On December 18, 2017 Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE:CFBI), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address cancer, liver and inflammatory diseases, reported an update on its Phase II clinical trial with drug candidate Namodenoson (CF102) in the treatment of advanced hepatocellular carcinoma (HCC). Ongoing close observation of enrolled subjects indicates a potentially favorable drug safety profile (Press release, Can-Fite BioPharma, DEC 18, 2017, View Source [SID1234522681]). The Company previously announced in August that it had successfully completed enrollment of 78 patients.

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The global Phase II study is being conducted in the U.S., Europe and Israel. Patients with advanced HCC, Child Pugh B, who failed Nexavar (sorafenib) as a first line treatment are treated twice daily with 25 mg of oral Namodenoson or placebo using a 2:1 randomization. The primary endpoint of the Phase II study is Overall Survival (OS). Secondary endpoints include Progression Free Survival (PFS), safety, and the relationship between outcomes and A3AR expression.

Although the trial remains blinded to the Company, accumulated safety data to date indicates a potentially favorable drug safety profile without hepatotoxicity and possible positive clinical effects. There are now subjects treated for more than one year and in some cases, two years. To date, 15 subjects have completed at least 12 cycles of treatment (each cycle is 28 days of treatment) of which two completed 24 cycles. The Company anticipates data release to occur in 2H2018.

Can-Fite CEO Dr. Pnina Fishman commented, "We are pleased with the progress so far in our clinical trial for Namodenoson for the treatment of advanced HCC, the third leading cause of cancer deaths worldwide, and look forward to data release later in 2018."

Can-Fite received Orphan Drug Designation for Namodenoson in Europe and the U.S., as well as Fast Track Status in the U.S. as a second line treatment for HCC.

About Namodenoson

Namodenoson is a small orally bioavailable drug that binds with high affinity and selectivity to the A3 adenosine receptor (A3AR). Namodenoson is being evaluated in Phase II trials for two indications, as a second line treatment for hepatocellular carcinoma, and as a treatment for non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH). A3AR is highly expressed in diseased cells whereas low expression is found in normal cells. This differential effect accounts for the excellent safety profile of the drug.

On December 18, 2017 Intellia Therapeutics, Inc. (NASDAQ:NTLA), a leading genome editing company focused on developing curative therapeutics using CRISPR/Cas9 technology, reported that it has named John Leonard, M.D., President and Chief Executive Officer (CEO), effective January 1, 2018 (Press release, Intellia Therapeutics, DEC 18, 2017, View Source [SID1234522683]). Dr. Leonard succeeds Nessan Bermingham, Ph.D., Intellia’s founding President and CEO, who is returning to the venture capital industry. In recognition of the company’s growth and expanding pipeline, the Board of Directors and Dr. Bermingham agreed that Dr. Leonard should lead the Company as it progresses toward clinical development, given his experience in successfully developing biopharmaceutical products and leading large scientific organizations.

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Dr. Leonard joined Intellia in 2014 as the Company was being formed. He initially served as Intellia’s Chief Medical Officer and as a member of its Board of Directors, and together with Dr. Bermingham, set the strategic direction of the Company. In 2016, Dr. Leonard became Intellia’s Executive Vice President of Research & Development (R&D). Prior to Intellia, Dr. Leonard was Chief Scientific Officer and Senior Vice President of Research and Development at AbbVie, Inc., a global biopharmaceutical company, which was spun off from Abbott Laboratories in 2013. At Abbott, Dr. Leonard served as Senior Vice President of Global Pharmaceutical Research & Development from 2008 to 2012.

His combined tenure at Abbott and AbbVie spanned 22 years from 1992, until his retirement from AbbVie in 2013. Dr. Leonard was responsible for the development of the groundbreaking HIV protease inhibitors Norvir and Kaletra, which led to new treatment paradigms for HIV/AIDS.

He also led AbbVie’s HCV programs, laid the foundation for its Oncology effort and guided the development of HUMIRA, the all-time, top-selling pharmaceutical product worldwide.

"After nearly four years of building Intellia and this exceptional team, the Company is now poised to begin development of CRISPR/Cas9-based therapies," says Nessan Bermingham, Ph.D. "At this stage, Intellia requires a CEO with a track record of successful drug development. John was the first to join me in starting Intellia, and was an ideal partner because of his unmatched R&D expertise and biopharmaceutical leadership experience. As I return to my roots in biotech venture capital, I am confident that Intellia, the science and our employees are in great hands."

"With more than a 30-year career in biopharmaceutical R&D, John is well recognized as a premier R&D leader, having developed many breakthrough medicines that turned into life-improving therapies for patients. As Intellia progresses towards clinical development, we are fortunate that he will lead the company," says Intellia’s Chairman Perry Karsen. "We thank Nessan for his passion and leadership in taking Intellia from an idea through preclinical science, initial public offering and the path to the clinic. As Intellia’s founder, Nessan had great vision for what was possible with the CRISPR/Cas9 technology and its application in human therapeutics."

"Intellia has made significant progress in advancing the CRISPR/Cas9 technology and in applying it in our pre-clinical programs, as well as in those of our partners Novartis and Regeneron," says John Leonard, M.D. "As we enter the next phase, our ambition and business strategy remains the same. We will build on Nessan’s vision, and advance our mission of developing curative genome editing treatments that can positively transform the lives of people living with severe and life-threatening diseases."

On December 17, 2017 Spectrum Pharmaceuticals, Inc. (NasdaqGS:SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in Hematology and Oncology, reported that its Board of Directors has terminated Rajesh C. Shrotriya, MD without cause from his position as Chief Executive Officer, and announced leadership changes under which Joseph W. Turgeon, the current President and Chief Operating Officer, has been named President and Chief Executive Officer and elected to the Board of Directors, and current Director Stuart M. Krassner, ScD, PsyD, has been named Chairman of the Board (Press release, Spectrum Pharmaceuticals, DEC 17, 2017, View Source [SID1234522672]). In addition, Thomas J. Riga, who currently serves as Executive Vice President, Chief Commercial Officer and Head of Business Development, has been named Chief Operating Officer. These changes are effective immediately.

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"The Board of Directors thanks Dr. Shrotriya for his contributions to Spectrum over the past fifteen years," said Dr. Krassner, Chairman. "The Board believes that now is the right time to effect these leadership changes. Mr. Turgeon and Mr. Riga have nearly 50 years of combined industry experience and the Board believes that they are the right leaders for Spectrum as the Company enters its next chapter."

"I am honored to serve as Spectrum’s next CEO and appreciate the confidence the Board has placed in me to guide the Company forward," said Mr. Turgeon, President and CEO. "We are at an exciting point in Spectrum’s history, and I look forward to driving the operation forward as we maintain our focus on our product pipeline."

Mr. Turgeon brings more than 30 years of experience in the pharmaceutical industry, including various executive leadership roles at Amgen Inc. He had served as Spectrum’s President and Chief Operating Officer since April 2014, and had previously served as the Company’s Senior Vice President and Chief Commercial Officer from October 2012 to April 2014. Prior to joining Spectrum, Mr. Turgeon spent 22 years at Amgen Inc. as Vice President of Sales.

Mr. Riga brings over 15 years of pharmaceutical sales and management experience in various positions at Amgen, Eli Lilly and Dendreon, including as Vice President of Sales at Dendreon. He had served as Spectrum’s Executive Vice President, Chief Commercial Officer and Head of Business Development since June 2017, and previously served as Spectrum’s Senior Vice President and Chief Commercial Officer from August 2014 to June 2017, and Vice President, Corporate Accounts from July 2013 to August 2014.

Dr. Krassner has served as a director of Spectrum since December 2004, and was previously a member of Spectrum’s Scientific Advisory Board from 1996 to 2001. Dr. Krassner’s career spans nearly four decades of experience in positions of increasing responsibility at the University of California at Irvine, most recently as Professor of Developmental and Cell Biology at the School of Biological Sciences. Dr. Krassner is Professor Emeritus, University of California, Irvine and has also been retained by pharmaceutical, medical device and other companies, including Allergan Pharmaceuticals, Lasermed Corporation, Automated Microbiology Systems, and In Vitro International, among others, to provide scientific and regulatory advisory services, including FDA compliance. He is a past member of the American Academy for the Advancement of Sciences, and the American Society of Tropical Medicine and Hygiene, among others.

On December 16, 2017 Celltrion, Inc. (KOSDAQ: 068270) reported that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion recommending that Herzuma (trastuzumab biosimilar) be granted marketing authorization in the European Union (EU) for the treatment of patients with early breast cancer, metastatic breast cancer, or metastatic gastric cancer whose tumors have either HER2 overexpression or HER2 gene amplification (Press release, Celltrion, DEC 16, 2017, View Source [SID1234522673]). The CHMP’s opinion will now be sent to the European Commission (EC) for final review.

Herzuma is a biosimilar to Herceptin​[i], a breast cancer and gastric cancer treatment antibody biologic drug developed by Genentech and marketed by Roche. Herceptin is a blockbuster drug which had worldwide sales of CHF 6.8 billion[ii] (US$6.8 billion) in 2016, of which CHF 2.1 billion[iii] (US$2.1 billion) was in European sales.

"We welcome the CHMP’s recommendation. By providing more treatment options, biosimilars open more opportunities for greater affordability and improve access to wider use of biotherapeutics. Herzuma could become a cost-effective alternative to biologics for treatment of breast cancer and gastric cancer, since biologics, which cost much more than conventional anticancer drugs, place undue financial burden on patients and the general healthcare system." said Woo Sung Kee, Chief Executive Officer of Celltrion.

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About Herzuma
Herzuma is an anticancer monoclonal antibody (mAb) biosimilar used to treat breast cancer and gastric cancer. Similarity of Herzuma to the reference product, Herceptin, was demonstrated in terms of pharmacokinetic, pharmacodynamics, efficacy and safety through multiple global clinical trials covering various indications such as HER2-positive early breast cancer, HER2-positive metastatic breast cancer, and HER2-positive metastatic gastric cancer. Celltrion also submitted the Biologics License Application (BLA) to the US Food and Drug Administration (FDA). In 2017, Celltrion launched Herzuma in Korea.

On December 15, 2017 Ohr Pharmaceutical, Inc. (Nasdaq: OHRP), a clinical-stage pharmaceutical company developing novel therapies for ophthalmic disease, reported financial results for its fiscal year ended September 30, 2017 (Press release, Ohr Pharmaceutical, DEC 15, 2017, View Source [SID1234522662]).

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"Our primary focus at Ohr continues to be the successful completion of the MAKO study, our ongoing clinical trial being conducted to evaluate the efficacy and safety of Squalamine in combination with Lucentis for treatment-naive patients with the wet form of age-related macular degeneration (wet-AMD)," said Dr. Jason Slakter, chief executive officer of Ohr Pharmaceutical. "The MAKO study enrolled a targeted population identified in the prior Phase 2 study which we believe is best suited for Squalamine combination therapy and is consistent with the mechanism of action of Squalamine and the vascular biology of the disease. We remain on track to receive and report top-line efficacy data from the MAKO study in early calendar 2018."

Corporate Highlights for the Fiscal Year Ended September 30, 2017

● Continued progress of the ongoing clinical study in wet-AMD, entitled the MAKO study. The study is a multi-center, randomized, double-masked, placebo controlled clinical trial designed to investigate Ohr’s lead candidate Squalamine in combination with Lucentis in wet-AMD.

○ Topline data from the study are expected in early calendar year 2018.

○ In April 2017, the Company made a strategic decision to amend the MAKO study from the original agreed-upon design to enable efficacy analyses at an earlier date than originally anticipated.

○ More than 200 patients were enrolled in the MAKO study. Patients received monthly Lucentis and either topical Squalamine or placebo eye drops twice daily. The primary endpoint is an assessment of visual acuity gain at nine months.

○ The MAKO study prospectively enrolled the patient population identified from the prior Phase 2 IMPACT study that had the greatest potential to benefit from Squalamine combination therapy.

● Raised approximately $19.5 million in combined net proceeds, after deducting placement agent fees and offering expenses payable, from two public offerings of common stock and warrants that closed on December 13, 2016 and on April 10, 2017.

● In May, the Company appointed the Honorable Mike Ferguson as a Director and Chairman of the Board of Directors.

○ Mr. Ferguson served for nearly a decade in the House of Representatives. As Vice Chairman of the House health subcommittee, he led policy reforms including the creation of the Medicare Part D prescription drug benefit and pharmaceutical and medical device user fee reauthorizations. He is also Senior Advisor and Leader of the Federal Policy Team at Baker Hostetler LLP, one of the nation’s largest law firms.

Financial Results for the Fiscal Year ended September 30, 2017

● For the year ended September 30, 2017, the Company reported a net loss of approximately $23.8 million, or ($0.53) per share, compared to a net loss of approximately $25.8 million, or ($0.82) per share, in the same period of 2016.

● For the year ended September 30, 2017, total operating expenses were approximately $23.8 million, consisting of $5.3 million in general and administrative expenses, $17.4 million of research and development expenses, and $1.2 million in depreciation and amortization. This compares to total operating expenses of approximately $24.6 million, consisting of approximately $7.7 million in general and administrative expenses, $16.5 million in research and development expenses, and $1.2 million in depreciation and amortization in the same period of 2016.

● At September 30, 2017, the Company had cash and cash equivalents of approximately $12.8 million, compared to cash and cash equivalents of approximately $12.5 million at September 30, 2016.

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