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Heeft CytoDyn het ultieme anti-HIV-middel??

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  1. forum rang 10 DeZwarteRidder 17 februari 2017 08:07
    About CytoDyn
    CytoDyn is a biotechnology company focused on the clinical development and potential commercialization of humanized monoclonal antibodies for the treatment and prevention of HIV infection. The Company has one of the leading monoclonal antibodies under development for HIV infection, PRO 140, which has completed Phase 2 clinical trials with demonstrated antiviral activity in man and is currently in Phase 3. PRO 140 blocks the HIV co-receptor CCR5 on T cells, which prevents viral entry. Clinical trial results thus far indicate that PRO 140 does not negatively affect the normal immune functions that are mediated by CCR5. Results from seven Phase 1 and Phase 2 human clinical trials have shown that PRO 140 can significantly reduce viral burden in people infected with HIV. A recent Phase 2b clinical trial demonstrated that PRO 140 can prevent viral escape in patients during several months of interruption from conventional drug therapy. CytoDyn intends to continue to develop PRO 140 as a therapeutic anti-viral agent in persons infected with HIV and to pursue non-HIV indications where CCR5 and its ligand CCL5 may be involved. For more information on the Company, please visit www.cytodyn.com.

    About PRO 140
    PRO 140 belongs to a new class of HIV/AIDS therapeutics – viral-entry inhibitors – that are intended to protect healthy cells from viral infection. PRO 140 is a humanized IgG4 monoclonal antibody directed against CCR5, a molecular portal that HIV uses to enter T-cells. PRO 140 blocks the predominant HIV (R5) subtype entry into T-cells by masking this required co-receptor, CCR5. Importantly, PRO 140 does not appear to interfere with the normal function of CCR5 in mediating immune responses. PRO 140 does not have agonist activity toward CCR5 but does have antagonist activity to CCL5, which is a central mediator in inflammatory diseases. PRO 140 has been the subject of seven clinical trials, each demonstrating efficacy by significantly reducing or controlling HIV viral load in human test subjects. PRO 140 has been designated a “fast track” product candidate by the FDA. The PRO 140 antibody appears to be a powerful antiviral agent leading to potentially fewer side effects and less frequent dosing requirements as compared to daily drug therapies currently in use.
  2. forum rang 10 DeZwarteRidder 17 februari 2017 08:08
    CytoDyn's PRO 140: A Paradigm Shift in the $20 Billion HIV Market
    [Accesswire]
    AccesswireJune 13, 2016

    NEW YORK, NY / ACCESSWIRE / June 13, 2016 / Rising Tide Equity Research, LLC announced today the release of its Initial Equity Report on CytoDyn (CYDY), a biotechnology company focused on the development of monoclonal antibodies for the treatment of human immunodeficiency virus (HIV) and Graph versus Host Disease (GvHD). The Company's lead clinical candidate, PRO 140, is currently in two Phase 3 trials evaluating its effectiveness as an adjunct therapy to current HIV treatment and as a monotherapy treatment for HIV.

    The Company believes PRO 140 is uniquely positioned to address a growing HIV market as an alternative or addition to current therapies, which are failing primarily due to drug resistance. In seven clinical trials previously conducted, PRO 140 was generally well-tolerated, and no drug-related serious adverse events or dose-proportional adverse events were reported. The results of these studies established that PRO 140's antiviral activity was potent, rapid, prolonged, dose-dependent, and statistically significant following a single dose. PRO 140's mechanism of action (monoclonal antibody use in HIV) is a relatively new therapeutic approach and provides an effective method of suppressing the virus in treatment-experienced patients and as well as new frontline therapy.

    Data from the PRO 140 monotherapy Phase 2b extension study will be discussed in an oral presentation entitled, "PRO 140 SC Monotherapy Provides Long-term, Full Virologic Suppression in HIV Patients," by Paul J. Maddon, MD, PhD, at the ASM Microbe 2016 Conference on Monday, June 20, 2016. Data from the Phase 2b extension study, found PRO 140 provided full virologic suppression, was well-tolerated, and enabled the avoidance of the potential toxicity of highly active anti-retroviral therapy (HAART), while preserving drug options for >1 year.

    Current HIV Market

    Gilead Sciences currently dominates the HIV treatment space, generating approximately $11 billion in revenue from their HAART regime. While effective, the HAART treatment is associated with significant side-effects, requires daily dosing, is susceptible to drug resistance, and not effective in all HIV patients. Current consensus within the medical community suggests that HIV treatment will soon be administered through intra-muscular or subcutaneous injections. ViiV Healthcare (a subsidiary of GlaxoSmithKline) and Janssen Pharmaceuticals are developing drugs that can be administered via intra-muscular injection and are in the early stages of clinical development. ViiV Healthcare is developing a drug cocktail using their integrase inhibitor cabotegravir and Janssen is utilizing a non-nucleoside reverse transcriptase inhibitor Edurant (rilpivirine). The intra-muscular approach requires clinic visits on a defined schedule in which the drug is injected into a large muscle group. TaiMed, a Taiwanese company, is developing a subcutaneous injection using ibalizumab, a human monoclonal antibody. Early proof of concept trials have shown positive results but further clinical development is pending at this time.

    CtyoDyn's PRO 140 Competitive Advantage

    In contrast to the HAART regime, PRO 140 is administered once weekly, via a self-administered subcutaneous injection. Clinical data has shown PRO 140 to have few toxicity or safety concerns and is equally efficacious to current treatment options. Patients in the ongoing Phase 2b monotherapy trial have experienced 20 months of full virologic suppression and the FDA recently approved a Compassionate Use Protocol for the continued administration of PRO 140 for patients completing CytoDyn's Adjunctive Therapy trial. CytoDyn's PRO 140 technology could revolutionize the treatment of HIV and other diseases such as GvHD. Key opinion leaders in the HIV field have indicated that injectable treatments are the future of HIV care and CytoDyn's PRO 140 is at the forefront of this space with two ongoing Phase 3 trials. If successful, the Company's technology would allow them to enter this multi-billion dollar market and initiate a paradigm shift in HIV treatment.

    The complete Rising Tide Equity Report, including important disclosures, is available to download at no cost on the Rising Tide Equity Research website, www.risingtideequity.com/equity-resea...
  3. forum rang 10 DeZwarteRidder 17 februari 2017 08:10
    Data Presented at CROI Show CytoDyn’s Pro 140 as a Single Agent Provided Maximal Virologic Suppression in HIV Patients for Nearly Two Years
    GlobeNewswire•February 16, 2017

    VANCOUVER, Washington, Feb. 15, 2017 (GLOBE NEWSWIRE) -- CytoDyn Inc. (CYDY), a biotechnology company focused on the development of new antibody therapies for combating human immunodeficiency virus (HIV) infection, announces that data from its ongoing Phase 2b extension study with PRO 140 administered as a single agent provided maximal virologic suppression and was well tolerated by 10 HIV-infected patients for nearly two years. The study data was the subject of a poster presentation by Dr. Kush Dhody, Senior Director, Clinical Operations at Amarex Clinical Research, at the Conference on Retroviruses and Opportunistic Infections (CROI) being held in Seattle.

    The abstract and poster, entitled “PRO140 Single-Agent Maintenance Therapy for HIV-1 Infection: A 2-Year Update,” are available on the company’s website at www.cytodyn.com. The study data will also be featured at CROI 2017 in a special hour-long Themed Discussion, “I Want a New Drug,” on February 16 beginning at 1:30 p.m. Pacific time (4:30 p.m. Eastern time). A delayed webcast of the Themed Discussion will be available on February 17, 2017 by 2:30 p.m. Pacific time at croiwebcasts.org, then select “Feb 16” and scroll down to “I Want a New Drug.”

    The poster reviews the two-year treatment data from the ongoing Phase 2b CD01 extension study into which 16 patients infected with CCR5-tropic HIV-1 were enrolled after maintaining virologic suppression (HIV-1 RNA levels below 40 copies/mL) following 12 weeks of weekly, subcutaneous injections of PRO 140 (350 mg) as a single agent under the initial CD01 study. Of the 16 patients, 14 were male and three were non-white; the median age was 54.9 years (range of 26-68) and median CD4 T-cell count was 593 cells/mm3 (range of 365-1059). These patients were trained to self-administer PRO 140 and were allowed to continue weekly subcutaneous injections as a monotherapy for up to three years (or 160 weeks). Of those enrolled, 13 patients (81.3%) maintained complete virologic suppression for more than 40 weeks and 10 patients (62.5%) maintained complete virologic suppression for nearly two years and are still continuing on PRO 140 monotherapy regimen. One patient discontinued at week 47 with complete virologic suppression due to relocation and five patients experienced virologic rebound, defined as two consecutive viral load measurements of =400 copies/mL. The mean time to virologic rebound was 329 days (range of 106-691). An advanced single-copy HIV RNA assay levels (to quantify the viral load below the limit of detection of commercially available assays) were evaluated for the 10 ongoing patients at two-year time point. Seven (7) patients reported viral load of <1 copy/mL; and other 3 patients reported values of 4, 10, and 19 copies/mL. These single-copy HIV-1 RNA results provide further evidence of potent antiviral activity of PRO 140.

    “HIV-infected patients are in need of new approaches for maintaining virologic suppression as many experience toxicity, intolerance or suboptimal adherence to the current standard of care, which is a daily oral combination antiretroviral therapy (ART),” said Dhody. “As highlighted in this poster, a subgroup of patients was able to maintain complete virologic suppression on PRO 140 over extended periods of time without the compliance, tolerance and resistance issues associated with oral combination ART. The strength of the data presented today demonstrates that PRO 140 warrants further evaluation as a long-acting, single-agent maintenance therapy in select HIV-1 patients. It is indeed an honor to present this data to attendees at CROI 2017.”

    “PRO 140 is a humanized IgG4 monoclonal antibody that works by blocking HIV-1 from entering and infecting immune cells by binding to CCR5 with high affinity, which is a novel approach to maintaining virologic suppression,” said Paul J. Maddon, MD, PhD, inventor of PRO 140 and Senior Science Advisor to CytoDyn. “It is exciting that a group of patients self-administering PRO 140 as a monotherapy were able to avoid the potential toxicity of ART, while preserving their option to return to an ART regimen at a later date. PRO 140 was well tolerated by a majority of patients in this extension study and there were no reports of serious adverse events or treatment discontinuation related to the drug. As anticipated, no anti-PRO140 antibodies were detected in any patient, indicating there were no signs of drug resistance.”
  4. forum rang 10 DeZwarteRidder 17 februari 2017 08:15
    02 december 2016 05:36
    Charlie Sheen gebruikt nieuw middel tegen HIV

    Charlie Sheen gebruikt een nieuw medicijn tegen HIV. Dat meldt het Britse dagblad The Daily Mail.

    Charlie sprak donderdag met de krant vanwege Wereld AIDS Dag. De acteur liet vorig jaar weten besmet te zijn met HIV en antiretrovirale medicijnen te slikken. Dat zijn vaak een of twee tabletten die dagelijks moeten worden ingenomen om het HIV virus te onderdrukken.

    Sinds januari maakt de acteur deel uit van een groep patiënten die experimenteert met een wekelijkse injectie, in plaats van het dagelijks slikken van de tabletten. "Het is onmogelijk geweldig", aldus een enthousiaste Charlie. "Persoonlijk: ik denk terug hoe ik me voelde toen ik hiermee begon en hoe ik me nu voel. Wow. Over een transformatie gesproken", vervolgt de 51-jarige acteur.

    De wekelijkse injectie is met het middel PRO-140, dat iets anders werkt dan de antiretrovirale pillen. Ook het feit dat het medicijn maar eenmaal per week hoeft te worden toegediend is hoopgevend, met name voor patiënten die in afgelegen gebieden wonen of meerdere gezondheidsklachten hebben. Als het experiment slaagt kan het medicijn eind 2017 of begin 2018 op de markt verschijnen.
    ANP

    2
  5. forum rang 10 DeZwarteRidder 19 februari 2017 10:49
    quote:

    beurspiet schreef op 19 februari 2017 10:31:


    ik zou niet durven denken ..........., doe gewoon uw dd en beslis voor jezelf ! Succes

    Piet,
    wat is jouw probleem??

    Verveel je je eigen??

    Ben je te lui om iets nuttigs te schrijven??

    Vertel eens iets interessants in meer dan 5 zinnen of maak je eigen draadje over het 4-letterwoord.
  6. beurspiet 19 februari 2017 11:23
    Probleem ????!!! GEEN
    Vervelen???!!! GEENSZINS
    Lui ?????!!!!! uhhhhh , eigenlijk wel , maar een positieve

    Ik post niet veel hé . En dit is het biopharma draadje hé . Was dus gewoon een "tipje" op uw tipje CYDY . Niets meer , niets minder . Ik lees niet wat anderen schrijven over hun aandelen , maar bekijk zelf wel wat er fundamenteel over geschreven staat en dan oordeel ik zelf wel of ik koop of niet !


    Succes
  7. forum rang 10 DeZwarteRidder 19 februari 2017 11:30
    quote:

    beurspiet schreef op 19 februari 2017 11:23:


    Probleem ????!!! GEEN
    Vervelen???!!! GEENSZINS
    Lui ?????!!!!! uhhhhh , eigenlijk wel , maar een positieve
    Ik post niet veel hé . En dit is het biopharma draadje hé . Was dus gewoon een "tipje" op uw tipje CYDY . Niets meer , niets minder . Ik lees niet wat anderen schrijven over hun aandelen , maar bekijk zelf wel wat er fundamenteel over geschreven staat en dan oordeel ik zelf wel of ik koop of niet !
    Succes

    Geweldig!!
    Meer dan 5 zinnen, maar helaas weer niks nuttigs.

    Dit is trouwens niet het BioPharma-draadje, maar het CytoDyn-draadje.

  8. forum rang 10 DeZwarteRidder 19 februari 2017 12:10
    quote:

    tehbart schreef op 19 februari 2017 12:05:


    Ik zie dat ze in phase 3 zitten, maar kan zo niet vinden wanneer ze verwachten dit af te ronden, heb je dit ergens kunnen vinden op hun site?

    Nog dit jaar, maar ze hebben een aanvraag ingediend bij de FDA voor een snellere procedure.

    De (voormalige)proefpersonen zijn zo tevreden dat ze het middel persè willen blijven gebruiken en dat kan met een speciale procedure.
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