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Jeff Sessions, who has criticized his predecessors for not enforcing the federal ban. The president’s preference may not make its way into Department of Justice policy. “I don’t get the sense Donald Trump is going to be a micromanager with the Justice Department,” Savino said. If New Jersey legalizes recreational use, like newly-legalized Massachusetts, New Yorkers must be careful — it’s still not legal in their state. “You are now in violation of federal law because you crossed state lines,” Savino said of New Yorkers who buy in other states. “Smoke it while you’re there … don’t bring it home because you will get arrested if you get caught and it’s not worth it.” While New Jersey prepares to enact progressive policies on the drug, Savino doesn’t see New York legalizing a smoking version of the medicinal drug, let alone recreational use. And she’s not pushing for recreational use. Part of her goal in crafting her legislation and adjusting the program is to focus on “changing the way people think about marijuana,” she said.

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If the clinical correlation between drug product VCN and hemoglobin production observed in the Northstar study continues with drug product manufactured utilizing process 2, we are hopeful that LentiGlobin drug product with higher VCNs will consistently yield clinically meaningful outcomes for patients with TDT across all genotypes. Severe Sickle Cell Disease Program Updates bluebird bio has amended the protocol of the ongoing HGB-206 study in patients with severe SCD to incorporate several changes with the goal of increasing production of HbAT87Q, such as increasing the percentage of transduced cells through manufacturing improvements, increasing target busulfan area under the curve (AUC), introducing a minimum period of regular blood transfusions prior to stem cell collection and exploring an alternate hematopoietic stem cell procurement method with the goal of increasing transduced cell dose. Enrollment has begun under this modified protocol, and the DP VCN for the first patient enrolled under the new protocol was pop over to this website 3.3 c/dg, with 83% of the stem cells LVV+, with infusion planned for early 2017. Interim data from the HGB-206 study were highlighted today in an oral presentation by Julie Kanter, M.D., Medical University of South Carolina, Charleston, SC. Interim Results from a Phase 1/2 Clinical Study of LentiGlobin Gene Therapy for Severe Sickle Cell Disease (Abstract #1176) HGB-206 is an ongoing, open-label study designed to evaluate the safety and efficacy of LentiGlobin drug product in the treatment of subjects with severe SCD. Results, as of November 9, 2016, include: Read More Seven patients with severe SCD have been infused with LentiGlobin drug product under the original study protocol. All patients are 18+ years of age with a history of symptomatic SCD, adequate organ function/performance status and no previous hematopoietic stem cell transplant or gene therapy. The median LentiGlobin drug product see page cell dose was 2.1 x106 CD34+ cells/kg (range: 1.6 5.1 x 106 cells/kg) The median LentiGlobin DP VCN was 0.6 c/dg (range: 0.3 1.3 c/dg) The median VCN in peripheral blood at last measurement was 0.09 c/dg (range: 0.05 to 0.24 c/dg) Patient 1309 has seen a steady increase in hemoglobin levels and is producing 2.0 g/dL HbAT87Q with 22.8% overall anti-sickling Hb (HbAT87Q + HbF) even after a substantial drop in VCN between DP and peripheral blood at latest follow up (0.9 to 0.24 at nine months follow up). As of the data cutoff, this was the only patient in HGB-206 who received chronic transfusions prior to receiving LentiGlobin drug product. At last follow up, all treated patients were producing measureable HbAT87Q, with a range of 0.1 2.0 g/dL HbAT87Q at last follow-up. Median follow up: 11.5 months (range: 8.1 17.1 months). The safety profile of LentiGlobin treatment in severe SCD remains consistent with bone marrow harvest and myeloablative conditioning Ten Grade 3 bone marrow harvest-related AEs were reported in three patients, including one SAE (pain/prolonged hospitalization) Six patients experienced at least one SAE post-DP infusion No AEs reported as related to LentiGlobin DP Ten Grade 3 bone marrow harvest-related AEs were reported in three patients, including one SAE (pain/prolonged hospitalization) Six patients experienced at least one SAE post-DP infusion No AEs reported as related to LentiGlobin DP Cerebral Adrenoleukodystrophy Program Updates bluebird bio also announced plans to expand enrollment by up to eight additional patients in the ongoing Starbeam Phase 2/3 clinical study of Lenti-D drug product in patients less than 18 years of age with cerebral adrenoleukodystrophy (CALD).

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