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Alnylam Pharmaceuticals, Inc. Message Board

robert.vince 22 posts  |  Last Activity: Jul 21, 2014 7:49 AM Member since: Aug 30, 2012
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  • Starpharma (SPL.AX) (SPHRY) today announced achievement of a major milestone with the receipt of Conformity Assessment Certification for the VivaGel® condom by the Australian Therapeutic Goods Administration (TGA). This TGA certification is similar to CE certification of devices (CE Mark) in Europe.

    Starpharma’s marketing partner, Ansell (ANN.AX) plans to launch the VivaGel® condom under their brand, LifeStyles Dual Protect™, in the coming months, following listing on the Australian Register of Therapeutic Goods (ARTG). TGA certification will also support certain regulatory processes in other markets.

    The VivaGel® condom is a world-first product based on innovative Australian technology. It is the only condom of its type, providing barrier protection and incorporating a proprietary antiviral compound (VivaGel®) in the lubricant.

    LifeStyles Dual Protect™ condoms to be marketed by Ansell will carry the VivaGel® brand and Starpharma will receive royalties based on sales.

    Ansell President & General Manager, Sexual Wellness Global Business Unit, Peter Carroll, said:

    “Ansell looks forward to rolling out its marketing and sales campaign to support the launch of LifeStyles Dual Protect™ over the coming months with the first product expected to be available on shelves soon.

    “Our partnership with Starpharma is a great example of two highly innovative Australian businesses working together to bring to market a ground-breaking new sexual health product. New product development is central to Ansell’s business strategy and this highly innovative product is exciting for both companies.”

    Ansell is a global leader in protection solutions, manufacturing and marketing condoms across the world and ranked number two globally. In Australia, Ansell’s share of the condom market is around 70%. The global branded condom market is estimated to be worth approximately $1.1 billion.

  • MONMOUTH JUNCTION, NJ--(July 17, 2014) - CytoSorbents Corporation (OTCQB: CTSO), a critical care immunotherapy company commercializing its CytoSorb® cytokine adsorber in multiple countries worldwide, announced the PDF availability of the first publication describing the use of CytoSorb® intra-operatively during cardiac surgery at the Ludwig Maximilian University of Munich Hospital - Grosshadern Campus, in Germany.

    The retrospective study, authored by Frank Born, et al., was recently published in the scientific journal "Kardiotechnik" and entitled, "Systemic Inflammatory Response Syndrome in Heart Surgery: New possibilities for treatment through the use of a cytokine adsorber during ECC?" The study compared the post-operative inflammatory response in 40 patients (20 control vs 20 CytoSorb® treated) undergoing high risk cardiac surgery involving hypothermic arrest and antegrade cerebral perfusion. In the treatment group, CytoSorb® was placed into a bypass blood circuit in the heart-lung machine and used intra-operatively (during surgery) to remove inflammatory mediators from the patients' blood. The control group did not utilize CytoSorb®.
    The authors demonstrate that CytoSorb® usage results in a statistically significant decline in inflammatory mediators such as interleukin-6 (IL-6) and procalcitonin in the treatment group, compared to the control group, during the three days after the operation.

  • Starpharma Holdings Ltd (SPL.AX) (SPHRY) today announced that the US Food and Drug Administration (FDA) has granted Special Protocol Assessment (SPA) agreement on the design and planned analyses of the phase 3 clinical studies of the VivaGel® bacterial vaginosis (BV) product for the prevention of recurrent BV.

    The favourable SPA outcome provides a binding agreement from the FDA that the phase 3 clinical study design, endpoints, statistical analyses and other aspects of the planned studies adequately address objectives in support of a US regulatory submission for approval of the product.

    The granting of SPA agreement by the FDA follows the earlier agreement of the European Medicines Agency (EMA) on the design of the phase 3 studies.

    Starpharma will now commence its two pivotal phase 3 clinical trials of VivaGel® for the prevention of recurrent BV at sites in North America, Europe and Asia.

    The two phase 3, double-blind, randomised, placebo-controlled trials will be identical in design and will compare the rate of BV recurrence in women using VivaGel® to the rate of recurrence in women using a placebo gel during a 16 week treatment period. Approximately 600 women will be recruited into each study.

    Starpharma Chief Executive Officer, Dr Jackie Fairley, said: “Receiving agreement on the SPA is an important and very positive development as it effectively eliminates the US regulatory risk associated with clinical development, by specifying upfront the FDA’s agreed trial design. This significantly reduces overall development risk for VivaGel®. SPA agreement from the FDA is protected by US law and gives Starpharma certainty and confidence that the studies will support a regulatory submission for the approval of VivaGel® for the prevention of recurrent BV in the US.”

  • robert.vince robert.vince Jul 9, 2014 3:51 PM Flag

    He can't say... just swallowed his tongue.

  • Cellceutix Corporation (OTCQB: CTIX) (the "Company"), a clinical stage biopharmaceutical company developing innovative therapies in oncology, dermatology, and antibiotic applications, is pleased to announce that a research collaboration with Fox Chase Chemical Diversity Center has led to the award of a Phase 2B Small Business Innovation Research (SBIR) grant to FCCDC from the National Institute of Allergy and Infectious Disease (NIAID) of the National Institute of Health (NIH).

    The SBIR grant is for up to $1.5 million over two years and research will be directed at developing the Cellceutix technology platform on host defense protein (HDP) mimics for treatment of disseminated fungal infections, particularly those caused by Candida species.

    "This grant to research our novel compounds dovetails with our strategy to partner with leading organizations and universities in the development of new therapeutic agents for some of the most difficult to treat fungal and bacterial infections," commented Leo Ehrlich, Chief Executive Officer at Cellceutix. "Candida infections were recently named in the final rule of the U.S. Food and Drug Administration's list of qualifying pathogens under the Generating Antibiotic Incentives Now Act. We clearly see the potential and value of new drugs for Candida infections and are very pleased that the funding is now in place for FCCDC to conduct studies on our compounds in this area."

  • Regado Biosciences, Inc. (RGDO), a biopharmaceutical company focused on the discovery and development of actively controllable aptamer therapeutics for the acute care setting, today announced the publication in the Journal of Thrombosis and Thrombolysis of data from a single escalating-dose Phase 1 clinical trial of the REG2 anticoagulation system. The published data demonstrates the dose and concentration-dependent attenuation of thrombin generation and subsequent restoration of thrombin following reversal associated with REG2.

    REG2 is a two-component system consisting of a subcutaneous depot formulation of pegnivacogin, an anticoagulant aptamer specifically targeting coagulation Factor IXa, and its complementary intravenous injectable oligonucleotide active control agent, anivamersen. REG2 is being developed to be the preferred therapeutic option in high value sub-acute venous thrombosis indications such as DVT and VTE prophylaxis. REG2 will be an important part of the life cycle franchise strategy associated with Revolixys™ Kit which ultimately entails broad use throughout the hospital.

    Christopher Rusconi, Ph.D., Regado's Chief Scientific Officer and co-discoverer of the Regado controllable aptamer technology, commented, "These results support the choice of FIXa as an excellent target for anticoagulant therapy. In addition, the concentration-dependent inhibition of thrombin generation observed in this study further supports the pegnivacogin dose selected for the REGULATE-PCI Phase 3 study of the companion product candidate, Revolixys™ Kit."

  • robert.vince robert.vince Jun 11, 2014 10:48 AM Flag

    AFFiRiS develops synthetic vaccines against chronic diseases with unmet medical needs and attractive markets. The antigens of these vaccines are short peptides which function as B-cell epitopes. The aim of an AFFITOPE vaccination is to induce antibody immune responses which will address each target structure with the relevant appropriate specificity. Cytotoxic T-cell responses and autoimmune helper T-cell induction are excluded simply because the peptides used are too small to trigger the respective pathways. The T-cell help required is provided by a carrier protein such as KLH covalently linked to the peptides.

  • robert.vince robert.vince Jun 4, 2014 10:56 AM Flag

    Ok total moron, take your bashing and low IQ to another board cause you are now on ignore!

  • robert.vince robert.vince May 29, 2014 12:01 PM Flag

    I'd venture a guess you'll be eating these words this time next year. The owner is a trustworthy man and has done it once before as he founded and CEO'd inContact, INc. He's not diluting, check out the innovative ways he's raising cash. He's got some folks with big money backing him and I for one am going aLONG for the ride.

  • We have updated our report on Aethlon Medical (AEMD) for several recent developments. See below for access to our full report on the company.

    DaVita Agreement for Pilot Study Finalized

    Earlier this month AEMD announced that they entered into a definitive agreement with DaVita Clinical Research (DCR), the CRO arm of dialysis services giant DaVita Healthcare, to provide clinical management services for Aethlon's recently approved 10-patient feasibility study. As a reminder, Aethlon first announced in February that they reached a preliminary agreement with DCR to manage the study - which was a change of course as AEMD had previously disclosed the study was expected to be conducted by the Renal Research Institute, a partnership between Fresenius Medical Care (FMS) and Beth Israel Medical Center in NYC. The pivot towards DCR was driven by the potential to leverage DCR's dialysis-related clinical trial experience, their large clinical site network and the expertise of Dr. Stephen Fadem, who will be leading the study.

    The feasibility safety study, which will enroll 10 ESRD patients with HCV, will be conducted at the DaVita MedCenter Dialysis clinic in Houston, TX - one of the largest dialysis centers in the U.S. - which could presumably support future, larger HCV studies as well. AEMD hopes to obtain IRB approval and commence enrollment by this summer. We note that DaVita MedCenter is also in close proximity to MD Anderson Cancer Center - which potentially opens up the possibility to collaborate with DCR and Dr. Fadem on future cancer-related studies as well.

  • Summary

    Initial marketing blitz could change the game altogether and results can be seen in real time.
    Creative, non-dilutive financing plan to speed things up, but not a deal breaker if it fails.
    A successful uplisting accompanied by membership expectations being met can result in significant stock price appreciation.

  • Aethlon Medical, Inc. (OTCQX:AEMD), the pioneer in developing selective therapeutic filtration devices to address infectious disease, cancer and other life-threatening conditions, today announced high rapid virologic response (RVR) and sustained virologic response (SVR) rates in Hepatitis-C virus (HCV) infected individuals who were administered Hemopurifier® therapy.
    The Aethlon Hemopurifier® is a first-in-class medical device that selectively targets the rapid clearance of viral pathogens and tumor-secreted exosomes from the entire circulatory system to improve the benefit of drug therapies administered to infectious disease and cancer patients. In HCV care, the device is positioned to address drug resistance associated with emerging all-antiviral therapies and also targets to accelerate HCV RNA depletion at the outset of peginterferon+ribavirin (PR) therapy.
    Aethlon recently disclosed that the United States Food and Drug Administration (FDA) approved an Investigational Device Exemption (IDE) that now allows the Company to initiate HCV human feasibility studies of Hemopurifier® therapy in the United States. Aethlon announced yesterday that its first U.S. clinical study will be conducted at the DaVita MedCenter Dialysis in Houston, Texas. It is estimated that approximately 170 million people worldwide are infected with HCV, which leads to chronic liver disease or cirrhosis, and is a leading cause of liver transplantation.

  • Stellar Biotechnologies, Inc. ("Stellar" or "the Company") (OTCQB: SBOTF) (TSX VENTURE: KLH) announced today the launch of its corporate video highlighting the Company's business of manufacturing Keyhole Limpet Hemocyanin (KLH) protein. KLH is an immune-stimulating molecule widely used in the growing field of immunotherapy.
    The video is available for viewing on Stellar's website

    The corporate video provides an overview of Stellar's commercial position in immunotherapy development. It includes interviews with Company executives and was filmed at Stellar's California-based aquaculture research and production facilities where Stellar KLH™ protein is manufactured for use as a vaccine carrier molecule or for immunotoxicology applications.

    "We have a dedicated team of scientists and personnel working in a unique environment that combines pharmaceutical manufacturing and marine technologies," said Frank Oakes, President and CEO of Stellar. "We are pleased to give viewers this glimpse at our pioneering work in scalable manufacture of sustainable GMP grade KLH."

  • robert.vince robert.vince May 20, 2014 9:19 AM Flag

    About DaVita Kidney Care
    DaVita Kidney Care is a division of DaVita HealthCare Partners Inc., a Fortune 500® company that, through its operating divisions, provides a variety of health care services to patient populations throughout the United States and abroad. A leading provider of dialysis services in the United States, DaVita Kidney Care treats patients with chronic kidney failure and end stage renal disease. DaVita Kidney Care strives to improve patients' quality of life by innovating clinical care, and by offering integrated treatment plans, personalized care teams and convenient health-management services. As of March 31, 2014, DaVita Kidney Care operated or provided administrative services at 2,098 outpatient dialysis centers located in the United States serving approximately 165,000 patients. The company also operated 75 outpatient dialysis centers located in 10 countries outside the United States. DaVita Kidney Care supports numerous programs dedicated to creating positive, sustainable change in communities around the world. The company's leadership development initiatives and social responsibility efforts have been recognized by Fortune, Modern Healthcare, Newsweek and WorldBlu.

  • robert.vince robert.vince May 20, 2014 9:19 AM Flag

    He is a Fellow of the American College of Physicians, Fellow of the American Society of Nephrology, diplomat of the American Board of Quality Assurance and Utilization Review Physicians (CHCQM - Certified Health Care Quality Management), and a member of the International Society of Nephrology, Renal Physicians Association, the American Association of Kidney Patients and The National Kidney Foundation. He is active in quality management, credentialing and peer review for his dialysis centers.
    On a national level, he is co-chairman of the Medical Advisory Board of the American Association of Kidney Patients, and a past vice-president of the Board of Directors. He has also served on the Board of Directors of the Renal Physicians Association, and actively serves on two national RPA committees, the Government Affairs Committee and the Health Finance Committee. Dr. Fadem has been active in the Forum of ESRD (end stage renal disease) Networks and was a member of the CMS Clinical Performance Measures Committee. He lectures frequently on dialysis management, preventive nephrology, vascular calcification, anemia, patient education, CKD education, computer technology and computer security. Dr. Fadem is a co-editor of AAKP Renalife and is a reviewer for several peer reviewed journals.
    Dr. Fadem has been nationally recognized by receiving the American Association of Kidney Patient's Nova Award, the National Kidney Foundation's Distinguished Service Award. He has also received the National Kidney Foundation's Presidents Award and the Myron L. Jenkins Award. He has been awarded the Peter Lundin Award for his contributions to patient education and The Visionary Award for his contributions to CKD education. He is the 2013 winner of the DaVita Core Value Award for Continuous Improvement. He has been named as one of America's Top Doctors by Castle Connolly and US News and World Report, and is consistently ranked as a Top Doctor in Houston by Texas Magazine.

  • robert.vince robert.vince May 20, 2014 9:18 AM Flag

    "The combination of DCR, DaVita MedCenter Dialysis, and Dr. Fadem provides Aethlon with the ideal team of professionals and infrastructure with which to conduct our infectious disease clinical study. Additionally, their proximity to M.D. Anderson Cancer Center and other specialty facilities located within the Texas Medical Center provide for a unique location to conduct future clinical investigations of Hemopurifier® therapy in a variety of life-threatening health conditions," stated Aethlon Medical CEO Jim Joyce.
    DCR is a specialty contract research organization (CRO) with experience in conducting more than 300 early phase clinical trials. As a subsidiary of DaVita Healthcare Partners Inc, DCR has access to one third of the total U.S. ESRD patient population and maintains a network that exceeds 150 investigative physicians' practices at more than 250 clinical sites.
    Dr. Fadem is a practicing Houston nephrologist and is currently the Chief Medical Officer at Kidney Associates, PLLC and the Medical Director for the Houston Kidney Center Integrated Service Network at DaVita Kidney Care, a division of DaVita HealthCare Partners Inc. He began practice in 1978 after completing a renal fellowship at The University of Texas Health Science Center in San Antonio. He is a graduate of the University of Oklahoma College of Medicine, and did his internal medicine residency at The University of Texas and MD Anderson Hospital in Houston. He is a Clinical Professor of Medicine at Baylor College of Medicine.

  • Aethlon Medical, Inc. (OTCQX:AEMD), the pioneer in developing selective therapeutic filtration devices to address infectious disease, cancer and other life-threatening conditions, announced today that it has entered into a definitive agreement with DaVita Clinical Research (DCR) to provide clinical management services to support the forthcoming feasibility study of the Aethlon Hemopurifier®. The Hemopurifier is a first-in-class therapeutic device that targets the rapid elimination of circulating viruses and tumor-secreted exosomes that suppress the immune system of cancer patients. Aethlon further announced that the Principal Investigator for this study will be Dr. Stephen Z. Fadem.
    The clinical trial site location will be DaVita MedCenter Dialysis in Houston. Dr. Fadem is co-medical director of DaVita MedCenter Dialysis and this center is one of the three largest dialysis centers in the country with 72 treatment stations.
    Aethlon previously disclosed that the United States Food and Drug Administration (FDA) had approved an Investigational Device Exemption (IDE) that allows the Company to initiate human feasibility studies of the Aethlon Hemopurifier in the United States. Under the feasibility study protocol, Aethlon is to treat ten ESRD patients infected with Hepatitis C virus (HCV) to demonstrate the safety of Hemopurifier therapy. Successful completion of the feasibility study will set the stage for Aethlon to conduct pivotal studies required for market clearance to treat HCV and potentially other disease indications.

  • PORT HUENEME, CA -- (Marketwired) -- 05/15/14 -- Stellar Biotechnologies, Inc. ("Stellar" or "the Company") (OTCQB: SBOTF) (TSX VENTURE: KLH) announces that Company Executives are scheduled to present at two upcoming conferences.

    Marcum MicroCap Conference at the Grand Hyatt in New York City on May 29, 2014 @ 2:00 PM EST (11:00 AM PST)
    Stansberry & Associates Investment Research Conference at the AT&T Performing Arts Center, Dallas, TX on May 31, 2014
    Frank Oakes, President and CEO of Stellar Biotechnologies, will present at both events and members of Stellar's executive team will be available for one-on-one meetings. A link to the Marcum conference webcast will be available in the Investor Relations section of the Company's website

  • Aethlon Medical, Inc. (OTCQB: AEMD), today released the following note authored by its Chairman and CEO, Jim Joyce.
    The discovery that our Hemopurifer® captures tumor-secreted exosomes provides hope for a new therapeutic paradigm to augment cancer care. Yes, the same Hemopurifier® we are preparing to advance in a forthcoming FDA approved infectious disease study. In my last CEO note, I referenced a National Institute of Health (NIH) – National Cancer Institute (NCI) sponsored article that referenced Hemopurifier® therapy as a candidate to address tumor-secreted exosomes.
    The article detailed several exosomal mechanisms that promote cancer progression, including suppression of the immune system, triggering resistance to cancer therapies, promotion of angiogenesis and seeding the spread of metastasis. The article also indicated that high levels of circulating exosomes correlated with advanced stage cancer.
    As researchers continue to unravel the deleterious mechanisms of exosomes underlying cancer, it has become clear that these particles also transport many molecular targets of interest to the pharmaceutical industry. Thus providing further support for a medical device that is able to target circulating exosomes without adding drug toxicity to established cancer therapies.
    In this regard, I am pleased to share the following overview authored by Dr. Annette Marleau (our Director of Tumor Immunology), which outlines oncology targets of the pharmaceutical industry that have been reported to be transported by exosomes.

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