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Seattle Genetics, Inc. Posts Record Adcetris Sales

Posted: October 31, 2014 at 5:52 am

Seattle Genetics is up in after-hours trading after posting record sales for its blood cancer drug Adcetris, and raising guidance for the year. The biotech sold $48 million worth of Adcetris in the U.S. and Canada, a 32% year-over-year increase.

Seattle Genetics also booked $8 million worth of royalty revenue from sales of Adcetris by its overseas partner Takeda . The drug is now approved in 47 countries, including 11 new approvals in the last 12 months.

In the U.S., the big driver of sales is coming from off-label use treating Hodgkin lymphomato knock back the lymphoma so patients can get a stem cell transplant. Adcetris is currently only approved to treat Hodgkin lymphomapatients that have failed a stem cell transplant, so Seattle Genetics can't promote it for use before stem cell transplants, even if doctors are choosing to use it then.

On the back of a strong third quarter, Seattle Genetics raised its guidance for sales of Adcetris this year to between $172 million and $177 million. That guidance implies fourth-quarter sales of $40 million to $45 million.

If you're playing along at home, you'll notice that's less than the $48 million in the third quarter. The holiday season will result in less shipping days, which will affect sales; but it doesn't necessarily mean that demand is down. The aforementioned off-label sales could also diminish -- they tend to be lumpy as doctors explore what's working. And, of course, there's a good chance that management is just sandbagging its guidance.

Looking forward, Adcetris sales growth should come fromconsolidation therapy immediately following an autologous stem cell transplant in patients with Hodgkin lymphoma. Using it on all patients -- not just those who have failed a stem cell transplant -- will obviously increase sales.

Seattle Genetics recently presented top-line data for a trial in that indication, which showed Adcetris significantly extended survival without the lymphoma progressing, referred to as progression-free survival. We'll get more data on the trial at the American Society of Hematology meeting in December, where Seattle Genetics expects to have data presented at eight oral presentations. The company plans to submit an application to the FDA in the first half of 2015 for using Adcetris as a consolidation therapy, which would put it on track for an approval toward the end of next year or in early 2016.

Of course, Seattle Genetics is more than just Adcetris. The drug is built on its antibody drug conjugate technology, which the biotech has licensed to 12 different companies, including Genmab , which signed up for a second collaboration in September. During the quarter, three of the collaborators -- GlaxoSmithKline , Takeda , and Bayer -- moved drugs along in the clinic, triggering milestone payments.

Seattle Genetics isn't profitable yet; but with $340 million in cash and investments, solid growth in sales of Adcetris, and potential for future royalties from collaborators' drugs, the biotech looks like it's in good shape for now.

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Stem cell patent to reach Supreme Court

Posted: October 31, 2014 at 5:51 am

Jeanne Loring holds a petri dish with induced pluripotent stem cells from a Parkinsons patient.

The U.S. Supreme Court will be asked to intervene over a controversial embryonic stem cell patent, opponents of the patent said Thursday.

Jeanne Loring, a stem cell scientist at The Scripps Research Institute, said the court will be asked Friday to overturn a lower court decision and allow the opponents to seek cancellation of the patent held by the Wisconsin Alumni Research Foundation, or WARF.

Loring and two public interest groups, Consumer Watchdog and the Public Patent Foundation, have been trying to get that patent overturned since 2006. Another patent giving rights over induced pluripotent stem cells has been waived by WARF.

Loring, who is researching the use of induced pluripotent stem cells to treat Parkinson's disease, said the remaining patent impedes development of embryonic stem cell therapies.

Embryonic stem cell therapies are reaching the clinical stage, such as San Diego's ViaCyte, which recently began trials of its therapy for Type 1 diabetes, derived from human embryonic stem cells.

"We think that now embryonic stem cells really are showing their worth in clinical studies, it's very important to just wipe this thing off the books, so nobody can either shut down trials or require huge licensing fees for successful efforts," Loring said.

The foundation got the patent for work by James Thomson of the University of Wisconsin-Madison. He was the first to derive human embryonic stem cells, in 1998.

Opponents say Thomson's feat, while significant, was not a patent-worthy technological advance. Loring has said other qualified scientists could have isolated the cells with methods used for finding animal embryonic stem cells, so the advance was obvious.

Moreover, embryonic stem cells are a product of nature and therefore not patentable according to a 2012 Supreme Court ruling, they say.

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Lab-grown stem cell trial gets green light

Posted: October 31, 2014 at 5:51 am

Irelands first human stem cell trial using lab-grown cells is due to get underway in Galway in the new year following approval from the medicines watchdog.

The trial will involve extracting adult mesenchymal stem cells (MSC) from the bone marrow of patients with a condition known as critical limb ischemia (CLI) a severe blockage of the arteries resulting in marked reduction in blood flow to the extremities.

Reduction in blood flow to the legs puts patients at risk of gangrene, ulceration, and amputation, and the Galway trial will look at the use of MSCs to grow new stems cells which will then be injected back into the patients leg with the hope of growing new blood cells and improving circulation.

The harvested stem cells will be grown to much greater quantities in a highly specialised lab before being injected back into the patients leg.

Tim OBrien, director of the Galway-based Regenerative Medicine Institute, said their research was focused on whether MSC therapy could improve blood flow to the legs in patients with CLI a condition common in diabetics and therefore avoid the need for amputation. The trial is aimed predominantly at testing the safety and feasibility of what is very much an experimental therapy, Prof OBrien said.

We will be doing a dose escalation study, with some patients given a small dose, others a medium dose and the remainder a high dose, he said. We want to try and establish how many cells do you need to give a patient.

The study, the first in humans in Ireland, will be a year-long study involving nine patients. Prof OBrien said they would not be advertising for participants, but rather would let clinicians know and await referrals of suitable patients.

In the meantime, they would be preparing the custom-built facility where the cells are grown, at the Centre for Cell Manufacturing Ireland in NUI Galway, the first such facility in Ireland to receive a licence from the Health Products Regulatory Authority.

Prof OBrien said MSCs have a lot of properties that may make them useful in treating a wide variety of disease because of their reparative and regenerative qualities.

Prof OBrien delivered a talk yesterday on the Therapeutic Potential of MSCs in Diabetic Complications on the second day of a two-day international stem cell conference at NUI Galway.

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Identifying the source of stem cells

Posted: October 31, 2014 at 4:49 am

16 hours ago Amy Ralston, MSU biochemist and molecular biologist, has identified a possible source of stem cells, which can advance regenerative and fertility research. Credit: G.L. Kohuth

When most animals begin life, cells immediately begin accepting assignments to become a head, tail or a vital organ. However, mammals, including humans, are special. The cells of mammalian embryos get to make a different first choice to become the protective placenta or to commit to forming the baby.

It's during this critical first step that research from Michigan State University has revealed key discoveries. The results, published in the current issue of PLOS Genetics, provide insights into where stem cells come from, and could advance research in regenerative medicine. And since these events occur during the first four or five days of human pregnancy, the stage in which the highest percentage of pregnancies are lost, the study also has significant implications for fertility research.

Pluripotent stem cells can become any cell in the body and can be created in two ways. First, they can be produced when scientists reprogram mature adult cells. Second, they are created by embryos during this crucial four-day window of a mammalian pregnancy. In fact, this window is uniquely mammalian, said Amy Ralston, MSU assistant professor of biochemistry and molecular biology, and lead author on the study.

"Embryos make pluripotent stem cells with 100 percent efficiency," she said. "The process of reprogramming cells, manipulating our own cells to become stem cells, is merely 1 percent efficient. Embryos have it figured out, and we need to learn how they're doing it."

The researchers' first discovery is that in mouse embryos, the gene, Sox2, appears to be acting ahead of other genes traditionally identified as playing crucial roles in stem cell formation. Simply put, this gene could determine the source of stem cells in mammals. Now researchers are trying to decipher why Sox2 is taking the lead role.

"Now we know Sox2 is the first indicator that a cell is pluripotent," Ralston said. "In fact, Sox2 may be the pre-pluripotent gene. We show that Sox2 is detectable in just one or two cells of the embryo earlier than previously thought, and earlier than other known stem cell genes."

The second discovery is that Sox2 has broader influence than initially thought. The gene appears to help coordinate the cells that make the fetus and the other cells that establish the pregnancy and nurture the fetus.

Future research will focus on studying exactly why Sox2 is playing this role. The team has strong insights, but they want to go deeper, Ralston said.

"Reprogramming is amazing, but it's inefficient," she said. "What we've learned from the embryo is how to improve efficiency, a process that could someday lead to generating stem cells for clinical purposes with a much higher success rate."

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Seminar on Regenerative Medicine Open to Public

Posted: October 31, 2014 at 4:48 am

JACKSON, Tenn. (PRWEB) October 30, 2014

Dr. Roy Schmidt and the staff of the Pain Specialist Center will host a free seminar and question-and-answer session about regenerative medicine on Tuesday, Nov. 11 at 6 p.m. Held at the clinic at 15 Stonebridge Blvd. in Jackson, the hour-long event will allow attendees to ask questions about stem cell therapy and platelet rich plasma therapy in a relaxed atmosphere. Guests also will have the chance to talk to individuals who have received regenerative medicine treatments, which focus on helping patients relieve pain by supporting the healing process.

Stem cell therapy focuses on delivering the patients own stem cells to parts of the body that are in need. After adipose tissue (comprised of fat cells) is taken from the patients body, it is made into a stem cell concentrate. That concentrate is injected at the focal point of pain or area that needs healing. Schmidt, who is certified to administer stem cell therapy, was trained by Bioheart Chief Scientific Officer Kristin Comella. Comella has been recognized as a national leader in stem cell therapy.

Platelet rich plasma (PRP) or platelet concentrates have been studied extensively since the 1990s. While similar products previously used in medicine (fibrin glue) were very expensive, PRP provides a cost-effective alternative. Plasma concentrates seek to help the body continue the healing process and strengthen the weakened tissue. It is often used for tendon problems, in addition to issues with ligaments, muscles, meniscus, cartilage, bone, wound and intervertebral discs. The supplemental role of hyperbaric oxygen therapy will be discussed at the event, also.

A board certified anesthesiologist, Schmidt has practiced pain management in the Jackson area for two decades. The Pain Specialist Center provides consultation and pain management services to patients suffering from chronic pain syndromes and terminal cancer pain. Individuals can learn more by going online to http://beyondpills.com, http://nopainmd.com and http://hyperbaricoxygentherapies.com, calling 731-660-2056 or e-mailing info(at)beyondpills(dot)com. Event information is on Facebook at http://www.facebook.com/PainSpecialistCenter.

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High-Intensity Sound Waves May Aid Regenerative Medicine

Posted: October 31, 2014 at 4:48 am

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Newswise WASHINGTON, D.C., October 30, 2014 Researchers at the University of Washington have developed a way to use sound to create cellular scaffolding for tissue engineering, a unique approach that could help overcome one of regenerative medicines significant obstacles. The researchers will present their technique at the 168th meeting of the Acoustical Society of America (ASA), held October 27-31, 2014, at the Indianapolis Marriott Downtown Hotel.

The development of the new technique started with somewhat of a serendipitous discovery. The University of Washington team had been studying boiling histotripsy - a technique that uses millisecond-long bursts of high-intensity ultrasound waves to break apart tissue - as a method to eliminate cancerous tumors by liquefying them with ultrasound waves. After the sound waves destroy the tumors, the body should eliminate them as cellular waste. When the researchers examined these decellularized tissues, however, they were surprised by what the boiling left intact.

In some of our experiments, we discovered that some of the stromal tissue and vasculature was being left behind, said Yak-Nam Wang, a senior engineer at the University of Washingtons Applied Physics Laboratory. So we had the idea about using this to decellularize tissues for tissue engineering and regenerative medicine.

The structure that remains after decellularizing tissues is known as the extracellular matrix, a fibrous network that provides a scaffold for cells to grow upon. Most other methods for decellularizing tissues and organs involve chemical and enzymatic treatments that can cause damage to the tissues and fibers and takes multiple days. Histrostipsy, on the other hand, offers the possibility of fast decellularization of tissue with minimal damage to the matrix.

In tissue engineering, one of the holy grails is to develop biomimetic structures so that you can replace tissues with native tissue, Wang said. Stripping away cells from already developed tissue could provide a good candidate for these structures, since the extracellular matrix already acts as the cellular framework for tissue systems, Wang said.

Due to its bare composition, the matrix also induces only a relatively weak immune response from the host. The matrix could then theoretically be fed with stem cells or cells from the same person to effectively re-grow an organ.

The other thought is that maybe you could just implant the extracellular matrix and then the body itself would self-seed the tissues, if its just a small patch of tissue that youre replacing, Wang said. You wont have any immune issues, and because you have this biomimetic scaffold thats closer to the native tissue, healing would be better, and the body would recognize it as normal tissue.

Wang is currently investigating decellularization of kidney and liver tissue from large animals. Future work involves increasing the size of the decellularized tissues and assessing their in-vivo regenerative efficacy.

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Stem Cell Therapy | stem cells fraud – Video

Posted: October 31, 2014 at 4:43 am


Stem Cell Therapy | stem cells fraud
http://www.arthritistreatmentcenter.com Too good to be true. And I was fooled also Japanese stem cell breakthrough, a fraud Reported by Rob Stein in Shots, a prestigious scientific journal...

By: Nathan Wei

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Dr Joseph Purita MD FACS Interview Global Stem Cells Group – Video

Posted: October 30, 2014 at 8:40 pm


Dr Joseph Purita MD FACS Interview Global Stem Cells Group
Leading Stem Cell Scientist and Physician Dr Joseph Purita , speaking for Global Stem Cells Group in Buenos Aires Argentina http://www.stemcellsgorup.com.

By: StemCellsGroup

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FDA awards grants to stimulate drug, device development for rare diseases

Posted: October 30, 2014 at 8:40 pm

The U.S. Food and Drug Administration today announced it has awarded 15 grants totaling more than $19 million to boost the development of medical device, drug, and biological products for patients with rare diseases, with at least a quarter of the funding going to studies focused solely on pediatrics.

The FDA awards grants for clinical studies on safety and/or effectiveness of products that could either result in, or substantially contribute to, approval of the products.

The FDA is in a unique position to help those who suffer from rare diseases by offering several important incentives to promote the development of products for rare diseases, one of which is this grants program, said Gayatri R. Rao, M.D., director of the FDAs Office of Orphan Product Development. The grants awarded this year support much-needed research in difficult-to-treat diseases that have little, or no, available treatment options.

The program is administered through the FDAs Orphan Products Grants Program. This program was created by the Orphan Drug Act, passed in 1983, to promote the development of products for rare diseases. Since its inception, the program has given more than $330 million to fund more than 530 new clinical studies on developing treatments for rare diseases and has been used to bring more than 50 products to marketing approval.

A panel of independent experts with experience in the disease-related fields reviewed the grant applications and made recommendations to the FDA.

The 2014 grant recipients are:

For the grants program therapies, a disease or condition is considered rare if it affects less than 200,000 persons in the United States. There are about 7,000 rare diseases and conditions, according to the National Institutes of Health. In total, nearly 30 million Americans suffer from at least one rare disease.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nations food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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Stem Cell Therapy | stem cells fraud – Video

Posted: October 30, 2014 at 8:40 pm


Stem Cell Therapy | stem cells fraud
http://www.arthritistreatmentcenter.com Too good to be true. And I was fooled also Japanese stem cell breakthrough, a fraud Reported by Rob Stein in Shots, a prestigious scientific journal...

By: Nathan Wei

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Stem Cell Therapy | stem cells fraud - Video

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