Dr. Rahman’s 18 years of pharmaceutical industry experience is highlighted by 16 successful BLA/NDAs and sBLAs
VANCOUVER, Washington, Oct. 21, 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 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.
CONTACTS
Investors:
Michael Mulholland
Office: 360.980.8524, ext. 102
mmulholland@cytodyn.com
