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van der Zwan, L. et al. Systemic inflammation is linked to low arginine and high ADMA plasma levels resulting in an unfavourable NOS substrate-to-inhibitor ratio: the Hoorn Study. Clinical science 121, 71–78 (2011).

Under the Companies Law, and the Securities Law, 5738—1968, or the Securities Law, a company may indemnify, or undertake in advance to indemnify, an Office Holder for the following liabilities and expenses, imposed on Office Holder or incurred by Office Holder due to acts performed by him or her as an Office Holder, provided its articles of association include a provision authorizing such indemnification:

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NK cell cytotoxicity was assessed as previously described42. Target (T) cells labeled with 5 μM calcein AM (Invitrogen) for 1 h at 37°C and effector (E) cells were co-incubated with 200 μl complete medium in a 96 well plate for 4 h at 37°C. Spontaneous release of calcein was determined by incubating loaded target cells in medium alone, and maximal release was determined by adding 0.1% Triton X-100 to lyse all target cells. After incubation, plates were centrifuged at 300 × g for 5 min, and 100 μl of supernatant from each sample was transferred to a 96-well plate. Fluorescence was measured at 480 nm excitation/538 nm emission wavelengths. Cytotoxicity, measured as a percent specific release of calcein, was calculated using the following formula: percent specific release = (experimental release – spontaneous release)/(maximum release – spontaneous release) × 100.

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To confirm the inhibitory effects of 8-Br-ADPR on the translocation of intracellular perforin and granzyme B to the plasma membrane in response to tumor cell contact, we examined the subcellular distributions of perforin and granzyme B by Western blot. Subcellular organelles of NK cells were separated by sucrose density gradient centrifugation. Perforin and granzyme B were enriched in higher density fractions, consisting of plasma membrane from NK cells treated with plasma membrane extracts (PME) from B16F10 cells, compared to those from NK cells that had not been treated (Fig. 3d). 8-Br-ADPR inhibited the tumor-induced translocation of cytoplasmic granular proteins to the plasma membrane. These results are consistent with those in Fig. 3c, showing that intracellular perforin and granzyme B were translocated to the plasma membrane in response to tumor contact. Furthermore, we found that the B16F10 cell-induced granzyme B release from NK cells, as well as the cytolytic activity of NK cells against B16F10 cells, were inhibited by 8-Br-ADPR but not by any other inhibitors we tested (Fig. 3e and f). Taken together, these results suggest that ADPR is a key player in mediating the degranulation and cytolytic activity of NK cells.

Cornerstone Therapeutics Inc . (NasdaqCM: CRTX ) Cornerstone Therapeutics is a specialty pharmaceutical company focused on acquiring, developing and commercializing prescription products for the respiratory market. The Company currently promotes multiple marketed products in the United States to respiratory-focused physicians and key retail pharmacies with its specialty sales force. The Company also has a late-stage clinical pipeline with six regulatory approval submissions targeted within the next three years. The Company’s commercial strategy is to grow market share for its currently marketed products using its sales and marketing capabilities, acquire non-promoted or underperforming branded pharmaceutical products and implement life cycle management techniques to maximize the value of its currently marketed products, newly acquired products and product candidates that are in development.

        In March 2019, we announced pre-clinical data for the extended release, or XR, formulation of zilucoplan, in which a single subcutaneous dose achieved greater than one week of target drug concentrations in non-human primates, supporting once weekly or less frequent dosing. We anticipate the XR program entering human clinical studies in the first half of 2020.

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These issues would not have come up in a customer review of changes to the manufacturing process, either. So if the resulting problems reflect a failure of change management, it occurred at a fundamental level.

        (d)   Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

Payers of dividends on our ordinary shares, including the Israeli stockbroker effectuating the transaction, or the financial institution through which the securities are held, are generally required, subject to any of the foregoing exemptions, reduced tax rates and the demonstration of a shareholder regarding his, her or its foreign residency, to withhold tax upon the distribution of dividend at the rate of 25% (whether the recipient is a Substantial Shareholder or not), so long as the shares are registered with a nominee company.


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