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Home  /  Forum  /  BioPharma  /  Heeft CytoDyn het ultieme anti-HIV-middel??

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Heeft CytoDyn het ultieme anti-HIV-middel??

1.071 Posts
Pagina: «« 1 2 3 4 5 6 ... 54 »» | Laatste | Omlaag ↓
  1. [verwijderd] 29 februari 2020 10:48
    Staat nu op $1.048. Gisteren nog een pluk bijgekocht op $0.93. Ik ben er klaar voor.

    Leronlimab is één van de meest veelbelovende medicijnen ter behandeling van virale ziekten (dus ook Corona). Koers heeft nog niet veel gedaan de laatste week: het was een balans tussen de vertraging van het indienen van de BLA voor HIV behandeling en de positieve ontwikkelingen in kanker. Corona was nauwelijks zichtbaar de afgelopen paar weken.

    fc

    CytoDyn to Hold Conference Call for Updates on Filing Phase 2 Trial with FDA for Treatment of Coronavirus in U.S., Status of BLA, Breakthrough Therapy Designation, Basket Trial for 22 Solid Tumor Cancers and Licensing Opportunities in Several Countries

    VANCOUVER, Washington, Feb. 28, 2020 (GLOBE NEWSWIRE) -- CytoDyn Inc. (CYDY), (“CytoDyn” or the “Company"), a late-stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, announced today that Nader Pourhassan, Ph.D., president and chief executive officer, and Craig Eastwood, chief financial officer, will host an investment community conference call on March 5, 2020 to provide a comprehensive update on several recent developments. The conference call will focus on the following key agenda items:

    * Bruce Patterson, M.D., chief executive officer and founder of IncellDx, a diagnostic partner and advisor to CytoDyn, will provide a detailed explanation of the mechanism of action for treating coronavirus with leronlimab

    * Filing of an IND and Phase 2 clinical trial protocol with the FDA for the treatment of coronavirus with leronlimab in the U.S.

    * Status of U.S. filing of the Biologics License Application (BLA) for leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients

    * Status of the Company’s request for Breakthrough Therapy Designation for the treatment of mTNBC with leronlimab

    * Expected timing of the Company’s filing for a new request for Breakthrough Therapy Designation for the treatment of 22 different solid tumor cancers

    * Anticipated timing of potential approval by TFDA (Taiwanese FDA) of leronlimab for the treatment of cancer, HIV and coronavirus

    * Anticipated timing of potential approval by CFDA (Chinese FDA) of leronlimab for the treatment of cancer and coronavirus

    * Testimony from cancer patients regarding their experiences with leronlimab for cancer treatment

    * Overview of ongoing licensing opportunities with several countries for the use of leronlimab for the treatment of HIV, cancer and coronavirus

    Management will dedicate approximately 45 minutes to address questions from analysts and investors.

    Date: Thursday, March 5, 2020
    Time: 4:00 p.m. ET / 1:00 p.m. PT
    Dial-In: 877-407-2986 US / 201-378-4916 International
  2. [verwijderd] 29 februari 2020 22:26
    Lees ook de kritische stukken over dit bedrijf, en hoe ze elke keer maar weer zaken uitstellen (BLA, aanvraag bij de FDA enz.). Ik zeg niet dat het een scam is, maar vertrouwen doe ik het ook niet.
    Ik zou zeggen koop voor bijv euro1000, als het is wat er beloofd wordt dan is het zo het 100-voudige waard. En anders ben je je geld kwijt.
  5. [verwijderd] 2 maart 2020 18:31
    CytoDyn Reports Remarkable Outcomes for Additional Cancer Patients in mTNBC Trial; Following an Overwhelming Community Response, CytoDyn Expects to Enroll More Than 20 Patients in its 22 Solid Tumor Cancer Trial in the Next 60 Days

    VANCOUVER, Washington, March 02, 2020 (GLOBE NEWSWIRE) -- CytoDyn Inc. (CYDY), (“CytoDyn” or the “Company"), a late-stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, announced today continued positive data for its mTNBC and MBC patients.

    Metastatic triple-negative breast cancer (mTNBC), an aggressive histological subtype, has a poor prognosis. In addition, metastatic breast cancer (MBC) is breast cancer that has spread beyond the breast and lymph nodes to other organs in the body (typically the bones, liver, lungs, or brain). Both types of cancer pose significant challenges for patients due to their aggressiveness and limited treatment options. An integral part of CytoDyn’s mission and purpose is to provide effective therapeutic solutions to these patients. Results of the first five patients are as follows:

    Patient #1: Enrolled in mTNBC Phase 1b/2 - Injected on 9/27/2019. CTC (circulating tumor cells) dropped to zero in two weeks on 10/11/2019. Total CTC and EMT (Epithelial Mesenchymal Transition in Tumor Metastasis) dropped to zero after about one month of treatment with leronlimab (once-a-week 350 mg dose). Results from the patient’s earlier CT scan indicated a more than 25% tumor shrinkage within the first few weeks of treatment with leronlimab. Most importantly, after more than five months of treatment with leronlimab and Carboplatin, the patient not only has zero CTC and zero EMT, but also zero detectible CAML (cancer-associated microphages like cells).

    Patient #2: Enrolled in single IND. Patient is MBC with HER2+ stage 4 metastasis to lung, liver, and brain. Patient’s radiologist cancelled 2nd round of treatment due to leronlimab’s effect on shrinking the largest tumor in the brain by 56% and other lesions being stable. Leronlimab has and continues to be the only treatment in place for brain metastasis after radiation was administered to this patient in July 2019. Four and one-half months after successful radiation treatment, the patient received her first dose of leronlimab (700 mg) and no other drugs to treat the brain metastasis. The 56% shrinkage in the brain lesions occurred after only two once-weekly injections of leronlimab. After 10 weeks of treatment with leronlimab, this patient’s CTC and EMT results were all zeros (results reported on 2/12/2020). The patient’s CT scan in mid-February was reported as stable.

    Patient #3: Enrolled on 1/3/2020. This patient’s CAML counts decreased from 45 to 30. CTC+EMT are stable and there has been no change in the total number. Despite positive results, this patient stopped treatment due to complications with her implanted port, which was unrelated to leronlimab.

    Patient #4: Enrolled on 1/7/2020. This patient’s total CTC dropped by 75% in the first two weeks of treatment with leronlimab. After almost five weeks of treatment, the CTC remained at zero.

    Patient #5: Enrolled on 2/4/2020. This patient has traveled from England to receive leronlimab. Initial response from treatment indicated tumor shrinkage and, importantly, CTC dropped to zero after three weeks of leronlimab treatment.

    Patients #6 and #7: Enrolled and waiting for the first results post-baseline results.

    Patients #8 through #10: Will be injected in early March.

    Bruce Patterson, M.D., chief executive officer and founder of IncellDx, a diagnostic partner and advisor to CytoDyn, commented, “Patients continue to be actively enrolled in this trial based on the expression of CCR5 on lymphocytes and macrophages in the tumor microenvironment. The proposed mechanism of action (MOA) consisting of inhibition of Tregs and repolarization of macrophages has demonstrated a predictable, sustained response that has reduced the size of primary and metastatic tumors and reduced circulating tumor cells in all patients tested so far.”

    Nader Pourhassan, Ph.D., president and chief executive officer of CytoDyn, added, “These findings are solidifying our belief of the four mechanism of actions (MOA) for leronlimab in the treatment of cancer, as previously verified through preclinical animal studies and in published papers. These MOAs indicate that leronlimab may potentially stop metastasis in many types of solid tumor cancers, trigger the body’s immune response system to destroy the cancer tumor and perhaps more. This could represent the beginning of the transformation of CytoDyn from a potential leader in HIV therapy to providing potentially a new innovative treatment opportunity to patients with various forms of cancer and potentially NASH, GvHD, MS, and perhaps many more indications. With the possibility of our first approval in HIV late this year, we could have over 30 label expansion opportunities post-HIV approval.”

    About Triple-Negative Breast Cancer
    Triple-negative breast cancer (TNBC) is a type of breast cancer characterized by the absence of the three most common types of receptors in the cancer tumor known to fuel most breast cancer growth–estrogen receptors (ER), progesterone receptors (PR) and the hormone epidermal growth factor receptor 2 (HER-2) gene. TNBC cancer occurs in about 10 to 20 percent of diagnosed breast cancers and can be more aggressive and more likely to spread and recur. Since the triple-negative tumor cells lack these receptors, common treatments for breast cancer such as hormone therapy and drugs that target estrogen, progesterone, and HER-2 are ineffective.
  6. [verwijderd] 6 maart 2020 17:58
    Gisteren een positieve presentatie. Testen van behandeling van Corona komt eraan. CytoDyn is in overleg met de FDA over de BLA voor HIV. Lijkt nu toch echt dicht tegen een indiening aan te zitten. In kanker metastase zijn de resultaten bijzonder bemoedigend.

    De commerciële naam van leronlimab wordt Virulogics.

    Nog een aantal aandelen bijgekocht op $1.07.

    fc
  7. [verwijderd] 8 maart 2020 21:06
    De ruim een uur durende call is de moeite waard:

    www.cytodyn.com/investors/news-events...

    Morgen publiceren ze vermoedelijk meer informatie over de fase 2 in corona. Met Leronlimab hebben ze mogelijkerwijs een middel dat werkt tegen de fatale longontsteking.

    Maar koop het aandeel vooral niet om de tijdelijke corona hype: koop het om HIV, NASH, etc. Ook MS ziet er veelbelovend uit!

    fc
  8. [verwijderd] 8 maart 2020 23:31
    CytoDyn Files IND and Protocol for Phase 2 Clinical Trial for Treatment of Patients with Coronavirus with Leronlimab (PRO 140)

    Coronavirus Can Quickly Progress to Severe Pneumonia and Even Death Due to Immune Hyperactivity Including Acute Respiratory Distress Syndrome (ARDS);
    CytoDyn's Trial Focuses on Patients Who Develop Mild-To-Moderate Respiratory Illness After Contracting Coronavirus
    CytoDyn Negotiating to Expedite Setup of Treatment Clinics in New York and San Francisco

    VANCOUVER, Washington, March 08, 2020 (GLOBE NEWSWIRE) - CytoDyn Inc. (OTC.QB: CYDY), (“CytoDyn” or the “Company"), a late-stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, announced today that the Company has submitted an investigational new drug (IND) application to the U.S. Food and Drug Administration (FDA) to conduct a Phase 2 clinical trial with leronlimab (PRO 140) as a therapy for patients who experience respiratory complications as a result of contracting the coronavirus disease 2019 (COVID-19).

    Bruce Patterson M.D., CEO of IncellDX and advisor to CytoDyn explains: “Leronlimab inhibits migration of Tregs, which can inhibit the innate immune response against pathogens, into areas of inflammation. Most importantly, the migration of macrophages and the release of inflammatory cytokines including TNF and IL-6 (cytokine storm) is what causes the profound damage in the lungs in some patients. Leronlimab binding to CCR5 changes the macrophages migration and cytokine production. Taken together, these activities may reduce the morbidity and mortality in moderate to severe cases of COVID-19. IncellDx has developed a suite of diagnostics to monitor these effects of leronlimab on the immune system in these critical patients.”

    “Coronavirus deaths are linked to patients’ immune systems that have an inflammatory response to the virus causing Acute Respiratory Distress Syndrome (ARDS). With ARDS, the entire lung is affected, unlike pneumonia where often only part of the lung is affected,” said Nader Pourhassan, Ph.D., president and chief executive officer of CytoDyn. “Our scientists believe that our data in cancer patients indicated that leronlimab’s role in blocking Tregs and macrophages demonstrates that leronlimab modulates the inflammatory response to more effectively provide effector function. With more than 840 patients treated with leronlimab in our clinical trials, we believe leronlimab could reduce the inflammation which contributes to ARDS, thereby potentially reducing morbidity and mortality rates in coronavirus patients. If we can show a similar response in our current Phase 2 trial, then leronlimab could have a powerful impact on improving the prognosis for coronavirus patients. With leronlimab’s Fast Track designation from the FDA for the treatment of HIV and mTNBC (triple-negative breast cancer), we are expediting the initiation of this trial to address the rapid spread of this disease and are eager to test this proof of concept in clinical trials as a potential treatment for coronavirus,” added Dr. Pourhassan.

    The following is a brief summary of excerpts from the Company’s Phase 2 clinical trial protocol:
    Indication for Use: Leronlimab is indicated for treatment of adult patients with mild-to-moderate symptoms of respiratory illness caused by coronavirus 2019 infection.
    Objective: The purpose of this study is to assess the safety and efficacy of leronlimab administered as weekly subcutaneous injection in subjects with coronavirus 2019 infection.
    Primary Outcome (Endpoint) Measure: Clinical Improvement based on change in total symptom score (for fever, myalgia, dyspnea and cough)
    Note: The total score per patient ranges from 0 to 12 points. Each symptom is graded from 0 to 3 [0=none, 1=mild, 2=moderate, and 3=severe].
    Trial Design: This is a Phase 2, single arm, open-label, multicenter study to evaluate the safety and efficacy of leronlimab (PRO 140) in patients with mild-to-moderate symptoms of respiratory illness caused by coronavirus 2019 infection. Leronlimab (PRO 140) will be administered subcutaneously as weekly dose of 700 mg.
    The study will have three phases: Screening Period, Treatment Period, and Follow-Up Period.
    Treatment Period: 4 weeks ± allowed windows.

    Inclusion Criteria:

    * Male or female adult = 18 years of age at time of enrollment.
    * Laboratory confirmation of coronavirus 2019 infection by polymerase chain reaction (PCR) or other commercial or public health assay from any diagnostic sampling source.
    * Subjects with mild-to-moderate symptoms of respiratory illness caused by coronavirus 2019 infection
    * Clinically normal resting 12-lead ECG at Screening Visit or, if abnormal, considered not clinically significant by the Principal Investigator.
    * Subject (or legally authorized representative) provides written informed consent prior to initiation of any study procedures.
    * Understands and agrees to comply with planned study procedures.
    * Women of childbearing potential must agree to use at least one primary form of contraception for the duration of the study (acceptable methods will be determined by the site).

    About Coronavirus Disease 2019
    The coronavirus disease 2019 (COVID-19) was identified as the cause of an outbreak of respiratory illness first detected in Wuhan, China.1 The origin of COVID-19 is uncertain and it is unclear how easily the virus spreads. COVID-19 is thought to be transmitted person to person through respiratory droplets, commonly resulting from coughing sneezing and close personal contact. Coronaviruses are a large family of viruses, some causing illness in people and others that circulate among animals. For confirmed COVID-19 infections, symptoms have included fever, cough and shortness of breath. It is believed that symptoms of COVID-19 may appear in as few as two days or as long as 14 days prior to exposure, and that symptoms in patients have ranged from non-existent to severe and fatal. There are currently no known antiviral treatments effective at suppressing COVID-19.
  9. [verwijderd] 13 maart 2020 08:22
    Leronlimab Moving Toward Breakthrough Designation With Positive mTNBC Data

    Thu March 12, 2020

    The FDA has recommended that a preliminary meeting for a potential Breakthrough Therapy designation be requested for leronlimab (PRO 140) as a treatment of patients with metastatic triple-negative breast cancer (TNBC), based on positive data from a phase Ib/II study, CytoDyn, developer of the CCR5 antagonist, announced in a press release.

    The first patient was enrolled in the study and received their first treatment in September of 2019. Following 2 treatments with leronlimab and carboplatin, the patients’ circulating tumor cells (CTC) decreased to 0. Additionally, the total CTC and epithelial mesenchymal transition in tumor metastasis (EMT) levels decreased to 0 after a month of weekly treatments.

    A CT scan was given to the patient to measure tumor shrinkage and showed a 25% reduction in size within a few weeks of treatment with leronlimab and carboplatin. The patient had 0 detectible cancer-associated microphage-like cells, in addition to continuing to show no CTCs or EMTs after about 5 months of treatment. Since these results were recorded, the patient has discontinued treatment with carboplatin but continues treatment with leronlimab at the oncologist’s recommendation.

    “Our first patient in the phase Ib/II trial has shown remission of the tumor and her oncologist has attributed this primarily to leronlimab and discontinued the carboplatin (a form of chemotherapy). This patient’s latest results of zero CTC, EMT, and CAML are unique and we now have another patient with 3 zeros identical to the first patient. We are very excited to continue enrolling patients and hopeful to have our first patient treated in our basket trial for 22 solid tumor cancers very soon,” said Nader Pourhassan, PhD, president and CEO of CtyoDyn, in a statement. “We are also very hopeful to have several more patients in our phase Ib/II mTNBC trial before our preliminary meeting with the FDA for Breakthrough Therapy designation.”

    The ongoing study consists of 4 experimental arms, 3 of which were included in the phase I stage, and 1 in the phase II stage. Patients in phase I receive either leronlimab 350 mg, 525 mg, or 700 mg of leronlimab weekly plus carboplatin AUC 5 every 3 weeks. In phase II, patients receive the maximum tolerated dose (MTD) of leronlimab plus carboplatin AUC 5.

    The primary end point of phase Ib was to determine the MTD of leronlimab when combined with carboplatin. The primary end point of phase II is progression-free survival (PFS). The secondary end points of phase II include PFS per RECIST v1.1 criteria in patients with PD-L1 expression; overall response rate; time to new metastases; the change in CTC level in the peripheral blood from baseline; overall survival, and the number, frequency, and severity of adverse events to evaluate the safety of leronlimab.

    The study included patients with histologically confirmed TNBC who were positive for CCR5 by immunohistochemistry. Eligible patients were also a minimum of 18 years old with an ECOG performance status of 0 to 1, a life expectancy of at least 6 months, and adequate organ and bone marrow function.

    Patients who presented with HER2 overexpression or HER2-amplified metastatic breast cancer (MBC), ER and PR expressing tumors, prior systemic chemotherapy for MBC, active infection, active central nervous system metastasis, and other conditions that had the potential to interfere with the results, were excluded from the study.

    Preclinical research has shown that CCR5 is important for tumor invasion and metastasis, and increased expression of CCR5 is indicative of disease status in several cancers. Studies in animal models have also shown that blocking CCR5 can reduce tumor metastases in prostate cancer.

    Leronlimab also received an Orphan Drug designation from the FDA for the prevention of graft-versus-host disease (GVHD), based on preclinical studies. A phase II study was initiated to explore its activity in the treatment of GVHD further. The agent is also being explored as a potential treatment for HIV and other diseases.

    Reference:
    CytoDyn’s first MTNBC patient in phase 1b/2 is in remission and oncologist ordered termination of treatment with carboplatin (chemotherapy drug) and remains on leronlimab only as monotherapy; patient’s testimony about her condition after nearly 6 months of leronlimab treatment is very strong [news release]. Vancouver, Washington: CytoDyn, Inc; March 12, 2020. bit.ly/2xxXxHE. Accessed March 12, 2020.

    www.targetedonc.com/news/leronlimab-m...
  10. [verwijderd] 19 maart 2020 18:43
    U.S. Food and Drug Administration (FDA) Grants Emergency IND for Two Coronavirus Patients Treated in New York with CytoDyn’s Leronlimab

    A leading academic medical center has administered the test medication, leronlimab, in two of their sickest COVID-19 patients. Neither patient has had any serious adverse reactions to leronlimab since it was administered. We are hopeful leronlimab will provide help to severely ill COVID-19 patients.

    VANCOUVER, Washington, March 19, 2020 (GLOBE NEWSWIRE) - CytoDyn Inc. (CYDY), (“CytoDyn” or the “Company"), a late-stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, announced today that two coronavirus patients were treated with the Company’s investigational new drug, leronlimab. The treatment was administered at a leading medical center in the New York City area under an emergency Investigational New Drug (IND) recently granted by the U.S. Food and Drug Administration (FDA). Leronlimab is intended to serve as a therapy for patients who experience respiratory illness as a result of contracting the Coronavirus Disease 2019 (COVID-19). The treatment of these patients was not under the Company’s proposed randomized controlled Phase 2 clinical trial protocol recently submitted to the FDA.

    Bruce Patterson M.D., CEO of IncellDX and advisor to CytoDyn, added, “Leronlimab binds to the CCR5 receptor inhibiting the migration of macrophages and the release on inflammatory cytokines including TNF and IL-6. This release of cytokines is what is commonly referred to as the 'cytokine storm' and is believed to cause profound damage in the lungs in some patients. In addition, leronlimab can block Regulatory T cells (Tregs), which can inhibit the innate immune response against pathogens, into areas of inflammation. These combined mechanisms of action may reduce the morbidity and mortality in moderate to severe cases of COVID-19, preventing the acute respiratory distress syndrome associated with this highly destructive and potentially fatal disease.”

    Nader Pourhassan, Ph.D., president and chief executive officer of CytoDyn said, “We are very pleased that we have a potential treatment option for patients affected by COVID-19 infection. To be very clear, leronlimab does not kill the novel coronavirus. It acts as a CCR5 antagonist by blocking pro-inflammatory cytokines, which prevents cytokine storm and thus could be useful in treatment of COVID-19. Leronlimab is administered as a once-a-week injection. It has a strong safety profile demonstrated in nine clinical trials with over 800 people and is available for urgent treatment. If results are promising, we have leronlimab available for immediate use and the ability to scale production. We are open and willing to work with government agencies and pharmaceutical partnerships to assist in serving those in dire need of a treatment option for this devastating disease. We appreciate the FDA’s prompt response and are working in full support of the treating medical team.”
  12. [verwijderd] 23 maart 2020 22:07
    Two Additional Coronavirus Patients Treated at Leading New York Hospital with CytoDyn’s Leronlimab, Bringing the Total to Four Patients

    VANCOUVER, Washington, March 23, 2020 (GLOBE NEWSWIRE) -- CytoDyn Inc. (CYDY), (“CytoDyn” or the “Company"), a late-stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, announced today that the third and fourth coronavirus patients were treated with the Company’s investigational new drug, leronlimab. The treatment of the third patient occurred on Friday and the fourth coronavirus patient was treated on Saturday. These patients are under the care of the same leading medical center in the New York City area that treated the first and second patients.

    The treatment with leronlimab is being administered under an emergency IND recently granted by the U.S. Food and Drug Administration (FDA). The treatment with leronlimab is intended to serve as a therapy for patients who experience respiratory complications as a result of contracting SARS-CoV-2 causing the Coronavirus Disease 2019 (COVID-19).

    Bruce Patterson, M.D., CEO of IncellDx, a diagnostic partner and advisor to CytoDyn, said, “IncellDx has developed specific companion diagnostic tests to determine the efficacy and dosing of leronlimab in these severe cases of COVID-19. We believe that leronlimab acts by enhancing the immune response while mitigating the ‘cytokine storm’ that leads to morbidity and mortality in these patients.”

    Nader Pourhassan, Ph.D., president and chief executive officer of CytoDyn said, “We are encouraged that the onsite medical team is reporting no safety issues and our team continues to be responsive and supportive in any way we can.”

    Langzaam maar zeker komt CytoDyn in de picture. Gewoon nog een paar dagen resultaten afwachten...

    fc
  13. [verwijderd] 23 maart 2020 22:14
    quote:

    skyD schreef op 20 maart 2020 14:32:

    Dus alle pijlen op het HIV vaccin en niet op corona, want werkt niet 100%?
    CytoDyn werkt niet aan inentingen, ze werken aan het onderdrukken/voorkomen van virale aanvallen. Dat geldt voor HIV, maar ook voor andere virussen...

    Het is een OTC stock en daarmee hoog risico, maar wellicht waard een gokje.

    fc
  15. [verwijderd] 27 maart 2020 09:56
    COVID-19 testing is important but has 10 to 15% rate of producing false, negative results, pathologist says

    Friday, March 27, 2020 1:45AM
    SAN CARLOS, Calif. (KGO) - The rollout of COVID-19 testing is accelerating as more kits become available. However, a leading pathologist who was director of virology at Stanford, points out that the results are not 100% accurate.

    "It's not that these tests can't detect virus," said Dr. Bruce Patterson. "My concern is that the sampling involved in detecting the virus can lead to clinical false negatives."

    Patterson says he expects the rate of false negatives to be 10 to 15% in line with testing for other viruses, including seasonal flu.

    "Are they positive when you have the disease or are they positive or negative when you don't have the disease?" Dr. Patterson asked. "Those are the clinical performance metrics that physicians rely on with every test that we do."

    Patterson is the CEO of IncellDx, which is running samples of COVID-19 at the company's San Carlos labs. His research and development are focused on treatments for patients with HIV and cancer who have at risk for the coronavirus.

    You've probably heard White House task force member Dr. Anthony Fauci underscore the need for more testing. Current COVID-19 testing is being done with nasal swabs. However, Dr. Patterson says pathologists learned 17 years ago during the SARS epidemic that throat swabs provided better data.

    "We were surprised by the fact oralpharngeal swabs had a higher viral load than the nasopharyngeal swaps which, of course, contributes to sensitivity for detection," he said.

    Doing a throat swab is more invasive and more time consuming compared to drive-by testing.

    With pressure to get people back to work, Dr. Patterson believes blood tests to detect individuals who have developed antibodies to COVID-19 could be a key step. They would have protection.

    In the meantime, IncellDx is expecting results soon from a treatment it has been working on with a partner.

    "We're thinking like chess players, four moves ahead... to say, what is the next wave of diagnostics that will be critical in defeating this pandemic," he said.

    abc7news.com/society/coronavirus-test...

  17. [verwijderd] 27 maart 2020 11:26
    En dit ook wel :).

    CytoDyn Files FDA-Suggested Modifications to IND and Protocol for Phase 2 Clinical Trial for COVID-19 Patients with Mild to Moderate Indications and a Second Randomized Protocol for All COVID-19 Patients in Severe Condition Will be Filed Next Week per FDA Recommendation

    VANCOUVER, Washington, March 27, 2020 (GLOBE NEWSWIRE) -- CytoDyn Inc. (CYDY), (“CytoDyn” or the “Company"), a late-stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, announced today that, at the suggestion of the U.S. Food and Drug Administration (FDA), the Company filed another round of modifications to its IND and protocol for a Phase 2 clinical trial with leronlimab (PRO 140). In addition, the FDA suggested the Company file a second randomized protocol for all COVID-19 patients in severe condition, so as to preclude each physician from filing an emergency IND for every patient to be treated with leronlimab.

    The treatment with leronlimab is targeted as a therapy for patients who experience respiratory complications as a result of contracting SARS-CoV-2 causing the Coronavirus Disease 2019 (COVID-19). Leronlimab is believed to provide therapeutic benefit by enhancing the immune response while mitigating the “cytokine storm” that leads to morbidity and mortality in these patients.

    The first Phase 2 clinical trial that was filed on March 26 is a randomized, double blind, placebo-controlled study to evaluate the efficacy and safety of leronlimab in patients with mild to moderate documented COVID-19 illness and calls for 75 planned patients in up to 10 centers in the United States. Patients enrolled in the trial are expected to have a treatment window of approximately 6 weeks.

    Jacob Lalezari, M.D., Interim Chief Medical Officer for CytoDyn, said, “We are grateful for the responsiveness of the FDA and very pleased that the same New York medical center currently treating severely ill COVID-19 patients with leronlimab under emergency access has agreed to take the lead on initiating this randomized Phase 2 trial in patients with mild to moderate illness."

    Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn said, “On behalf of all COVID-19 patients, we are thankful for the FDA’s responsiveness and their ability to provide timely guidance in order to collaboratively finalize our Phase 2 trial protocols. We will now also immediately file a second trial protocol, per the FDA’s suggestion, for severely ill COVID-19 patients.”
  18. Fortuno 27 maart 2020 13:58
    Cytodyn wordt in alle mogelijke opzichten zo belachelijk niet gewaardeerd eigenlijk.
    Deze CV resultaten zijn ook weer uitzonderlijk goed.
    2 geintubeerde IC patienten met ernstige complicaties binnen een week van beademing en IC af.
    Volgende 2 patienten reageren goed binnen 3 dagen.

    Werkelijk waar dit is een $100 aandeel.

    Geloof het niet, maar neem de tijd om je te verdiepen in dit bedrijf.

    Binnenkort (ik hoop binnen een week) wordt aanvraag voor goedkeuring als HIV therapie ingediend.
    Er staat erg, erg veel te gebeuren op korte termijn.
    Dit gaat een big pharma company worden (als ze niet voortijdig wordt overgenomen)

    Disclosure: long
  19. [verwijderd] 27 maart 2020 14:09
    quote:

    greedfearfear schreef op 27 maart 2020 13:58:

    Cytodyn wordt in alle mogelijke opzichten zo belachelijk niet gewaardeerd eigenlijk.
    Deze CV resultaten zijn ook weer uitzonderlijk goed.
    2 geintubeerde IC patienten met ernstige complicaties binnen een week van beademing en IC af.
    Volgende 2 patienten reageren goed binnen 3 dagen.

    Werkelijk waar dit is een $100 aandeel.

    Geloof het niet, maar neem de tijd om je te verdiepen in dit bedrijf.

    Binnenkort (ik hoop binnen een week) wordt aanvraag voor goedkeuring als HIV therapie ingediend.
    Er staat erg, erg veel te gebeuren op korte termijn.
    Dit gaat een big pharma company worden (als ze niet voortijdig wordt overgenomen)

    Disclosure: long
    Ik hoop dat je gelijk hebt (heb ook een paar aandelen), maar er zijn ook een hoop negatieve geluiden te horen.
    Ze zijn onderanderen al jaren bezig om bepaalde formulieren in te vullen, die andere bedrijven in een maand invullen. En ook zijn er nog steeds geen echte resultaten .
  20. Fortuno 27 maart 2020 16:43
    quote:

    lute11 schreef op 27 maart 2020 14:09:

    [...]
    Ik hoop dat je gelijk hebt (heb ook een paar aandelen), maar er zijn ook een hoop negatieve geluiden te horen.
    Ze zijn onderanderen al jaren bezig om bepaalde formulieren in te vullen, die andere bedrijven in een maand invullen. En ook zijn er nog steeds geen echte resultaten .
    Ik weet niet wat je bedoelt. Over welke formulieren heb je het? Geen echte resultaten? Wat bedoel je daarmee? Er is een fase 3 klinisch onderzoek succesvol afgesloten met betrekking tot HIV. Nu zijn ze bezig met de afronding van de aanvraag om goedkeuring ervan. Er zijn alvast contracten met Samsung afgesloten voor levering van dit product.

    Er is geen enkel vergelijkbaar product op de markt ter behandeling van HIV. De resultaten zijn uitzonderlijk goed. De response rate is 86%, terwijl de laatst goedgekeurde HIV medicatie maar een response rate van 46% had.

    Er lopen nu ook klinische onderzoeken m.b.t. kanker en met name de metastase ervan.
    De eerste die behandeld is met Leronlimab was uitbehandeld en levensverwachting was 1-3 maanden.
    We zijn nu 7 maanden verder, mevrouw leeft nog en doet het goed.

    En zo is er meer en meer.
    Ik heb hier 100% vertrouwen in en niet omdat ik dit aandeel nu toevallig een maandje in bezit heb. Nee, ik ben al sinds een jaar of drie aandeelhouder en volg de ontwikkelingen aktief.
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