Astellas Pharma Inc., of Tokyo, said results from the phase II TERRAIN trial of Xtandi (enzalutamide), the androgen receptor inhibitor approved by U.S. regulators in the summer of 2012, compared to the anti-androgen therapy bicalutamide (Casodex, Astrazeneca plc) in metastatic castration-resistant prostate cancer were published in Lancet Oncology. The TERRAIN study achieved its primary endpoint demonstrating a statistically significant increase in progression-free survival (PFS) for enzalutamide compared to bicalutamide (hazard ratio = 0.44; 95 percent confidence interval, 0.34-0.57; p<0.0001). Median PFS was 15.7 months in the enzalutamide group compared to 5.8 months in the bicalutamide group. The observed adverse event profile in TERRAIN appeared consistent with that from phase III enzalutamide trials. (See BioWorld Today, Jan. 30, 2014.)
Cellular Biomedicine Group Inc., of Shanghai, reported 48-week data from the phase IIb trial of its human adipose-derived mesenchymal progenitor cell therapy Rejoin for knee osteoarthritis. Data from 53 patients showed the primary and secondary endpoints of the therapy group having all improved significantly compared to their baseline, which has confirmed some of the company's phase I/IIa results. The total WOMAC scores (consisting of pain, stiffness and function scores of joints) as a primary endpoint show statistical treatment significance at week 48 compared to the baseline. The total knee cartilage volume change measured by a semi-automated segmentation method by two different blinded researchers show significant gain of cartilage in the Rejoin group but a loss of cartilage in Artz (sodium hyaluronate) group, reaching statistical difference between the two groups 48 weeks after therapy.
Crystalgenomics Inc., of Seoul, South Korea, signed a license and supply agreement with TR-Pharm, of Istanbul, to commercialize osteoarthritis drug Acelex (polmacoxib) in Turkey and the Middle East and North Africa region. TR-Pharm will secure exclusive rights to Turkey and 18 additional countries in the MENA region to sell and market a 2-mg capsule of the nonsteroid anti-inflammatory drug. Sales are expected to reach $253 million in the license region over the course of the agreement.
Cynata Therapeutics Ltd., of Melbourne, Australia, published a scientific study of Cymerus induced pluripotent stem cell-derived mesenchymal stem cells (MSCs) in Cytotherapy, which describes findings from a preclinical study of Cymerus MSCs in treating critical limb ischemia. Research showed they markedly improved blood flow in the ischemic limb, with corresponding benefits to muscle and limb health. The study was conducted by a group of independent scientists at the University of Wisconsin-Madison.
Eisai Ltd., of Hatfield, U.K., part of Eisai Co. Ltd., of Tokyo, submitted a new marketing authorization application (MAA) to the EMA for the use of lenvatinib in combination with everolimus to treat unresectable advanced or metastatic renal cell carcinoma in patients who have received one prior vascular endothelial growth factor-targeting therapy. Lenvatinib is an oral molecular trispecific targeted therapy that has a potent selectivity. A similar application has already been submitted to the FDA. Lenvatinib was granted an accelerated assessment in Europe in October. The MAA is based on a phase II trial of lenvatinib with everolimus that showed progression-free survival was significantly extended when compared with everolimus alone.
Hutchison China Meditech Ltd., of Shanghai, said its R&D subsidiary, Hutchison Medipharma Ltd., started a phase I trial in Australia of HMPL-523, a small-molecule oral inhibitor targeting spleen tyrosine kinase, in patients with hematological malignancies. The trial follows successful completion in October of a phase I trial in healthy volunteers. The open-label, dose-escalation study will evaluate patients who are unable to tolerate standard therapy or for whom there is no effective therapy. Primary objectives are safety and tolerability, and to determine the maximum tolerated dose and recommended phase II dose.
Immuron Ltd., of Melbourne, Australia, said IMM-529, its oral therapeutic, demonstrated prevention of Clostridium difficile (C. difficile) infection recurrence in more than 77.8 percent of infected mice. The mouse model was designed to evaluate the effectiveness of IMM-529 when used in conjunction with standard-of-care antibiotic treatment (vancomycin), and data showed combination therapy significantly reduced disease recurrence and mortality to 22.2 percent, compared to 88.9 percent mortality in the vancomycin-only group. The results were statistically significant. IMM-529 is designed to prevent and treat C. difficile infections without destroying the microbiome.
Laboratorios Salvat SA, of Barcelona, Spain, and Lee's Pharmaceutical Ltd., part of Lee's Pharmaceutical Holding Ltd., of Hong Kong, said they agreed to an exclusive license and supply arrangement to market and distribute Duoxal ear drops (ciprofloxacin and fluocinolone acetonide) in China, Hong Kong, Macau and Taiwan, with an option of adding Thailand. Duoxal is Salvat's treatment for acute otitis media in those with tympanostomy tubes and acute otitis externa, or swimmer's ear, in adults and children older than 6 months. The drug is being reviewed by the FDA and Health Canada, and approval is expected sometime this year. Financial terms were not disclosed.
MMJ Phytotech Ltd., of Perth, Australia, reported that its wholly owned subsidiary, United Greeneries (UG), has received notification from Health Canada that a pre-license inspection of UG's Duncan, British Columbia-based facility will be conducted on Feb. 1. The company said it will be the most important milestone to date for UG because an approval positions it to become one of only 25 companies legally allowed to produce medical cannabis in Canada.
Numedii Inc., of Palo Alto, Calif., formed a collaboration with Tokyo-based Astellas Pharma Inc. to identify new indications for a number of undisclosed Astellas compounds using Numedii's predictive Big Data intelligence technology. The technology enables the discovery of new uses for marketed drugs and shelved development assets. It consists of hundreds of millions of human, biological, pharmacological and clinical data points that Numedii has normalized and annotated. Financial terms were not disclosed.
Pfizer Inc., of New York, said it acquired Treerly Health Co. Ltd. and its family of nutritional health care products from Sirio Pharma Co. Ltd., of Guangdong, China, a manufacturer of drugs and dietary supplements, which will continue to supply the Treerly products to Pfizer Consumer Healthcare. Financial terms were not disclosed.
Regeneus Ltd., of Sydney, said it completed a safety review from the first cohort of 10 patients in the STEP trial, identifying no safety concerns. Enrollment is now open to the second and final cohort of 10 patients. STEP (Safety, Tolerability and Efficacy of Progenza) is the first clinical trial of Progenza, the company's allogeneic off-the-shelf stem cell product for the treatment of knee osteoarthritis, and includes 20 patients treated at two different doses of cells via ultrasound-guided injections. The primary objective is safety and tolerability, while secondary objectives are to investigate the effect of Progenza on knee pain and function; quality of life; knee joint structures using magnetic resonance imaging; and osteoarthritis biomarkers. Participants will be monitored for 12 months.
Takeda Pharmaceutical Co. Ltd., of Osaka, Japan, and Engene Inc., of Montreal, said they entered an agreement to discover, develop and commercialize therapies for specialty gastrointestinal diseases utilizing Engene's gene delivery platform, Gene Pill. Under the terms, Takeda will select up to two undisclosed targets that Engene will develop through preclinical proof of concept and investigational new drug research. Takeda retains the option to exclusively license the global rights to any such drug candidates and would be responsible for their development and commercialization. Engene receives up-front payments and reimbursement of any R&D costs, plus is eligible for milestone awards for certain goals reached. No further details of the agreement were disclosed.
Tianyin Pharmaceutical Inc., of Chengdu, China, received an acceptance letter from the NYSE MKT LLC exchange regarding a compliance plan to meet continued listing requirements. The company was notified of its noncompliance due to the delay in filing its quarterly report on Form 10-Q for the period ended Sept. 30, 2015, in addition to the delay in filing of its annual report on Form 10-K for the year ended June 30, 2015. Tianyin has until April 1 to regain possession of files taken by the Sichuan Province Public Security Department.
Researchers from the Australian Walter and Eliza Hall Institute of Medical Research have reported altered immune system function at birth in babies who went on to develop food allergies. At birth, such infants had a stronger innate immune response, particularly higher levels of monocytes, a white blood cell of the innate immune system. When they were stimulated, those monocytes also secreted more cytokines than those from babies who did not go on to develop a food allergy. Those cytokines inhibited the generation of anti-inflammatory interleukin-2, which normally furthers the production of regulatory T cells, which inhibit other T-cell types. As a result, the infants also had fewer regulatory T cells. Whether the cells of infants who go on to develop allergies are different due to genetic or environmental factors, or both, is not clear at this point, though the team did note a link between the duration of labor and the abundance of several cell types. Overall, the authors said their results "provide a mechanistic explanation for susceptibility to food allergy in infants and suggest anti-inflammatory approaches to its prevention." They published their results in the Jan. 14, 2016, issue of Science Translational Medicine.
Yabao Pharmaceutical Co. Inc., of Beijing, and Sciecure Pharma Inc., of Monmouth Junction, N.J., said they inked a partnership to co-develop, manufacture and commercialize high technological barrier generics medicines for both the U.S. and China markets. Under the terms, Yabao will exclusively own rights to commercialize certain Sciecure-developed products in China and to manufacture products for both the U.S. and China markets, while Sciecure will retain rights to commercialize in the U.S. and all other markets. Financial terms were not disclosed.
More than three months after placing drugs from Zhejiang Hisun Pharmaceutical Co. Ltd. on import alert, the FDA sent the company a warning letter about data integrity issues at its facility in Taizhou City, China. The Dec. 31 letter, posted to the agency website this week, cited concerns about several instances of data deletion, which were "heightened by the significant number of customer complaints for subpotency and out-of-specification (OOS) impurity levels from 2012-2014." Additionally, during the agency's inspection in March, a Hisun analyst removed a thumb drive from a computer controlling high-performance liquid chromatography. When the FDA investigator asked for the drive, the analyst took it from the room. About 15 minutes later, management gave the investigator the purported thumb drive. The warning letter also cited problems with the company's microbiological testing on API batches and noted Hisun had dismissed customer complaints about OOS microbial results as insignificant. Products from the plant were placed on import alert Sept. 9, and Hisun has committed to hire a third-party consultant, set up user access restrictions on its data systems and upgrade its computerized systems with audit trails. However, more steps are needed to correct the problems at the facility, the FDA said.