Paclitaxel/Encequidar mesylate

SAN FRANCISCO, June 12, 2023 /PRNewswire/ -- Biostar Pharma, Inc., the US subsidiary of Beijing Biostar Pharmaceuticals Co., Ltd. which is a synthetic biology driven biopharma company focusing on the discovery, development and commercialization of innovative oncology drugs, is pleased to announce that the first patient has been enrolled today for a Phase 1 clinical study (BG02-2201; NCT05681000) of its proprietary oral formulation product of utidelone, UTD2 (utidelone capsule) in advanced solid tumor patients in the US. This study will be conducted at multiple clinical research centers including Sarah Cannon Research Institute (Florida Cancer Specialists & Research Institute), University of Southern California, Washington University School of Medicine in St. Louis, et al. Unmet Medical Need With the improvement of treatment regimen, the overall survival of cancer patients has increased significantly in the past years. Therefore, good patient compliance is an important factor for clinical efficacy in the long-term care of cancer patients. Chemotherapy, represented by microtubule inhibitors, remains the most common systemic treatment for cancer, However, most microtubule inhibitors are through I.V. administration, which may potentially cause allergic reactions and inconvenience. So far there have been barely oral dosage forms of microtubule inhibitors successfully developed due to low solubility and being a substrate of drug-resistant P-glycoprotein. Liporaxel is an oral taxane that has only been approved for marketing in South Korea, and its oral bioavailability was still quite low. Other oral dosage forms such as Tesetaxel and Oraxol have failed in clinical trials due to safety and other problems, suggesting a huge unmet medical need. Advantage for Oral Administration UTD2 is the world's first oral epothilone microtubule inhibitor. Utidelone has the advantage for oral formulation since it's not the substrate of P-glycoprotein. Pre-clinical studies of UTD2 demonstrated good PK and safety profiles and relatively high bioavailability. Compared with injections, utidelone capsules do not require the addition of organic solvents and surfactants. Thus, they may reduce the adverse events caused by intravenous administration, shorten the hospital stay of patients, improve administration convenience, enhance patient compliance and broaden the potential for combination therapy with other anti-cancer drugs. Dr. Li Tang, Chairman of Biostar Pharma said: "The first patient enrollment of UTD2 in the US clinical trial is an important step for our international development strategy. We are honored to have a number of well-known research institutions and investigators in the US to carry out the study. We are confident that this breakthrough product will provide more benefits for numerous cancer patients and bring about a substantial change to microtubule inhibitors administration. The company is fully committed to advancing this study in order to meet substantial clinical needs around the world." About UTD2 and Utidelone UTD2 is the oral formulation of utidelone (utidelone capsule), which is developed through the proprietary microbial drug formulation platform of Beijing Biostar Pharmaceuticals Co., Ltd. Utidelone is a genetically engineered microtubule inhibitor and its injectable dosage has been launched in China in 2021 for the treatment of metastatic breast cancer (MBC). It is the only approved new molecular of microtubule inhibitor in the past 10 years around the world. Among all single agent or combination regimen of non-taxane chemotherapies, utidelone injectable is the only one to achieve both PFS and OS benefits for heavily pretreated MBC patients. It demonstrated several advantageous features, such as overcoming taxane-resistant, low hematological toxicity suitable for longer term exposure, ability to cross the blood-brain barrier that is able to prevent and treat tumor brain metastasis. The phase 3 study results of utidelone injectable were twice selected for oral presentations at ASCO annual meetings and invited to publish in Lancet Oncology and Annals of Oncology. It is also recommended by "2023 CSCO Guidelines for Diagnosis and Treatment of Breast Cancer" as Class I (category IA). Clinical studies for multiple indication expansion are in progress, including phase 3 trials for non-small-cell lung cancer and breast cancer neoadjuvant, respectively, as well as phase 2 trial for the first line treatment of advanced esophageal cancer and gastric cancer. About BG02-2201 Study BG02-2201 represents the "Phase I Clinical Study on the Tolerability of Utidelone Capsule in Patients with Advanced Solid Tumors" (NCT05681000), which is an open-label phase I dose escalation study and will be conducted at several clinical research centers in the United States. 16-28 patients with advanced solid tumors are expected to be enrolled. The primary objective is to evaluate the safety and tolerability of UTD2 to determine the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT). The secondary objectives are to evaluate the pharmacokinetic profile of UTD2 and to preliminarily assess the anti-tumor efficacy of UTD2 in advanced solid tumor patients. About Beijing Biostar Pharmaceuticals Co., Ltd. Beijing Biostar Pharmaceuticals Co., Ltd. is an integrated biopharma company focusing on the developing of first- and best-in-class innovative anti-cancer drugs with independent intellectual property through state-of-the-art technology platforms of combinatorial biosynthesis, microbial fermentation production and microbial drug formulation development. With an insight-driven strategy, experienced R&D teams, cGMP-compliant manufacturing facility and domestic commercialization capability, the company have built a balanced product pipeline, covering both lead product life-cycle expansion and early-stage projects development. Further information can be found on the company's website or by contacting our business development team at [email protected] on partnering with us. SOURCE Biostar Pharma, Inc.

Analysis of safety data demonstrated that patients with elevated liver tests were at increased risk of neutropenia related toxicities Post hoc analysis of this subgroup of patients with hepatic impairment was conducted and showed a median survival rate of 18.9 months in patients treated with Oral Paclitaxel vs 10.1 months in those treated with IV Paclitaxel, with a hazard ratio of 0.59 This increase in overall survival counterbalanced the risk of complications of neutropenia related toxicities BUFFALO, N.Y., Nov. 22, 2021 (GLOBE NEWSWIRE) -- 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, today announced that an abstract for a subgroup analysis of its Phase 3 study of oral paclitaxel and encequidar (Oral Paclitaxel) for the treatment of metastatic breast cancer has been accepted for poster presentation at the 2021 San Antonio Breast Cancer Symposium (SABCS), to be held from December 7 to December 10, 2021. The abstract and poster provide data from a post hoc, subgroup analysis of safety, progression free survival and overall survival of patients with elevated liver enzymes (AST or bilirubin) from study KX-ORAX-001, a Phase 3 study of weekly Oral Paclitaxel plus Encequidar vs IV Paclitaxel 175mg/m2 every three weeks. 402 subjects were randomized in a 2:1 ratio to Oral Paclitaxel and Encequidar vs IV Paclitaxel. Prior to treatment, 122 patients out of 402 total study patients (30.3%) had elevated AST or bilirubin, primarily mild hepatic dysfunction. For patients with elevated liver enzymes receiving Oral Paclitaxel, the median survival was 18.9 months compared to 10.1 months for patients receiving IV Paclitaxel: with a hazard ratio of 0.593 (95.5% CI 0.382 - 0.921) favoring Oral Paclitaxel. Although metastatic breast cancer patients with mild hepatic dysfunction at baseline are at increased risk of early serious neutropenic and infectious/septic complications this risk may be counterbalanced by a potential increase in efficacy after treatment with Oral Paclitaxel. Details of the poster presentation is as follows: Abstract Title: Oraxol + Encequidar (OPac+E) vs IV paclitaxel (IVPac) in the treatment of patients with metastatic breast cancer (mBC) (Study KX-ORAX-001): Subgroup survival analysis of patients with hepatic dysfunction Session: 1 Program Number: P1-16-05 Date and Time: Wednesday, December 8, 2021. 7:00 am CT For more information, please visit: About Athenex, Inc. Founded in 2003, Athenex, Inc. is a global clinical-stage biopharmaceutical company dedicated to becoming a leader in the discovery, development, and commercialization of next generation drugs for the treatment of cancer. Athenex is organized around three platforms, including an Oncology Innovation Platform, a Commercial Platform, and a Global Supply Chain Platform. The Company’s current clinical pipeline is derived mainly from the following core technologies: (1) Orascovery, based on P-glycoprotein inhibitor, (2) Src kinase inhibition, and (3) Cell therapy. Athenex’s employees worldwide are dedicated to improving the lives of cancer patients by creating more active and tolerable treatments. For more information, please visit . Forward-Looking Statements Except for historical information, all of the statements, expectations, and assumptions contained in this press release are forward-looking statements. These forward-looking statements are typically identified by terms such as “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “foresee,” “goal,” “guidance,” “intend,” “likely,” “may,” “plan,” “potential,” “predict,” “preliminary,” “probable,” “project,” “promising,” “seek,” “should,” “will,” “would,” and similar expressions. Actual results might differ materially from those explicit or implicit in the forward-looking statements. Important factors that could cause actual results to differ materially include: the development stage of our primary clinical candidates, including NKT Cell Therapy and related risks involved in drug development, clinical trials, regulation, uncertainties around regulatory reviews and approvals; our ability to pivot our business and to find new uses for the capacity at our Dunkirk manufacturing facility, once operational; our ability to scale our manufacturing and commercial supply operations for current and future approved products, and ability to commercialize our products, once approved; ability to successfully demonstrate the safety and efficacy of its drug candidates and gain approval of its drug candidates on a timely basis, if at all; the preclinical and clinical results for Athenex’s drug candidates, which may not support further development of such drug candidates; risks related to our ability to successfully integrate the business of Kuur into our existing businesses, including uncertainties associated with maintaining relationships with customers, vendors and employees, as well as differences in operations, cultures, and management philosophies that may delay successful integration and our ability to support the added cost burden of Kuur’s business; risks related to counterparty performance, including our reliance on third parties for success in certain areas of Athenex’s business; our history of operating losses and our need and ability to raise additional capital to continue as a going concern; uncertainties around our ability to enter into new financing agreements as we are unable to meet funding conditions under our existing financing agreements and access to capital thereunder; risks and uncertainties inherent in litigation, including purported stockholder class actions; risks and uncertainties related to the COVID-19 pandemic and its ongoing impact on our operations, supply chain, cash flow and financial condition; competition; intellectual property risks; uncertainties around our ability to successfully integrate acquired and merged businesses in a timely and cost-effective manner and to achieve synergies; risks relating to doing business internationally and in China; the risk of development, operational delays, production slowdowns or stoppages or other interruptions at our manufacturing facilities as well as our ability to find alternative sources of supply to meet our obligations and requirements; and the other risk factors set forth from time to time in our SEC filings, copies of which are available for free in the Investor Relations section of our website at or upon request from our Investor Relations Department. All information provided in this release is as of the date hereof and we assume no obligation and do not intend to update these forward-looking statements, except as required by law. Athenex Contacts Investors Daniel Lang, MD Athenex, Inc. Email: danlang@athenex.com Caileigh Dougherty Athenex, Inc. Email: cdougherty@athenex.com