Management Service Organization. Based in Knoxville, SMG includes 220 providers who work with SSS to coordinate care for one of East Tennessee's largest at-risk patient populations. Based on its performance implementing value-based care strategies and participating in Medicare Advantage plan contracts, SSS is identified as a national leader in population health.
Avant Diagnostics, Inc. (OTCQB:AVDX), an innovative molecular diagnostics company, began calibration testing in preparation for the validation study of OvaDx®, which will be used to support a pre-Submission package to the United States Food and Drug Administration. Avant expects to have the calibration testing completed within 30 days. Once the calibration testing is completed, Avant plans to test the previously purchased set of ovarian cancer specimens, including serial sets obtained from women diagnosed previously with ovarian cancer, which will serve as the validation study and form the basis of the pre-Submission package that will be submitted to FDA for review and comment prior to the commencement of the OvaDx® 510(k) trial. The OvaDx® microarray test is intended for use as an aid in monitoring women diagnosed previously with ovarian cancer. The validation study and 510(k) trial will be conducted in a double-blinded environment supervised by DOCRO, Inc., an independent clinical research organization. The results from the validation study are expected to be published in a peer-reviewed scientific journal within six months of test completion and data analysis.
Bellerophon Therapeutics, Inc. (Nasdaq:BLPH), a clinical-stage biotherapeutics company, today announced positive data from an interim analysis of the Company's Phase 2 long-term extension study of INOpulse for the treatment of Pulmonary Arterial Hypertension (PAH) (Part 2 of the Company's Phase 2 trial). The data reinforce the results from Part 1 of the Phase 2 trial and indicate a sustainability of benefit to PAH patients who received INOpulse therapy. Bellerophon also reported today that the U.S. Food and Drug Administration (FDA) has issued a Special Protocol Assessment (SPA) for the Company's Phase 3 PAH program for INOpulse, which will include two confirmatory clinical trials, undertaken either sequentially or in parallel, with the first patient expected to be enrolled later this year. A conference call to discuss today's news will be held tomorrow, Friday, September 25, 2015 at 9:00am ET. Details on the conference call are provided below.
Caladrius Biosciences, Inc. (NASDAQ:CLBS), a cell therapy company combining an industry-leading external development and manufacturing provider with a development pipeline including a Phase 3 clinical program in immuno-oncology and a portfolio of projects in immune modulation and ischemic repair, announces that it has received a $300,000 contract from the National Institutes of Health's (NIH) National Cancer Institute (NCI) to wholly fund the first phase of a project for process optimization of its therapeutic agent targeting tumor-initiating cells (often referred to as cancer stem cells). The contract anticipates an additional $2 million in funding for the project should both the government and Caladrius agree to proceed at the conclusion of the first phase which is expected in June 2016. Hans Keirstead, PhD, Chief Science Officer of Caladrius, is the principal investigator for the project.
Capnia, Inc. (NASDAQ:CAPN), focused on the development of novel products based on its proprietary technologies for precision metering of gas flow, today announced a paper, titled "Measuring End-Tidal Carbon Monoxide of Jaundiced Neonates in the Birth Hospital to Identify Those with Hemolysis," has been published online in Neonatology (2016;109:1-5 [DOI:10.1159/000438482]). This peer-reviewed paper, which is expected to appear in the January 2016 print issue, discusses recent clinical research demonstrating the superiority of CoSense® End-Tidal Carbon Monoxide (ETCO) Monitor at detecting hemolysis in jaundiced newborns.
Cempra, Inc. (Nasdaq:CEMP), a clinical-stage pharmaceutical company focused on developing antibiotics to meet critical medical needs in the treatment of bacterial infectious diseases, today announced it will be making a poster presentation at the European Respiratory Society (ERS) International Congress, being held in Amsterdam from September 26-30, 2015. Presentation at ERS International Congress: A poster presentation will be made on Cempra's Phase 3 clinical trial for oral solithromycin in which oral solithromycin was found to be non-inferior to and have a comparable safety and tolerability profile versus oral moxifloxacin for treatment of adult community acquired bacterial pneumonia (CABP). In elderly patients and those with COPD or asthma, compared to moxifloxacin, the number of responders on solithromycin was numerically greater. Late-Breaking Abstract (PA2655), Hall 14-29, Session 277, September 28, 12:50 p.m. CET. An abstract is available from the ERS website at www.erscongress.org.
EDAP TMS SA (Nasdaq:EDAP), the global leader in therapeutic ultrasound, today provided an update on the growing momentum being experienced by HIFU technology in the European market, in particular the rapidly increasing interest in the use of focal therapy in the treatment of prostate cancer. On September 15-17, 2015, EDAP actively participated in the EAU Robotic Urology Section (ERUS) congress held in Bilbao, Spain, where a remote prostate cancer HIFU treatment using Focal One® was performed live by Dr. Rochat and Dr. Regusci from the Geneva Beaulieu Hospital. The HIFU treatment was shown live to more than 300 robotic surgeons with interactive discussions taking place. The event was well attended by leading urologists with a focus on robotic surgery who are seeking a focal option to complement their surgical offering for prostate cancer.
Entellus Medical, Inc. (NASDAQ:ENTL), a medical technology company focused on the design, development and commercialization of products for the minimally invasive treatment of chronic and recurrent sinusitis patients in the physician office setting or operating room, today announced the release of its MiniFESS family of products and its FocESS Sinuscopes, representing a total of eleven new products. These products are designed to enable, enhance and expand the number of patients who can benefit from the superior patient experience and improved healthcare economics offered by office-based treatment. In combination with effective local anesthesia protocols, the MiniFESS family of products features eight steel surgical instruments designed to enable procedures from turbinate reductions to anterior ethmoidectomies to be performed in the ENT physician office instead of the operating room. This transition to the ENT physician office offers patients reduced risk and requires less time than a traditional operating room procedure using general anesthesia.
Galectin Therapeutics Inc. (NASDAQ:GALT), the leading developer of therapeutics that target galectin proteins to treat fibrosis and cancer, announces the start of a 10-patient pilot study with GR-MD-02 in patients with moderate-to-severe plaque psoriasis. The genesis of this study is the apparent remission of a patient with severe psoriasis who participated in the Company's Phase 1 study cohort of 4 mg/kg of GR-MD-02 for the treatment of non-alcoholic steatohepatitis (NASH). That patient received her fourth infusion of GR-MD-02 in May 2014, and her psoriasis remained in complete remission for 17 months, with slight scaling becoming evident on her elbows just this month. "We are excited to begin this study at the Brooke Army Medical Center in San Antonio, Texas," said Peter G. Traber, M.D., Galectin's president, chief executive officer and chief medical officer. "We know from the scientific literature that galectin-3 is at higher levels in the skin of psoriasis patients, and that GR-MD-02 inhibits galectin-3. It would follow that GR-MD-02 could affect this disease. We are hopeful that patients with moderate-to-severe plaque psoriasis will show a clearing of their disease without the negative side effects associated with many of the currently available therapies. In addition, a successful pilot study would add to our robust therapeutic pipeline for this compound."
Global Blood Therapeutics (NASDAQ:GBT), a biopharmaceutical company developing novel therapeutics for the treatment of grievous blood-based disorders with significant unmet needs, today announced the appointment of Philip A. Pizzo, M.D., founding director of the Stanford Distinguished Careers Institute and former Dean of Stanford University School of Medicine, to the Company's Board of Directors. "We are delighted to expand our Board of Directors to add an individual with such robust and specialized knowledge as Dr. Philip Pizzo," said Ted W. Love, M.D., chief executive officer of GBT. "Dr. Pizzo is a distinguished physician and brings unparalleled pediatrics expertise from which we will benefit as we aim to transform the treatment of severe blood disorders such as sickle cell disease, a chronic condition that begins in early childhood."
Green Technology Solutions, Inc. (OTCBB: GTSO) remains hard at work developing and marketing new solutions for cannabis businesses across the country as the emerging industry continues to smash new milestones. Colorado, the state on the cutting edge of the nation’s regulated cannabis industry, is now on pace to nearly double its revenues from sales of the plant. In 2014, Colorado brought in $76 million in revenues from its excise, retail and medical cannabis taxes. Seven months later, the state has collected $73.5 million, with many experts predicting that it will rake in more than $125 million this year. GTSO attributes the boom in revenues to a boom in demand, with industry professionals and consumers becoming comfortable with new laws and products.
Herbalife (NYSE: HLF) has announced a $15,000 donation as part of its ongoing commitment as Official Nutrition Sponsor of the 2015 YMCA Stair Climb for Los Angeles. This is the third straight year Herbalife will serve as the Official Nutrition Sponsor of the YMCA Stair Climb. The $15,000 donation will help support the downtown YMCA’s programs that promote youth development, healthy living and social responsibility. The YMCA stair climb—taking place on Friday, September 25—will showcase a range of Herbalife sports nutrition products throughout the event, including Herbalife’s popular H30 hydration product and its effervescent Liftoff® energy product, all designed to keep athletes of all levels fueled during competition. Herbalife products will be placed into 4,000 gift bags prepared by the YMCA for stair climb participants.
Intra-Cellular Therapies, Inc. (Nasdaq:ITCI), a biopharmaceutical company focused on the development of therapeutics for central nervous system (CNS) disorders, today announced that Sharon Mates, Ph.D., Chief Executive Officer and Chairman, will present at the Ladenburg Thalmann 2015 Healthcare Conference 2015 in New York, NY. The presentation is scheduled for Tuesday, September 29, 2015 at 11:30 AM EDT. The live and archived webcast can be accessed under "Events & Presentations" in the Investor Relations section of the Company's website at www.intracellulartherapies.com. Please log in approximately 5-10 minutes prior to the event to register and to download and install any necessary software.
KemPharm, Inc. (NASDAQ:KMPH), a clinical-stage specialty pharmaceutical company engaged in the discovery and development of proprietary prodrugs, announced today that KemPharm has initiated the development of an acetaminophen (APAP)-free formulation of its immediate release (IR) hydrocodone product, KP201, adding to its hydrocodone prodrug pipeline of product candidates. KemPharm expects this highly differentiated product candidate to feature the same abuse-deterrent properties demonstrated by KP201/APAP, KemPharm's most advanced product candidate, in the most recent clinical trial, KP201.A03. In addition, the Company announced it has initiated the development of an IR formulation of its oxycodone prodrug, KP606.
Keryx Biopharmaceuticals, Inc. (Nasdaq:KERX) today announced that the European Commission has approved Fexeric® (ferric citrate coordination complex) for the control of elevated serum phosphorus levels, or hyperphosphatemia, in adults with chronic kidney disease (CKD), including both dialysis and pre-dialysis patients. The European Commission considered ferric citrate coordination complex a New Active Substance, which provides 10 years of data and marketing exclusivity in Europe. "We are pleased that this medicine was approved for broad use, in both the pre-dialysis and dialysis settings, to control hyperphosphatemia in adults with chronic kidney disease," said John Neylan, M.D., chief medical officer of Keryx. "Importantly, the EU product information contains data that is reflective of Fexeric's full clinical profile, including all of the primary and secondary endpoint data from the Phase 3 study. With Fexeric's broad label, nephrologists have a new, well tolerated and effective phosphate binder to control hyperphosphatemia as the patient progresses through the late stages of CKD and into dialysis."
MEDTECH (Euronext, FR0010892950 – ROSA), a company specialized in designing, developing and marketing innovative surgical assistance robots, is proud to announce that it will highlight its ROSA™ robotic surgery system at the 2015 Congress of Neurological Surgeons (CNS) Annual Meeting, held in New Orleans (USA) from September 28 to 30, 2015. The CNS Annual Meeting is a premier forum gathering around 3,000 specialists in the field of neurosurgery and featuring the most cutting-edge procedures, approaches, and technologies in the field. MEDTECH will be exhibiting two ROSA™ robotic surgery systems at its booth (#417) for hands-on demonstrations of surgical procedures on the brain and spine.
Medical Marijuana, Inc. (OTC Pink:MJNA) is announcing the next milestone achievement in their plan to actively and aggressively register a pipeline of cannabis products for healthcare professionals and pharmacies. For the first time, twelve of Medical Marijuana, Inc.'s products received overseas registration and approval as international medicinal products. This opens the ability for pharmacies and healthcare providers to distribute cannabis products to patients. "HempMeds is proud to announce that 12 of our RSHO products have received certificates of approval 'Registro de Medicamentos' issued by Departmento de Salud (Department of Health)," states Stuart W. Titus, PhD and Chief Executive Officer of Medical Marijuana, Inc. "Our distribution partners have many inroads within the local over-the-counter and pharmacy space, thus we look forward to supporting their efforts with education and future studies regarding the benefits of natural botanical hemp-based CBD products."
Minerva Neurosciences, Inc. (NASDAQ:NERV), a clinical-stage biopharmaceutical company focused on the development of innovative therapies to treat central nervous system (CNS) disorders, today provided an update on two ongoing clinical trials with MIN-202 (JNJ-42847922), a selective orexin-2 receptor antagonist under joint development with Janssen Pharmaceutica NV. Patient recruitment is ongoing in both trials, which include a Phase 2a trial in insomnia disorder and a Phase 1b trial in adjunctive major depressive disorder (MDD). "We are pleased with the progress that is being made in the development of MIN-202 in insomnia and adjunctive MDD," said Dr. Remy Luthringer, president and chief executive officer of Minerva. "The ongoing trials in these indications are designed to provide assessments of the effects of this compound in sleep and major depressive disorder. We believe that MIN-202 has the potential to physiologically regulate biological rhythm and control of the wake drive based on its unique mechanism of action as a selective orexin-2 receptor antagonist."
Myriad Genetics, Inc. (NASDAQ:MYGN), a leader in molecular diagnostics and personalized medicine, today announced three poster presentations that will be featured at the 40th European Society for Medical Oncology (ESMO) meeting being held Sept. 25 to 29, 2015 in Vienna, Austria. The presentations include new studies on the myChoice™ HRD and Tumor BRACAnalysis CDx™ companion diagnostic tests and final results from the EMPATHY-P clinical utility study on Prolaris®. "Myriad continues to place a strong emphasis on molecular diagnostic research with the goal of enabling personalized medicine and improving patient outcomes. We are presenting exciting new data on the unique ability of our companion diagnostics to identify the highest number of patients who may benefit from drugs that target the DNA-repair pathway, such as PARP inhibitors," said Jerry Lanchbury, Ph.D., chief scientific officer, Myriad. "We're also presenting the final results for the EMPATHY-P study that show the Prolaris test provides essential clinical information to help physicians select men with prostate cancer who are good candidates for active surveillance versus those who need more medical treatment based on a genetic evaluation of their tumor."
Neuralstem, Inc. (Nasdaq: CUR), a biopharmaceutical company using neural stem cell technology to develop small molecule and cell therapy treatments for central nervous system diseases, announced that principal investigator, Eva Feldman, MD, PhD, will give an update on NSI-566 Phase I and Phase II trial data in amyotrophic lateral sclerosis (ALS) at the American Neurological Association Annual Meeting in Chicago, Il on Monday, September 28, 2015. Dr. Feldman will review the current state of cell-based therapies being studied for the treatment of neurological disorders, including Neuralstem's NSI-566, an investigational spinal cord-derived stem cell therapy in development for ALS, in "The Current State of Stem Cell Therapies" session. The Phase I and II trials are the first in the world to use intraspinal stem cell transplantation. She will also discuss NSI-532.IGF, Neuralstem's next-generation cell therapy for Alzheimer's disease, at the meeting as part of the "Dementia and Aging" special interest group symposium. Dr. Feldman is Director of the A. Alfred Taubman Medical Research Institute and Director of Research of the ALS Clinic at the University of Michigan Health System, and an unpaid consultant to Neuralstem.
NewLink Genetics Corporation (NASDAQ:NLNK) announced today that the Defense Threat Reduction Agency (DTRA) of the United States Department of Defense has awarded a subsidiary of NewLink Genetics an $8.1 million base contract with future options totaling $5.2 million to support various development activities of the investigational rVSV-ZEBOV (Ebola) vaccine candidate. NewLink has exclusively licensed research, development and manufacturing of the rVSV-ZEBOV vaccine to Merck. The rVSV-ZEBOV (Ebola) vaccine candidate was originally developed by the Public Health Agency of Canada (PHAC) and was subsequently licensed to a subsidiary of NewLink Genetics. In late 2014, Merck, known as MSD outside the United States and Canada, licensed the vaccine from NewLink Genetics to apply Merck's vaccine expertise to help accelerate the development of this vaccine candidate. Clinical studies of the rVSV-ZEBOV are ongoing.
NewLink Genetics Corporation (NASDAQ:NLNK), a biopharmaceutical company at the forefront of discovering, developing and commercializing novel immuno-oncology product candidates to improve the lives of patients with cancer, today announced that data from a phase 1a study of GDC-0919, an IDO checkpoint inhibitor being developed in collaboration with Genentech, a member of the Roche Group, will be presented at the European Cancer Congress 2015 (ECC) being held September 25-29 in Vienna, Austria.
Oramed Pharmaceuticals, Inc. (NASDAQ: ORMP), a developer of oral drug delivery systems, announced today that the Company's patent for its invention, titled "Methods and Compositions for Oral Administrations of Proteins" has been allowed by the United States Patent and Trademark Office. Nadav Kidron, CEO of Oramed, stated, "This is an important milestone which paves our entrance into the US diabetes market which is the largest single diabetes market worldwide." About ORMD-0801 Capsule for Type 2 Diabetes -- ORMD-0801 has the potential to create a new paradigm in the treatment of diabetes by oral delivery of insulin at an earlier stage of treatment, potentially slowing disease progression and delaying or even eliminating late-stage complications. Orally administered insulin should bring with it enhanced patient compliance. In addition, intestinally absorbed-oral insulin actually mimics insulin's natural location and gradients in the body by first passing through the liver before entering the bloodstream.
Otonomy, Inc. (Nasdaq:OTIC), a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapeutics for diseases and disorders of the ear, today announced the upcoming presentation of results from two of its programs; Phase 3 trials evaluating AuriProTM in pediatric patients with middle ear effusion undergoing tympanostomy tube placement surgery, and a Phase 2b trial evaluating OTO-104 in patients with unilateral Ménière's disease. Clinical results from these studies will be presented at the 2015 American Academy of Otolaryngology - Head & Neck Surgery Foundation (AAO-HNSF) Annual Meeting being held in Dallas on September 27-30, 2015. The results for both programs have been previously announced or presented.
Pineapple Express, Inc. (OTC Pink:PNPL), a Wyoming corporation engaged in cannabis industry consulting, announced today that it has retained CorProminence, LLC, a leading investor relations and strategic advisory firm, to assist the Company with investor relations and shareholder communications services. CorProminence will focus on expanding market awareness for Pineapple Express, conveying the Company's business model and growth strategies to the institutional and retail investment communities. CorProminence, LLC, a boutique investor relations firm, specializes in leveraging the most effective investment, growth and exposure strategies for small to mid-sized companies through an integrated approach to relationship development and corporate communications. "We are very pleased to engage CorProminence to expand our outreach and communications efforts to the institutional and retail investment communities," said Matthew Feinstein CEO, President, Chairman and Co-Founder of Pineapple Express. "We have a very compelling story that we feel will be well received as we raise awareness with our continued outreach efforts," he continued.
Portola Pharmaceuticals (Nasdaq:PTLA) today announced the appointment of David C. Stump, M.D., to its board of directors. Dr. Stump most recently served as executive vice president, research and development, at Human Genome Sciences, Inc. "Dr. Stump has over 25 years of experience, most notably at Genentech and Human Genome Sciences, bringing some of the most successful drugs for heart disease, stroke, B-cell lymphoma and other cancers through the clinic and regulatory process to the market," said Bill Lis, chief executive officer of Portola. "His knowledge, network and track record are directly and immediately relevant and applicable as we enter the pivotal phases of our three near-term pipeline opportunities that could transform Portola to a fully integrated commercial biopharmaceutical company in 2016."
SANUWAVE Health, Inc. (OTCQB:SNWV), announced today the issuance of U.S. Patent Number 9,119,888 by the U.S. Patent and Trademark Office entitled "Methods for Cleaning and Sterilization of Implant Tissue Ex Vivo with Shock Waves" that has a maximum term extending to September 2030. For repair of damaged tissue as skin, tendons, ligaments, cartilage, bones, etc. the modern medicine uses harvested tissues from human donors and cadavers or animals. The harvested tissue needs to be cleaned and sterilized to not introduce any pathogens into the implantation target and to not trigger any infection and immune rejection. The cleaning of harvested tissues is done with ethanol, ether, acetone and hydrogen peroxide and for sterilization the method of preference is irradiation. This new patent issued to SANUWAVE includes nineteen claims related to the use of shock waves to clean and sterilize harvested human or animal tissues for human implantation to reduce or avoid the use of chemicals or irradiation. Furthermore, this patent describes the use of shock waves in cleaning and sterilization methods that can be done manually or automatically for both soft and hard tissue harvested for implantation.
Signal Genetics, Inc. (NASDAQ:SGNL), a commercial stage, molecular genetics diagnostic company focused on providing innovative diagnostic services that help physicians make better-informed decisions concerning the care of their patients suffering from cancer, today announced the grant of EU Patent Number 2537942 for its proprietary MyPRS® genetic test. The patent, which was published on September 23, 2015, covers the use of the Company's gene expression profiling assay to predict survival in multiple myeloma patients. With the patent in place, the Company plans to seek licensing opportunities with European partners in order to expand its global footprint for MyPRS®.
Skyline Medical Inc. (NASDAQ:SKLN) (NASDAQ:SKLNU) today issued the following letter to shareholders: Dear Fellow Shareholders, Skyline Medical has never been in a stronger position for long-term success. Given recent commercial accomplishments, as well as the enhanced capital position of the company and our NASDAQ listing, we want to take this opportunity to highlight our plans to drive future growth. Thus far in 2015, with limited sales personnel, we have signed numerous agreements with major hospitals. In total, there are 90 STREAMWAY® Systems installed in 45 hospitals and surgery centers in 19 states across the U.S., including the recent addition of several larger hospitals, teaching hospitals and surgical centers, such as Duke University Health System, Beth Israel Deaconess Medical Center (a Harvard Medical School Affiliate), Dartmouth-Hitchcock Medical Center, Penn State Milton S. Hershey Medical Center and Oscar G. Johnson VA Medical Center. We believe the early adoption of our product by such esteemed institutions further highlights our product as the best for its application.
Summit Therapeutics plc (AIM:SUMM) (NASDAQ:SMMT), the drug discovery and development company advancing therapies for Duchenne muscular dystrophy ('DMD') and Clostridium difficile infection, today announced that it will present additional clinical data from its Phase 1b modified diet trial of SMT C1100 for the treatment of DMD, as well as preclinical data supporting SMT C1100 and the broader utrophin modulation pipeline, at the 20th International Congress of the World Muscle Society, taking place 30 September-4 October 2015 in Brighton, UK.
TESARO, Inc. (NASDAQ:TSRO), an oncology-focused biopharmaceutical company, today announced the decision of the National Comprehensive Cancer Network (NCCN) to include VARUBI™ (rolapitant) in the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) Antiemesis Version 2.2015, as a recommended option in combination with other antiemetic agents for patients receiving both high emetic risk intravenous chemotherapy (HEC) and moderate emetic risk intravenous chemotherapy (MEC). Category 1, the highest level category of evidence and consensus, was granted to rolapitant for both HEC and MEC chemotherapy. VARUBI is a selective and competitive antagonist of human substance P/neurokinin 1 (NK-1) receptors, with a plasma half-life of approximately seven days. Results from three Phase 3 trials of VARUBI demonstrated a significant reduction in episodes of vomiting or use of rescue medication during the 25 to 120 hour period following administration of highly emetogenic and moderately emetogenic chemotherapy regimens.
TOMI™ Environmental Solutions, Inc. (OTCQB:TOMZ), a global bacteria decontamination and infection prevention company, announced it signed an exclusive agreement with the Singapore Distribution Team to distribute TOMI's SteraMist™ product platform in Singapore. The Singapore Distribution Team is headed by Dr. Hasbi Abu Bakar, Mohamad Hafidz and Muhammad Faezin. TOMI received approximately $178,000 in initial order of SteraMist products. Dr. Hasbi stated: "We are excited to distribute SteraMist to our Singapore customers as it offers distinct advantages in speed and efficacy over competing disinfectants and sporicides. While we will first target the hospital and healthcare industries in Singapore, there is also significant opportunity for TOMI's SteraMist platform in additional markets such as childcare and educational facilities where the threat of infectious disease, virus and bacteria is present. We look forward to partnering with TOMI to expand its share of the disinfection market."
VBI Vaccines Inc. (Nasdaq:VBIV) is scheduled to present at the Sachs Associates' 15th Annual Biotech in Europe Forum on Tuesday, September 29th at 6:45 AM ET (12:45 PM CST). The event is being held at the Congress Center Basel in Basel, Switzerland. Jeff Baxter, VBI's President and CEO, will provide an overview of VBI's business during his presentation. In addition, Mr. Baxter will participate in a vaccines panel discussion on September 29th at 3:45 AM ET (9:45 AM CST). The Biotech in Europe Forum brings together a cross-section of early-stage, late-stage, and public companies with leading investors, analysts, money managers, and pharmaceutical licensing executives. For more information, visit: http://bit.ly/sachs-2015.
Xenon Pharmaceuticals Inc. (Nasdaq:XENE), a clinical-stage biopharmaceutical company, today announced the initiation of a Phase 1 clinical trial of its lead proprietary program, XEN801, as a potential treatment for acne. The Clinical Trial Application (CTA) for XEN801 was accepted by Health Canada and the first patient has been dosed in the Phase 1 clinical trial. If supported by positive data from the Phase 1 trial, the Company plans to initiate a proof-of-concept Phase 2 trial in patients with moderate-to-severe acne by the end of the year with data expected in 2016. XEN801 is a novel, topically administered, selective, small molecule inhibitor of stearyl Co-A desaturase (SCD1), an enzyme involved in lipid synthesis that is expressed in sebaceous glands in the skin.
Zafgen, Inc. (Nasdaq:ZFGN), a biopharmaceutical company dedicated to significantly improving the health and well-being of patients affected by obesity, today announced that the Company will participate in the 2015 Leerink Rare Disease Roundtable in New York City. Thomas Hughes, Chief Executive Officer of Zafgen, is scheduled to present in a fireside chat on Wednesday, September 30, 2015 at 12:55 p.m. ET. The presentation will be webcast live and will be available via the following link: http://leerink.metameetings.com/confbook/rd15/directlink?p=723. A replay of the presentation will be available through the Events and Presentations page of the Investors section of the Company's website (www.zafgen.com) for 90 days following the conclusion of the live event.