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 27, 2018 JHL Biotech reported that the first patient at Beijing Cancer Hospital has been successfully randomized in the Phase III study of JHL1101 to treat diffuse large B-cell lymphoma (DLBCL) (Press release, JHL Biotech, DEC 27, 2018, View Source [SID1234532295]).

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The Phase III study is a multinational, randomized, double-blind, positive-controlled, parallel group clinical study. It compares the efficacy and safety of JHL1101 in combination with CHOP (J-CHOP) versus rituximab in combination with CHOP (R-CHOP) in patients with previously untreated diffuse large B-cell lymphoma. CHOP is the standard chemotherapy treatment for diffuse large B-cell lymphoma. The study is being conducted in Europe, China, and other parts of Asia.

JHL1101, a biosimilar product to rituximab which is a monoclonal antibody targeting CD20, is being developed by JHL Biotech for the treatment of non-Hodgkin’s lymphoma (NHL), chronic lymphocytic leukemia (CLL), and rheumatoid arthritis (RA).

After completion of similarity assessment in quality attributes and preclinical, a pharmacokinetic (PK) study is being conducted in RA patients in Europe. Earlier this year, the Chinese regulatory authority approved the clinical trial application of the Phase III study.

"Rituximab is an important biologic for the treatment of lymphoma and rheumatoid arthritis. Unfortunately, it is very expensive for patients and healthcare payers. JHL1101 would provide an affordable treatment for these patients," said Mr. Racho Jordanov, CEO, JHL Biotech. "This is a significant milestone for JHL, and a step forward in our goal to become a global leader in developing, manufacturing, and commercializing biologics."

In addition to JHL1101, JHL has several other biosimilars currently in or expected to be in clinical trials. These include:

Bevacizumab biosimilar, JHL1149, used for the treatment of several cancers, the most common of which are metastatic colorectal cancer, non-small cell lung cancer, and ovarian cancer, as well as cervical cancer, renal cell carcinoma, and glioblastoma. Pharmacokinetics study in Europe has been conducted. Received clinical trial approval for Phase III in China in 2018.
Dornase alfa biosimilar, JHL1922, to manage symptoms of cystic fibrosis. Pharmacokinetics study in Europe has been conducted. Expected Phase III trial in Europe in 2019.
Trastuzumab biosimilar, JHL1188, to treat breast cancer. Expected pharmacokinetics study in Australia in 2019.
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On December 27, 2018 Xynomic Pharma, a clinical stage US-China oncology drug development company, reported that its Trials-in-Progress poster discussing the ongoing, potentially pivotal, phase 3 trial of abexinostat plus pazopanib as first- or second-line therapy in patients with locally advanced or metastatic renal cell carcinoma (RCC) will be presented by Dr. Rahul Aggarwal of University of California San Francisco, a lead investigator, at the ASCO (Free ASCO Whitepaper)-Genitourinary Cancers Symposium on February 16, 2019 in San Francisco, California, USA (Press release, Xynomic Pharmaceuticals, DEC 27, 2018, View Source [SID1234532296]).

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Xynomic Pharma has also filed 3 China Investigational New Drug (IND) applications with China National Medical Products Administration (NMPA) to test abexinostat, Xynomic’s lead drug candidate and a China Category 1 drug, against RCC and lymphoma. All 3 clinical trials are potentially pivotal and will test (1) abexinostat in combination with pazopanib as a first- or second-line therapy against RCC, (2) abexinostat as a third-line mono therapy against diffuse large B-cell lymphoma, the most common aggressive non-Hodgkin’s lymphoma (NHL) subtype according to the Leukemia & Lymphoma Society (LLS), and (3) abexinostat as a third-line mono therapy against follicular lymphoma, the most common indolent NHL subtype according to LLS. The first clinical trial will also be a part of an on-going multinational, multi-center trial. Furthermore, Xynomic Pharma has filed an IND with the NMPA for a fourth trial, not intended for registration purpose in China, to test abexinostat as a fourth-line mono therapy against follicular lymphoma. This fourth trial will be a part of an on-going multinational, multi-center trial.

In addition, Xynomic Pharma has officially commissioned its dedicated R&D Innovation Center in Shanghai, China with a ribbon cutting ceremony. This center is staffed with a team of multinational scientists from China and India and focuses on leveraging kinase inhibition, immuno-oncology and epigenetic modification to discover and develop innovative small molecule oncology drugs. The center is designed to have research capabilities from lead identification to pre-clinical drug candidate selection and development capabilities in early phase clinical trials.

On December 27, 2018 Nektar Therapeutics’ (Nasdaq: NKTR) President and Chief Executive Officer, Howard Robin, is reported to present at the upcoming 37th Annual J.P. Morgan Healthcare Conference in San Francisco on Tuesday, January 8, 2019 at 9:00 a.m. Pacific Time (Press release, Nektar Therapeutics, DEC 27, 2018, View Source [SID1234532297]).

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The presentation will be accessible via a Webcast through a link posted on the Investors, Events Calendar section of the Nektar website: View Source In addition, the company will webcast the Q&A breakout session immediately following its presentation at 9:30 a.m. Pacific Time. This Webcast will be available for replay until February 18, 2019.