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Tyme Technologies, Inc. (NASDAQ: TYME, an emerging biotechnology company developing cancer metabolism-based therapies (CMBTs™), announced the appointment of John Rothman Ph.D. as Executive Vice President, Product Development.
"Dr. Rothman is an accomplished pharmaceutical executive with an excellent record of developing important therapeutics for multiple indications worldwide," said Steve Hoffman, Chairman and CEO of TYME. "John will play a critical role at TYME as we advance our lead cancer-metabolism compound, SM-88, in pivotal trials in pancreatic cancer, in the HopES Sarcoma Phase II study as well as develop plans to expand the potential of SM-88 in metastatic breast cancer, lymphomas and recurrent prostate cancer.
Dr. Rothman has more than 30 years of experience in product development across many disciplines and markets. He was a clinical scientist at the pharmaceutical companies, Schering Plough and Roche, where he was also a clinical director for a number of different therapeutic areas and senior director for all of Roche’s data acquisition, statistical analysis and report writing for all experimental and approved drugs in the Roche portfolio. His work on Interferon-α in AIDs-related Kaposi’s Sarcoma resulted in the approval of first recombinant drug and AIDS treatment called Referon-A. Dr. Rothman later held R&D director positions at Roche and was associated with a number of development programs that resulted in marketed drugs, including Rocephin, Coactin, Rimadyl, Larotid, Dalmane, Rimantidine, Gantrisin, Versed and more. Dr. Rothman was later an executive vice president of science and operations at the biotech company, Advaxis, where he was responsible for R&D, toxicology, regulatory, chemistry, data management, manufacturing and intellectual property. Dr. Rothman has since held chief executive roles with several biopharmaceutical companies. Also, previously, during his career, Dr. Rothman filed numerous patents and managed a portfolio of over 80 issued patents and patent applications.
Dr. Rothman attended the Tulane University School of Medicine, where he studied Pharmacology in the laboratory of Dr. Louis Ignarro awarded the Nobel Prize in Medicine in 1998 and conducted his graduate research at the New Orleans VA Hospital in the laboratory of Dr. Andrew Schally awarded the Nobel Prize in Medicine in 1977.
SM-88 is an oral investigational modified proprietary tyrosine derivative that is believed to interrupt the metabolic processes of cancer cells by breaking down the cells’ key defenses and leading to cell death through oxidative stress and exposure to the body’s natural immune system. Clinical trial data have shown that SM-88 has demonstrated encouraging tumor responses across 15 different cancers, including pancreatic, lung, breast, prostate and sarcoma cancers with minimal serious grade 3 or higher adverse events. SM-88 is an investigational therapy that is not approved for any indication in any disease. Learn more.
TYME-18 is composed of a proprietary surfactant delivery agent with a specific sulfonic acid component3. It is designed for intra-tumoral administration of difficult to treat tumors and leverages the acidic tumor microenvironment and signaling pathways to kill cancer cells. TYME-18 is distinct in composition, but like SM-88, aims to leverage susceptibilities of a cancer that are related to its altered metabolism. Initial preclinical data for TYME-18 in animal tumor models demonstrate rapid and complete tumor regression, with no reported local or systemic toxicities. TYME-18 continues to be studied as a potential therapy for difficult to treat tumors that may not be eligible for surgical or other interventions. Learn more.
About TYME-88-Panc Pivotal Trial
The TYME-88-Panc pivotal trial applies the latest advances in the field of cancer metabolism by evaluating the efficacy and safety of an oral investigational compound that targets the metabolic mechanisms of the disease at its source. A prospective, open label pivotal trial in metastatic pancreatic cancer for patients who have failed two lines of any prior systemic therapy. The trial is designed to evaluate the safety and efficacy of SM-88 used with MPS (methoxsalen, phenytoin and sirolimus) in advanced pancreatic cancer and will measure multiple endpoints, including overall survival, progression free survival, relevant biomarkers, quality of life, safety, and overall response rate. Learn more.
About Tyme Technologies
Tyme Technologies, Inc., is an emerging biotechnology company developing cancer therapeutics that are intended to be broadly effective across tumor types and have low toxicity profiles. Unlike targeted therapies that attempt to regulate specific mutations within cancer, the Company’s therapeutic approach is designed to take advantage of a cancer cell’s innate metabolic weaknesses to compromise its defenses, leading to cell death through oxidative stress and exposure to the body’s natural immune system. For more information, visit www.tymeinc.com. Follow us on social media: @tyme_Inc, LinkedIn, Instagram, Facebook and YouTube.
Forward-Looking Statements/Disclosure Notice
In addition to historical information, this press release contains forward-looking statements under the Private Securities Litigation Reform Act that involve substantial risks and uncertainties. Such forward-looking statements within this press release include, without limitation, statements regarding our drug candidates, including SM-88 and TYME-18, and its clinical potential and non-toxic safety profile, our drug development plans and strategies, ongoing and planned preclinical or clinical trials, preliminary data results and the therapeutic design and mechanisms of our drug candidates; and readers can identify forward-looking statements by sentences or passages involving the use of terms such as "believes," "expects," "hopes," "may," "will," "plan," "intends," "estimates," "could," "should," "would," "continue," "seeks," or "anticipates," and similar words including their use in the negative or by discussions of future matters such as effect of the novel coronavirus (COVID-19) pandemic and the associated economic downturn and impacts on the Company's ongoing clinical trials and ability to analyze data from those trials, the cost of development and potential commercialization of our lead drug candidate and of other new products, expected releases of interim or final data from our clinical trials, possible collaborations, the timing, scope and objectives of our ongoing and planned preclinical or clinical trials and other statements that are not historical. The forward-looking statements contained in this press release are based on management’s current expectations, which are subject to uncertainty, risks and changes in circumstances that are difficult to predict and many of which are outside of TYME’s control. These statements involve known and unknown risks, uncertainties and other factors which may cause the Company’s actual results, performance or achievements to be materially different from any historical results and future results, performances or achievements expressed or implied by the forward-looking statements. These risks and uncertainties include, but are not limited to, the severity, duration, and economic impact of the COVID-19 pandemic; that the information is of a preliminary nature and may be subject to change; uncertainties inherent in the cost and outcomes of research and development, including the cost and availability of acceptable-quality clinical supply and the ability to achieve adequate clinical study design and start and completion dates; the possibility of unfavorable study results, including unfavorable new clinical data and additional analyses of existing data; risks associated with early, initial data, including the risk that the final data from any clinical trial may differ from prior or preliminary study data; final results of additional clinical trials that may be different from the preliminary data analysis and may not support further clinical development; that past reported data are not necessarily predictive of future patient or clinical data outcomes; whether and when any further applications or other submissions for SM-88 may be filed with regulatory authorities; whether and when regulatory authorities may approve any applications or submissions or retract and such approvals; decisions by regulatory authorities regarding labeling and other matters that could affect commercial availability of SM-88; the ability of TYME and its collaborators to develop and realize collaborative synergies; competitive developments; and the factors described in the section captioned "Risk Factors" of TYME’s Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission on May 22, 2020, as well as subsequent reports we file from time to time with the U.S. Securities and Exchange Commission available at www.sec.gov.
The information contained in this press release is as of its release date and TYME assumes no obligation to update forward-looking statements contained in this release as a result of future events or developments.
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