On December 28, 2018 CTI BioPharma Corp. (NASDAQ: CTIC) reported the completion of full enrollment of 150 patients in the PAC203 Phase 2 study of pacritinib (Press release, CTI BioPharma, DEC 28, 2018, View Source [SID1234532309]). The Company expects to report the determination of the optimal dose of pacritinib in mid-2019 following a meeting with the U.S. Food and Drug Administration (FDA). Topline efficacy and safety data are expected in the third quarter of 2019, with the new Phase 3 study targeted to commence enrollment in the third quarter of 2019.

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As previously announced, the Company has received input from the FDA on key elements of the design of a new randomized Phase 3 study of pacritinib in adult patients with myelofibrosis (primary myelofibrosis, post-polycythemia vera myelofibrosis, or post-essential thrombocythemia myelofibrosis) and who have severe thrombocytopenia (as defined by patients with platelet counts of less than 50,000 per microliter), an indication that has been recognized by the medical community as an important unmet medical need. A planned interim safety review by an Independent Data Monitoring Committee (IDMC) is scheduled to occur in the first quarter of 2019.

The PAC203 study is evaluating the safety and efficacy of three dosing schedules (100 mg once daily, 100 mg twice daily and 200 mg twice daily) over 24 weeks in patients with myelofibrosis previously treated with ruxolitinib. More information on the PAC203 trial can be found at ClinicalTrials.gov at View Source

On December 28, 2019 Helix BioPharma Corp. (TSX, FSE: "HBP") ("Helix" or the "Company"), an immuno-oncology company developing innovative drug candidates for the prevention and treatment of cancer, reported it has closed a final tranche of a private placement financing for gross proceeds of CAD348,000 (Press release, Helix BioPharma, DEC 28, 2018, View Source [SID1234533055]).

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The terms of the placement are for the purchase of units at $1.20 per unit. Each unit is comprised of one common share and one common share purchase warrant. Each common share purchase warrant will entitle the holder to purchase one common share at an exercise price of $1.50 and have an expiry of five years from the date of issuance. Helix intends to use the net proceeds of the private placement for working capital and research and development activities.

ACM Alpha Consulting Management AG provided financial advisory services to Helix in connection with the private placement.

On December 28, 2018 Medtronic plc (NYSE:MDT), the global leader in medical technology, reported it will participate in the 37th Annual J.P. Morgan Healthcare Conference in San Francisco (Press release, Medtronic, DEC 28, 2018, View Source;p=RssLanding&cat=news&id=2381699 [SID1234532302]).

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Omar Ishrak, Medtronic chairman and chief executive officer, will make a formal presentation on the company beginning at 9:00 a.m. PST (11:00 a.m. CST) on Monday, January 7, 2019. Shortly following the presentation, Ishrak and Karen Parkhill, executive vice president and chief financial officer, will answer questions on the company.

A live audio webcast of the presentation and Q&A session will be available on January 7, 2019, by clicking on the Investor Events link at View Source An archive of the presentation and Q&A session will be available on the same webpage later in the day.

On December 28, 2018 Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, reported that management will present a company overview at the 37th Annual J.P. Morgan Healthcare Conference onMonday, January 7, 2019 at 10:30 am PT (1:30 pm ET) at The Westin St. Francis in San Francisco (Press release, Alnylam, DEC 28, 2018, View Source;p=RssLanding&cat=news&id=2381687 [SID1234532303]). This presentation will include an update on unaudited fourth quarter 2018 global net product revenues for ONPATTRO (patisiran) as well as additional updates on the product’s commercial launch. In addition, the Company will webcast the Q&A breakout session immediately following its presentation at 11:00 am PT (2:00 pm ET).

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A live audio webcast of both the presentation and breakout session will be available on the Investors section of the Company’s website, www.alnylam.com. A replay will be available on the Alnylam website within 48 hours after the event.

On December 27, 2018 Innovent Biologics, Inc. (Innovent) (HKEX: 01801) and Eli Lilly and Company ("Lilly") jointly reported that the co-developed Tyvyt (fully human anti-PD-1 therapeutic monoclonal antibody, generic name: sintilimab injection) has been granted approval for market authorization by the National Medical Products Administration of China ("NMPA", formerly the China Food and Drug Administration) for the treatment of patients with classical Hodgkin’s lymphoma (cHL) that has relapsed or refractory (r/r) after two or more lines of systemic chemotherapy (r/r cHL) (Press release, Innovent Biologics, DEC 27, 2018, View Source [SID1234532284]). The approval of Tyvyt (sintilimab injection) highlights the emergence of China in the field of Immuno-Oncology.

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According to Cancer Today from the WHO’s International Agency for Research for Cancer, China will have about 4.28 million newly diagnosed cancer patients and 2.86 million deaths from cancer in 2018[1]. Thus China faces massive challenges from its growing burden of cancer. Lymphoma is one of the common cancers in China, and cHL, a type of B-cell lymphoma affects young and middle-aged people. Although the combination therapy of chemotherapy and radiation has a good likelihood of inducing a complete response, patients have a 15- 20% chance of recurrence after the first line treatment. Therefore, patients urgently need new innovative medications and treatment solutions. Delivering effective treatment for r/r cHL is a serious challenge for the oncology and hematology community.

Dr. Michael Yu, the Founder, Chief Executive Officer and Chairman of Innovent, said, "Tyvyt (sintilimab injection) is an example of our success with the National Mega Innovation Program, and its approval highlights our achievements in immunotherapy and contributions to China’s efforts to deliver innovative medicines. Innovent has shown its ability to develop large molecule drug and this approval is also a validation and the recognition of Innovent’s R&D capabilities. I have confidence that Tyvyt (sintilimab injection), with its global quality and cost-effectiveness, will bring better treatment to cancer patients in China."

Dr. Wang Li, Senior Vice-President of Lilly China and Head of Lilly China Drug Development and Medical Affairs, said, "The efficacy and safety profile of Tyvyt (sintilimab injection) is well proven in the ORIENT-1 trial. The drug provides a new immuno-oncology treatment option for patients with relapsed/refractory classical Hodgkin’s lymphoma (r/r cHL). Lilly will continue to collaborate with outstanding local pharmaceutical companies to bring more innovative medicines to patients and help in demonstrating local R&D capabilities in global oncology community."

Currently, Tyvyt (sintilimab injection) is being studied in more than twenty clinical trials, including studies in first line non-squamous non-small cell lung cancer (NSCLC), first line squamous NSCLC, second line squamous NSCLC, EGFR mutant NSCLC after EGFR TKI treatment failure, first line gastric cancer, first line liver cancer, first line esophageal cancer, and second line esophageal cancer.

About Tyvyt (sintilimab injection)

Tyvyt (sintilimab injection) is an innovative drug co-discovered by Innovent and Adimab, jointly developed by Innovent and Eli Lilly and Company in China. Tyvyt (sintilimab injection) is a type of immunoglobulin G4 monoclonal antibody, which binds to the PD-1 molecule on the surface of T-cells, blocks the PD-L1 (Programmed Cell Death-1 Ligand-1, PD-L1 pathway) and reactivates T-cells to kill cancer cells. Tyvyt (sintilimab injection) is the only PD-1 antibody in China branded by both a local biopharmaceutical company and a global pharmaceutical company.