On February 28, 2018 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 its Phase II clinical trial with drug candidate Namodenoson (CF102) in the treatment of NAFLD/NASH (Press release, Can-Fite BioPharma, FEB 28, 2018, View Source [SID1234524643]).

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The current Phase II study is being conducted in three Israeli sites including Hadassah Medical Center, Jerusalem and the Rabin Medical Center, Petach Tikva. Patients who suffer from NAFLD/NASH with evidence of active inflammation are treated twice daily with 12.5 or 25 mg of oral Namodenoson vs. placebo. The primary end point of the Phase II study is the anti-inflammatory effect of the drug, as determined by ALT blood levels, and the secondary end points include percentage of liver fat, as measured by MRI-PDFF (proton density fat fraction). The company anticipates the completion of patient enrollment toward the end of 2018 and data release in the first half of 2019.

Recent safety data showed that Namodenoson has a favorable profile and lack of hepatotoxicity in patients. Preclinical data demonstrate robust anti-inflammatory, anti-fibrogenic and anti-steatotic effects, supporting its development for the NAFLD/NASH indication.

Can-Fite CEO Dr. Pnina Fishman commented, "We are pleased with the progress so far in our clinical trial with Namodenoson for the treatment of NAFLD/NASH, and we look forward to data release later in H1/2019."

There is currently no U.S. FDA approved drug for the treatment of NASH, which is an addressable pharmaceutical market estimated to reach $35-40 billion by 2025.

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 February 28, 2018 Intellia Therapeutics, Inc. (NASDAQ:NTLA), a leading genome editing company focused on the development of curative therapeutics using CRISPR/Cas9 technology, will participate at the following upcoming healthcare conferences in March (Press release, Intellia Therapeutics, FEB 28, 2018, View Source [SID1234524239]):

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Tuesday, March 13, 2018
Barclays Capital Global Healthcare Conference
Who: John Leonard, M.D., Chief Executive Officer and President
Location: Miami, Florida
Presentation Time: 3:50pm EST

Tuesday, March 20, 2018
Morgan Stanley Healthcare Corporate Access Day
Who: Tom Barnes, Ph.D., Senior Vice President, Innovative Sciences
Location: Boston, Massachusetts
One on one meetings only

Wednesday, March 21, 2018
Oppenheimer & Co. 28th Annual Healthcare Conference
Who: Tom Barnes, Ph.D., Senior Vice President, Innovative Sciences
Location: New York, New York
Presentation Time: 1:35pm EST

A live webcast of Intellia’s presentations will be accessible through the Events and Presentations page of the Investor Relations section of the company’s website at www.intelliatx.com. To access the webcasts, please log on to the Intellia website approximately 15 minutes prior to the start time to ensure adequate time for any software downloads that may be required. A replay of the webcast will be available on Intellia’s website for 14 days following each conference.

On February 28, 2018 CTI BioPharma Corp. (CTI BioPharma) (NASDAQ: CTIC) reported that management plans to report its fourth quarter and full year 2017 financial results on Wednesday, March 7, 2018, after the close of the U.S. financial markets (Press release, CTI BioPharma, FEB 28, 2018, View Source;p=RssLanding&cat=news&id=2335261 [SID1234524226]). Following the announcement, members of the management team will host a webcast conference call to discuss the results and provide a general corporate update at 4:30 p.m. ET (1:30 p.m. PT). Access to the event can be obtained as follows:

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Wednesday, March 7, 2018
1:30 p.m. PT/4:30 p.m. ET/10:30 p.m. CET
1-800-289-0517 (domestic)
+1 323-994-2084 (international)

To access the live audio webcast or the subsequent archived recording, visit CTI BioPharma’s website, www.ctibiopharma.com. Webcast and telephone replays of the conference call will be available approximately two hours after completion of the call. Callers can access the replay by dialing 1-888-203-1112 (domestic) or +1 719-457-0820 (international). The access code for the replay is 2516357. The telephone replay will be available until Wednesday, March 14, 2018.

On February 27, 2018 Shire plc (LSE: SHP, NASDAQ: SHPG), the global biotechnology leader in rare diseases, reported that the U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for Calaspargase Pegol (Cal-PEG; SHP663) (Press release, Shire, FEB 28, 2018, View Source [SID1234524260]). The investigational-stage compound is being reviewed as a component of a multi-agent chemotherapeutic regimen for the treatment of patients with acute lymphoblastic leukemia (ALL). The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of December 22, 2018 for Cal-PEG.

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Shire is developing SHP663 based on more than a decade of data, research and experience with ONCASPAR (pegaspargase), which is approved in the United States as a first-line treatment for patients with ALL.2 The mechanism of action of ONCASPAR is thought to be based on selective killing of leukemic cells due to the depletion of plasma asparagine, an amino acid that certain tumor cells depend on for growth and development.2 Asparagine depletion remains a cornerstone of ALL treatment regimens. Cal-PEG is also thought to be based on plasma L-asparagine depletion. The totality of the clinical trial data submitted to the FDA for review, as part of the BLA, included a comparable safety profile and efficacy outcomes to ONCASPAR. If approved, Cal-PEG could provide a treatment that has an extended shelf life beyond that of the current PEGylated asparaginase treatment, helping ensure availability to patients.

"Today’s FDA acceptance of the Cal-PEG BLA is an important milestone as we work to help address the unmet needs for rare and underserved cancers," said Andreas Busch, Ph.D., Head of Research and Development at Shire. "Developing Cal-PEG underscores our commitment to evolving the standard of care in ALL, including taking innovative steps to improve treatment options for patients."

The BLA filing is supported by data obtained in ALL patients treated with calaspargase pegol first-line as a component of a multi-agent chemotherapeutic regimen.

Acute Lymphoblastic Leukemia (ALL)
ALL is a cancer of the white blood cells and is characterized by an excess of lymphoblasts, an immature white blood cell. Lymphoblasts are normally found in the bone marrow but can be found in the blood and other locations in people with ALL. ALL accounts for about 75 percent of childhood leukemia in the U.S. and around 78 percent in Europe;1,3 however, it can be a curable disease.4

About Calaspargase Pegol
Calaspargase Pegol (Cal-PEG) is under review with the U.S. Food and Drug Administration (FDA) as a component of a multi-agent chemotherapeutic regimen for the treatment of patients with acute lymphoblastic leukemia (ALL).

About ONCASPAR
In the United States, ONCASPAR (pegaspargase) is indicated as a component of a multi-agent chemotherapeutic regimen for first-line treatment of patients with acute lymphoblastic leukemia (ALL) and for the treatment of patients with ALL and hypersensitivity to native forms of L-asparaginase.2

Select Important Safety Information2
ONCASPAR is contraindicated in patients with a history of: serious allergic reactions to ONCASPAR, history of the following with prior L-asparaginase therapy: serious thrombosis, pancreatitis or serious hemorrhagic events.

ONCASPAR Warning & Precautions include:

Anaphylaxis and Serious Allergic Reactions – observe patients for 1 hour after administration; discontinue if serious allergic reactions occur
Thrombosis – discontinue if serious thrombotic events occur
Pancreatitis – evaluate for pancreatitis in patients with abdominal pain; discontinue in patients with pancreatitis
Glucose Intolerance – monitor serum glucose
Coagulopathy and Hepatotoxicity – perform appropriate monitoring

The most common adverse reactions with ONCASPAR (≥2%) are allergic reactions (including anaphylaxis), hyperglycemia, pancreatitis, central nervous system (CNS) thrombosis, coagulopathy, hyperbilirubinemia and elevated transaminases. Hyperlipidemia (hypercholesterolemia and hypertriglyceridemia) has been reported in patients exposed to ONCASPAR.

Horizon Pharma has filed a 10-K – Annual report [Section 13 and 15(d), not S-K Item 405] with the U.S. Securities and Exchange Commission (Filing, 10-K, Horizon Pharma, 2018, FEB 28, 2018, View Source [SID1234524273]).

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