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Category Archives: Genetics
Seattle Genetics to test possible new Adcetris use
Posted: December 16, 2012 at 10:41 pm
Seattle Genetics Inc. plans to proceed with a late-stage study of a possible additional use for its lymphatic cancer treatment Adcetris after releasing results from a small, early-stage test.
The Bothell, Wash., company said Sunday 23 of 26 patients with an aggressive form of non-Hodgkin lymphoma who received Adcetris combined with chemotherapy achieved complete remission, which means they had no trace of the cancer after the treatment was completed.
CEO Clay B. Siegall said in a statement the data offers a "strong rationale" for late-stage testing that will compare Adcetris combined with chemotherapy to the standard chemotherapy treatment for the disease. The company plans to start the trial by early next year.
Seattle Genetics announced the results at the American Society of Hematology's annual meeting in Atlanta.
Adcetris is Seattle Genetics' only marketed product. It is already approved to treat two types of lymphoma. The company also is seeking approval to market the drug as a treatment for mycosis fungoides, a type of non-Hodgkin lymphoma that starts in the skin.
Last month, the Food and Drug Administration gave the treatment orphan drug status for that indication. That means that if Adcetris is approved as a treatment for that disease, the FDA won't approve similar products for seven years.
Orphan drug status is given to treatments for disease that affect fewer than 200,000 Americans.
Shares of Seattle Genetics fell 14 cents to $25.40 in Monday morning trading, while the Nasdaq exchange rose less than 1 percent. The company's shares are still up about 52 percent since closing 2011 at $16.72.
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Seattle Genetics Reports Data from Phase I Trial of ADCETRIS® (Brentuximab Vedotin) in Front-line Hodgkin Lymphoma at …
Posted: December 16, 2012 at 10:41 pm
ATLANTA--(BUSINESS WIRE)--
Seattle Genetics, Inc. (SGEN) today announced results from a phase I clinical trial of ADCETRIS (brentuximab vedotin) in combination with chemotherapy for the treatment of newly diagnosed advanced stage Hodgkin lymphoma (HL) patients. The data were presented at the 54th American Society of Hematology (ASH) Annual Meeting and Exposition being held December 8-11, 2012 in Atlanta, GA. ADCETRIS is an antibody-drug conjugate (ADC) directed to CD30, a defining marker of classical HL. ADCETRIS is currently not approved for use in the front-line treatment of HL.
In the phase I trial, newly diagnosed patients received ADCETRIS concomitantly with either ABVD (Adriamycin, bleomycin, vinblastine and dacarbazine) or AVD, which removes bleomycin from the regimen. At the end of front-line therapy, 24 of 25 patients (96 percent) treated with ADCETRIS plus AVD and 21 of 22 (95 percent) patients treated with ADCETRIS plus ABVD had a complete remission. None of the patients treated in the ADCETRIS plus AVD cohort experienced pulmonary toxicity, compared with an expected rate of pulmonary toxicity caused by ABVD alone of 10-25 percent. The trial was designed to establish the safety profile and maximum tolerated dose when adding ADCETRIS to ABVD or AVD. Antitumor activity was assessed as a secondary endpoint.
"For over 30 years, the standard of care for front-line HL has been a chemotherapy regimen called ABVD that has demonstrated a complete remission rate of 70 to 80 percent and is associated with considerable life-threatening toxicities. There is a significant need to identify better treatment options for patients in the front-line HL setting, said Clay B. Siegall, Ph.D., President and Chief Executive Officer of Seattle Genetics. "Our goal is to redefine front-line treatment of HL with the addition of ADCETRIS, and the encouraging results of this phase I trial clearly support this goal and provide rationale for the ongoing ADCETRIS phase III trial in this setting."
Front-line Therapy with Brentuximab Vedotin Combined with ABVD or AVD in Patients with Newly Diagnosed Advanced Stage Hodgkin Lymphoma (Abstract #798)
In this open-label, multicenter trial, cohorts of patients received an escalating dose of ADCETRIS (0.6 milligrams per kilogram (mg/kg), 0.9 mg/kg, 1.2 mg/kg) every two weeks concomitantly with ABVD or a dose of 1.2 mg/kg every two weeks concomitantly with AVD.
Fifty-one patients were enrolled in the phase I study and 47 were evaluable for response at trial completion. The 47 evaluable patients included 25 in the ADCETRIS plus AVD cohort and 22 in the ADCETRIS plus ABVD cohorts. All patients were previously untreated and 45 percent had Stage IV HL. The median age of patients across all cohorts of the trial was 33 years. Key findings, which were highlighted in an oral presentation by Dr. Stephen Ansell, Professor of Medicine, Division of Hematology, from the Mayo Clinic, included:
For decades researchers have strived to improve our front-line HL treatment strategy by enhancing the activity of traditional chemotherapy regimens while reducing the significant toxicities and long-term side effects of such regimens, said Stephen Ansell,M.D., Ph.D., Professor of Medicine, Division of Hematology, Mayo Clinic. There is a significant need to identify better treatment options for patients in the front-line setting. With a complete response rate of 96 percent and a manageable safety profile, data from this trial support further evaluation of ADCETRIS administered concomitantly with AVD in previously untreated HL patients to potentially improve the current standard of care.
Seattle Genetics and Millennium: The Takeda Oncology Company have initiated a phase III clinical trial in advanced stage front-line HL patients. The randomized trial is comparing progression-free survival in patients receiving ADCETRIS in combination with AVD to patients receiving ABVD alone. For more information about the trial visit http://www.seattlegenetics.com or http://www.clinicaltrials.gov.
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Seattle Genetics Announces Data from Investigator-Sponsored Trials of ADCETRIS® (Brentuximab Vedotin) in Cutaneous T …
Posted: December 16, 2012 at 10:41 pm
ATLANTA--(BUSINESS WIRE)--
Seattle Genetics, Inc. (SGEN) today announced that results from two ongoing investigator-sponsored phase II clinical trials of ADCETRIS (brentuximab vedotin) in patients with relapsed cutaneous T-cell lymphoma (CTCL) were presented at the 54th American Society of Hematology (ASH) Annual Meeting and Exposition being held December 8-11, 2012 in Atlanta, GA. ADCETRIS is an antibody-drug conjugate (ADC) directed to CD30. ADCETRIS has not been approved for use in the treatment of CTCL.
Brentuximab Vedotin Demonstrates Significant Clinical Activity in Relapsed or Refractory Mycosis Fungoides with Variable CD30 Expression (Abstract #797)
The ongoing phase II clinical trial is enrolling CTCL patients with mycosis fungoides (MF) or Sezary syndrome. Twenty patients have been enrolled to date with a median of six prior systemic therapies. The primary endpoint of the trial is clinical response rate. Secondary endpoints include correlation of clinical response with CD30 expression levels, duration of response and safety. The study was led by principle investigator Dr. Youn H. Kim from Stanford University School of Medicine in Stanford, CA, and was presented in an oral session. Key findings include:
Results of a Phase II Trial of Brentuximab Vedotin (SGN-35) for CD30+ Cutaneous T-Cell Lymphomas and Lymphoproliferative Disorders (Abstract #3688)
Data were presented from a phase II investigator-sponsored trial evaluating the use of ADCETRIS in CD30-positive CTCL patients, including lymphomatoid papulosis (LyP), primary cutaneous anaplastic large cell lymphoma (pcALCL) or MF. The ongoing study is being conducted by Dr. Madeleine Duvic from The University of Texas MD Anderson Cancer Center in Houston, TX. Among 54 patients enrolled to date, 46 patients were evaluable at the time of analysis. The primary endpoint of the trial is to evaluate the safety and efficacy of ADCETRIS in CD30-positive CTCL. The key findings include:
Seattle Genetics and Millennium: The Takeda Oncology Company have initiated the ALCANZA trial, a randomized phase III clinical trial of ADCETRIS for relapsed CD30-positive CTCL patients. The trial is assessing ADCETRIS versus investigators choice of methotrexate or bexarotene in patients with CD30-positive CTCL, including those with pcALCL or MF. The primary endpoint of the study is overall response rate lasting at least four months. Approximately 124 patients will be enrolled in the pivotal trial. The ALCANZA trial is being conducted under a Special Protocol Assessment agreement from the U.S. Food and Drug Administration (FDA). The study also received European Medicines Agency scientific advice.
About CTCL
Lymphoma is a general term for a group of cancers that originate in the lymphatic system. There are two major categories of lymphoma: Hodgkin lymphoma and non-Hodgkin lymphoma. Cutaneous lymphomas are a category of non-Hodgkin lymphomas that primarily involve the skin. According to the Cutaneous Lymphoma Foundation, CTCL is the most common type of cutaneous lymphoma and typically presents with red, scaly patches or thickened plaques of skin that often mimic eczema or chronic dermatitis. Progression from limited skin involvement is variable and may be accompanied by tumor formation, ulceration and exfoliation, complicated by itching and infections. Advanced stages are defined by involvement of lymph nodes, peripheral blood and internal organs. According to published literature, up to 50 percent of CTCL patients lesions express CD30.
About ADCETRIS
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Seattle Genetics Announces Data from Investigator-Sponsored Trials of ADCETRIS® (Brentuximab Vedotin) in Cutaneous T ...
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Clinical Data from NewLink Genetics' HyperAcute Prostate Cancer Immunotherapy Published in Journal of Immunotherapy
Posted: December 16, 2012 at 10:41 pm
AMES, Iowa, Dec. 13, 2012 /PRNewswire/ --NewLink Genetics Corporation (NLNK) today announced that the results of a Phase 1 dose escalation study with its proprietary HyperAcute Prostate Cancer Immunotherapy were published in the Journal of Immunotherapy. The article, entitled "Cellular Immunotherapy Study of Prostate Cancer Patients and Resulting IgG Responses to Peptide Epitopes Predicted From Prostate Tumor-associated Autoantigens," is featured in the current edition of the Journal.
The study was conducted at the University of Nebraska Medical Center and included eight patients. Patients were scheduled to receive a priming dose on day one, followed by eleven boost doses every two weeks and patients received up to 12 intradermal vaccinations at doses ranging from 30 million to 500 million cells per injection. Patients were tested for safety, immunological and clinical responses arising after immunotherapy.
The study demonstrated that the immunotherapy was safe, and that the first immunization differentially increased the anti-alphaGal IgG response in all patients compared with baseline levels. These data indicated that administration of HyperAcute-Prostate immunotherapy increases the immune response against alphaGal epitopes, demonstrating the immunogenicity of the vaccine in prostate cancer patients.
The patients that received the highest dose of immunotherapy developed antibody responses against prostate tumor-associated antigens that were not seen in a control group of untreated volunteers. Data demonstrated that 37.5 percent (3/8) of patients responded with Prostate Specific Antigen (PSA) level stabilization for more than 100 days.
The adverse events data reported in this publication confirm the safety of this immunotherapy, consistent with previous studies on the safety of alpha-Gal-expressing allogeneic vaccines (HyperAcute immunotherapy) in the treatment of lung, melanoma and pancreatic cancers. Median overall survival for the study was 25.1 months with one patient with bone metastases surviving for more than 70 months.
"The favorable safety profile of this agent combined with evidence of vaccine induced immunologic responses in patients clearly suggests this therapy should be studied in a large controlled trial," said Dr. George P. Hemstreet, III, University of Nebraska Medical Center, the Principal Investigator for the study.
NewLink Genetics is currently evaluating its lead immunotherapy product candidate algenpantucel-L (HyperAcute-Pancreas) in a Phase 3 clinical trial in surgically-resected pancreatic cancer patients.
About HyperAcute Prostate Cancer Immunotherapy
NewLink's HyperAcute Prostate Cancer immunotherapy product candidate consists of two allogeneic prostate cancer tumor cell lines modified to express alpha-Gal. These cell lines were chosen to provide a broad coverage of prostate cancer antigens. Each of the modified cell lines is grown in large cultures, harvested, packaged and irradiated. Each of the two vaccine components was administered separately.
About Prostate Cancer
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Seattle Genetics Highlights Next Generation Antibody-Drug Conjugate SGN-CD33A at ASH Annual Meeting
Posted: December 16, 2012 at 10:41 pm
ATLANTA--(BUSINESS WIRE)--
Seattle Genetics, Inc. (SGEN) today presented preclinical data from SGN-CD33A, an antibody-drug conjugate (ADC) in development for the treatment of acute myeloid leukemia (AML), at the 54th American Society of Hematology (ASH) Annual Meeting and Exposition being held December 8-11, 2012 in Atlanta, GA. SGN-CD33A is a novel CD33-directed ADC utilizing Seattle Genetics next generation technology. The CD33 antibody is attached to a highly potent cytotoxic agent called a pyrrolobenzodiazepine (PBD) dimer via a proprietary site-specific conjugate technology to a monoclonal antibody with engineered cysteines (EC-mAb). Seattle Genetics expects to advance SGN-CD33A into a phase I clinical trial in 2013.
Our SGN-CD33A program showcases our next generation ADC technology, including our latest highly potent cell-killing agent and our new engineered antibody technology, said Jonathan Drachman, M.D., Senior Vice President, Research and Translational Medicine at Seattle Genetics. Of approximately 30 ADCs in development, more than 50 percent utilize Seattle Genetics technology. Through our continued innovation we are leading the development of novel ADCs, and believe that ADCs can transform the way cancer is treated.
ADCs are monoclonal antibodies that are designed to selectively deliver cytotoxic agents to tumor cells. This approach is intended to spare non-targeted cells and thus reduce many of the toxic effects of traditional chemotherapy while enhancing antitumor activity.
PBDs are a class of DNA-crosslinking agents that are significantly more potent than systemic chemotherapeutic drugs. Seattle Genetics has been working with PBDs since 2008 under an exclusive licensing arrangement with Spirogen Ltd. Over the past four years, Seattle Genetics has selected and optimized specific PBD molecules combined with novel linkers for use in ADCs, and has conducted process development and scale-up activities to create robust synthetic GMP manufacturing processes for these PBD drug-linkers.
SGN-CD33A: A Novel CD33-Directed Antibody-Drug Conjugate, Utilizing Pyrrolobenzodiazepine Dimers, Demonstrates Preclinical Antitumor Activity Against Multi-Drug Resistant Human AML (Abstract #3589)
Key findings from the preclinical evaluation of SGN-CD33A included:
About Seattle Genetics
Seattle Genetics is a biotechnology company focused on the development and commercialization of monoclonal antibody-based therapies for the treatment of cancer. The U.S. Food and Drug Administration granted accelerated approval of ADCETRIS in August 2011 for two indications. ADCETRIS is being developed in collaboration with Millennium: The Takeda Oncology Company. In addition, Seattle Genetics has three other clinical-stage ADC programs: SGN-75, ASG-5ME and ASG-22ME. Seattle Genetics has collaborations for its ADC technology with a number of leading biotechnology and pharmaceutical companies, including Abbott, Agensys (an affiliate of Astellas), Bayer, Celldex Therapeutics, Daiichi Sankyo, Genentech, GlaxoSmithKline, Millennium, Pfizer and Progenics, as well as ADC co-development agreements with Agensys and Genmab. More information can be found at http://www.seattlegenetics.com.
Certain of the statements made in this press release are forward looking, such as those, among others, relating to the initiation of future clinical trials with SGN-CD33A. Actual results or developments may differ materially from those projected or implied in these forward-looking statements. Factors that may cause such a difference include the inability to generate the appropriate data and information to support an investigational new drug submission to the FDA. More information about the risks and uncertainties faced by Seattle Genetics is contained in the companys 10-Q for the quarter ended September 30, 2012 filed with the Securities and Exchange Commission. Seattle Genetics disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
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Seattle Genetics Highlights Next Generation Antibody-Drug Conjugate SGN-CD33A at ASH Annual Meeting
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Seattle Genetics Highlights Data Presentations from Genentech ADC Collaborator Programs at ASH Annual Meeting
Posted: December 16, 2012 at 10:41 pm
ATLANTA--(BUSINESS WIRE)--
Seattle Genetics, Inc. (SGEN) today highlighted clinical data from two antibody-drug conjugate (ADC) programs in development by Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY) that utilize Seattle Genetics technology. The data were presented at the 54th American Society of Hematology (ASH) Annual Meeting and Exposition being held December 8-11, 2012 in Atlanta, GA. Phase I data from both ADCs, an anti-CD22 ADC (DCDT2980S, RG7593) and an anti-CD79b ADC (DCDS4501A, RG7596), demonstrated antitumor activity in relapsed or refractory B-cell non-Hodgkin lymphoma (NHL) patients at generally well-tolerated doses. These ADC programs are currently being evaluated in a phase II clinical trial for patients with relapsed or refractory B-cell NHL.
Genentechs phase I data and their advancement of these two ADCs into phase II clinical development, as well as their utilization of our technology in six other clinical-stage programs,illustrates their commitment to ADCs as an innovative, targeted approach to treat cancer,saidEric Dobmeier, ChiefOperatingOfficer of Seattle Genetics. Across our ADC collaborations, there is broad potential for our industry-leading technologyto address thesignificant needformore effective and better tolerated treatment options.
Anti-CD22-MMAE and anti-CD79b-MMAE are ADCs designed to deliver potent cytotoxic treatment to targeted cells with improved tolerability. With over a decade of experience and knowledge in ADC innovation, Seattle Genetics has developed proprietary technology employing synthetic cytotoxic agents, such as monomethyl auristatin E (MMAE), and stable linker systems that attach these cytotoxic agents to the antibody. Seattle Genetics linker systems are designed to be stable in the bloodstream and release the potent cell-killing agent once inside targeted cancer cells. This approach is intended to spare non-targeted cells and thus reduce many of the toxic effects of traditional chemotherapy while enhancing antitumor activity. ADCETRIS (brentuximab vedotin) is the first drug approved utilizing Seattle Genetics ADC technology.
A Phase I Study of the Anti-CD79b Antibody-Drug Conjugate (ADC) DCDS4501A Targeting CD79b in Relapsed or Refractory B-Cell Non-Hodgkins Lymphoma (Abstract #56)
A phase I clinical trial is being conducted to evaluate the safety and activity of DCDS4501A in patients with relapsed or refractory B-cell NHL. DCDS4501A is an ADC consisting of an anti-CD79b monoclonal antibody conjugated to the cytotoxic agent MMAE using Seattle Genetics ADC technology. In this analysis, 47 patients were evaluable for safety and 32 were evaluable for efficacy.
Key findings included:
A Phase I Study of DCDT2980S, an Antibody-Drug Conjugate (ADC) Targeting CD22, in Relapsed or Refractory B-Cell Non-Hodgkins Lymphoma (Abstract #59)
A phase I clinical trial is being conducted to evaluate the safety and activity of DCDT2980S in patients with relapsed or refractory B-cell NHL. DCDT2980S is an ADC candidate consisting of an anti-CD22 monoclonal antibody conjugated to the cytotoxic agent MMAE using Seattle Genetics ADC technology. In this analysis, 43 patients were evaluable for safety and 33 were evaluable for efficacy.
Key findings included:
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Seattle Genetics Highlights ADCETRIS® (Brentuximab Vedotin) Data in Relapsed Hodgkin Lymphoma and Other CD30-Positive …
Posted: December 13, 2012 at 12:45 am
ATLANTA--(BUSINESS WIRE)--
Seattle Genetics, Inc. (SGEN) today summarized ADCETRIS (brentuximab vedotin) data in relapsed Hodgkin lymphoma (HL) and other CD30-positive malignancies from multiple presentations at the 54th American Society of Hematology (ASH) Annual Meeting and Exposition being held December 8-11, 2012 in Atlanta, GA. Highlights include compelling survival data from long-term follow up in a pivotal clinical trial of ADCETRIS in relapsed or refractory HL and a retrospective comparison of overall survival among patients treated with ADCETRIS to those not treated with ADCETRIS following an autologous stem cell transplant (ASCT). In addition, data describe the activity and tolerability of ADCETRIS in the salvage HL setting from an investigator-sponsored trial and in relapsed patients age 60 or over with CD30-positive malignancies, including HL. ADCETRIS is an antibody-drug conjugate (ADC) directed to CD30, a defining marker of classical HL.
"There are more than a dozen data presentations at ASH evaluating the use of ADCETRIS in CD30-positive malignancies and we are very encouraged by both the broad application across multiple hematologic disease areas as well as the encouraging activity associated with ADCETRIS, said Clay B. Siegall, Ph.D., President and Chief Executive Officer of Seattle Genetics. The extensive investigator and corporate data presentations at ASH clearly demonstrate the important role ADCETRIS plays in the treatment of relapsed HL and systemic anaplastic large cell lymphoma and the promise of the role it potentially will play in additional future indications.
Long-term Survival Analysis of an Ongoing Phase 2 Study of Brentuximab Vedotin in Patients with Relapsed or Refractory Hodgkin Lymphoma (Abstract #3689)
A pivotal, single-arm trial was conducted in 102 relapsed or refractory HL patients after ASCT to assess efficacy and safety of single-agent ADCETRIS. In addition, the trial was designed to determine duration of response, progression-free survival and overall survival. Enrolled patients had received a median of more than three prior chemotherapy regimens.
Data highlights from the long-term survival analysis in the pivotal trial were:
Overall Survival Benefit for Patients with Relapsed Hodgkin Lymphoma Treated with Brentuximab Vedotin After Autologous Stem Cell Transplant (Abstract #3701)
An independent retrospective comparison conducted by MD Anderson Cancer Center evaluated overall survival in 102 relapsed HL patients treated with ADCETRIS in a pivotal clinical trial compared to data from 756 relapsed HL patients treated at six international centers (Horning et al., 2008). The authors compared median overall survival, starting at the time of receiving an ASCT, among ADCETRIS treated patients to patients not treated with ADCETRIS. Key findings, which were highlighted in a presentation by Dr. Meghan Karuturi from MD Anderson Cancer Center, included:
Brentuximab Vedotin as a First Line Salvage Therapy in Relapsed/Refractory HL (Abstract #3699)
An investigator-sponsored trial was conducted to evaluate ADCETRIS as a salvage therapy for HL. Fourteen patients were evaluated for response and safety and all had relapsed or refractory HL after initial therapy with the chemotherapy regimens ABVD (Adriamycin, bleomycin, vinblastine, dacarbazine) or BEACOPP (bleomycin, etoposide, Adriamycin, cyclophosphamide, Oncovin, procarbazine hydrochloride, prednisone) or a combination of chemotherapy with or without consolidative radiation treatment. Patients were treated with ADCETRIS every three weeks for a maximum of four cycles. Data were presented by Dr. Robert Chen from City of Hope National Medical Center in Duarte, CA.
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Seattle Genetics Announces ADCETRIS® Receives European Commission Conditional Marketing Authorization
Posted: November 6, 2012 at 8:41 pm
BOTHELL, Wash.--(BUSINESS WIRE)--
Seattle Genetics, Inc. (SGEN) today announced that its collaborator, Millennium: The Takeda Oncology Company, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, announced that the European Commission has granted conditional marketing authorization for ADCETRIS (brentuximab vedotin). ADCETRIS was approved for two indications: (1) the treatment of adult patients with relapsed or refractory CD30-positive Hodgkin lymphoma (HL) following autologous stem cell transplant (ASCT) or following at least two prior therapies when ASCT or multi-agent chemotherapy is not a treatment option, and (2) for the treatment of adult patients with relapsed or refractory systemic anaplastic large cell lymphoma (sALCL). As a result, under the collaboration Seattle Genetics will receive two milestone payments from Millennium, one for each indication, totaling $25 million. ADCETRIS is an antibody-drug conjugate (ADC) directed to CD30.
The approval of ADCETRIS by the European Commission marks a significant milestone for the product and for the many relapsed or refractory HL and systemic ALCL patients in need of effective new treatment options in Europe, said Clay B. Siegall, Ph.D., President and Chief Executive Officer of Seattle Genetics. In addition to the U.S. and EU approvals of ADCETRIS, we are making regulatory progress for approval in Canada while Millennium and Takeda are pursuing regulatory approvals in other countries. Complementing these regulatory activities is a robust ADCETRIS clinical development program to support our goal of establishing it as the foundation of therapy for CD30-positive malignancies.
The conditional marketing authorization for ADCETRIS is valid in the 27 member states of the European Union (EU) as well as Norway, Liechtenstein and Iceland. Similar to accelerated approval regulations inthe United States, conditional marketing authorizations are granted in the EU to medicinal products that fulfill an unmet medical need with a positive benefit/risk assessmentand whose immediate availability would result in a significant public health benefit. Conditional marketing authorization by the European Commission includes obligations to provide additional clinical data at a later stage to confirm the positive benefit-risk assessment. The ADCETRIS Marketing Authorization Application was filed by Takeda Global Research & Development Centre (Europe) to the European Medicines Agency.
About ADCETRIS
ADCETRIS (brentuximab vedotin) is an ADC comprising an anti-CD30 monoclonal antibody attached by a protease-cleavable linker to a microtubule disrupting agent, monomethyl auristatin E (MMAE), utilizing Seattle Genetics proprietary technology. The ADC employs a linker system that is designed to be stable in the bloodstream but to release MMAE upon internalization into CD30-expressing tumor cells.
ADCETRIS received accelerated approval from the U.S. Food and Drug Administration (FDA) in August 2011 for relapsed HL and sALCL.
Seattle Genetics and Millennium are jointly developing ADCETRIS. Under the terms of the collaboration agreement, Seattle Genetics has U.S. and Canadian commercialization rights and the Takeda Group has rights to commercialize ADCETRIS in the rest of the world. Seattle Genetics and the Takeda Group are funding joint development costs for ADCETRIS on a 50:50 basis, except in Japan where the Takeda Group will be solely responsible for development costs. Seattle Genetics is entitled to royalties based on a percentage of Millennium's net sales in its territory at rates that range from the mid-teens to the mid-twenties based on sales volume, subject to offsets for royalties paid by Millennium to third parties.
About Seattle Genetics
Seattle Genetics is a biotechnology company focused on the development and commercialization of monoclonal antibody-based therapies for the treatment of cancer. The FDA granted accelerated approval of ADCETRIS in August 2011 for two indications. ADCETRIS is being developed in collaboration with Millennium: The Takeda Oncology Company. In addition, Seattle Genetics has three other clinical-stage ADC programs: SGN-75, ASG-5ME and ASG-22ME. Seattle Genetics has collaborations for its ADC technology with a number of leading biotechnology and pharmaceutical companies, including Abbott, Bayer, Celldex Therapeutics, Daiichi Sankyo, Genentech, GlaxoSmithKline, Millennium, Pfizer and Progenics, as well as ADC co-development agreements with Agensys, an affiliate of Astellas, and Genmab. More information can be found at http://www.seattlegenetics.com.
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STEM CELL THERAPY cure HIV patient – Video
Posted: November 1, 2012 at 7:42 pm
STEM CELL THERAPY cure HIV patient
STEM CELL THERAPY NOW made AFFORDABLE trough LAMININE......." The Miracle of Life in a Capsule" What is Laminine? Laminine is a complete Synergy of : 22 Amino Acids Trace Minerals Vitamins Fibroblast Growth Factor (FGF) Laminine contains a patented bio-rich extract from fertilized eggs that acts as a powerful "adaptogen". To this base ingredient additional amino acids from plant and marine sources are added to create a complete amino acid profile. The proprietary formula contains 22 amino acids, trace minerals and vitamins. It is also the only known food source of Fibroblast Growth Factor-2 (abundant before birth) which is thought to mobilize and instruct the body #39;s stem cells to do their repair work. It is believed that these instructions allow the body to determine when a structure needs to be repaired or if needed destroyed. What is Fibroblast Growth Factor-2 (and Why is it Important?) Fibroblast Growth Factor-2 is a substance that is abundant in the developing embryo. It is believed to act like an architect directing the growth and development of the new life. Under the direction of FGF-2, the blue print of life is followed precisely making sure that all of the parts are perfectly made and placed. It also nourishes the stem cells that carry on this vital work. Without FGF-2, the body #39;s structure can be compromised. And, unfortunately, this substance is missing from the adult human body. In medicine, synthesized Fibroblast Growth Factor-2 is used routinely. However ...From:doxciesViews:38 1ratingsTime:03:06More inScience Technology
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STEM CELL THERAPY cure HIV patient - Video
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Is stem cell therapy really effective? – Video
Posted: November 1, 2012 at 7:42 pm
Is stem cell therapy really effective?
The health department issues a warning to the public against stem cell therapy as it has not been fully-researched yet. But a doctor who offers the service stands by its effectivity. More from Niña Corpuz. Prime Time, ANC, October 24, 2012From:TheABSCBNNewsViews:798 0ratingsTime:01:42More inNews Politics
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Is stem cell therapy really effective? - Video
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