"Small Businesses have always formed the backbone of the American economy. These entrepreneurial pioneers embody the spirit of possibility, the tireless work ethic, and the simple hope for something better that lies at the heart of the American ideal." ��President Obama�
The full implementation of the Patient Protection and Affordable Care Act, also known as Obamacare, is now just six and a half months away. This bill will drastically change the landscape of how we view health care reform by limiting insurers' medical loss ratio, or MLR, to 80% and ensuring that patients receive high quality care when they need it. In addition, it will also require individuals carry health insurance or face a penalty.
The purpose behind the PPACA for President Obama was to increase the quality of care Americans received while also stemming what's been a precipitous rise in medical costs over the past couple of decades. As we've looked at over the past few weeks, there are clearly defined benefits associated with Obamacare and plenty of weaknesses�-- as well as unanswered questions.
Top 5 Medical Stocks For 2014: StemCells Inc (STEM)
StemCells, Inc. (StemCells), incorporated in August 1988, is engaged in the research, development, and commercialization of stem cell therapeutics and related tools and technologies for academia and industry. The Company is focused on developing and commercializing stem and progenitor cells as the basis for therapeutics and therapies, and cells and related tools and technologies to enable stem cell-based research and drug discovery and development. The Company�� primary research and development efforts are focused on identifying and developing stem and progenitor cells as potential therapeutic agents. The Company has two therapeutic product development programs, including its CNS Program, which is developing applications for HuCNS-SC cells, its human neural stem cell product candidate, and its Liver Program, which is characterizing the Company�� human liver cells as a therapeutic product.
CNS Program
The Company in its CNS Program, is in clinical development with its HuCNS-SC cells for a range of disorders of the central nervous system. The CNS includes the brain, spinal cord and eye. In February 2012, the Company had completed a Phase I clinical trial in Pelizeaus-Merzbacher Disease (PMD), a fatal myelination disorder in the brain.
The Company�� CNS Program is focused on developing clinical applications, in which transplanting HuCNS-SC cells protect or restore organ function of the patient before such function is irreversibly damaged or lost due to disease progression. The Company�� initial target indications are PMD, and more generally, diseases in which deficient myelination plays a central role, such as cerebral palsy or multiple sclerosis; spinal cord injury, disorders in which retinal degeneration plays a central role, such as age-related macular degeneration or retinitis pigmentosa. The Company�� product candidate, HuCNS-SC cells, is a purified and expanded composition of normal human neural stem cells. Its HuCNS-SC cells can be directly transp! lanted.
Liver Program
Liver stem or progenitor cells offer an alternative treatment for liver diseases. A liver cellular therapy or cell-based therapeutic provide or support liver function in patients with liver disease. The Company held a portfolio of issued and allowed patents in the liver field, which cover the isolation and use of both hLEC cells and the isolated subset, as well as the composition of the cells themselves.
The Company�� range of cell culture products, which are sold under the SC Proven brand, includes iSTEM, GS1-R, GS2-M, RHB-A, RHB-Basal, NDiff N2, and NDiff N2B27. Its iSTEM is a serum-free, feeder-free medium that maintains mouse embryonic stem cells in their pluripotent ground state by using selective small molecule inhibitors to block the pathways, which induce differentiation. RHB-A is a defined, serum-free culture medium for the selective culture of human and mouse neural stem cells and their maintenance and expansion as adherent cell populations. RHB-Basal is a defined, serum-free basal medium. When supplemented with specific growth factors, this media is formulated for the propagation and differentiation of adherent neural stem cells. RHB-Basal can also be tailored to specific-cell type requirements by the addition of customer preferred supplements.
The Company�� NDiff N2 is a defined serum-free scell culture supplement for the derivation, maintenance, expansion and/or differentiation of human and mouse embryonic stem (ES) cells and tissue-derived neural stem cells supplement. Its NDiff N2-AF is a serum-free and animal component-free version of NDiff N2. Its NDiff N2B27 is a defined, serum-free medium for the differentiation of mouse embryonic stem cells to neural cell types. NDiff N27-AF is a serum-free and animal component-free version of NDiff N27. Its GS1-R is a serum-free media formulation shown to enable the derivation and long-term maintenance of true, germline competent rat embryonic stem cells without the add! ition of ! cytokines or growth factors. Its GS2-M is a defined, serum- and feeder-free medium for the derivation and long-term maintenance of true, germline competent mouse iPS cells.
The Company also markets a number of antibody reagents for use in cell detection, isolation and characterization. These reagents are also under the SC Proven brand and it includes STEM24, STEM101, STEM121 and STEM123. Its STEM24 is a human antibody that recognizes human CD24, also known as heat stable antigen (HSA), a glycoprotein expressed on the surface of many human cell types, including immature human hematopoietic cells, peripheral blood lymphocytes, erythrocytes and many human carcinomas. Its CD24 is also a marker of human neural differentiation. Its STEM101 is a human-specific mouse antibody that recognizes the Ku80 protein found in human nuclei. Its STEM121 is a human-specific mouse antibody that recognizes a cytoplasmic protein of human cells. Its STEM123 is a human-specific mouse antibody that recognizes human glial fibrillary acidic protein (GFAP).
The Company�� Other products marketed under SC Proven include total cell genomic DNA (gDNA), RNA and protein lysate reagents purified from homogenous stem cell populations for intra-comparative studies, such as Epigenetic fingerprinting, Southern, Western and Northern blots, PCR, RT-PCR and microarrays. This range of purified stem cell line lysates includes mouse embryonic stem (ES) cells propagated in SC Proven 2i inhibitor-based GS2-M media and mouse ES cell-derived and fetal tissue-derived neural stem (NS) cells propagated in SC Proven RHB-A media.
Advisors' Opinion:- [By John Udovich]
The results of a recent Pew Center Poll regarding attitudes towards abortion and various forms of stem cell research could be a good sign for the stem cell industry along with small cap stem cell stocks like StemCells Inc (NASDAQ: STEM), NeoStem Inc (NASDAQ: NBS), Neuralstem, Inc (NYSEMKT: CUR),�International Stem Cell Corp (OTCMKTS: ISCO) and BioRestorative Therapies (OTCBB: BRTX). Basically, Americans think that having an abortion is a moral issue with 49% of American adults believing abortion is morally wrong, 23%�view it not as a moral issue and and 15% view it as morally acceptable. However and when Americans were asked about issues surrounding�human embryos, such as stem cell research or in vitro fertilization, as a matter of morality, their views were different.
- [By James E. Brumley]
When an investor thinks of spinal-related stem cell stocks, usually a name like Neuralstem, Inc (NYSEMKT: CUR) or StemCells Inc (NASDAQ: STEM) comes to mind. And well they should. STEM has logged some amazing breakthroughs in the field of spinal cord repair, while CUR has done the same. Not all back problems are spinal cord related though. In fact, most back problems - and therefore the most opportunity - are bone and disc related problems. That's where a young gun like BioRestorative Therapies (OTCBB: BRTX) can step in and make stem cell waves. BRTX has developed an approach to rejuvenate and revive failing spinal discs, potentially ending pain for millions of back-pain sufferers, and circumventing expensive spinal surgeries that are in increasing burden on insurance companies.
Top 5 Medical Stocks For 2014: Myriad Genetics Inc (MYGN.O)
Myriad Genetics, Inc. (Myriad) is a molecular diagnostic company. The Company is focused on developing and marketing predictive medicine, personalized medicine and prognostic medicine tests. It performs all of its molecular diagnostic testing and analysis in its own reference laboratories. These technologies include the cornerstone technologies of biomarker discovery, high-throughput deoxyribo nucleuc acid (DNA) sequencing, ribo nucleic acid (RNA) expression and multiplex protein analysis. The Company uses this information to guide the development of new molecular diagnostic tests that are designed to assess an individual's risk for developing disease later in life (predictive medicine), identify a patient's likelihood of responding to drug therapy and guide a patient's dosing to ensure optimal treatment (personalized medicine), or assess a patient's risk of disease progression and disease recurrence (prognostic medicine).
As of June 30, 2012, the Company h ad launched nine commercial molecular diagnostic tests. The Company markets these tests through its own approximate 385-person sales force in the United States. The Company also markets its BRACAnalysis, COLARIS, and COLARIS AP tests through its own European sales force and have entered into marketing collaborations with other organizations in selected Latin American, European and Asian countries. The Company also generates revenue by providing companion diagnostic services to the pharmaceutical, and biotechnology industries and medical research institutions utilizing its multiplexed immunoassay technology.
Molecular Diagnostic Tests
The Company's molecular diagnostic tests are designed to analyze genes, their mutations, expression levels and proteins to assess an individual's risk for developing disease later in life, determine a patient's likelihood of responding to a particular drug, assess a patient's risk of disease progression and disease recu rrence and measure a patient's exposure to drug therapy to! e! nsure optimal dosing and reduced drug toxicity. The Company's BRACAnalysis test is a analysis of the BRCA1 and BRCA2 genes for assessing a woman's risk of developing hereditary breast and ovarian cancer. BRACAnalysis accounted for 81.7% of the Company's total revenue during the fiscal year ended June 30, 2012. Its The Company's COLARIS test is an analysis of the MLH1, MSH2, MSH6 and PMS2 genes for assessing a person's risk of developing colorectal cancer or uterine cancer.
The Company's COLARIS AP test detects mutations in the APC and MYH genes, which cause a colon polyp-forming syndrome known as Familial Adenomatous Polyposis (FAP), a more common variation of the syndrome known as attenuated FAP, and the MYH-associated polyposis signature (MAP). The Company's MELARIS test analyzes mutations in the p16 gene to determine genetic susceptibility to malignant melanoma. The Company's OnDose test is a nanoparticle immunoassay that is designed to assist oncologists in optimizing 5-FU (fluorouracil) anti-cancer drug therapy in colon cancer patients on an individualized basis. The Company's PANEXIA test is a comprehensive analysis of the PALB2 and BRCA2 genes for assessing a person's risk of developing pancreatic cancer later in life. The Company's PREZEON test is an immunohistochemistry test that analyzes the PTEN gene and assesses loss of PTEN function in many cancer types.
The Company's Prolaris test is a 46-gene molecular diagnostic assay that assesses whether a patient is likely to have a slow growing, indolent form of prostate cancer that can be safely monitored through active surveillance, or a more aggressive form of the disease that would warrant aggressive intervention, such as a radical prostatectomy or radiation therapy. The Company's TheraGuide 5-FU test analyzes mutations in the DPYD gene and variations in the TYMS gene to assess patient risk of toxicity to 5-FU (fluorouracil) anti-cancer drug therapy.
< p>Companion Diagnostic Services and Other RevenueThe Company has compiled a library of over 550 individual human and rodent immunoassays for use in its multi-analyte profile (MAP) testing services. The Company has also developed RodentMAP, a panel for use in pre-clinical animal studies and OncologyMAP, which measures cancer-related proteins to assists researchers accelerate the pace of discovery, validation and translation of cancer biomarkers for early detection, patient stratification and therapeu tic monitoring. The Company has developed multiplexed immunoassay kits that enable its customers to leverage its technology services with their in-house capabilities. The Company's internally developed multiplexed immunoassay kits include all of the components necessary for a customer to perform a test on their own Luminex instrument. TruCulture is a simple, self-contained whole blood culture that can be deployed to clinical sites around the world for acquiring cell culture data without specialized facilities or training.
Top Undervalued Stocks To Own For 2014: DENTSPLY International Inc.(XRAY)
DENTSPLY International Inc. designs, develops, manufactures, and markets dental consumable products, dental laboratory products, and dental specialty products worldwide. The company?s dental consumable products include dental sundries, such as dental anesthetics, prophylaxis pastes, dental sealants, impression materials, restorative materials, tooth whiteners, and topical fluoride; and small equipment, including high and low speed handpieces, intraoral curing light systems, dental diagnostic systems, and ultrasonic scalers and polishers used in dental offices for the treatment of patients. Its dental laboratory products comprise dental prosthetics, including artificial teeth, precious metal dental alloys, dental ceramics, and crown and bridge materials, as well as equipment, such as computer aided machining ceramic systems and porcelain furnaces used in the preparation of dental appliances by dental laboratories. The company?s dental specialty products consist of endodonti c instruments and materials, implants and related products, bone grafting materials, 3D digital implantology, and orthodontic appliances and accessories. Its customers include dentists, dental hygienists, dental assistants, dental laboratories, and dental schools. The company distributes its dental products directly to dental laboratories and dental professionals, as well as through distributors, dealers, and importers. DENTSPLY International Inc. was founded in 1983 and is headquartered in York, Pennsylvania.
Advisors' Opinion:- [By Monica Gerson]
DENTSPLY International (NASDAQ: XRAY) shares touched a new 52-week high of $47.65. DENTSPLY's trailing-twelve-month ROE is 15.95%.
Sun Life Financial (NYSE: SLF) shares gained 2.47% to create a new 52-week high of $34.80 on Q3 results. Sun Life reported its Q3 operating net income from continuing operations of $422 million.
Top 5 Medical Stocks For 2014: Boston Scientific Corp (BSX)
Boston Scientific Corporation is a developer, manufacturer and marketer of medical devices that are used in a range of interventional medical specialties. During the year ended December 31, 2011, its products were offered for sale by seven core businesses: Interventional Cardiology, CRM, Endoscopy, Peripheral Interventions, Urology/Women�� Health, Neuromodulation, and Electrophysiology. In January 2011, it completed the acquisition of Intelect Medical, Inc. In January 2011, it completed the acquisition of Sadra Medical, Inc. In March 2011, the Company completed the acquisition of Atritech, Inc. In February 2011, it announced the acquisitions of S.I. Therapies and ReVascular Therapeutics, Inc. In January 2011, the Company sold its Neurovascular business to Stryker Corporation. In June 2012, the Company acquired Cameron Health, Inc. of San Clemente, California and, as a result, added to its product portfolio subcutaneous implantable cardioverter defibrillator, called the S-ICD System.
Interventional Cardiology
The Company offers coronary stent product. Coronary stents are tiny, mesh tubes used in the treatment of coronary artery disease, which are implanted in patients to prop open arteries and facilitate blood flow to and from the heart. The Company offers a two-drug platform strategy with its paclitaxel-eluting and everolimus-eluting stent system offerings, and it offers a range of stent sizes. The Company markets its next-generation internally-developed and self-manufactured PROMUS Element stent system in the United States, its Europe/Middle East/Africa (EMEA) region and certain Inter-Continental countries, including China and India. It markets the PROMUS everolimus-eluting stent system, supplied to the Company by Abbott Laboratories, in Japan. It also markets its TAXUS paclitaxel-eluting stent line, including its third-generation TAXUS Element paclitaxel-eluting stent system in the U.nited States, Japan, EMEA and certain Inter-Continental countries.
The Compa! ny markets a line of products used to treat patients with atherosclerosis, a principal cause of coronary artery obstructive disease. Its product offerings include balloon catheters, rotational atherectomy systems, guide wires, guide catheters, embolic protection devices, and diagnostic catheters used in percutaneous transluminal coronary angioplasty (PTCA). The Company markets a family of intraluminal catheter-directed ultrasound imaging catheters and systems for use in coronary arteries and heart chambers, as well as certain peripheral vessels. The iLab Ultrasound Imaging System continues as its flagship console and is compatible with its line of imaging catheters. The system is designed to enhance the diagnosis and treatment of blocked vessels and heart disorders. Sadra is developing a repositionable and retrievable device for transcatheter aortic valve replacement (TAVR) to treat patients with severe aortic stenosis. The Lotus Valve System consists of a stent-mounted tissue valve prosthesis and catheter delivery system for guidance and placement of the valve. Atritech has developed a device designed to close the left atrial appendage in patients with atrial fibrillation who are at risk for ischemic stroke. The WATCHMAN Left Atrial Appendage Closure Technology, developed by Atritech, is the first device proven in a randomized clinical trial to offer an alternative to anticoagulant drugs, and is approved for use in CE Mark countries.
Cardiac Rhythm Management
The Company develops, manufactures and markets a variety of implantable devices that monitor the heart and deliver electricity to treat cardiac abnormalities, including Implantable cardioverter defibrillator (ICD) systems used to detect and treat abnormally fast heart rhythms (tachycardia) that could result in sudden cardiac death, including implantable cardiac resynchronization therapy defibrillator (CRT-D) systems used to treat heart failure, and implantable pacemaker systems used to manage slow or irregular heart rhyth! ms (brady! cardia), including implantable cardiac resynchronization therapy pacemaker (CRT-P) systems used to treat heart failure. Its product offerings include its COGNIS cardiac resynchronization therapy defibrillator (CRT-D), its TELIGEN ICD systems and its ALTRUA family of pacemaker systems. During 2011, it began the United States launch of its next-generation line of defibrillators, INCEPTA, ENERGEN and PUNCTUA.
Endoscopy
The Company markets a range of products to diagnose, treat and ease a variety of digestive diseases, including those affecting the esophagus, stomach, liver, pancreas, duodenum, and colon. Common disease states include esophagitis, portal hypertension, peptic ulcers as well as esophageal, biliary, pancreatic and colonic cancer. The Company offers the Radial Jaw 4 Single-Use Biopsy Forceps, which are designed to enable collection of large high-quality tissue specimens without the need to use large channel therapeutic endoscopes. Its exclusive line of RX Biliary System devices are designed to provide greater access and control for physicians to diagnose and treat challenging conditions of the bile ducts, such as removing gallstones, opening obstructed bile ducts and obtaining biopsies in suspected tumors. The Company also markets the Spyglass Direct Visualization System for direct imaging of the pancreatico-biliary system. The Spyglass System is a single-operator cholangioscopy device that offers clinicians a direct visualization of the pancreatico-biliary system and includes supporting devices for tissue acquisition, stone management and lithotripsy. Its products also include the WallFlex family of stents, in particular, the WallFlex Biliary line and WallFlex Esophageal line; and in 2011, the Company launched its Advanix Biliary Plastic Stent System and the Expect Endoscopic Ultrasound Aspiration Needle in the United States and certain international markets. Its Resolution Clip Device is an endoscopic mechanical clip designed to treat gastrointestinal bleeding.
T! he Company markets devices to diagnose, treat and ease pulmonary disease systems within the airway and lungs. Its products are designed to help perform biopsies, retrieve foreign bodies from the airway, open narrowings of an airway, stop internal bleeding, and ease symptoms of some types of airway cancers. Its product line includes pulmonary biopsy forceps, transbronchial aspiration needles, cytology brushes and tracheobronchial stents used to dilate narrowed airway passages or for tumor management. Asthmatx, Inc. designs, manufactures and markets a less-invasive, catheter-based bronchial thermoplasty procedure for the treatment of severe persistent asthma. The Alair Bronchial Thermoplasty System, developed by Asthmatx, has both CE Mark and Food and Drug Administration (FDA) approval and is the first device-based asthma treatment approved by the FDA.
Peripheral Interventions
The Company sells various products designed to treat patients with peripheral disease, including a line of medical devices used in percutaneous transluminal angioplasty and peripheral vascular stenting. Its peripheral product offerings include stents, balloon catheters, wires, peripheral embolization devices and vena cava filters. In 2010 and 2011, it launched several of its products internationally, including the EPIC self-expanding nitinol stent system in certain international markets, and the Carotid WALLSTENT stent system in Japan. The Company launched three new peripheral angioplasty balloons in 2011, including its next-generation Mustang percutaneous transluminal angioplasty (PTA) balloon, its Coyote balloon catheter, a highly deliverable and ultra-low profile balloon dilatation catheter designed for a range of peripheral angioplasty procedures and its Charger PTA Balloon Catheter, a 0.035 inch percutaneous transluminal angioplasty balloon catheter designed for post-stent dilatation, as well as conventional balloon angioplasty to open blocked peripheral arteries. The Company has commenced a limited ma! rket rele! ase of its OFFROAD re-entry catheter system in certain international markets, and in February 2012, it launched its TRUEPATH intraluminal CTO device in the United States.
The Company sells products designed to treat patients with non-vascular disease. Its non-vascular suite of products include biliary stents, drainage catheters and micro-puncture sets designed to treat, diagnose and ease various forms of benign and malignant tumors. The Company continues to market its extensive line of Interventional Oncology product solutions, including the Renegade HI-FLO Fathom microcatheter and guidewire system and Interlock - 35 Fibered IDC Occlusion System for peripheral embolization. The Company�� FilterWire EZ Embolic Protection System is a filter designed to capture embolic material that may become dislodged during a procedure, which could otherwise travel into the microvasculature where it could cause a heart attack or stroke. It is commercially available in the United States, its EMEA region and certain Inter-Continental countries for multiple indications, including the treatment of disease in peripheral, coronary and carotid vessels. It is also available in the United States for the treatment of saphenous vein grafts and carotid artery stenting procedures.
Urology/Women�� Health
The Company�� Urology/Women�� Health division develops, manufactures and sells devices to treat various urological and gynecological disorders. The Company sells a variety of products designed to treat patients with urinary stone disease, stress urinary incontinence, pelvic organ prolapse and excessive uterine bleeding. The Company offers a line of stone management products, including ureteral stents, wires, lithotripsy devices, stone retrieval devices, sheaths, balloons and catheters.
The Company markets a range of devices for the treatment of conditions, such as female urinary incontinence, pelvic floor reconstruction (rebuilding of the anatomy to its original state), and ! menorrhag! ia (excessive menstrual bleeding). It offers a breadth of mid-urethral sling products, sling materials, graft materials, pelvic floor reconstruction kits, and suturing devices. The Company markets its Genesys Hydro ThermAblator (HTA) system, a next-generation endometrial ablation system designed to ablate the endometrial lining of the uterus in premenopausal women with menorrhagia. The Genesys HTA System features a smaller and lighter console, simplified set-up requirements, and an enhanced graphic user interface and is designed to improve operating performance.
Neuromodulation
The Company within its Neuromodulation business markets the Precision Spinal Cord Stimulation (SCS) system, used for the management of chronic pain. In 2011, the Company launched its Clik Anchor for its Precision Plus SCS System, a rechargeable SCS device for chronic pain management. During 2011, it received FDA approval for and launched the Infinion 16 Percutaneous Lead, a 16-contact percutaneous lead. The Company also markets the Linear 3-4 and Linear 3-6 Percutaneous Leads for use with its SCS systems, which are designed to provide physicians more treatment options for their chronic pain patients. Intelect Medical, Inc. is a development-stage company developing advanced visualization and programming for the Vercise system.
Electrophysiology
The Company within its Electrophysiology business develops less-invasive medical technologies used in the diagnosis and treatment of rate and rhythm disorders of the heart. Included in its product offerings are radio frequency (RF) generators, steerable RF ablation catheters, intracardiac ultrasound catheters, diagnostic catheters, delivery sheaths, and other accessories. Its products include the Blazer and Blazer Prime line of temperature ablation catheters, designed to deliver enhanced performance, responsiveness, and durability. Its cooled ablation portfolio includes the closed-loop irrigated catheter on the market, the Chilli II cooled! ablation! catheter, and the newly launched Blazer Open-Irrigated ablation catheter with a Total Tip Cooling Design.
The Company competes with Abbott Laboratories, Medtronic, Inc., St. Jude Medical, Inc. and Johnson & Johnson.
Advisors' Opinion:- [By Keith Speights]
Has anyone noticed a common theme among the first-quarter results for many of the big medical-device companies? In case you missed earnings announcements from Abbott Labs (NYSE: ABT ) , Boston Scientific (NYSE: BSX ) , Edwards Lifesciences (NYSE: EW ) , Johnson & Johnson (NYSE: JNJ ) , or Stryker (NYSE: SYK ) , the following chart shows how their medical-device business fared during the quarter.
Top 5 Medical Stocks For 2014: Galena Biopharma Inc (GALE.PH)
Galena Biopharma, Inc. (Galena), formerly RXi Pharmaceuticals Corporation, incorporated on April 3, 2006, is a biotechnology company focused on discovering, developing and commercializing therapies addressing unmet medical needs using targeted biotherapeutics. The Company is pursuing the development of cancer therapeutics using peptide-based immunotherapy products, including its main product candidate, NeuVaxTM (E75), for the treatment of breast cancer and other tumors. NeuVax is a peptide-based immunotherapy intended to reduce the recurrence of breast cancer in low-to-intermediate HER2-positive breast cancer patients not eligible for trastuzumab (Herceptin; Genentech/Roche). On January 19, 2012, the Company initiated enrollment in its Phase 3 PRESENT clinical trial for NeuVax (E75 peptide plus GM-CSF) vaccine in low-to-intermediate HER2 1+ and 2+ breast cancer patients in the adjuvant setting to prevent recurrence (Clinicaltrials.gov identifier NCT01479244). The Preven tion of Recurrence in Early-Stage, Node-Positive Breast Cancer with Low to Intermediate HER2 Expression with NeuVax Treatment study is a randomized, multicenter, multinational clinical trial that will enroll approximately 700 breast cancer patients. The Company�� Phase 2 trial of NeuVax achieved its primary endpoint of disease-free survival (DFS). On April 13, 2011, the Company completed its acquisition of Apthera, Inc.,(Apthera).
The Company focuses to start a Phase 2 trial comparing NeuVax in combination with trastuzumab (Herceptin) versus trastuzumab, alone, in a 300-patient, randomized study in the adjuvant breast cancer setting. The Company's second product candidate, Folate Binding Protein-E39 (FBP), is a vaccine, consisting of the peptides E39 and J65, aimed at preventing the recurrence of ovarian, endometrial, and breast cancers. On February 14, 2012, the Company announced the initiation of a Phase 1/2 clinical trial in two gynecological cancers: ovari an and endometrial adenocarcinomas. Folate binding protein! h! as very limited tissue distribution and expression in non-malignant tissue and is over-expressed in more than 90% of ovarian and endometrial cancers, as well as in 20% to 50% of breast, lung, colorectal and renal cell carcinomas.
In April 2011, the Company acquired Apthera Inc and its NeuVax product candidate. The Company focuses on developing a pipeline of immunotherapy product candidates for the treatment of various cancers based on the E75 peptide, the advanced of which is NeuVax, which is targeted at preventing the recurrence of breast cancer. NeuVax has had positive Phase 1/2 clinical trial results for the prevention of breast cancer recurrence in patients who have had breast cancer and received the standard of care treatment (surgery, chemotherapy, radiotherapy and hormonal therapy as indicated). The Company had also initiated its Phase 3 PRESENT clinical trial of NeuVax for the prevention of breast cancer recurrence in early-stage low-to-intermediate HER2 breast cancer patients. NeuVax directs killer T-cells to target and destroy cancer cells that express HER2/neu, a protein associated with epithelial tumors in breast, ovarian, pancreatic, colon, bladder and prostate cancers. NeuVax is comprised of a HER2/neu-derived peptide called E75. E75 is a nine-amino acid sequence that is immunogenic (produces an immune response) and GM-CSF is a commercially available protein that acts to stimulate and activate components of the immune system such as macrophages and dendritic cells.
The Company also develops novel applications for NeuVax based on preclinical studies and phases 2 clinical trials which suggest that combining NeuVax and trastuzumab (Herceptin; Genentech/Roche) can increase antigen presentation by tumor cells by promoting receptor internalization and subsequent proteosomal degradation of the HER2 protein. The Company also is pursuing additional therapeutic indications for NeuVax that are in Phase 1/2 clinical trials. RXI-109, is a dermal anti-scarring therapy that ! targ! ets! conne! ctive tissue growth factor (CTGF) and that may inhibit connective tissue formation in human fibrotic disease.
The Company competes with Roche Laboratories, Inc., Pfizer Inc., Bayer HealthCare AG, Sanofi-Aventis, US, LLC, Amgen, Inc., GlaxoSmithKline plc, Renovo Group plc, CoDa Therapeutics, Inc., Sirnaomics, Inc., FirstString Research, Inc., Merz Pharmaceuticals, LLC, Capstone Therapeutics, Halscion, Inc., Garnet Bio Therapeutics, Inc., AkPharma Inc., Promedior, Inc., Kissei Pharmaceutical Co., Ltd., Eyegene, Derma Sciences, Inc., Healthpoint Biotherapeutics, Pharmaxon, Excaliard Pharmaceuticals, Inc., Alnylam Pharmaceuticals, Inc., Marina Biotech, Inc., Tacere Therapeutics, Inc., Benitec Limited, OPKO Health, Inc., Silence Therapeutics plc, Quark Pharmaceuticals, Inc., Rosetta Genomics Ltd., Lorus Therapeutics, Inc., Tekmira Pharmaceuticals Corporation, Arrowhead Research Corporation, Regulus Therapeutics Inc. and Santaris.
No comments:
Post a Comment