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China FDA Approves CTAs for BeyondSpring’s Second Global Plinabulin Registrational Trial for Chemotherapy-Induced Neutropenia Prevention

NEW YORK, July 06, 2017 (GLOBE NEWSWIRE) -- BeyondSpring Inc. (NASDAQ:BYSI), a global clinical stage biopharmaceutical company focused on the development of innovative immuno-oncology cancer therapies, today announced that the China Food and Drug Administration (CFDA) has approved the Company’s Clinical Trial Applications (CTAs) to allow the initiation of two global Phase 2/3 trials for its innovative lead asset, Plinabulin, for the prevention of chemotherapy-induced neutropenia in China. This is the second global registration trial for Plinabulin in addition to the Phase 3 non-small cell lung cancer (NSCLC) trial.

“These two studies with Plinabulin aim to recruit 370 patients who are at risk for chemotherapy-induced neutropenia (studies BPI-2358-105 to evaluate the effect in docetaxel and BPI-2358-106 in the effect with the TAC regimen),” said Dr. Yuankai Shi, Principal Investigator for BeyondSpring’s neutropenia registrational trials in China. “The studies were designed based on the highly statistically significant reduction of neutropenia data that was generated from the previous Phase 2 study in NSCLC patients. This collective dataset, if replicated in a pivotal study, would transform Plinabulin into an invaluable asset in the prevention of neutropenia, a condition that afflicts a large patient population all over the world.”

Dr. Shi is the Vice Chairman of the Cancer Hospital Chinese Academy of Medical Sciences in Beijing, which treats over 370,000 cancer patients a year. He has been instrumental in developing G-CSF products, the current standard of care for chemotherapy-induced neutropenia, for the China market.

Plinabulin is a novel small molecule with immune-enhancing effects and anti-cancer activity that is administered by IV infusion – one hour after chemotherapy – and has the potential to be a safe, cost-effective and convenient alternative to G-CSF, with less bone pain and a more favorable safety profile.

Plinabulin offers a same-day dosing advantage over G-CSF, which, per product label, should be administered 24 hours after chemotherapy (next-day dosing), by which time a significant insult to neutrophil production has occurred. Plinabulin has also demonstrated a reduction in the clinical sequelae associated with docetaxel-induced neutropenia – i.e., infections, sepsis, hospitalizations and the need for docetaxel dose reductions.

“This is an important achievement for BeyondSpring in China, and we are gratified to have made history with the rapid CFDA approval of both of our CTAs,” added Dr. Gordon Schooley, Chief Regulatory Officer, BeyondSpring. “The CTA approval to initiate the 106 study was received just one month after its submission to the CFDA, and the CTA approval for the 105 study was received in only five months. This achievement underscores BeyondSpring's unique regulatory strength and speed in China."

“This regulatory milestone highlights not only the CFDA’s support for, and belief in, Plinabulin as a first-in-class treatment for neutropenia prevention but also demonstrates BeyondSpring’s unique ability to work with the CFDA in China to obtain agreement in an accelerated manner,” said Dr. Ramon Mohanlal, M.D., Ph.D., BeyondSpring Chief Medical Officer and Head of Business Development.

Neutropenia, a common side effect of chemotherapy in cancer patients, is the destruction of a type of white blood cell (neutrophil) that is a key component of the innate immune system. Neutrophils are a patient’s first line of defense against infections, and patients with severe (grade 4) neutropenia (an abnormally low concentration of neutrophils in the blood) are more susceptible to severe bacterial, viral and fungal infections and sepsis, which require hospitalization.

More than 60,000 patients in the U.S. are hospitalized each year for chemotherapy-induced severe neutropenia, which is associated with fever, infections and death in up to 18 percent of cases. When severe neutropenia occurs, the chemotherapy dose is often reduced or interrupted until the neutropenia subsides. This reduction or interruption ultimately causes patients to receive suboptimal chemotherapy cancer treatment.

“China has a large number of eligible patients for these neutropenia trials, and we are fortunate to be able to tap into the country’s vast resources as we continue the path to bringing Plinabulin to market,” added Lihua Du, BeyondSpring’s China General Manager and a veteran in the development of pharmaceutical products in China for over 25 years. “This will enable us to advance Plinabulin through its pivotal studies and, ultimately, for chemotherapy-induced neutropenia patients across the globe.”

“The CFDA’s approval of BeyondSpring’s CTAs for the registration trials of Plinabulin for the prevention of chemotherapy-induced neutropenia marks another vital regulatory milestone for our team, which continues to work to bring our vision for innovative cancer treatments to reality,” concluded Dr. Lan Huang, BeyondSpring CEO. "Opening China sites for what we expect to be rapid patient enrollment for these studies supports our confidence that we will meet our targets for reporting Phase 2 efficacy data in the second half of 2017 and Phase 3 interim data in 2018, as well as in submitting a New Drug Application (NDA) in 2019 to the FDA and CFDA. This history-making achievement further validates our distinctive business model of time- and cost-efficiency in innovative drug development."

About BeyondSpring
BeyondSpring is a global clinical stage biopharmaceutical company developing innovative immuno-oncology cancer therapies with a robust pipeline from internal development and from collaboration with Fred Hutchinson Cancer Research Center and University of Washington. BeyondSpring’s lead asset, Plinabulin, is in a Phase 3 clinical trial as a direct anticancer agent in non-small cell lung cancer and a Phase 2/3 clinical program in the prevention of chemotherapy-induced neutropenia. BeyondSpring has a seasoned management team with many years of experience bringing drugs to market.

About Plinabulin
Studies on Plinabulin's method of action indicate that Plinabulin activates GEF-H1, a guanine nucleotide exchange factor. GEF-H1 activates downstream transduction pathways leading to the activation of the protein c-Jun. Activated c-Jun enters the nucleus of dendritic cells to upregulate immune-related genes, which contributes to the up-regulation of a series of genes leading to dendritic cell maturation, T-cell activation and other effects that prevent neutropenia.

Cautionary Note Regarding Forward-Looking Statements
This press release includes forward-looking statements that are not historical facts. Words such as "will," "expect," "anticipate," "plan," "believe," "design," "may," "future," "estimate," "predict," "objective," "goal," or variations thereof and variations of such words and similar expressions are intended to identify such forward-looking statements. Forward-looking statements are based on BeyondSpring's current knowledge and its present beliefs and expectations regarding possible future events and are subject to risks, uncertainties and assumptions. Actual results and the timing of events could differ materially from those anticipated in these forward-looking statements as a result of several factors including, but not limited to, the anticipated amount needed to finance the company's future operations, unexpected results of clinical trials, delays or denial in regulatory approval process, our expectations regarding the potential safety, efficacy or clinical utility of our product candidates, or additional competition in the market. The forward-looking statements made herein speak only as of the date of this release and BeyondSpring undertakes no obligation to update publicly such forward-looking statements to reflect subsequent events or circumstances, except as otherwise required by law.

CONTACT INFO: Caitlin Kasunich / Amy Singh KCSA Strategic Communications 212.896.1241 / 212.896.1207 ckasunich@kcsa.com / asingh@kcsa.com

Source:BeyondSpring, Inc.