Uncategorized – Page 15761 – 1stOncology™: Cancer Intelligence Service

Astellas Receives Orphan Designation from the European Commission for Gilteritinib for the Treatment of Acute Myeloid Leukaemia (pdf 377KB)

On January 22, 2018 Astellas Pharma Inc. (TSE: 4503, President and CEO: Yoshihiko Hatanaka, "Astellas") reported that the European Commission (EC) has issued Orphan Designation to gilteritinib for the treatment of patients with acute myeloid leukaemia (AML) (Press release, Astellas, JAN 22, 2018, View Source [SID1234523405]). The decision follows a positive recommendation for Orphan Designation from the European Medicines Agency’s (EMA) Committee for Orphan Medicinal Products (COMP). In Europe, an Orphan Designation is granted to a medicine that may be of significant benefit to patients with a rare condition, affecting no more than five in 10,000 people.1

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The announcement follows the recent Orphan Drug Designation in the United States granted by the US Food and Drug Administration (FDA) to gilteritinib on July 13, 2017.2

"Around 13,000 people will be diagnosed with AML in Western Europe and, while AML patients constitute a small proportion of the overall population, they are faced with a life-threatening condition," said Steven Benner, M.D., Senior Vice President and Global Therapeutic Area Head, Oncology Development, Astellas. "We are grateful to the EMA for acknowledging the unique needs of patients with rare diseases, and for providing a potential path forward for gilteritinib in supporting these patients."

AML is a cancer that impacts the blood and bone marrow, and its incidence increases with age.3 In Western Europe, there are around 13,000 new cases of AML every year.4 In Japan, approximately 4,500 patients are diagnosed with AML each year.5,6 The American Cancer Society estimates that in 2017 approximately 21,000 new patients will be diagnosed with AML in the United States and about 10,000 cases will result in death.7

About Gilteritinib
Gilteritinib is an investigational compound that has demonstrated inhibitory activity against FLT3 internal tandem duplication (ITD) as well as FLT3 tyrosine kinase domain (TKD),8 two common types of FLT3 mutations that are seen in approximately one-third of patients with AML.9 Further, gilteritinib has also demonstrated inhibition of the AXL receptor in AML cell lines.8 Astellas is currently investigating gilteritinib in various FLT3 mutation-positive AML patient populations through several Phase 3 trials.10,11 Visit www.clinicaltrials.gov to learn more about ongoing gilteritinib clinical trials.

Gilteritinib was discovered through a research collaboration with Kotobuki Pharmaceutical Co., Ltd., and Astellas has exclusive global rights to develop, manufacture and potentially commercialise gilteritinib. Gilteritinib has been granted

ONC/17/0046/APEL
Date of preparation: January 2018

Orphan Drug designation2 and Fast Track Designation12 by the U.S. FDA, and SAKIGAKE Designation by the Japan Ministry of Health, Labour and Welfare.13

The safety and efficacy of the agent discussed herein are under investigation and have not been established. There is no guarantee that the agent will receive regulatory approval and become commercially available for the uses being investigated.

Agilent Technologies to Host Webcast of First-Quarter Fiscal Year 2018 Financial Results Conference Call

On January 22, 2018 Agilent Technologies Inc. (NYSE: A) reported that it will release first-quarter fiscal 2018 financial results after the stock market closes on February 14 (Press release, Agilent, JAN 22, 2018, http://www.agilent.com/about/newsroom/presrel/2018/22jan-gp17027.html [SID1234523889]). The company will host a live webcast of its investor conference call in listen-only mode.

Date: Wednesday, February 14, 2018
Time: 1:30 p.m. (Pacific Time)
Web access: http://www.investor.agilent.com

Listeners may log on and select "Q1 2018 Agilent Technologies Inc. Earnings Conference Call" in the "News & Events — Calendar of Events" section. The webcast will remain on the company site for 90 days.

In addition, a telephone replay of the conference call will be available at approximately February 14, 2018 at 4:30 p.m. (Pacific Time) after the call and through February 21 by dialing +1 855 859-2056 (or +1 404 537 3406 from outside the United States) and entering pass code 1482568.

VistaGen Therapeutics to Provide Update on Phase 2 Study for Major Depressive Disorder and Outline Key 2018 Initiatives at the 14th Annual Noble Capital Markets’ Investor Conference

On January 22, 2018 VistaGen Therapeutics Inc. (NASDAQ: VTGN), a clinical-stage biopharmaceutical company focused on developing new generation medicines for depression and other central nervous system (CNS) disorders, reported that Shawn Singh, Chief Executive Officer of VistaGen, will provide an update on the Company’s Phase 2 study of AV-101 as an oral new generation adjunctive treatment for Major Depressive Disorder (MDD) and outline key 2018 initiatives at the 14th Annual Noble Capital Markets’ Investor Conference – NobleCon14 – to be held at the W Fort Lauderdale hotel in Fort Lauderdale, FL on Monday, January 29th at 4:30 p.m. ET (Press release, VistaGen Therapeutics, JAN 22, 2018, View Sourcenews/detail/80/vistagen-therapeutics-to-provide-update-on-phase-2-study-for-major-depressive-disorder-and-outline-key-2018-initiatives-at-the-14th-annual-noble-capital-markets-investor-conference" target="_blank" title="View Sourcenews/detail/80/vistagen-therapeutics-to-provide-update-on-phase-2-study-for-major-depressive-disorder-and-outline-key-2018-initiatives-at-the-14th-annual-noble-capital-markets-investor-conference" rel="nofollow">View Source [SID1234523421]).

The event will be available via video webcast on VistaGen’s investor relations website, View Source, the day following the live presentation.

For more information about NobleCon14, or to schedule a one-on-one meeting with VistaGen’s management, please contact your Noble Capital Markets representative directly, or visit the conference website here.

Athenex Announces Encouraging Results of the First Cohort of Phase I Clinical Trial of Oraxol and CYRAMZA® (Ramucirumab) Combination Treatment in Gastric Cancer

On January 22, 2018 Athenex, Inc. (Nasdaq:ATNX), a global biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies for the treatment of cancer and related conditions, reported the completion of the first cohort of patients in its Phase 1b clinical trial of Oraxol (oral paclitaxel) plus CYRAMZA (ramucirumab) in gastric cancer patients that failed previous chemotherapies. Oraxol, an innovative development in the treatment of cancer, is a novel oral formulation of paclitaxel, a very effective and commonly used chemotherapy treatment for many cancers, combined with HM30181A (a novel P-gp inhibitor) (Press release, Athenex, JAN 22, 2018, View Source;p=RssLanding&cat=news&id=2327621 [SID1234523406]).

A previously completed Phase II clinical trial of Oraxol in the second-line treatment of gastric cancer patients showed an encouraging overall median survival of 10.7 months. The expected overall survival for advanced gastric cancer patients who have failed previous chemotherapy and do not receive second-line therapy is approximately 4.0 months.

Ramucirumab, as a single agent or in combination with paclitaxel, is FDA-approved for the treatment of patients with advanced or metastatic, gastric or gastroesophageal junction (GEJ) adenocarcinoma with disease progression on or after prior fluoropyrimidine or platinum-containing chemotherapy. Ramucirumab is manufactured and marketed by Eli Lilly and Company. Athenex is evaluating the effect of Oraxol plus ramucirumab in gastric cancer in collaboration with Lilly.

Of the six patients in the first cohort, the Oraxol and ramucirumab combination treatment was well tolerated. Grade 4 neutropenia occurred in one patient who fully recovered and there were no patient deaths. There was no neuropathy. Two patients had partial responses (tumor shrinkage of 34-42%) and three patients had stable diseases (with tumor shrinkage of 27% in one patient). Only one patient had progressive disease. Although early, these results are regarded as encouraging compared with previous IV paclitaxel and ramucirumab combination therapy Phase III clinical trial results. Athenex is advancing to the second cohort with Oraxol dose escalation.

Dr. Rudolf Kwan, Athenex’s Chief Medical Officer, commented, "We are heartened to see Oraxol and ramucirumab is well-tolerated with encouraging tumor response in our first cohort of patients with gastric cancer that failed previous chemotherapies in this Phase I clinical trial. We are proceeding to the second cohort of patients with an escalation dose of Oraxol to explore the possibility of even better clinical efficacy with a higher dose."

Oraxol was initially discovered by Hanmi Pharmaceuticals and licensed to Athenex.

PharmaEssentia Corp., licensed the Taiwan rights to Oraxol from Athenex and is a partner in the development of Oraxol in Taiwan.

Athenex Announces Encouraging Early Clinical Efficacy and Safety Data of Oraxol in Clinical Trial for the Treatment of Breast Cancer

On January 22, 2018 Athenex (Nasdaq:ATNX), a global biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies for the treatment of cancer and related conditions, reported encouraging preliminary efficacy and safety data of Oraxol in the treatment of breast cancer in a pharmacokinetics (PK) and Phase I/II clinical trial of 24 patients in Taiwan (Press release, Athenex, JAN 22, 2018, View Source;p=RssLanding&cat=news&id=2327623 [SID1234523407]). Oraxol, an innovative development in the treatment of cancer, is a novel oral formulation of paclitaxel, an effective and commonly used chemotherapy treatment for many cancers, combined with HM30181A (a novel P-gp inhibitor).

Among the first 12 evaluable patients, 50% had a partial response (>30% tumor shrinkage) and 50% had stable disease (all patients had tumor reduction, some up to 27%). There was no progressive disease. The follow-up time was only 2.6 months and such early response results are most encouraging. Grade 4 neutropenia was observed in 3 patients, all recovered completely with no patient death. There was no neuropathy.

Dr. Rudolf Kwan, Athenex’s Chief Medical Officer, commented, "We have seen consistent encouraging results in different clinical studies, showing the robust performance of Oraxol. We are delighted by the recent recommendation and positive comments from the Drug Safety and Monitoring Board, as well as the United Kingdom Medicines and Healthcare products Regulatory Agency giving Oraxol a Promising Innovative Medicine designation that will facilitate the development of Oraxol in Europe. We are very excited with these encouraging results and we are moving full speed to develop Oraxol for cancer patients in need of an effective oral paclitaxel with very low incidence of neuropathy."

Athenex previously announced that the Drug Safety and Monitoring Board unanimously recommended the continuation of our Phase III clinical trial comparing Oraxol versus intravenous paclitaxel in the treatment of metastatic breast cancer after the interim analysis of the first 90 patients on October 5, 2017. Additionally, the Company announced the receipt of the Promising Innovative Medicine designation for Oraxol by the United Kingdom Medicines and Healthcare products Regulatory Agency on December 27, 2017, qualifying Athenex to apply for Step II of the Early Access to Medicines Scheme to provide patients early access to Oraxol prior to receiving marketing authorization. Athenex also recently announced that the Chinese FDA has allowed the Investigational New Drug application for Oraxol on January 8, 2018.