On January 11, 2018 Novartis reported that Elizabeth (Liz) Barrett, currently Global President Oncology at Pfizer, Inc., has been appointed CEO Novartis Oncology and a member of the Executive Committee of Novartis, effective February 1, 2018 (Press release, Novartis, JAN 11, 2018, View Source [SID1234523064]). She will be based in Basel. Mrs. Barrett succeeds Bruno Strigini who decided to retire from Novartis for personal reasons.

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Vasant (Vas) Narasimhan, designated CEO of Novartis, said: "Liz is a highly accomplished and recognized oncology and people leader with an impressive record of building successful business organizations in the US, Europe and globally. She has been instrumental in creating new commercial models, driving innovation in close partnership with research and development and leveraging business development opportunities. Her long-time commercial pharma industry experience, marketing skills and perspectives make Liz a great fit to further develop our oncology business."

Mrs. Barrett said: "I feel honored to join Novartis, a recognized pioneer in the oncology area. It is key to me to contribute to transformative advancements in oncology, and to serve in a highly impactful leadership role to this end."

Mrs. Barrett has held numerous leadership positions in the pharmaceutical industry as well as in the consumer sector. In her most recent role at Pfizer, she led the oncology business through a significant period of growth achieved in less than three years. Before joining Pfizer in 2009, she worked at Cephalon, Inc. and Johnson & Johnson. She started her career at Kraft Foods Group, Inc. in 1984.

Mrs. Barrett is a US citizen and has lived and worked in the US and Europe. She obtained an MBA in Marketing from the Saint Joseph’s University in Philadelphia and a BSc in Business Administration from the University of Louisiana.

Novartis also announced today that Robert Kowalski, Pharm.D., Head of Global Regulatory Affairs, will assume ad interim leadership of the Drug Development Organization, effective February 1, 2018. Dr. Kowalski has been Head of Global Regulatory Affairs for Novartis since February 2016 and has played an important leadership role in securing approvals for several breakthrough medicines including our revolutionary CAR-T therapy Kymriah. The definitive Head of Global Drug Development will be announced in due course.

Disclaimer

This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995, . Forward-looking statements can generally be identified by words such as "effective," "will," "to further develop," or similar expressions, or by express or implied discussions regarding potential future sales or earnings of the Novartis Group. You should not place undue reliance on these statements. Such

forward looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward looking statements. There can be no guarantee that Novartis will be commercially successful in the future, or achieve any particular financial results. In particular, our expectations could be affected by, among other things: regulatory actions or delays or government regulation generally; the potential that the strategic benefits, synergies or opportunities expected from the significant reorganizations of recent years may not be realized or may take longer to realize than expected; the uncertainties inherent in the research and development of new healthcare products; our ability to obtain or maintain proprietary intellectual property protection on key products; safety, quality or manufacturing issues; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures; uncertainties regarding actual or potential legal proceedings; and other risks and factors referred to in Novartis AG’s current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.

On January 10, 2018 Polaris Group reported that the combination of its lead therapeutic ADI‑PEG 20 (pegylated arginine deiminase) with the standard first-line chemotherapy cisplatin + pemetrexed doublet (PemCis) has shown promising clinical activity in an ongoing phase 1 study cohort of non-squamous non-small cell lung carcinoma (NSCLC) patients (Press release, Polaris Pharmaceuticals, JAN 10, 2018, View Source [SID1234526281]). The results will be presented by Dr. Peter Szlosarek from Barts Cancer Institute, London, at the fifth AACR (Free AACR Whitepaper)-IASLC International Joint Conference in San Diego.

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Twenty-one chemo-naïve NSCLC patients were enrolled in the single-arm, open label study to assess the safety and preliminary activity of ADI+PemCis. The treatment was well tolerated, and demonstrated robust tumor responses. Ten patients (47.6%) had a partial response, and 8 patients (38.1%) had stable disease for a disease control rate of 85.7%.

"We are excited to see that ADI+ PemCis demonstrated robust anti-tumor activity in the chemo-naïve NSCLC patients," said John Bomalaski, M.D., Executive Vice President, Medical Affairs at Polaris Pharmaceuticals, Inc. "There have been many exciting developments for NSCLC treatment in the past few years, especially in the area of immunooncology. We are planning new clinical studies that would combine ADI‑PEG 20 with standard chemotherapy as well as immunooncology therapy to maximize treatment effect for cancer patients."

About ADI-PEG 20

ADI‑PEG 20 is a biologic being developed by Polaris Group to treat cancers carrying a major metabolic defect that renders them unable to internally synthesize arginine. Because arginine is essential for protein synthesis and survival of cells, these cancer cells become dependent upon the external supply of arginine to survive and grow. ADI‑PEG 20 is designed to deplete the external supply of arginine, causing arginine-dependent cancer cells to die while leaving the patient’s normal cells unharmed. Multiple cancers have been reported to have a high degree of arginine-dependency and can potentially be treated with ADI‑PEG 20.

On January 10, 2018 Moleculin Biotech, Inc., (NASDAQ: MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company focused on the development of anti-cancer drug candidates, some of which are based on license agreements with The University of Texas System on behalf of the MD Anderson Cancer Center ("MD Anderson"), reported it has expanded the Company’s development pipeline for the treatment of acute myeloid leukemia ("AML") with an immuno-stimulating STAT3 inhibitor (Press release, Moleculin, JAN 10, 2018, View Source [SID1234523052]).

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"Leading experts in the treatment of AML, Dr. Jorge Cortes and Dr. Sanjay Awasthi have now asked us to expand our clinical research to include WP1066, our immuno-stimulating agent and STAT3 inhibitor, to increase therapeutic options for AML patients," commented Walter Klemp, Chairman and CEO of Moleculin. "This would potentially be complementary and synergistic with Annamycin and existing first line treatments and could position us as a leader in the advancement of leukemia treatments."

Dr. Sanjay Awasthi, Professor of the Department of Internal Medicine, Division of Hematology & Oncology, Texas Tech University Health Sciences Center and Medical Director, Southwest Cancer Center Lubbock, Texas, added, "The apparent ability in pre-clinical trials of WP1066 to stimulate the patient’s natural immune response and simultaneously inducing tumor cell death by inhibiting the activated form of STAT3 is highly promising and unique. Importantly, based on current scientific findings, such properties should be extremely valuable in developing improved treatments for AML patients and expanding their therapeutic options.

"We are clearly excited to see what Moleculin’s Annamycin can do for relapsed or refractory AML patients in the Company’s recently launched clinical trial," continued Dr. Awasthi, "thus given the potential for an even broader arsenal of AML drugs, we are encouraging Moleculin to expand their AML clinical research to include this novel immuno-stimulating STAT3 inhibitor drug candidate."

Another noted AML expert, Dr. Jorge Cortes, is also encouraging Moleculin’s clinical expansion, commenting: "AML appears to be associated with a significant increase in the activation of STAT3 and many of us in the AML clinical community have been eager to test the ability of a STAT3 inhibitor to treat AML patients. Part of the difficulty in pursuing this path has been finding a safe and effective STAT3 inhibitor and, if successful, WP1066 may have finally opened this pathway."

Mr. Klemp concluded: "Of course, our first priority will be to demonstrate single agent activity in both Annamycin and WP1066, but we see exploring the potential for synergistic effect as a longer-term opportunity as well."

Researchers have shown that ritanserin is a novel DGK-alpha inhibitor, with activity against glioblastoma (GBM) in vitro and in vivo. They have shown that it is synergistic with temozolomide chemotherapy and radiation against GBM cells. Furthermore, ritanserin has preferential cytotoxicity against mesenchymal GBM cells, a particularly treatment-resistant subset lacking any selective and effective therapies at this time.

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On January 10, 2018 PTC Therapeutics presented at the 36th Annual J.P. Morgan Healthcare Conference (Presentation, PTC Therapeutics, JAN 10, 2018, View Source [SID1234523051]).

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