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Tobira Therapeutics Inc. Announces Phase I Data Demonstrating Pharmacokinetic Properties Of TAK-652 For The Treatment Of HIV
Tobira Therapeutics Inc., a clinical stage biotechnology company committed to research and product discovery for the treatment of life-threatening and life-altering infectious diseases, today announced pharmacokinetic data and results from two Phase I pharmacokinetic studies for TAK-652, an investigational compound being developed for the treatment of HIV. These data suggest that TAK-652 is rapidly absorbed and demonstrate relatively good oral bioavailability (as shown by the plasma TBR-652 concentration data) and has a long plasma half-life of TBR-652 (approximate mean of 35 hours) supporting once-daily dosing. Mean TBR-652 plasma concentrations were well above the predicted target plasma concentration (2ng/mL) with or without food. In both studies TBR-652 was safe and well tolerated in this healthy subject population when administered over a dose range of 10 mg to 800 mg in 2 tablet formulations. "These two Phase I studies provide encouraging support for TAK-652 as a therapeutic option for the treatment of HIV. We look forward to results from our on-going proof-of-concept study," said James Sapirstein, CEO.
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One Of ASCO's Sleeper Hits: OGX-011 Cuts Provenge's Death Rate In Half

OGX-011 survival benefit: an even better Hazard Ratio. With the release of ASCO abstracts last night we saw additional data and statistical analyses from OGXI"s Phase II trial. This was a randomized, controlled Phase II trial in prostate cancer with their lead compound OGX-011, that had shown a 10.6 month survival advantage, including a new multivariate analysis and hazard ratio. Until last night the hazard ratio, (a statistical measure of how much good or harm a treatment does to a patient) the company had presented was 0.6, i.e. patients treated with OGX-011 plus docetaxel had a 40% reduction in their death rate versus patients that only received docetaxel. Last night, in the more mature data, this impressive HR of 0.6 was not only maintained, but also further reduced to 0.54, which translated to a further reduction in the death rate to 46%. To put this into context: the hazard ratio for Dendreon"s (DNDN Market Outperform) Provenge"s successful Phase III trial was 0.775, or a 22.5% reduction in the death rate. To take this interpretation a step further, treatment with OGX-011 cut the death rate that Provenge"s impressive data demonstrated by half. A look at Hazard Ratios (HR) and Survival Benefits and a caveat: 1) HR: Provenge 0.775 (22.5% reduction in death rate), OGX-011 0.54 (46% reduction in death rate), or OGX-011"s death rate is half of what it is for Provenge. 2) Survival benefits: Taxotere 2.4 months, Provenge 4.1 months, OGX-011 10.6 months, Abiraterone: has not been demonstrated that it has a survival benefit, just PSA declines, MDV3100: has not been demonstrated that it has a survival benefit, just PSA declines 3) A Caveat on Survival Benefits and HR: Taxotere"s and Provenge"s survival benefits were from large Phase III trials, while OGX-011 comes from a randomized, yet smaller, Phase II trial of 82 patients Five points of comparison with Cougar (CGRB Market Perform), a company that also has Phase II data and is trading at an EV of $620M: 1) Abiraterone is about one year ahead in development than OGX-011, and 2) Abiraterone is an oral agent, vs. OGX-011 which is IV, but 3) the two drugs would not compete head-to-head with each other, since Abiraterone is oral and mostly going after an earlier patient population, while OGX-011 will be used together with Taxotere, and patients would have to go to their oncologist"s office to receive their chemo treatment anyway. 4) In addition, Abiraterone has only shown a reduction in PSA levels and not a survival benefit, and 5) its data are all from single-arm studies, while the OGX-011 data come from randomized, controlled studies A word on Abiraterone, Valuations and Market Inefficiencies: We believe Abiraterone has shown an impressive efficacy and safety profile and could end up being a clinical and commercial success. We are not trying to imply that one compound is better than the other. We are simply pointing out a major inefficiency in the market (due to the lack of investor awareness for OGXI), that we believe has lead to a disconnect and imbalance between the two companies" valuations, which we believe represents an opportunity for investors to benefit from. We are not arguing that CGRB should not be where it is in terms of valuation; we are arguing that OGXI should be trading significantly closer to CGRB"s valuation than where it is currently trading. ASCO


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