(Press release, Telik, APR 5, 2011, View Source [SID:1234504369])

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Thirty-one patients were treated at 6 dose levels ranging from 0.01 to 0.09 mg/kg and 7 had paired pre- and posttreatment biopsies (Poster AACR (Free AACR Whitepaper) 2011, Genprex, APR 2, 2011, View Source [SID:1234500633]). RT-PCR analysis detected high TUSC2 plasmid expression in 6 of 7 posttreatment tumor specimens but not in pretreatment specimens and negative controls. Immunohistochemical staining has been performed on one paired specimen, demonstrating low background TUSC2 protein staining in the pretreatment tissue compared with high intense TUSC2 protein staining in the posttreatment tissue. RT-PCR gene expression profiling analysis of apoptotic pathway genes in one paired specimen demonstrated significant upregulation and downregulation of genes involved in both the intrinsic and extrinsic apoptotic pathways. Among 4 patients treated without premedications, all 4 developed grade 2 or 3 fever. Among the 27 patients premedicated with dexamethasone and diphenhydramine, the highest fever was grade 2, which occurred in 2 subjects. The only dose-limiting toxicities were 2 episodes of transient grade 3 hypophosphatemia, resulting in an MTD of 0.06 mg/kg. Twentythree patients who received two or more doses were evaluable for response, with 5 achieving stable disease (2.6-10.8 months) and 18 progressing. One patient with stable disease had evidence of a durable metabolic response on positron emission tomography imaging. The pretreatment apoptotic index was predictive of disease stability. Median survival time was 9.1 months.

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(Press release, Champions Oncology, APR 1, 2011, View Source [SID:1234504158])

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On March 30, 2011 Dr. Reddy’s Laboratories (NYSE: RDY) reported the completion of the acquisition of GlaxoSmithKline’s (GSK) United States oral penicillin facility and product portfolio pursuant to the agreement signed and announced by the companies on Nov 23, 2010 (Press release, Dr Reddy’s, MAR 30, 2011, View Source [SID1234571043]). As a result of the acquisition, Dr. Reddy’s assumes the ownership of the penicillin manufacturing site in Bristol, Tennessee, United States, and rights for the Augmentin and Amoxil brands in the United States. GSK will retain the existing rights for these brands outside the United States. Further financial terms and conditions of the transaction are not being disclosed.

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On March 29, 2014 Ono Pharmaceutical and OncoTherapy Science reported that the companies entered into a license agreement for new therapeutic peptide vaccines for all types of cancer, including hepatocellular carcinoma (Press release Ono, MAR 29, 2011, www.ono.co.jp/eng/news/pdf/sm_cn110329.pdf [SID:1234500749]). Under this agreement, Ono is granted the exclusive rights (including sublicense rights) in Japan, South Korea and Taiwan to develop, manufacture and commercialize OncoTherapy’s therapeutic peptide vaccines derived from three kinds of oncoantigens. Ono will pay to OncoTherapy an upfront payment at closing of this agreement, followed by milestone payments based on development stages and achievement of projected sales as well as royalties on sales of the vaccines. In addition, Ono retains an option to expand the licensed territory based on the future development status.

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OncoTherapy is a company in the development of novel therapeutic agents for cancer. It has collaborated with Human Genome Center, the Institute of Medical Science, the University of Tokyo to identify and analyze functions of genes playing an important role for development and progression of cancer using comprehensive analysis of gene expressions, and to select proteins for drug discovery. OncoTherapy has already identified various peptide vaccines through its research and development on oncoantigens enhancing specific immune function for target protein.

Meanwhile, since we have already estimated the upfront payment under this license agreement in research and development expenditures of the current fiscal period ending March 2011, there is no financial impact on the projected business performance of this fiscal period.