Category Archives: FDA Stem Cell Trials

San Diego, CA (PRWEB) June 13, 2013 Stemedica Cell Technologies, Inc., a leader in adult allogeneic stem cell manufacturing, research and clinical development, announced today they have entered into a Global Distribution Agreement with Life Technologies Corporation. Under the terms of this agreement, Life Technologies will exclusively offer Stemedicas ischemic tolerant allogeneic adult mesenchymal stem cells (itMSCs) and neural stem cells (itNSCs) for sale worldwide to research, academic institutions and corporations both in the United States and internationally. Stemedica stem cell lines will be sold under the brand name Gibco and will be available to purchase for research initiatives beginning Q2, 2013. The label will also carry the name of Stemedica as the manufacturer of the cell lines. Life Technologies is a global biotechnology company with customers in more than 180 countries, providing more than 50,000 end-to-end solutions for customers in the fields of scientific research, genetic analysis and applied sciences. The Companys systems, reagents and consumables represent some of the most cited brands in scientific research. Life Technologies employs approximately 10,000 people and upholds its ongoing commitment to innovation with more than 5,000 patents and exclusive licenses. The Company had sales of $3.8 billion in 2012. We are honored … Continue reading →

WILMINGTON, Del.--(BUSINESS WIRE)-- Incyte Corporation (INCY) announced today that the U.S. Food and Drug Administration (FDA) has updated prescribing information for Jakafi (ruxolitinib) to include new recommended dosing guidance for patients with low platelet counts and additional safety information. Approved in November 2011, Jakafi is the first and only FDA-approved product for the treatment of patients with intermediate or high-risk myelofibrosis. The prescribing information for Jakafi now includes a new recommended starting dose of 5 mg twice daily of Jakafi for patients with baseline platelet counts between 50100 x 109/L (50,000 to 100,000) and the flexibility for subsequent dose modifications based on safety and efficacy. The FDA decision to expand the dosing information followed a review of the supplemental New Drug Application (sNDA), which included data from an ongoing Phase II trial (Study 258) of patients with baseline platelet counts of 50,000 to 100,000. In this trial, the starting dose of 5 mg twice daily could be adjusted up or down based on protocol defined hematology criteria with a target dose of 10 mg twice daily to achieve clinical response. The safety and efficacy findings from the current interim analysis of Study 258 are generally consistent with the results observed … Continue reading →

SEATTLE, June 11, 2013 /PRNewswire/ -- Cell Therapeutics, Inc. (CTI) (NASDAQ and MTA: CTIC) today announced the upcoming presentation of data highlighting PIXUVRI (pixantrone), the first approved treatment in the European Union for aggressive B-cell non-Hodgkin lymphoma (NHL) for adult patients who have failed 2 to 3 prior lines of therapy, and results from a pooled analysis of data from completed Phase 1 and 2 studies of pacritinib, a novel, oral JAK2/FLT3 inhibitor, at the 18th Congress of the European Hematology Association (EHA) Annual Meeting, June 13-16, 2013 in Stockholm, Sweden. "At EHA, we plan to present further analyses of the final safety and efficacy data from our EXTEND pivotal trial of PIXUVRI that we believe expand our understanding of the potential clinical benefit for patients with aggressive B-cell NHL who had received 2 to 3 prior regimens," said Jack Singer, M.D., Executive Vice President, Global Medical Affairs and Translational Medicine at CTI. "In addition, at EHA, results from a pooled integrated safety analysis from four Phase 1 and 2 clinical trials will be presented that quantify clinical toxicities of pacritinib, our novel, oral JAK2/FLT3 inhibitor currently being investigated in a Phase 3 clinical program." Information regarding the EHA presentations … Continue reading →

BOTHELL, Wash.--(BUSINESS WIRE)-- Seattle Genetics, Inc. (SGEN) today announced the initiation of a phase 1/2 clinical trial evaluating ADCETRIS (brentuximab vedotin) in combination with bendamustine for patients with Hodgkin lymphoma (HL) after first relapse. The multi-phase study is divided into two cohorts to determine the recommended dosing level and tolerability of combination use and to assess the complete remission rate associated with ADCETRIS in combination with bendamustine. Seattle Genetics is the leader in the field of antibody-drug conjugates (ADCs) and ADCETRIS is an ADC directed to CD30, a defining marker of classical HL. ADCETRIS is not approved for salvage HL patients who are deemed eligible for autologous stem cell transplant (ASCT). One of the key goals of our broad ADCETRIS clinical development program is to evaluate its use in earlier lines of HL therapy. This trial will assess the ability of ADCETRIS in combination with bendamustine to induce durable complete remissions in second-line treatment of HL patients prior to transplant, said Clay B. Siegall, Ph.D., President and Chief Executive Officer at Seattle Genetics. In this treatment setting, single-agent bendamustine has been shown to induce a high rate of remissions with limited durability. Data from an investigator-sponsored trial with single-agent ADCETRIS … Continue reading →

NEW YORK, June 10, 2013 (GLOBE NEWSWIRE) -- Stemline Therapeutics, Inc. (STML) today announced that SL-401 has received Orphan Drug designation from the U.S. Food and Drug Administration (FDA) for the treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN), a rare and aggressive hematologic malignancy for which there is no effective treatment. SL-401 also has Orphan Drug status for the treatment of acute myeloid leukemia (AML). SL-401 is a novel targeted therapy directed to the interleukin-3 receptor (IL-3R) present on tumor bulk and cancer stem cells (CSCs) of multiple hematologic cancer indications. SL-401 has demonstrated single agent clinical activity in patients with advanced hematologic cancers, including BPDCN, AML, and myelodysplastic syndrome (MDS). "We are focused on the rapid development of SL-401 due to its potential for the treatment of IL-3R-expressing hematologic malignancies," commented Eric K. Rowinsky, M.D., Chief Medical Officer and Head of Research and Development at Stemline. "SL-401 is demonstrating robust clinical activity in heavily-pretreated patients with BPDCN who are refractory to available therapies, including high-dose chemotherapy and allogeneic stem cell transplantation. This Orphan Drug designation provides us with a number of benefits that further strengthen our SL-401 program. Stemline will progress SL-401 into pivotal trials in BPDCN and … Continue reading →

SAN DIEGO, CA--(Marketwired - Jun 7, 2013) - Regen BioPharma, wholly owned subsidiary of Bio-Matrix Scientific Group, Inc. (OTCQB: BMSN), announced today its submission of responses to the U.S. Food and Drug Administration's (FDA) comments regarding its IND # 15376 covering the use of HemaXellerate for treatment of immune suppressant resistant aplastic anemia.As part of the response to comments, Regen BioPharma provided new data demonstrating efficacy of the HemaXellerate product at accelerating stem cell recovery after chemotherapeutic injury. "We are pleased with the responses that we have provided to the FDA and look forward to initiating our clinical trials," stated David Koos, Chairman and CEO of Regen BioPharma. "Although it is possible that a second round of comments may be issued, we feel this process is extremely useful to creating a clinical trial that is optimized for safety and detection of efficacy." The HemaXellerate clinical trial aims to recruit 10 patients with aplastic anemia that have not shown material signs of improvement under the current the standard of care.If successful, the company will progress to larger efficacy-finding trials, as well as expansion to other diseases that would benefit from enhancement of bone marrow stem cells. The scientific rationale for HemaXellerate, … Continue reading →

Celgene (NASDAQ: CELG) announced good news today about its blockbuster drug Revlimid. Did the stock jump as a result? Nope. Shares actually fell by more than 4%. Here's what happened. Good news The U.S. Food and Drug Administration approved Revlimid as atreatment for patients with mantle cell lymphoma whose disease has relapsed or progressed after two prior therapies, one of which included Velcade, a drug marketed by Johnson & Johnsonand Takeda. Revlimid was previously approved in the U.S. as a second-line treatment for multiple myeloma and for treating myelodisplastic syndromes. Mantle cell lymphoma is a type of non-Hodgkin's lymphoma that is very rare, affecting only around 15,000 patients in the United States. Although a few treatments for the disease are available, Dr.Andre Goy with the Hackensack University Medical Center says that "there remains a tremendous unmet need" for patients who have not responded satisfactorily after previous treatments. FDA approval for Revlimid makes it the first oral therapy for mantle cell lymphoma. ... but old news? You might think that approval of a new indication would cause some excitement for investors. So why did Celgene's shares fall? One reason is that the market most likely already baked this approval into the … Continue reading →

SUMMIT, N.J.--(BUSINESS WIRE)-- Celgene Corporation (CELG) today announced the U.S. Food and Drug Administration (FDA) has approved the companys supplemental new drug application (sNDA) for REVLIMID (lenalidomide) for the treatment of patients with mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib. There remains a tremendous unmet need for patients with previously-treated mantle cell lymphoma, said Andre Goy, M.D., M.S., Chairman and Director and Chief of Lymphoma, John Theurer Cancer Center at Hackensack UMC and Chief Science Officer and Director of Research and Innovation at Regional Cancer Care Associates, LLC. The approval of lenalidomide delivers a new option, and the first oral therapy in this area of lymphoma. The approval was based on the results of MCL-001, a phase II, multi-center, single arm, open label study evaluating lenalidomide in 134 patients with MCL who had received prior treatment with rituximab, cyclophosphamide, an anthracycline (or mitoxantrone), and bortezomib alone or in combination. Patients were required to have documented refractory disease (defined as without any response of partial response or better during treatment with bortezomib or a bortezomib-containing regimen), or relapsed disease (defined as progression within one year after treatment with bortezomib … Continue reading →

(RTTNews.com) - In an effort to extend its cash runway for at least two years, AVEO Oncology ( AVEO ) on Tuesday announced a strategic restructuring that will reportedly include slashing 62% of its workforce. More details about the restructuring will be revealed during a conference call that will be hosted at 8:30 a.m. ET on Wednesday, June 5. Last month, an FDA panel voted 13 to 1 against approving AVEO's Tivozanib for advanced renal cell carcinoma. AVEO's partner Astellas has also decided not to proceed with a European filing for Tivozanib or financially support future clinical trials in renal cell carcinoma. AVEO closed Tuesday's trading at $2.49, down 2.35%. In after-hours, the stock gained 1.61% to $2.53. Bristol-Myers Squibb Co.'s ( BMY ) and AstraZeneca's ( AZN ) Biologics License Application for Metreleptin, an investigational agent for treatment of metabolic disorders associated with rare forms of lipodystrophy has been accepted and granted a Priority Review designation by the FDA. The BLA for Metreleptin was submitted on a rolling basis - with the submission initiated in December 2010 and completed in April 2012. InVivo Therapeutics Holdings Corp. ( NVIV ), which trades on the over the counter Bulletin Board, touched … Continue reading →

By RTT News, June 04, 2013, 12:58:00 AM EDT (RTTNews.com) - AbbVie Inc. ( ABBV ) on Monday announced that its investigational oncology compound ABT-199, developed in partnership with Genentech, has demonstrated potential in treating patients with relapsed/refractory chronic lymphocytic leukemia, or CLL, in a phase I study. The company's amended clinical trial protocols for studies of ABT-199 in patients with CLL were recently accepted by the FDA and enrollment for ABT-199 clinical trials in CLL, NHL and multiple myeloma has been re-instated. AbbVie and Genentech expect to move ABT-199 into later-stage clinical trials in the near future. ABBV closed Monday's trading 1.57% higher at $43.36. Biologix Hair Inc. ( BLGX ) rose over 9% on Monday after the company announced that its network has expanded from 196 clinics at the time of inception to 276 clinics through the end of April 2013. During the same period, the number of countries in which clinicians has been contracted has increased from 11 to 37. BioTime Inc. ( BTX ) has offered to sell up to an aggregate of 2,180,016 common shares and 545,004 warrants to purchase common shares, in "units" with each unit consisting of one common share and one-quarter of … Continue reading →