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 appointment
of Mahboob U. Rahman, M.D., Ph.D., FACR, to the executive position
of Chief Scientific Officer.
Dr. Rahman was most recently Global Head of Immunology
Development and Pharmacovigilance at Mesoblast Inc. (ASX:
MSB; Nasdaq: MESO), a global
leader in allogenic cellular medicines for inflammatory
diseases.
Dr. Rahman received his medical degree from Dhaka Medical
College, Bangladesh and a Ph.D. in molecular biology from the
Medical College of Pennsylvania. He completed his internal medicine
residency at the Medical College of Pennsylvania, Philadelphia and
rheumatology fellowship at Massachusetts General Hospital/Harvard
Medical School, Boston. He then joined the Harvard Medical School
faculty, and obtained an NIH Research Grant. His research interests
included molecular mechanisms of joint destruction in inflammatory
arthritides, as well as clinical research in various rheumatologic
conditions. In early 2002, Dr. Rahman joined Centocor/Johnson &
Johnson and was involved in the development of Infliximab,
golimumab, ustekinumab and several small molecules as the
Rheumatology Clinical Team Leader. In 2010, Dr. Rahman moved to
Pfizer as a Vice President and the Therapeutic Area Head for
Inflammatory Diseases and was involved in the development of
tofacitiniband etanercept. In 2013, he joined Novartis as a Vice
President and the Therapeutic Area Head for Immunology and
Musculoskeletal Disease, where he was involved in the development
of several compounds of which two achieved FDA and EMA approval for
marketing, Canakinumab and secukinumab in several indications. In
2018, he joined Glenmark as an Executive VP of Clinical Development
and within a month, he became the President and Chief Medical
Officer, a position he held until joining Mesoblast in October
2019.
While working in the pharmaceutical industry, Dr. Rahman
maintained his educational and clinical activities. He was an
adjunct Professor at University of Pennsylvania School of Medicine
from 2002 to 2016 and a Clinical Professor at the Rutgers RWJ
School of Medicine, Rheumatology Division, from 2016 to 2018. He
has published more than 100 scientific papers in peer-reviewed
journals.
Scott A. Kelly, M.D., Chairman of the Board, Chief Medical
Officer and Head of Business Development for CytoDyn, stated, “We
are very pleased Dr. Rahman has joined our executive team. We
expect his deep knowledge of immunology and successful regulatory
experience to prove invaluable for patients and our Company.”
Nader Pourhassan, Ph.D., CytoDyn’s President and Chief Executive
Officer, commented, “We believe Dr. Rahman’s proven track record in
our industry, coupled with his medical and research expertise will
undoubtedly help accelerate many of our clinical and regulatory
priorities. With the addition of Dr. Rahman, along with Dr. Scott
Kelly, our CMO, and Dr. Nitya Ray, our CTO, we believe we are
well-positioned to move CytoDyn into its next phase of
development.”
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. The FDA met
telephonically with Company key personnel and its clinical research
organization and provided written responses to the Company’s
questions concerning its recent Biologics License Application
(“BLA”) for this HIV combination therapy in order to expedite the
resubmission of its BLA filing for this indication.
CytoDyn has completed 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. No drug-related serious site injection
reactions reported in about 800 patients treated with leronlimab
and no drug-related SAEs reported in patients treated with 700 mg
dose of leronlimab. 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 six 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. Forward-looking
statements specifically include statements about leronlimab, its
ability to have positive health outcomes, the possible results of
clinical trials, studies or other programs or ability to continue
those programs, the ability to obtain regulatory approval for
commercial sales, and the market for actual commercial sales. 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.
CONTACTSInvestors: Michael
MulhollandOffice: 360.980.8524, ext. 102mmulholland@cytodyn.com
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