Bloomberg: "Leronlimab Used in Seven Patients with
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Posted On: 09/29/2020 9:24:49 AM
Bloomberg: "Leronlimab Used in Seven Patients with Severe COVID-19 Demonstrated Promise with Two Intubated Patients in ICU, Removed from ICU" September 29, 2020, 9:21 AM EDT
Leronlimab Used in Seven Patients with Severe COVID-19 Demonstrated Promise
with Two Intubated Patients in ICU, Removed from ICU and Extubated with
Reduced Pulmonary Inflammation
IncellDx’s evaluation of test results from the first four patients suggests
immunological benefit within three days following treatment with leronlimab on
all four patients and lower level of cytokine storm, especially IL-6 and
TNF-α, which were reduced significantly
VANCOUVER, Washington, March 27, 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 the three-day results
post-leronlimab treatment of the first four patients under an Emergency
Investigational New Drug (EIND) granted by the U.S. Food and Drug
Administration (FDA). A total of seven patients have been enrolled thus far
under EIND in the same leading medical center in the New York City area.
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.
Bruce Patterson, M.D., Chief Executive Officer and founder 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 found that patients with
severe COVID-19 disease are in the midst of immunologic chaos which includes
the cytokine storm. Our companion diagnostics showed that after three days of
therapy, the immune profile in these patients approached normal levels and the
levels of cytokines involved in the cytokine storm were much improved.”
Jacob Lalezari, M.D., Interim Chief Medical Officer of CytoDyn, commented,
“These preliminary results give hope that leronlimab may help hospitalized
patients with COVID-19 recover from the pulmonary inflammation that drives
mortality and the need for ventilators. A leading medical center in the heart
of the New York City epidemic was instrumental in giving the preliminary
data.”
Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn
said: “We are extremely pleased for the coronavirus patients under the care of
the treating medical team and that the FDA is so responsive to advance our
Phase 2 clinical trial. I am very hopeful that leronlimab can help to reduce
the rate of mortality among COVID-19 patients with severe symptoms of ARDS and
to assist our government to fight this battle.”
About Coronavirus Disease 2019
SARS-CoV-2 was identified as the cause of an outbreak of respiratory illness
first detected in Wuhan, China. The origin of SARS-CoV-2 causing the COVID-19
disease is uncertain, and the virus is highly contagious. COVID-19 typically
transmits 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. The symptoms of COVID-19 may appear in
as few as two days or as long as 14 days after exposure. Clinical
manifestations in patients have ranged from non-existent to severe and fatal.
At this time, there are minimal treatment options for COVID-19.
About Leronlimab (PRO 140)
The FDA has granted a “Fast Track” designation to CytoDyn for two potential
indications of leronlimab for deadly diseases. The first as a combination
therapy with HAART for HIV-infected patients and the second is for metastatic
triple-negative breast cancer. Leronlimab is an investigational humanized IgG4
mAb that blocks CCR5, a cellular receptor that is important in HIV infection,
tumor metastases, and other diseases, including NASH. Leronlimab has completed
nine clinical trials in over 800 people, including meeting its primary
endpoints in a pivotal Phase 3 trial (leronlimab in combination with standard
antiretroviral therapies in HIV-infected treatment-experienced patients).
In the setting of HIV/AIDS, leronlimab is a viral-entry inhibitor; it masks
CCR5, thus protecting healthy T cells from viral infection by blocking the
predominant HIV (R5) subtype from entering those cells. Leronlimab has been
the subject of nine clinical trials, each of which demonstrated that
leronlimab could significantly reduce or control HIV viral load in humans. The
leronlimab antibody appears to be a powerful antiviral agent leading to
potentially fewer side effects and less frequent dosing requirements compared
with daily drug therapies currently in use.
In the setting of cancer, research has shown that CCR5 may play a role in
tumor invasion, metastases, and tumor microenvironment control. Increased CCR5
expression is an indicator of disease status in several cancers. Published
studies have shown that blocking CCR5 can reduce tumor metastases in
laboratory and animal models of aggressive breast and prostate cancer.
Leronlimab reduced human breast cancer metastasis by more than 98% in a murine
xenograft model. CytoDyn is, therefore, conducting a Phase 1b/2 human clinical
trial in metastatic triple-negative breast cancer and was granted Fast Track
designation in May 2019.
The CCR5 receptor appears to play a central role in modulating immune cell
trafficking to sites of inflammation. It may be crucial in the development of
acute graft-versus-host disease (GvHD) and other inflammatory conditions.
Clinical studies by others further support the concept that blocking CCR5
using a chemical inhibitor can reduce the clinical impact of acute GvHD
without significantly affecting the engraftment of transplanted bone marrow
stem cells. CytoDyn is currently conducting a Phase 2 clinical study with
leronlimab to support further the concept that the CCR5 receptor on engrafted
cells is critical for the development of acute GvHD, blocking the CCR5
receptor from recognizing specific immune signaling molecules is a viable
approach to mitigating acute GvHD. The FDA has granted “orphan drug”
designation to leronlimab for the prevention of GvHD.
About CytoDyn
CytoDyn is a late-stage biotechnology company developing innovative treatments
for multiple therapeutic indications based on leronlimab, a novel humanized
monoclonal antibody targeting the CCR5 receptor. CCR5 appears to play a
critical role in the ability of HIV to enter and infect healthy T-cells. The
CCR5 receptor also appears to be implicated in tumor metastasis and
immune-mediated illnesses, such as GvHD and NASH. CytoDyn has successfully
completed a Phase 3 pivotal trial with leronlimab in combination with standard
antiretroviral therapies in HIV-infected treatment-experienced patients.
CytoDyn plans to seek FDA approval for leronlimab in combination therapy and
plans to complete the filing of a Biologics License Application (BLA) in the
first quarter of 2020 for that indication. CytoDyn is also conducting a Phase
3 investigative trial with leronlimab as a once-weekly monotherapy for
HIV-infected patients. CytoDyn plans to initiate a registration-directed study
of leronlimab monotherapy indication. If successful, it could support a label
extension. Clinical results to date from multiple trials have shown that
leronlimab can significantly reduce viral burden in people infected with HIV
with no reported drug-related serious adverse events (SAEs). Moreover, a Phase
2b clinical trial demonstrated that leronlimab monotherapy can prevent viral
escape in HIV-infected patients; some patients on leronlimab monotherapy have
remained virally suppressed for more than five years. CytoDyn is also
conducting a Phase 2 trial to evaluate leronlimab for the prevention of GvHD
and a Phase 1b/2 clinical trial with leronlimab in metastatic triple-negative
breast cancer. More information is at www.cytodyn.com.
Forward-Looking Statements
This press release contains certain forward-looking statements that involve
risks, uncertainties and assumptions that are difficult to predict. Words and
expressions reflecting optimism, satisfaction or disappointment with current
prospects, as well as words such as “believes,” “hopes,” “intends,”
“estimates,” “expects,” “projects,” “plans,” “anticipates” and variations
thereof, or the use of future tense, identify forward-looking statements, but
their absence does not mean that a statement is not forward-looking. The
Company’s forward-looking statements are not guarantees of performance, and
actual results could vary materially from those contained in or expressed by
such statements due to risks and uncertainties including: (i) the sufficiency
of the Company’s cash position, (ii) the Company’s ability to raise additional
capital to fund its operations, (iii) the Company’s ability to meet its debt
obligations, if any, (iv) the Company’s ability to enter into partnership or
licensing arrangements with third parties, (v) the Company’s ability to
identify patients to enroll in its clinical trials in a timely fashion,
(vi) the Company’s ability to achieve approval of a marketable product,
(vii) the design, implementation and conduct of the Company’s clinical trials,
(viii) the results of the Company’s clinical trials, including the possibility
of unfavorable clinical trial results, (ix) the market for, and marketability
of, any product that is approved, (x) the existence or development of
vaccines, drugs, or other treatments that are viewed by medical professionals
or patients as superior to the Company’s products, (xi) regulatory
initiatives, compliance with governmental regulations and the regulatory
approval process, (xii) general economic and business conditions,
(xiii) changes in foreign, political, and social conditions, and (xiv) various
other matters, many of which are beyond the Company’s control. The Company
urges investors to consider specifically the various risk factors identified
in its most recent Form 10-K, and any risk factors or cautionary statements
included in any subsequent Form 10-Q or Form 8-K, filed with the Securities
and Exchange Commission. Except as required by law, the Company does not
undertake any responsibility to update any forward-looking statements to take
into account events or circumstances that occur after the date of this press
release.
CYTODYN CONTACTS
Investors:
Dave Gentry, CEO
RedChip Companies
Office: 1.800.RED.CHIP (733.2447)
Cell: 407.491.4498
dave@redchip.com
Bloomberg Link
Leronlimab Used in Seven Patients with Severe COVID-19 Demonstrated Promise
with Two Intubated Patients in ICU, Removed from ICU and Extubated with
Reduced Pulmonary Inflammation
IncellDx’s evaluation of test results from the first four patients suggests
immunological benefit within three days following treatment with leronlimab on
all four patients and lower level of cytokine storm, especially IL-6 and
TNF-α, which were reduced significantly
VANCOUVER, Washington, March 27, 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 the three-day results
post-leronlimab treatment of the first four patients under an Emergency
Investigational New Drug (EIND) granted by the U.S. Food and Drug
Administration (FDA). A total of seven patients have been enrolled thus far
under EIND in the same leading medical center in the New York City area.
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.
Bruce Patterson, M.D., Chief Executive Officer and founder 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 found that patients with
severe COVID-19 disease are in the midst of immunologic chaos which includes
the cytokine storm. Our companion diagnostics showed that after three days of
therapy, the immune profile in these patients approached normal levels and the
levels of cytokines involved in the cytokine storm were much improved.”
Jacob Lalezari, M.D., Interim Chief Medical Officer of CytoDyn, commented,
“These preliminary results give hope that leronlimab may help hospitalized
patients with COVID-19 recover from the pulmonary inflammation that drives
mortality and the need for ventilators. A leading medical center in the heart
of the New York City epidemic was instrumental in giving the preliminary
data.”
Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn
said: “We are extremely pleased for the coronavirus patients under the care of
the treating medical team and that the FDA is so responsive to advance our
Phase 2 clinical trial. I am very hopeful that leronlimab can help to reduce
the rate of mortality among COVID-19 patients with severe symptoms of ARDS and
to assist our government to fight this battle.”
About Coronavirus Disease 2019
SARS-CoV-2 was identified as the cause of an outbreak of respiratory illness
first detected in Wuhan, China. The origin of SARS-CoV-2 causing the COVID-19
disease is uncertain, and the virus is highly contagious. COVID-19 typically
transmits 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. The symptoms of COVID-19 may appear in
as few as two days or as long as 14 days after exposure. Clinical
manifestations in patients have ranged from non-existent to severe and fatal.
At this time, there are minimal treatment options for COVID-19.
About Leronlimab (PRO 140)
The FDA has granted a “Fast Track” designation to CytoDyn for two potential
indications of leronlimab for deadly diseases. The first as a combination
therapy with HAART for HIV-infected patients and the second is for metastatic
triple-negative breast cancer. Leronlimab is an investigational humanized IgG4
mAb that blocks CCR5, a cellular receptor that is important in HIV infection,
tumor metastases, and other diseases, including NASH. Leronlimab has completed
nine clinical trials in over 800 people, including meeting its primary
endpoints in a pivotal Phase 3 trial (leronlimab in combination with standard
antiretroviral therapies in HIV-infected treatment-experienced patients).
In the setting of HIV/AIDS, leronlimab is a viral-entry inhibitor; it masks
CCR5, thus protecting healthy T cells from viral infection by blocking the
predominant HIV (R5) subtype from entering those cells. Leronlimab has been
the subject of nine clinical trials, each of which demonstrated that
leronlimab could significantly reduce or control HIV viral load in humans. The
leronlimab antibody appears to be a powerful antiviral agent leading to
potentially fewer side effects and less frequent dosing requirements compared
with daily drug therapies currently in use.
In the setting of cancer, research has shown that CCR5 may play a role in
tumor invasion, metastases, and tumor microenvironment control. Increased CCR5
expression is an indicator of disease status in several cancers. Published
studies have shown that blocking CCR5 can reduce tumor metastases in
laboratory and animal models of aggressive breast and prostate cancer.
Leronlimab reduced human breast cancer metastasis by more than 98% in a murine
xenograft model. CytoDyn is, therefore, conducting a Phase 1b/2 human clinical
trial in metastatic triple-negative breast cancer and was granted Fast Track
designation in May 2019.
The CCR5 receptor appears to play a central role in modulating immune cell
trafficking to sites of inflammation. It may be crucial in the development of
acute graft-versus-host disease (GvHD) and other inflammatory conditions.
Clinical studies by others further support the concept that blocking CCR5
using a chemical inhibitor can reduce the clinical impact of acute GvHD
without significantly affecting the engraftment of transplanted bone marrow
stem cells. CytoDyn is currently conducting a Phase 2 clinical study with
leronlimab to support further the concept that the CCR5 receptor on engrafted
cells is critical for the development of acute GvHD, blocking the CCR5
receptor from recognizing specific immune signaling molecules is a viable
approach to mitigating acute GvHD. The FDA has granted “orphan drug”
designation to leronlimab for the prevention of GvHD.
About CytoDyn
CytoDyn is a late-stage biotechnology company developing innovative treatments
for multiple therapeutic indications based on leronlimab, a novel humanized
monoclonal antibody targeting the CCR5 receptor. CCR5 appears to play a
critical role in the ability of HIV to enter and infect healthy T-cells. The
CCR5 receptor also appears to be implicated in tumor metastasis and
immune-mediated illnesses, such as GvHD and NASH. CytoDyn has successfully
completed a Phase 3 pivotal trial with leronlimab in combination with standard
antiretroviral therapies in HIV-infected treatment-experienced patients.
CytoDyn plans to seek FDA approval for leronlimab in combination therapy and
plans to complete the filing of a Biologics License Application (BLA) in the
first quarter of 2020 for that indication. CytoDyn is also conducting a Phase
3 investigative trial with leronlimab as a once-weekly monotherapy for
HIV-infected patients. CytoDyn plans to initiate a registration-directed study
of leronlimab monotherapy indication. If successful, it could support a label
extension. Clinical results to date from multiple trials have shown that
leronlimab can significantly reduce viral burden in people infected with HIV
with no reported drug-related serious adverse events (SAEs). Moreover, a Phase
2b clinical trial demonstrated that leronlimab monotherapy can prevent viral
escape in HIV-infected patients; some patients on leronlimab monotherapy have
remained virally suppressed for more than five years. CytoDyn is also
conducting a Phase 2 trial to evaluate leronlimab for the prevention of GvHD
and a Phase 1b/2 clinical trial with leronlimab in metastatic triple-negative
breast cancer. More information is at www.cytodyn.com.
Forward-Looking Statements
This press release contains certain forward-looking statements that involve
risks, uncertainties and assumptions that are difficult to predict. Words and
expressions reflecting optimism, satisfaction or disappointment with current
prospects, as well as words such as “believes,” “hopes,” “intends,”
“estimates,” “expects,” “projects,” “plans,” “anticipates” and variations
thereof, or the use of future tense, identify forward-looking statements, but
their absence does not mean that a statement is not forward-looking. The
Company’s forward-looking statements are not guarantees of performance, and
actual results could vary materially from those contained in or expressed by
such statements due to risks and uncertainties including: (i) the sufficiency
of the Company’s cash position, (ii) the Company’s ability to raise additional
capital to fund its operations, (iii) the Company’s ability to meet its debt
obligations, if any, (iv) the Company’s ability to enter into partnership or
licensing arrangements with third parties, (v) the Company’s ability to
identify patients to enroll in its clinical trials in a timely fashion,
(vi) the Company’s ability to achieve approval of a marketable product,
(vii) the design, implementation and conduct of the Company’s clinical trials,
(viii) the results of the Company’s clinical trials, including the possibility
of unfavorable clinical trial results, (ix) the market for, and marketability
of, any product that is approved, (x) the existence or development of
vaccines, drugs, or other treatments that are viewed by medical professionals
or patients as superior to the Company’s products, (xi) regulatory
initiatives, compliance with governmental regulations and the regulatory
approval process, (xii) general economic and business conditions,
(xiii) changes in foreign, political, and social conditions, and (xiv) various
other matters, many of which are beyond the Company’s control. The Company
urges investors to consider specifically the various risk factors identified
in its most recent Form 10-K, and any risk factors or cautionary statements
included in any subsequent Form 10-Q or Form 8-K, filed with the Securities
and Exchange Commission. Except as required by law, the Company does not
undertake any responsibility to update any forward-looking statements to take
into account events or circumstances that occur after the date of this press
release.
CYTODYN CONTACTS
Investors:
Dave Gentry, CEO
RedChip Companies
Office: 1.800.RED.CHIP (733.2447)
Cell: 407.491.4498
dave@redchip.com
Bloomberg Link
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