Category Archives: Genetics

REYKJAVIK, Iceland, October 4, 2012 /PRNewswire/ --

ORF Genetics announced today that the company has added endotoxin- and animal-free human Fibroblast Growth Factor Basic (FGF basic) and mouse Leukemia Inhibitory Factor (mouse LIF) to its portfolio of growth factors for stem cell research.

Most growth factors applied in stem cell research today are made in E. coli bacteria, which produce endotoxins that can have adverse effect on stem cell cultures. Other manufacturers of growth factors have various methods to remove these endotoxins, but traces inevitably remain, which can lead to increased death rate of cells and other suboptimal effects in cell cultures. Other growth factors on the market today are made by animal cells. However, most stem cell researchers prefer to use growth factors of non-animal origin to exclude risks of viral contamination and the inclusion of growth factor homologs.

This has led to a market demand for alternative sources of animal-free growth factors, void of endotoxins. ORF Genetics' unique growth factors are produced in the seeds of the barley plant, which does not produce any endotoxins or other substances toxic to mammalian cells.

FGF basic and mouse LIF are key growth factors for the cultivation of their respective stem cells, i.e. FGF basic for human stem cells and mouse LIF for mouse stem cells. Each protein is used to expand the stem cells' populations before researchers make them differentiate into various cell types, such as heart, liver or neural cells.

"ORF Genetics has built a reputation for offering the first plant-made, endotoxin-free and animal-free growth factor portfolio for stem cell researchers. As we are producing these growth factors in our novel plant expression system ORFEUS, we are very happy to be able to offer these high quality growth factors at more efficient prices than market leaders," said Bjrn rvar, CEO of ORF Genetics.

ORF Genetics is a world leader of plant made growth factors and offers a portfolio of endotoxin- and animal-free growth factors for human stem cell research. The company's production takes place in a biorisk-free production system in barley, bypassing conventional bacteria and animal cell production systems. The cultivation of barley takes place in greenhouses in inert volcanic pumice, using renewable geothermal energy.

For more information please contact:

Dr. Hakon Birgisson, Director of Global Market Development Tel: +354-821-1585 email:hakon.birgisson@orfgenetics.com

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ORF Genetics to Offer endotoxin- and Animal-free FGFb and mLIF for Stem Cell Research

CAMBRIDGE, Mass. & BOTHELL, Wash.--(BUSINESS WIRE)--

Seattle Genetics, Inc. (SGEN) and Millennium: The Takeda Oncology Company, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited (TSE:4502), today announced the completion of patient enrollment in a phase III clinical trial of ADCETRIS (brentuximab vedotin) for post-transplant Hodgkin lymphoma (HL) patients. The phase III trial, also known as the AETHERA trial, is evaluating ADCETRIS versus placebo for the treatment of patients at high risk of residual Hodgkin lymphoma following autologous stem cell transplant (ASCT). ADCETRIS is an antibody-drug conjugate (ADC) directed to CD30, a defining marker of classical HL.

We are pleased to complete the enrollment of this important phase III trial, evaluating the use of ADCETRIS for Hodgkin lymphoma patients who are at high risk of residual disease following an ASCT, said Thomas C. Reynolds, M.D., Ph.D., Chief Medical Officer of Seattle Genetics. The AETHERA trial is designed to provide the medical community with valuable insight into the potential for ADCETRIS to consolidate responses in Hodgkin lymphoma patients following a transplant, and will be the first data on the use of ADCETRIS in a maintenance-type setting. We anticipate data from this trial will be available in late 2013 or early 2014.

Completing enrollment of the AETHERA trial in the post-transplant Hodgkin lymphoma patient population at high risk for residual disease is a significant milestone for our ADCETRIS clinical development program, said Karen Ferrante, M.D., Chief Medical Officer, Millennium. We look forward to continuing to work with our partner Seattle Genetics to determine the potential benefit of this targeted treatment in other CD30-expressing tumors.

The AETHERA trial is a randomized, double-blind, placebo-controlled phase III study, comparing progression-free survival in 329 post-ASCT patients receiving ADCETRIS to those receiving placebo. Patients must be at high risk for residual HL, defined as those with a history of refractory HL, those who relapse or progress within one year from receiving front-line chemotherapy and/or those who have disease outside of the lymph nodes at the time of pre-ASCT relapse. Secondary endpoints of the trial include overall survival, safety and tolerability. Patients receive ADCETRIS every three weeks for up to approximately one year. This international multi-center trial is being conducted in the United States, Europe and Russia.

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) for two indications: (1) the treatment of patients with Hodgkin lymphoma 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 systemic anaplastic large cell lymphoma (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.

ADCETRIS is not approved for use outside the United States. The marketing authorization application for ADCETRIS in relapsed or refractory Hodgkin lymphoma and sALCL, filed by Takeda Global Research & Development Centre (Europe), was accepted for review by the European Medicines Agency (EMA) in June 2011. In July 2012, the Committee for Medicinal Products for Human Use (CHMP) of the EMA issued a positive opinion for the conditional approval of ADCETRIS, supporting an approval decision in the European Union.

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.

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Seattle Genetics and Millennium Complete Enrollment in Phase III AETHERA Trial of ADCETRIS® for Post-Transplant ...

While $34.7 million is a touch more than $34.5 million, that's not exactly huge quarter-over-quarter growth from Seattle Genetics' (Nasdaq: SGEN) Adcetris.

Still, investors seem to be shaking off the lackluster growth, and for good reason: Sales of Adcetris -- a drug for treating relapsed Hodgkin lymphoma and anaplastic large-cell lymphoma -- are a very small part of the long-term success of Seattle Genetics.

The light growth seems to be the result of declining business at academic centers, where sales dropped off as patients stopped treatment because they finished their therapy cycles or had a strong enough response to undergo a stem-cell transplant.

The number of community doctors using the drug increased in the second quarter, which is good news for the sales trajectory, as most of the lymphoma patients for whom Adcetris is appropriate are seen in the community setting.

Don't expect much growth in the second half, though; management is guiding for sales of $140 million to $150 million in 2012 -- either flat or a 17% increase from the first half of the year to the second half.

Seattle Genetics lost $12.3 million on a GAAP basis in the quarter but didn't actually burn any cash. In fact, the cash, cash equivalents, and investments increased by $21.5 million during the quarter. I don't know how long investors can expect that to continue, as the biotech is still using product manufactured prior to approval.

Of course, aside from Adcetris, Seattle Genetics can bring in cash by licensing out its antibody-drug conjugate technology, which has attracted some big names, including Roche, GlaxoSmithKline (NYSE: GSK) , Pfizer (NYSE: PFE) , and Abbott Labs (NYSE: ABT) .

Internally, Seattle Genetics' future depends on expanding the use of Adcetris into frontline setting for the two lymphomas it's currently approved to treat, as well as other types of cancer. The potential there towers over the $150 million Seattle Genetics will bring in this year.

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A Growth-Free Quarter -- and That's OK

BOTHELL, Wash.--(BUSINESS WIRE)--

Seattle Genetics, Inc. (SGEN) today announced updated survival data from a pivotal clinical trial of single-agent ADCETRIS (brentuximab vedotin) in patients with relapsed or refractory Hodgkin lymphoma (HL) after autologous stem cell transplant (ASCT) showing that the median overall survival has not been reached after a 26.5 month median follow-up. The data will be reported during an oral presentation at the 17th European Hematology Association (EHA) Annual Meeting being held June 14-17, 2012 in Amsterdam, Netherlands. ADCETRIS is an antibody-drug conjugate (ADC) directed to CD30.

Heavily pretreated Hodgkin lymphoma patients who relapse following autologous stem cell transplant often have a poor prognosis and there is a high unmet medical need for effective treatment options, said Scott Smith M.D., Ph.D., Loyola University Medical Center. These updated overall survival results from the pivotal trial are encouraging and demonstrate that ADCETRIS may play an important role in the treatment of patients with relapsed or refractory disease.

Long-term Follow-up Results of an Ongoing Pivotal Study of Brentuximab Vedotin in Patients with Relapsed or Refractory Hodgkin Lymphoma

A pivotal trial was conducted in 102 patients with relapsed or refractory HL after ASCT. The primary endpoint was objective response rate (ORR) per independent review. The secondary endpoints were complete remission (CR) rate, duration of response, progression-free survival (PFS), overall survival (OS), and safety and tolerability. At the time of the long-term follow-up analysis, the median observation time from first dose was 26.5months. Data, to be presented by Dr. Smith, include:

Patients received 1.8milligrams per kilogram of ADCETRIS every 3 weeks as a 30-minute outpatient intravenous infusion for up to 16cycles. Patients received a median of nine cycles of ADCETRIS while on trial. The median age of patients in the pivotal trial was 31 years. Enrolled patients had received a median of 3.5 (range 113) prior cancer-related systemic therapies, excluding ASCT. Seventy-one percent of patients had primary refractory disease, defined in the study protocol as patients who relapsed within three months of attaining CR or failed to achieve a CR, and 42 percent had not responded to their most recent prior therapy.

Details of the oral presentation are as follows:

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) for two indications: (1) the treatment of patients with Hodgkin lymphoma 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 systemic anaplastic large cell lymphoma (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 Highlights Updated Survival Data from ADCETRIS® Pivotal Trial in Patients with Relapsed or Refractory ...

(RTTNews.com) - Biotechnology company Seattle Genetics Inc. (SGEN) Monday reported a loss for the fourth quarter that narrowed from a year ago, due mainly to sales of Hodgkin Lymphoma drug Adcetris approved last August. Loss for the quarter was smaller when compared to analyst estimates, while revenues too came in ahead of expectations.

Looking ahead, Seattle Genetics detailed its revenue forecast for 2012. Nonetheless, investors were not too impressed with the results, sending Seattle Genetics shares down 7 percent in after hours trade on the Nasdaq.

The Bothell, Washington-based company reported fourth-quarter net loss of $27 million or $0.24 per share compared to net loss of $34.5 million or $0.34 per share last year.

On average, 14 analysts polled by Thomson Reuters expected a loss of $0.31 per share for the quarter. Analysts' estimates typically exclude special items.

Results for the 2011 quarter include an $8.7 million valuation adjustment related to holdings in auction rate securities.

The company reported revenues of $48.9 million, compared to $8.1 million in the prior year. Street analysts expected revenues of $39.12 million.

Adcetris product sales for the quarter was $33.2 million. Adcetris (brentuximab vedotin) was approved by the FDA last August for the treatment of patients with Hodgkin lymphoma 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.

The drug has been also approved for the treatment of patients with systemic anaplastic large cell lymphoma after failure of at least one prior multi-agent chemotherapy regimen. Adcetris is the first drug approved by the FDA for Hodgkin lymphoma in more than 30 years.

CEO Clay Siegall said, "...We are also executing on a broad clinical development program of Adcetris to evaluate its potential in earlier lines of therapy for Hodgkin lymphoma and mature T-cell lymphomas, as well as in other CD30-positive malignancies."

Total expenses for the quarter rose to $67.6 million from $43 million last year, reflecting higher selling expenses related to the launch of Adcetris, and increased research expenses.

Seattle Genetics expects full year 2012 revenues from collaboration and license agreements between $55 million and $65 million.

Analysts currently expect the company to report revenues of $196.21 million for 2012.

SGEN closed Monday on the Nasdaq at $18.96, up $0.36 or 1.96%, on a volume of 1.6 million shares. In after hours, the stock lost $1.34 or 7.07%.

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Seattle Genetics Loss Narrows; But Stock Down - Update