Category Archives: Genetics

LUGANO, Switzerland--(BUSINESS WIRE)--

Takeda Pharmaceutical Company Limited (TSE:4502) and Seattle Genetics, Inc. (SGEN) today announced data from a post-hoc analysis examining progression-free survival (PFS) following treatment with ADCETRIS (brentuximab vedotin) versus last prior therapy in patients diagnosed with relapsed or refractory Hodgkin lymphoma (HL) post-autologous stem cell transplant (ASCT) or relapsed or refractory systemic anaplastic large cell lymphoma (sALCL). The data were highlighted during a presentation at the 12th International Conference on Malignant Lymphoma (ICML) being held June 1922, 2013 in Lugano, Switzerland.

ADCETRIS is an antibody-drug conjugate (ADC) directed to CD30, a defining marker of classical HL and sALCL.

The post-hoc analysis compared investigator assessed PFS following ADCETRIS single-agent treatment to the last prior systemic therapy in patients taking part in two pivotal Phase 2 studies. The post-hoc analysis was conducted in patients with relapsed or refractory HL post-ASCT or relapsed or refractory sALCL in the intent-to-treat (ITT) population. It also included prior systemic treatment histories and post-ADCETRIS stem cell transplant experience for each patient in the ITT populations.

These encouraging data suggest that ADCETRIS may delay disease progression compared to prior therapies used in this heavily pretreated patient population, said John Radford, M.D., Professor of Medical Oncology, University of Manchester, Manchester, UK. ADCETRIS is a CD30-targeted treatment option for patients with relapsed or refractory HL or relapsed or refractory sALCL that has shown a high overall response rate, including durable complete responses in both of its approved indications.

Progression-free survival analyses of two pivotal phase 2 studies of brentuximab vedotin in patients with relapsed or refractory Hodgkin lymphoma or systemic anaplastic large-cell lymphoma (Poster #303)

The analysis, presented by Dr. Radford, included:

Relapsed or Refractory HL post-ASCT

Relapsed or Refractory sALCL

Details of the poster presentation are as follows:

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Takeda and Seattle Genetics Highlight Post-Hoc Analysis Examining Progression-free Survival with ADCETRIS® ...

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 demonstrated encouraging activity and tolerability in this setting. This trial is designed to determine if the combination can result in durable complete remissions, potentially increasing the number of patients eligible to receive a transplant.

This phase 1/2 single-arm, open-label clinical trial will evaluate the efficacy and tolerability of ADCETRIS in combination with bendamustine in HL patients after first relapse. Patients will be eligible to receive up to six cycles of ADCETRIS in combination with bendamustine followed by additional single-agent ADCETRIS for up to a total of 16 cycles. As a part of the trial design, after patients receive ADCETRIS plus bendamustine combination therapy, they have the option to pause therapy to receive an ASCT and then resume treatment with single-agent ADCETRIS as consolidation. Bendamustine is an alkylating agent used in the treatment of chronic lymphocytic leukemias and lymphomas. The primary endpoint of the phase 1 cohort is to determine the recommended dosing level of bendamustine in combination with ADCETRIS as well as the safety and tolerability of the combination. The primary endpoint of the phase 2 cohort is to assess the complete remission rate. Key secondary endpoints include best response, duration of response and progression-free survival. The study is expected to enroll up to 50 patients at multiple centers in the United States.

At the 54th American Society of Hematology (ASH) Annual Meeting and Exposition held December 8-11, 2012 in Atlanta, GA, encouraging data were presented from an abstract titled Brentuximab Vedotin as a First Line Salvage Therapy in Relapsed/Refractory HL (Abstract #3699). The 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 chemotherapy regimens or a combination of chemotherapy with or without consolidative radiation treatment.

Of the 14 evaluable patients, 12 patients (85.7 percent) had an objective response rate, including seven (50 percent) complete remissions and five (35.7 percent) partial remissions. The most common Grade 1 or 2 adverse events were peripheral sensory neuropathy (42.9 percent), acneiform rash (35.7 percent), AST elevation (28.6 percent) and fatigue (28.6 percent). Grade 3 adverse events were rash acneiform (7.1 percent) and urinary tract infection (7.1 percent), and there were no Grade 4 adverse events. The abstract can be found at http://www.hematology.org.

More information about the phase 1/2 trial of ADCETRIS in combination with bendamustine, including enrolling centers, is available by visiting http://www.clinicaltrials.gov.

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 was granted accelerated approval by the FDA in August 2011 and approval with conditions by Health Canada in February 2013 for two indications: (1) the treatment of patients with HL after failure of autologous stem cell transplant (ASCT) or after failure of at least two prior multi-agent chemotherapy regimens in patients who are not ASCT candidates, and (2) the treatment of patients with sALCL after failure of at least one prior multi-agent chemotherapy regimen. The indications for ADCETRIS are based on response rate. There are no data available demonstrating improvement in patient-reported outcomes or survival with ADCETRIS.

Original post:
Seattle Genetics Announces Initiation of Phase 1/2 Trial of ADCETRIS® (Brentuximab Vedotin) in Combination with ...

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 demonstrated encouraging activity and tolerability in this setting. This trial is designed to determine if the combination can result in durable complete remissions, potentially increasing the number of patients eligible to receive a transplant.

This phase 1/2 single-arm, open-label clinical trial will evaluate the efficacy and tolerability of ADCETRIS in combination with bendamustine in HL patients after first relapse. Patients will be eligible to receive up to six cycles of ADCETRIS in combination with bendamustine followed by additional single-agent ADCETRIS for up to a total of 16 cycles. As a part of the trial design, after patients receive ADCETRIS plus bendamustine combination therapy, they have the option to pause therapy to receive an ASCT and then resume treatment with single-agent ADCETRIS as consolidation. Bendamustine is an alkylating agent used in the treatment of chronic lymphocytic leukemias and lymphomas. The primary endpoint of the phase 1 cohort is to determine the recommended dosing level of bendamustine in combination with ADCETRIS as well as the safety and tolerability of the combination. The primary endpoint of the phase 2 cohort is to assess the complete remission rate. Key secondary endpoints include best response, duration of response and progression-free survival. The study is expected to enroll up to 50 patients at multiple centers in the United States.

At the 54th American Society of Hematology (ASH) Annual Meeting and Exposition held December 8-11, 2012 in Atlanta, GA, encouraging data were presented from an abstract titled Brentuximab Vedotin as a First Line Salvage Therapy in Relapsed/Refractory HL (Abstract #3699). The 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 chemotherapy regimens or a combination of chemotherapy with or without consolidative radiation treatment.

Of the 14 evaluable patients, 12 patients (85.7 percent) had an objective response rate, including seven (50 percent) complete remissions and five (35.7 percent) partial remissions. The most common Grade 1 or 2 adverse events were peripheral sensory neuropathy (42.9 percent), acneiform rash (35.7 percent), AST elevation (28.6 percent) and fatigue (28.6 percent). Grade 3 adverse events were rash acneiform (7.1 percent) and urinary tract infection (7.1 percent), and there were no Grade 4 adverse events. The abstract can be found at http://www.hematology.org.

More information about the phase 1/2 trial of ADCETRIS in combination with bendamustine, including enrolling centers, is available by visiting http://www.clinicaltrials.gov.

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 was granted accelerated approval by the FDA in August 2011 and approval with conditions by Health Canada in February 2013 for two indications: (1) the treatment of patients with HL after failure of autologous stem cell transplant (ASCT) or after failure of at least two prior multi-agent chemotherapy regimens in patients who are not ASCT candidates, and (2) the treatment of patients with sALCL after failure of at least one prior multi-agent chemotherapy regimen. The indications for ADCETRIS are based on response rate. There are no data available demonstrating improvement in patient-reported outcomes or survival with ADCETRIS.

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Seattle Genetics Announces Initiation of Phase 1/2 Trial of ADCETRIS® (Brentuximab Vedotin) in Combination with ...

WASHINGTON--(BUSINESS WIRE)--

Today, the Genetics Policy Institute (GPI) announced the opening of a new, GPI National Affairs Office in Washington, D.C.

Recent years have seen GPIs involvement with policy and regulatory issues impacting the translation of stem cells and other advanced technologies into medicine steadily increase, necessitating the establishment of a new, permanent office location in the nations capital.

This new location will also give GPI the opportunity to begin hosting an array of high-level workshops, seminars, and events aimed at removing roadblocks to innovative bio-medical solutions found within the fields of stem cell research and regenerative medicine.

Said GPIs Executive Director, Bernard Siegel of the need for advocacy driven workshops and related events, While many other countries are establishing funded, national programs or strategies to advance cell therapies and regenerative medicine, the US lags.

He added that time is of the essence as patients are facing the crushing burden of chronic disease and immense human suffering. To fulfill the curative promise in years, rather than decades, Washington must declare regenerative medicine a national priority and immediately establish coordination between federal agencies. We need a consensus strategy that includes all necessary funding.

Being at the intersection of research, medicine, law and patient advocacy, GPI boasts a track record of bringing stakeholders together with the aim of delivering on the promise of stem cells and regenerative medicine.

About the Genetics Policy Institute (GPI): GPI is a 501(c)(3) nonprofit corporation with the mission to promote stem cell research and its application in medicine to develop therapeutics and cures for many otherwise intractable diseases and disorders. GPI pursues this mission through production of its flagship annual World Stem Cell Summit, publication of the World Stem Cell Report, the online newsletter 360 Weekly, special projects, speaking engagements, educational initiatives, and strategic collaborations.

GPI maintains offices in Palm Beach, Florida; Palo Alto, California and Washington, D.C. For more information, visit http://www.genpol.org.

Please direct all media inquires to GPI Associate Director, Alan Fernandez at Genetics Policy Institute, 701 8th Street NW, Suite 400, Washington, DC, telephone 888-238-1427 or email alan@genpol.org.

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Genetics Policy Institute Opens Washington, D.C. Office

PALM BEACH, Fla. & CAMBRIDGE, United Kingdom--(BUSINESS WIRE)--

The Genetics Policy Institute (GPI) and univerCELLmarket announced a joint initiative to produce the most comprehensive and timely online news aggregation and distribution service, providing actionable intelligence for the stem cell and regenerative medicine communities.

Expanding the current 360 newsletter published online by univerCELLmarket, the newsletter will be now co-published and distributed with GPI. Bernard Siegel, GPIs founder and executive director, joins Dr. Beverley Vaughan as the co-editor of the publication. GPI and univerCELLmarket maintain free subscription links on their respective web sites.

Bernard Siegel said, It is the aim of GPI to provide the highest quality information to all interested in stem cells and regenerative medicine. We are delighted to partner with univerCELLmarket. Their comprehensive news aggregation service enables users to efficiently research its archived news and records. With this partnership, interested stakeholders who are part of both GPIs and univerCELLmarkets extensive databases, honed over the past decade, will have easy access to news they can use to advance our field.

Dr. Cathy Prescott, respected thought-leader in the business of stem cells and regenerative medicine, and co-founder of univerCELLmarket said, As a result of partnering with GPI, 360 is now the most widely circulated news service in the world dedicated to this field. With this partnership, our combined contacts, which span academia, industry, government, law, ethics, medicine and advocacy will receive the news highlights in their in-box every Monday, with links to all the weeks news on univerCELLmarket.com.

Jeanette Walker, co-founder of univerCELLmarket stated, 360 is popular because it is so comprehensive and in a format that makes it quick and easy to scan. We are delighted to welcome Bernard Siegel to our editorial team as he is a recognized architect of the global stem cell community. Bernie founded GPI, the annual World Stem Cell Summit, the peer-reviewed World Stem Cell Report and is an acknowledged leader of the patient advocacy community.

About Genetics Policy Institute (GPI): GPI is a 501c3 nonprofit foundation with the mission to promote and defend stem cell research and its application in medicine to develop therapeutics and cures for many otherwise intractable diseases and disorders. GPI pursues this mission through production of its flagship annual World Stem Cell Summit, publication of the World Stem Cell Report, special projects, speaking engagements, teaching initiatives and strategic collaborations.

ABOUT univerCELLmarket

Launched in 2010, univerCELLmarket.com is an online, global source of relevant, up-to-date information for everyone interested in the field of stem cells and regenerative medicine. Users can rapidly search 10 directories for a wide range of information including stem cell tools, reagents, banks and therapies as well as manufacturers, professional services, academic centres, networks and societies all searchable by country/State - plus the latest news and upcoming events.

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Genetics Policy Institute and univerCELLmarket to co-publish 360 – the Free Newsletter Covering Stem Cells and ...

PALM BEACH, Fla. & CAMBRIDGE, United Kingdom--(BUSINESS WIRE)--

The Genetics Policy Institute (GPI) and univerCELLmarket announced a joint initiative to produce the most comprehensive and timely online news aggregation and distribution service, providing actionable intelligence for the stem cell and regenerative medicine communities.

Expanding the current 360 newsletter published online by univerCELLmarket, the newsletter will be now co-published and distributed with GPI. Bernard Siegel, GPIs founder and executive director, joins Dr. Beverley Vaughan as the co-editor of the publication. GPI and univerCELLmarket maintain free subscription links on their respective web sites.

Bernard Siegel said, It is the aim of GPI to provide the highest quality information to all interested in stem cells and regenerative medicine. We are delighted to partner with univerCELLmarket. Their comprehensive news aggregation service enables users to efficiently research its archived news and records. With this partnership, interested stakeholders who are part of both GPIs and univerCELLmarkets extensive databases, honed over the past decade, will have easy access to news they can use to advance our field.

Dr. Cathy Prescott, respected thought-leader in the business of stem cells and regenerative medicine, and co-founder of univerCELLmarket said, As a result of partnering with GPI, 360 is now the most widely circulated news service in the world dedicated to this field. With this partnership, our combined contacts, which span academia, industry, government, law, ethics, medicine and advocacy will receive the news highlights in their in-box every Monday, with links to all the weeks news on univerCELLmarket.com.

Jeanette Walker, co-founder of univerCELLmarket stated, 360 is popular because it is so comprehensive and in a format that makes it quick and easy to scan. We are delighted to welcome Bernard Siegel to our editorial team as he is a recognized architect of the global stem cell community. Bernie founded GPI, the annual World Stem Cell Summit, the peer-reviewed World Stem Cell Report and is an acknowledged leader of the patient advocacy community.

About Genetics Policy Institute (GPI): GPI is a 501c3 nonprofit foundation with the mission to promote and defend stem cell research and its application in medicine to develop therapeutics and cures for many otherwise intractable diseases and disorders. GPI pursues this mission through production of its flagship annual World Stem Cell Summit, publication of the World Stem Cell Report, special projects, speaking engagements, teaching initiatives and strategic collaborations.

ABOUT univerCELLmarket

Launched in 2010, univerCELLmarket.com is an online, global source of relevant, up-to-date information for everyone interested in the field of stem cells and regenerative medicine. Users can rapidly search 10 directories for a wide range of information including stem cell tools, reagents, banks and therapies as well as manufacturers, professional services, academic centres, networks and societies all searchable by country/State - plus the latest news and upcoming events.

Follow this link:
Genetics Policy Institute and univerCELLmarket to co-publish 360 – the Free Newsletter Covering Stem Cells and ...

Published:Tuesday, April 16, 2013

Updated:Tuesday, April 16, 2013 22:04

The Alcohol Research Center (ARC) at UConn received a grant that provides five years of funding through 2017 in order to continue research on several studies including one that began in 1989.

Dr. Victor Hesselbrock, the primary investigative researcher, explained over the phone the major benefits the grant will have to the ARC which includes further research on the study of the genetics of alcoholism (COGA). The research for COGA is looking at extensive evidence that genes influence the vulnerability to alcoholism. About 17,000 individuals have participated in the study from five different states across the country. The planning for the study began in 1988 and officially received funding in 1989. COGA also focuses around identifying genes associated with developmental problems caused by alcohol.

We have identified 30 different genes in different organ systems associated with problems of alcohol use (within the study), said Hesselbrock. We also learned about taste sensitivity. There are genes that prefer or like the taste of alcohol. Then there are other genes that dont like the taste of alcohol and it provides a protection factor. The grant is funding four main studies and pilot studies surrounding alcoholism according to Hesselbrock. The four main studies include: COGA, seeing if college students in the real world drink as much as in college, risk factors associated with alcohol and obesity among adolescent girls and using E-Technology to track alcohol use in patients that have alcohol problems. The pilot studies will begin in the early fall and will center around testing varied cells for IPS (Immature Pluripotent stem cells) to generate stem cells and neurons found in the brain and look at the affects of alcohol. Rather than using real brain tissue the ARC can duplicate it in a test tube. Hesselbrock joked that not many people are willing to donate their own brain tissue.

Another pilot study includes examining older people and to see how alcohol affects their balance, gate and cognition done in low doses. The patients are given one or two drinks and researchers will see how they are affected differently compared to younger college students. Hesselbrock explained that much of the studies done at the ARC offers opportunities to develop pharmacological interventions for alcoholism and important implications for prevention and treatments.

Working in the department of psychiatry and addiction is major part. We have identified genes and their vulnerability, said Hesselbrock. We have been able to identify types of individuals with different levels of risks and vulnerabilities for substance abuse. There is a lot of cognitive testing of these individuals. Weve identified styles or deficits that contribute to a persons risk of substance abuse. Hesselbrock says the study is considered to be large and by using large sample numbers of individual has led to finding results for the numerous studies.

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Genetics of alcoholism research

Seattle Genetics Inc. (SGEN) recently presented data on its antibody-drug conjugate (ADC) candidates at the annual meeting of the American Association for Cancer Research (:AACR).

Preclinical data on SGN-CD33A showed significant antitumor activity in acute myeloid leukemia (:AML) models. Seattle Genetics intends to file an investigational new drug (IND) application and start a phase I study in 2013.

Another candidate, SGN-LIV1A, showed encouraging pre-clinical data for breast cancer. Seattle Genetics will file an IND application for SGN-LIV1A as well and start a phase I study in 2013 for breast cancer.

Seattle Genetics sole marketed ADC product is Adcetris. Adcetris is used for the treatment of patients with Hodgkin's lymphoma (HL) after failure of autologous stem cell transplant (:ASCT) or after failure of at least two prior multi-agent chemotherapy regimens in patients who are not suitable for ASCT. Adcetris is also approved for the treatment of systemic anaplastic large cell lymphoma (sALCL) after failure of at least one multi-agent chemotherapy regimen.

Adcetris was approved by the US Food and Drug Administration (:FDA) in Aug 2011, got EU approval in Oct 2012 and marketing authorization in Canada in Feb 2013.

ADCs have been attracting a lot of interest of late with major companies entering into collaborations. Seattle Genetics has collaborations with companies like Roche Holding AG's (RHHBY) Genentech for the development of ADCs.

A few days back, Astellas Pharma, Inc. (ALPMY) announced a deal with Ambrx Inc. for the discovery and development of novel ADCs.

Seattle Genetics carries a Zacks Rank #3 (Hold). Right now Cleveland BioLabs, Inc. (CBLI) looks more attractive with a Zacks Rank #1 (Strong Buy).

Read the Full Research Report on SGEN

Read the Full Research Report on RHHBY

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ADC Data from Seattle Genetics

Seattle Genetics Inc. (SGEN) recently received approval from Health Canada for its oncology drug, Adcetris (brentuximab vedotin). Adcetris has been approved under Health Canada's Notice of Compliance with conditions (NOC/c) for the treatment of patients with Hodgkins lymphoma (HL) after failure of autologous stem cell transplant (ASCT) or after failure of at least two prior multi-agent chemotherapy regimens in patients who are not suitable for ASCT. Adcetris was also approved for the treatment of systemic anaplastic large cell lymphoma (sALCL) after failure of at least one multi-agent chemotherapy regimen.

For similar indications, Adcetris was approved by the US Food and Drug Administration (FDA) in Aug 2011 and in the EU in Oct 2012.

The NOC/c requires Seattle Genetics to conduct clinical trials to confirm the anticipated clinical benefit of Adcetris. Seattle Genetics is currently enrolling patients for two confirmatory phase III studies evaluating the drug for the front-line treatment of HL and mature T-cell lymphoma (MTCL), including sALCL.

Our Take

We are positive on Seattle Genetics' efforts to penetrate new markets. In Canada, Adcetris is the first in a new class of antibody-drug conjugates (ADCs) to be approved. Adcetris' revenues for the nine months ending Sep 30, 2012 were $102.8 million.

Seattle Genetics carries a Zacks Rank #4 (Sell). Right now Peregrine Pharmaceuticals, Inc. (PPHM), Valeant Pharmaceuticals (VRX) and Targacept, Inc. (TRGT) look more attractive with a Zacks Rank #1 (Strong Buy).

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Canada Approves Seattle Genetics' Adcetris - Analyst Blog

Seattle Genetics Inc. (SGEN) recently received approval from Health Canada for its oncology drug, Adcetris (brentuximab vedotin). Adcetris has been approved under Health Canada's Notice of Compliance with conditions (NOC/c) for the treatment of patients with Hodgkins lymphoma (HL) after failure of autologous stem cell transplant (:ASCT) or after failure of at least two prior multi-agent chemotherapy regimens in patients who are not suitable for ASCT.

Adcetris was also approved for the treatment of systemic anaplastic large cell lymphoma (sALCL) after failure of at least one multi-agent chemotherapy regimen.

For similar indications, Adcetris was approved by the US Food and Drug Administration (:FDA) in Aug 2011 and in the EU in Oct 2012.

The NOC/c requires Seattle Genetics to conduct clinical trials to confirm the anticipated clinical benefit of Adcetris. Seattle Genetics is currently enrolling patients for two confirmatory phase III studies evaluating the drug for the front-line treatment of HL and mature T-cell lymphoma (:MTCL), including sALCL.

Meanwhile, in Jan 2013, a global phase III study (ECHELON-2) was initiated on Adcetris. In this study, Adcetris plus chemotherapy will be evaluated for the front-line treatment of CD30-positive MTCL including patients with sALCL and other types of peripheral T-cell lymphomas.

Our Take

We are positive on Seattle Genetics efforts to penetrate new markets. In Canada, Adcetris is the first in a new class of antibody-drug conjugates (ADCs) to be approved. Adcetris revenues for the nine months ending Sep 30, 2012 were $102.8 million.

Seattle Genetics carries a Zacks Rank #4 (Sell). Right now Peregrine Pharmaceuticals, Inc. (PPHM), Valeant Pharmaceuticals (VRX) and Targacept, Inc. (TRGT) look more attractive with a Zacks Rank #1 (Strong Buy).

Read the Full Research Report on SGEN

Read the Full Research Report on TRGT

The rest is here:
Canada Approves Seattle Genetics' Adcetris