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Ocean Power Technologies, Inc. Message Board

fearingsf 12 posts  |  Last Activity: Nov 29, 2014 9:45 PM Member since: Jan 11, 2008
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  • I quote fromJoseph Wagner, Ph.D.
    Chief Executive Officer
    September 25, 2014
    Some pumping going on, could be true, could be good science, or maybe later.

    Multiple clinical studies reporting by year-end 2014,
    coupled with very large market potential of products may
    yield large, near-term valuation increases.

    : Initial clinical validation studies on three diagnostic products reporting by
    year-end 2014
    : Novel molecular cancer diagnostics that address major unmet medical
    needs
    : Potential for rapid initial adoption through KOL support and limitations of
    current diagnostic tests
    :Potential for broad eventual adoption due to advantages over current
    screening diagnostics
    : Favorable reimbursement landscape with opportunity for value-based
    pricing of tests
    Near-term revenue potential (12-18 months)
    : Potential for products to achieve “blockbuster” status ( $1B/year)

    :A substantial proportion of the mammalian
    genome is exclusively activated during
    embryonic development
    : These embryo-exclusive genes regulate:
    - Cell proliferation
    - Cell signaling
    - Organ formation
    - Angiogenesis
    :Many of these genes are accessed/activated by
    cells after oncogenic mutation & transformation
    : Many of these genes have not been previously
    associated with cancer

  • The U.S. Environmental Protection Agency’s decision to postpone the release of its 2014 renewable fuel standard regulations will create uncertainty within the biofuels market and may cause investors to scuttle plans to build refineries in the U.S., biofuel advocates told reporters at a Nov. 24 briefing.

    The standards—known as renewable volume obligations—set requirements for blending biofuels, such as ethanol, into gasoline at gasoline pumping stations.

    EPA announced on Nov. 21 that it would not issue its 2014 renewable percentage standards until sometime in 2015. In addition, EPA will not finalize a controversial rule that would have made cuts to below 2013 levels for blending requirements, and enabled the EPA to waive the obligation requirements based on concerns about the distribution of renewable fuels to consumers.

    Renewable fuel association officials said that EPA’s proposal, if made final, would have created a disincentive for producing and using biofuels. Brooke Coleman, Advanced Ethanol Council executive director, said “EPA’s decision to pull back the 2014 proposal is the right thing to do, but we need to move quickly in 2015” to get a better proposal in place.

    EPA has said it plans to issue a proposal late in 2015. Bob Dinneen, Renewable Fuels Association president and CEO, said, “2015 is going to be another year of missed opportunities” unless EPA acts quickly in 2015.

    The construction of refineries and supporting infrastructure has been a strong market for construction firms over the past several years. (ENR, 10/17/2011). A few commercial-scale, advanced biofuel refineries have opened in the past year, but the dozens of plants that are in the pipeline may be put on hold, or moved overseas, because of uncertainty about the future of the biofuels industry in the U.S., Coleman said.

    The oil and gas industry, however, believes the entire Renewable Fuel Standard is problematic and should be scrapped.

    Jack Gerard, American Petroleum Institute president and CEO, said in a statement, “The Renewable Fuel Standard was flawed from the beginning, horribly mismanaged, and is now broken."

    He added, "Failure to repeal could put millions of motorists at risk of higher fuel costs, damaged engines and costly repairs.” 



    Gerard cited a Congressional Budget Office report that predicts higher gasoline and diesel costs under higher ethanol mandates. E15—a fuel blend with 15% ethanol—can damage engines and cause vehicles that use it to break down, according to Gerard's account of the Coordinating Research Council’s testing.

    The American Fuel & Petrochemical Manufacturers went even further in response to EPA's announcement, calling the agency's inaction a "dereliction of responsibility." The group filed a notice on Nov. 21 saying it intended to sue EPA over its failure to to issue the 2014 regulations.

    Sen. Lisa Murkowski (R-Alaska), the top Republican on the Energy and Natural Resources Committee, said, “With the agency responsible for implementing the standard now unable to finalize the rule for a calendar year within that year, let alone in accordance with statutory requirements, it is time for Congress to revisit and rethink this entire policy.”

    But there is bipartisan support for the RFS and wider use of biofuels. In January 2014, a bipartisan group of lawmakers, including Sens. #$%$ Durbin (D-Ill.) and Chuck Grassley (R-Iowa), asked the EPA to modify its proposal to support “investments in the next generation of biofuels and the infrastructure necessary to deploy those fuels into the market.”

  • fearingsf by fearingsf Nov 18, 2014 3:13 PM Flag

    NeoStem presented the results from #$%$ sm#$%$ll study of c#$%$rdi#$%$c stem-cell ther#$%$py NBS10 #$%$t the Americ#$%$n He#$%$rt Associ#$%$tion #$%$nnu#$%$l meeting on Mond#$%$y.

    Its Ph#$%$se 2 PreSERVE AMI (or #$%$cute myoc#$%$rdi#$%$l inf#$%$rction) Clinic#$%$l Tri#$%$l tr#$%$cked 161 p#$%$tient being tre#$%$ted #$%$nd h#$%$ving received six month follow-up for im#$%$ging #$%$nd 12 month medi#$%$n length follow up for mort#$%$lity, #$%$dverse events, serious #$%$dverse events (SAEs) #$%$nd m#$%$jor #$%$dverse c#$%$rdi#$%$c events (MACE).

    Unfortun#$%$tely, NBS10, formerly known #$%$s AMR-001, w#$%$s no different th#$%$n #$%$ pl#$%$cebo #$%$t reviving blood flow through the he#$%$rt, #$%$nd it w#$%$s only slight better th#$%$n #$%$ pl#$%$cebo #$%$t preventing MACE in p#$%$tients studied. The drug is #$%$n #$%$utologous stem-cell ther#$%$py th#$%$t is t#$%$ken from #$%$ p#$%$tient’s own bone m#$%$rrow.

    In theory, the stem cells received #$%$re then supposed to rebuild d#$%$m#$%$ged he#$%$rt muscle #$%$nd tissue #$%$nd get blood circul#$%$ting #$%$g#$%$in. But when p#$%$tients tre#$%$ted with #$%$n infusion of the drug underwent non-inv#$%$sive im#$%$ging to #$%$ssess blood flow through the he#$%$rt six months #$%$fter the tre#$%$tment, there w#$%$s no st#$%$tistic#$%$l difference between those tre#$%$ted with NBS10 #$%$nd those tre#$%$ted with #$%$ pl#$%$cebo.

    Perh#$%$ps more concerning w#$%$s the d#$%$t#$%$ th#$%$t showed 17 percent of p#$%$tients tre#$%$ted with NBS10 still subsequently suffered #$%$ MACE event, only #$%$ slight dip from the 19 percent of p#$%$tients given #$%$ pl#$%$cebo.

    Too b#$%$d, we #$%$re in #$%$ rut till positive results s#$%$ve lives.

  • If the ALNY GalNac-sirna delivery is so adverse then the downstream effect for RGLS can't be great one would assume.

    Yet it is RGLS which was able to raise the needed capital and fully enrol for its upcoming trials. Which kind of negates any concerns an investor would have because of the regulatory approval required to get to that point.

    Which brings us back to the question of why does Benitec have such a stringent control on its trial? The upshot being only two patients have been dosed. The second conveniently on the eve of the annual meeting.

    My conclusion; it is because of serious toxicity concerns from the FDA.

    November 15, 2014 at 4:05 PM

  • RES Americas plans large energy storage projects
    Calling them the largest fully commercial energy storage projects in North America, renewable energy engineering and construction company Renewable Energy Systems Americas, Inc. (Broomfield, CO) will build two grid-scale, 19.8 megawatt (MW) energy storage projects in the Chicago area, the company announced on November 11. The Jake Energy Storage Center will be located in Joliet, while the Elwood Energy Storage Center will be located in West Chicago.

  • PARSIPPANY, NJ, USA I November 5, 2014 I The Medicines Company (NASDAQ:MDCO) today announced enrollment of the first patient in its Phase 3 clinical trial program for CARBAVANCE™ (meropenem/RPX7009), an investigational intravenous antibiotic under development for the treatment of serious bacterial infections due to gram-negative bacteria, particularly KPC (Klebsiella pneumoniae carbapenemase)-producing carbapenem-resistant Enterobacteriaceae (CRE).

    CARBAVANCEis a combination of the carbapenem antibiotic, meropenem, combined with RPX7009, the first of a novel class of beta-lactamase inhibitors. Beta-lactamase inhibitors are agents that inhibit bacterial enzymes, which destroy beta-lactam antibiotics and result in resistance to first line as well as "last defense" antimicrobials used in hospitals. Gram-negative bacterial infections are widely considered to be one of the largest areas of unmet medical need, as these pathogens are growing increasingly resistant to existing therapies with few antibiotics in development.

    The first CARBAVANCE clinical trial is designed to evaluate the efficacy, safety and tolerability of CARBAVANCE in approximately 850 patients with complicated urinary tract infections (cUTI) or acute pyelonephritis (AP). The second trial is designed to evaluate the safety, efficacy and tolerability of CARBAVANCE in approximately 150 patients with suspected or known serious infections due to CRE across multiple indications.

    Results from both CARBAVANCE Phase 3 trials are expected in 2016.

    In January 2014, the U.S. Food and Drug Administration (FDA) designated CARBAVANCE as a Qualified Infectious Disease Product (QIDP). The QIDP designation provides CARBAVANCE priority review by the FDA, eligibility for the FDA's "fast track" status, and an additional five years of exclusivity upon approval of the product for intravenous use in six indications. These include complicated urinary tract and intra-abdominal infections, hospital-acquired bacterial pneumonia/ventilator-associated bacterial pneumonia, and febrile neutropenia.

  • Onxeo S.A.: Positive Phase II preliminary results of Validive® For the prevention of Severe Oral Mucositis in Head and Neck cancer patients.

    Significant reduction of incidence of severe mucositis
    Improved oral mucositis related symptoms and decreased adverse events related to radiotherapy
    Good Safety profile
    Strong Compliance to treatment
    Trial Advisory Board validated data as supportive to enter into Phase III trial

    PARIS, France & COPENHAGEN, Denmark I October 30, 2014 I Onxeo S.A. (Paris:ONXEO) (NASDAQ OMX:ONXEO) (Euronext Paris, NASDAQ OMX Copenhagen: ONXEO), an innovative biopharmaceutical company specializing in the development of orphan oncology drugs, today announced positive preliminary top-line results from its Phase II clinical trial of Validive® (mucoadhesive buccal tablet MBT clonidine Lauriad®) for prevention of severe oral mucositis (OM).

    Onxeo has performed a large international randomized, double-blind, placebo-controlled Phase II trial comparing the efficacy and safety of Validive® 50 μg and 100 μg applied once daily to those of placebo in the prevention and treatment of chemoradiation therapy-induced severe oral mucositis in 183 patients with head and neck cancer.

    Validive® was granted a fast track designation by the FDA in January 2014, allowing facilitated interactions with the FDA and optimized development time and review period for drugs investigated as treatments for serious or life-threatening diseases with a high unmet medical need.

    Validive® is a therapeutic application of clonidine based on the mucoadhesive technology Lauriad®.

    Clonidine stimulates the alpha-2 adrenergic receptors traditionally used to treat high blood pressure. It stimulates these receptors in the brain. This leads to a decrease in peripheral resistance and thus a lowering of blood pressure, as well as a reduction in heart rate and renal vascular resistance.

    However, clonidine also acts as an agonist of the alpha-2 adrenergic receptors on leucocytes and macrophages, thereby decreasing the expression of the pro-inflammatory genes and the release of cytokines IL6, IL1β and TNFα. This effect leads to a reduction in the pro-inflammatory mechanisms. It also acts on the anti-inflammatory mechanisms by increasing the release of TGF β.

    Clonidine therefore has the following properties:

    Painkilling properties due to changes in the inflammatory response and its direct action on nociceptors;
    Anti-inflammatory properties due to its action on the expression of the pro-inflammatory genes and the resulting release of cytokines IL6, IL1 β and TNFα and due to the release of TGF β.

  • A paralysed man has been able to walk again after a pioneering therapy that involved transplanting cells from his nasal cavity into his spinal cord.

    The complex neural circuitry responsible for our sense of smell is the only part of the nervous system that regenerates throughout adult life.

    It is this ability that scientists have tried to exploit in stimulating repair in the spinal cord.

    Every time we breathe, molecules carrying different odours in the air come into contact with nerve cells in the nose.

    These transmit messages to our olfactory bulbs - at the very top of the nasal cavity, sitting at the base of the brain.

    The nerve cells are being continually damaged and must be replaced.

    This process of regeneration is made possible by olfactory ensheathing cells (OECs), which provide a pathway for the fibres to grow back.

  • fearingsf fearingsf Oct 22, 2014 12:45 AM Flag

    The complex neural circuitry responsible for our sense of smell is the only part of the nervous system that regenerates throughout adult life.

    It is this ability that scientists have tried to exploit in stimulating repair in the spinal cord.

    Every time we breathe, molecules carrying different odours in the air come into contact with nerve cells in the nose.

    These transmit messages to our olfactory bulbs - at the very top of the nasal cavity, sitting at the base of the brain.

    The nerve cells are being continually damaged and must be replaced.

    This process of regeneration is made possible by olfactory ensheathing cells (OECs), which provide a pathway for the fibres to grow back.

  • A Bulgarian man who was paralyzed from the chest down in a knife attack can now walk with the aid of a frame after receiving pioneering transplant treatment using cells from his nose.

    The technique, described as a breakthrough by a study in the journal Cell Transplantation, involved transplanting what are known as olfactory ensheathing cells into the patient’s spinal cord and constructing a “nerve bridge” between two stumps of the damaged spinal column.
    “We believe... this procedure is the breakthrough which, as it is further developed, will result in a historic change in the currently hopeless outlook for people disabled by spinal cord injury,” said Geoffrey Raisman, a professor at University College London’s (UCL) institute of neurology, who led the research.

  • Another method of operation. CYTR

    About Aldoxorubicin

    The widely used chemotherapeutic agent doxorubicin is delivered systemically and is highly toxic, which limits its dose to a level below its maximum therapeutic benefit. Doxorubicin also is associated with many side effects, especially the potential for damage to heart muscle at cumulative doses greater than 450 mg/m2. Aldoxorubicin combines doxorubicin with a novel single-molecule linker that binds directly and specifically to circulating albumin, the most plentiful protein in the bloodstream. Protein-hungry tumors concentrate albumin, thus increasing the delivery of the linker molecule with the attached doxorubicin to tumor sites. In the acidic environment of the tumor, but not the neutral environment of healthy tissues, doxorubicin is released. This allows for greater doses (3 ½ to 4 times) of doxorubicin to be administered while reducing its toxic side effects. In studies thus far there has been no evidence of clinically significant effects of aldoxorubicin on heart muscle, even at cumulative doses of drug well in excess of 2,000 mg/m2.

  • Two promising candidate vaccines

    Given the public health need for safe and effective Ebola interventions, WHO regards the expedited evaluation of all Ebola vaccines with clinical grade material as a high priority.

    Two candidate vaccines have clinical-grade vials available for phase 1 pre-licensure clinical trials.

    One (cAd3-ZEBOV) has been developed by GlaxoSmithKline in collaboration with the US National Institute of Allergy and Infectious Diseases. It uses a chimpanzee-derived adenovirus vector with an Ebola virus gene inserted.

    The second (rVSV-ZEBOV) was developed by the Public Health Agency of Canada in Winnipeg. The license for commercialization of the Canadian vaccine is held by an American company, the NewLink Genetics company, located in Ames, Iowa. The vaccine uses an attenuated or weakened vesicular stomatitis virus, a pathogen found in livestock; one of its genes has been replaced by an Ebola virus gene.

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