Hutchison China MediTech Limited announces that it has initiated a Phase II study of a combination therapy using fruquintinib and Iressa® in the first-line setting for patients with advanced or metastatic non-small cell lung cancer (“NSCLC”) in China. Fruquintinib is a highly selective and potent oral inhibitor of vascular endothelial growth factor receptors (“VEGFR”).
Tocagen Inc., a clinical-stage, cancer-selective gene therapy company, announced its randomized, controlled phase 2/3 clinical trial, called Toca 5, is now enrolling patients in South Korea. The trial is ongoing in the United States, Canada and Israel. The study compares a cancer-selective virus, Toca 511 (vocimagene amiretrorepvec), in combination with Toca FC (extended-release 5-fluorocytosine), to standard of care in patients with first or second recurrence of glioblastoma or anaplastic astrocytoma who are undergoing resection.
SpineGuard announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its new DSG™ (Dynamic Surgical Guidance) integration module to be used in combination with Zavation’s spinal fusion system to make its pedicle screws “smart.”
Eisai Co., Ltd.,a leading global research and development-based pharmaceutical company, and Chugai Pharmaceutical Co., Ltd. (Chugai) announced that Eisai’s acquisition of the rights for manufacturing active pharmaceutical ingredients (API) for Japan from F. Hoffman-La Roche Ltd. for the insomnia treatment/anaesthesia induction agent flunitrazepam (Eisai product name: Silece, Chugai product name: Rohypnol) as well as the marketing authorization held by Chugai for Rohypnol in Japan has been agreed upon by the three companies, and this contract has come into effect.
Pluristem Therapeutics Inc., a leading developer of placenta-based cell therapy products, has completed enrollment of all 172 patients in a multinational phase II trial of its PLX-PAD cells in the treatment of intermittent claudication (IC), a peripheral artery disease (PAD). Enrollment took place at 30 clinical sites in the US, Germany, South Korea, and Israel. IC is characterized by leg cramps and pain while walking, caused by insufficient blood flow through arteries that are partially obstructed by atherosclerotic plaques.
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Kitov Pharmaceuticals Holdings Ltd, an innovative biopharmaceutical company, has announced the expansion of its pipeline through the acquisition of a majority stake in TyrNovo Ltd., a privately held developer of novel small molecules in the immuno-oncology therapeutic field.
The expansion into developing immuno-oncology drugs comes as Kitov plans to file its New Drug Application (NDA) with the US Food and Drug Administration (FDA) for its flagship combination drug, KIT-302, which is intended to treat osteoarthritis pain and hypertension simultaneously, in Q1 2017, with commercial launch anticipated for the first half of 2018. Kitov plans to harness its development and regulatory capabilities in proceeding towards submitting an investigational new drug (IND) application with the US FDA and initiate clinical trials for its newly acquired drug, NT219.
The market for immuno-oncology treatments is believed to become worth USD 14 billion by 2019 and to grow to USD 34 billion by 2024, driven by long-term and durable tumor responses to immuno-oncology drugs, according to Global Data.
Kitov will initially acquire an approximately 56 per cent equity stake in TyrNovo from its majority shareholder, for consideration of USD 2 million in cash and USD 1.8 million equivalent ordinary shares of Kitov based on the closing price of Kitov's shares on the TASE on January 11, 2017. Following the closing of this initial acquisition, which is expected to take place on January 13, 2017, Kitov anticipates that it may acquire additional equity stakes in TyrNovo from all or part of TyrNovo's additional minority shareholders for consideration consisting of ordinary shares of Kitov in such amounts as to be agreed with the shareholders.
"The TyrNovo acquisition represents a major milestone in Kitov's strategic vision of establishing a diverse pipeline that we believe will secure long term value creation for its shareholders. We are excited about NT219 and its prospects in the oncology field. NT219 can be developed as a platform combination drug for overcoming multi-drug resistance often observed in various tumors. It has the potential to be developed as a combination therapy with several approved oncology drugs for multiple types of tumors," stated Dr. Paul Waymack, Kitov's Chairman and Chief Medical Officer.
"The Kitov regulatory team has a proven track record in the development and approval of drugs for oncology as well as other indications required to develop NT219 towards submission of an IND and initiation of clinical trials," Waymack added.
TyrNovo is led by its CEO, Dr. Hadas Reuveni, a co-inventor of the TyrNovo technology, who received her Ph.D., Summa Cum Laude, for anti-cancer drug discovery from the Hebrew University of Jerusalem and has nearly two decades of R&D experience in Biotechnology. Dr. Reuveni commented, "I am excited to join Kitov and its team to expedite the development of NT219, which addresses a true unmet medical need for numerous oncology indications. Cancer drug resistance is the major reason for failure in anti-cancer drug treatment. Preventing resistance to the drugs is critical for improving effective cancer treatment."
Eli Lilly and Company and Incyte Corporation announced that the U.S. Food and Drug Administration (FDA) has extended the review period for the new drug application (NDA) for investigational baricitinib, a once-daily oral medication for the treatment of moderate to severe rheumatoid arthritis (RA). The NDA for baricitinib was submitted to the FDA in January 2016.
Abbott has announced the US launch and the first commercial uses of the new ensite precision cardiac mapping system and advisor FL circular mapping catheter, sensor enabled to map cardiac arrhythmias during ablation treatments. The first commercial use of the system after US Food and Drug Administration (FDA) clearance occurred at the Intermountain Heart Institute at Intermountain Medical Center in Salt Lake City during ablation procedures conducted by electrophysiologist John Day, M.D.
Mylan N.V. and Biocon Ltd. announced that the U.S. Food and Drug Administration (FDA) has accepted Mylan's biologics license application (BLA) for MYL-1401O, a proposed biosimilar trastuzumab, for filing through the 351(k) pathway. This product is a proposed biosimilar to branded trastuzumab, which is indicated to treat certain HER2-positive breast cancers. The anticipated FDA goal date set under the Biosimilar User Fee Act (BsUFA) is Sept. 3, 2017.
Sangamo Therapeutics, Inc. . the leader in therapeutic genome editing, announced today that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to SB-318, a genome editing product candidate for the treatment of Mucopolysaccharidosis Type I (MPS I), a rare lysosomal storage disorder. Orphan drug designations are granted to drugs and biologics intended to treat rare diseases. The designation provides incentives to advance development of rare disease drugs and for commercialization of those drugs that progress to approval.
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