By Christine McConville | Wednesday, January 28, 2009 | http://www.bostonherald.com | Business & Markets

The Massachusetts Life Sciences Center agreed yesterday to award a $7.4 million grant to Organogenesis Inc. to facilitate a major expansion.

The Canton-based regenerative medicine company treats diseases by using living cells to restore damaged tissues and organs.

The grant money will help the company expand its presence in Canton. The company has said that with the expanded location, the company will provide an additional 280 jobs.

Organogenesis currently employs 200 people.

Also yesterday, the Center appointed three new members to its scientific advisory board. Jonathan Fleming, managing general partner at Oxford Bioscience Partners; Doug Cole, general partner at Flagship Ventures; and Jean M. George, partner at Advanced Technology Ventures, will join the board’s 12 other members in making decisions about the Center’s scientific funding.

Article URL: http://www.bostonherald.com/business/general/view.bg?articleid=1148312

CANTON, Mass., /PRNewswire/ — organogenesis, Inc., a leading regenerative medicine company, has just been named the recipient of two prestigious awards honoring the company’s cutting edge development, manufacturing and economic impact.

Organogenesis’ manufacturing division has been named 2008 “Team of the Year” by Pharmaceutical Manufacturing, a prominent industry publication. The “Team of the Year” honor will be highlighted in the magazine’s upcoming December 2008 issue. Additionally, the company was honored by the Massachusetts Alliance for Economic Development as the Silver winner of its Fifth Annual Team Massachusetts Economic Impact Award, presented at a November 25th awards event.

Organogenesis was the first company to successfully mass produce living regenerative medicine products — reaching hundreds of thousands of patients in the U.S. and around the world. Its signature product, Apligraf(R), is the first living cell therapy to have received U.S. Food and Drug Administration (FDA) approvals to close both diabetic foot ulcers (DFUs) and venous leg ulcers (VLUs).

“We are honored to receive national and state recognition of the company’s vision, its ingenuity and hard work,” said Geoff MacKay, CEO of organogenesis. “Organogenesis is committed to bringing the promise of regenerative medicine into everyday medical care. To have our efforts and hard work recognized in this way is very gratifying for the company and our employees.”

MacKay continued, “The intricate processes required to mass produce a living cell therapy product require a great deal of innovation and dedication, and our top-notch manufacturing group hits its target every day. This team is in large part responsible for the quality, the growth and the contribution that marks organogenesis as a regenerative medicine leader in Massachusetts and around the world.”

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What is regenerative medicine?

Regenerative medicine aims to restore and repair tissue function via the interplay of living cells, an extra-cellular matrix and cell communicators.

“Tissue Regeneration”, “Tissue Engineering”, and “Regenerative Medicine” are related terms and sometimes used interchangeably.

Where does regenerative medicine fit into modern medical practice? Current traditional approaches to treat medical diseases include:

· Drugs, hormones, and enzymes

· Vaccines

· Prosthetic substitution

· Surgical reconstruction

· Organ transplantation

These methods are all considered essential, but have their limitations. For example, drugs have unwanted side effects, prosthetics are not biologically active and do not integrate or remodel into the body, surgery is invasive, and organ transplantation is limited by donor availability and toxic immunosuppressive cocktails.

Regenerative medicine is an emerging revolutionary approach in modern medicine as it delivers living tissue, stimulating the body’s own natural healing process by activating the body’s inherent ability to repair and regenerate. Innovative regenerative medicine therapies are now available that aim to heal or reconstruct diseased tissue and support the regeneration of diseased or injured organs.

Doctors use regenerative medicine to speed up healing and to help injuries that will not heal or repair on their own. Regenerative medicine may help heal broken bones, severe burns, chronic wounds, heart damage, nerve damage, and many other diseases.

Regenerative medicine is a multidisciplinary field involving biology, medicine and engineering.

Cenegenics Carolinas, a preventive health and age management medical facility, will begin offering stem cell collection and storage services for adults. It will do so through a partnership it has formed with Florida-based AssureImmune, one of three companies in the U.S. that collects and preserves adult stem cells.

Staff Report
Published Jan. 27, 2009

Cenegenics is the only facility in the Carolinas to offer the service. Cost for the procedure is $3,395 per person and includes four years of storage. After four years, storage costs range from $219-$349 per year, depending on the amount of time prepaid.

“At Cenegenics, we help our patients maximize their health and quality of life, which also helps improve the quality of their stem cells,” said Dr. Mickey Barber, CEO of Cenegenics Carolinas. “What better way to further protect our future health than to offer this breakthrough technology that is as simple as collecting blood but provides health ‘insurance’ for our future.”

Stem cells are cells within the body that have the potential to become any cell, organ or tissue, thus making them valuable for any number of medical purposes, such as curing disease or facilitating research.

Whereas the controversial embryonic stem cells are essentially blank slates that can become anything, adult stem cells are found within major organs or tissues and are generally limited to that type of cell. For example, some adult stem cells function to form all the types of blood cells in the body, others form all the bone and cartilage, and still others form the nerves in the brain.

According to the National Institutes of Health, scientists have found adult stem cells in the brain, bone marrow, peripheral blood, blood vessels, skeletal muscle, skin and liver.

AssureImmune collects adult stem cells, a relatively new technology, from the peripheral blood of adults and older children, as well as stem cells from the cord blood of newborns.

As one of the few stem cell banks in the world to use automated, computer-controlled equipment for the processing and storage of the samples, AssureImmune is able to recover more viable stem cells from each sample. Additionally, it is the only company that produces duplicate samples and stores them at different locations for backup security.

(BioWorld Today Via Acquire Media NewsEdge) Q&A: Robert Lanza

Google.com/news, January 27, 2009 — With the recent swearing in of new President Barack Obama there is much anticipation that the U.S. government will be more supportive of embryonic stem cell (ESC) research. In our first BioWorld Q&A feature, we spoke with Robert Lanza, chief scientific officer of Advanced Cell Technology and chief scientific advisor for Worcester, Mass.-based International Stem Cell & Regenerative Medicine International, a recently formed joint venture between ACT and CHA Biotech.

BioWorld: Why was this joint venture created?

Lanza: It will initially develop human blood cells and other clinical therapies based on ACTC’s proprietary hemangioblast cell technology. It holds the exclusive license to all of ACT’s hemangioblast technology. It is anticipated that this technology may some day help address the critical care shortage of blood for emergency situations, including military needs. The technology also has been shown to repair vascular damage in animals after heart attacks, limb ischemia and diabetes.

BioWorld: What are the major issues facing stem cell researchers today?

Lanza: One of the major issues is the problem of tissue rejection. To date, there is no way to transplant replacement cells derived from ESCs into a patient without powerful immunosuppressive drugs, which of course, are associated with cancer, infection and a long list of other serious side effects. In fact, the need for systemic immunosuppression could make the treatment worse than the disease. This is why we are focusing on “universal” blood, platelets and diseases that involve immune-privileged sites, such as the eye. Another major problem: You need to have a source of cells that is readily available, safe and that can be generated on a large scale. Unfortunately, it turns out that only a few replacement cell types can – at least at present – be reliably generated from hESCs. Assessment of safety and efficacy also are critical before hESC therapies can move into the clinic.

BioWorld: With restrictions on federal funding under President Bush, many researchers headed overseas and there was concern that the U.S. was losing talent and momentum. Do you see this changing under President Obama?

Lanza: Yes, all of this will change under President Obama. His inauguration marks the end of a sad chapter in American scientific history – where laws were passed that actually criminalized scientific research. As you know, the Bush administration has had an adversarial relationship with the scientific community (bordering on being antiscience). The new U.S. leadership (both the White House and Congress) will hopefully now listen to advice from the medical and scientific community (rather than taking sides in religious debates). The black cloud that has hovered over stem cell research in the United States has finally been lifted. We have been operating for the last decade with one hand tied behind our back. Under the new Obama administration, money will hopefully flow to all promising avenues of research based on scientific merit (and not skewed to fit a conservative Christian agenda). This extends not only to NIH and SBIR grants, but to NIST and even to DARPA grants. The impact on the private sector is equally critical. The day after Obama was elected, investors started to come out of the woodwork. For instance, we were on the verge of bankruptcy, and did an about-face as soon as Obama was elected.

BioWorld: How far away are we from having meaningful therapies for patients?

Lanza: As far as ESCs, there are really only two companies on the verge of clinical trials – ACT and Geron. We’ve already had our official Pre-IND meeting with the FDA. They seemed happy with our data and clinical plans. We hope to file an IND to begin clinical trials to prevent blindness by summer. We still have a few studies to complete, but everything looks great so far. Of course, the field desperately needs a big clinical success. We have developed a technology to treat degenerative eye diseases such as macular degeneration. We have demonstrated that these hESC-derived cells can rescue visual function in animals that otherwise would have gone blind.

BioWorld: Last week, Geron became the first company to get FDA approval to begin a Phase I trial of an ESC product, GRNOPC1, to treat patients with spinal cord injury. (See BioWorld Today, Jan. 26, 2009.) Is this a clear sign of things to come for the field?

Lanza: This is a huge advance for the entire field – my hat is off to them. This is what we’ve all been waiting for. It has been over a decade since ESCs were first discovered. This sends a message that we’re ready at last to start helping people. Again, we are planning to file an IND with the FDA to begin clinical trials to prevent blindness this summer. Sometimes, it’s the second mouse that gets the cheese. Now that the FDA is comfortable with the safety of ESC therapies, all eyes will be looking for results. That is, can you really treat or cure a disease? Of course, it’s extremely important that Geron does well in this trial. It could be a disaster if something goes wrong. Remember what happened with gene therapy. They shut everyone down.

BioWorld: What sort of advantage does your technology offer?

Lanza: In addition to generating “universal” blood, there are also advantages of using retinal cells to treat blindness and eye disease. We have been able to consistently and reliably generate retinal cells – known as “retinal pigment epithelium” (or RPE) – from every hESC line we have studied. These cells have been extensively characterized and have all the markers and behavior of normal retinal cells. The retinal pigment epithelium is an important eye tissue, which plays a critical role in the pathogenesis of macular degeneration, retinitis pigmentosa and other retinal degenerative diseases. In the RCS rat, improvement in visual performance was 100 percent over untreated controls without any apparent adverse effects. In untreated animals, the layer of cells the animals see with was only one layer deep after 100 days. However, in the treated animals, the cells were five-to-seven cells deep! Of course, control sham-treated eyes showed no improvement.

BioWorld Q&A is a periodic feature that profiles industry leaders and particular companies, or serves as a sounding board for a variety of issues. If you have suggestions for a particular subject, send your emails to newsdesk@bioworld.com.

…………………………………………
Obama Brings Hope to Stem Cell Research

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By Heather Ishimaru

ABCNEWS.COM, President-elect Barack Obama has promised to end federal restrictions on stem cell research. A lot of advocates are eagerly waiting for that to happen because they believe stem cell research could help cure them.

Eight years ago the Bush administration all but ended stem cell research by restricting federal financing.

California voters kept the work alive here with passage of Proposition 71, which provided state funding for stem cell research. But Obama has promised to clear the way for federal funding once again. It’s the best news Fremont resident Roman Reed has had in eight years.

It’s so exciting, the hope. I just feel renewed energy knowing that Barack Obama cares, knowing that we’re going to be able to put aside the past-partisan stem cell politics. We’ll actually be able to put the research first… care about the people that are suffering,” said Reed.

Reed was a promising 19-year-old Chabot College linebacker when a tackle broke his neck and changed his life. Now 34, Reed has use of his hands. He has two children with a third on the way, and he now has new hope that stem cell research will help him walk again.

“When you’re dealing with complicated pioneering research, it is fits and starts. So we don’t know exactly when the cures will come, but the cures will come down the road,” said Reed.

Stem cells hold promise for curing all kinds of diseases. The most promising results require embryonic stem cells. Scientists get them from frozen embryos that would otherwise be thrown away.

The Vatican just reaffirmed its opposition to stem cell research in a document released last month. It refers to an embryo as a “human being in his or her embryonic state,” not a cluster of cells subject to “utilitarian treatment” in a lab.

Terry Thompson is with the Life Legal Defense Foundation. He says Obama will not be walking a fine line on this one.

“I don’t think it’s a fine moral line, I think it’s a real bright red line. On one side you’re going to do research that kills embryos, and on the other side you don’t do it,” said Thompson.

Harvard Medical School, January 27, 2009, by Howard Lewine — I have a recurring problem with the skin at the corners of my mouth. The skin gets irritated with small cracks. It gets better, then for no apparent reason, the problem returns. What could be causing this condition? Can I prevent it from happening again?

This condition is called angular cheilitis, also know as angular stomatitis or perleche. The skin cracking at the corners of your mouth can be associated with redness and scaling. The cause is frequent or persistent saliva touching the skin outside the mouth. This can occur because of a poor seal of your lips at the angles of your mouth, braces, ill-fitting dentures or because you frequently lick the area. Less commonly, this can be the result of an allergic skin reaction to lipstick or face cream, or too vigorous dental flossing. The cause of angular cheilitis could also be a vitamin or iron deficiency, but that’s rare.

The cracks in the skin and the excess moisture provide a fertile environment for yeast. The yeast causes a low-grade infection, which may make the corners of the mouth even more irritated.

While the angular cheilitis is active, you can apply an over-the-counter antifungal cream, such as clotrimazole, then topical hydrocortisone 1 percent ointment an hour later. You can do this two to three times a day. Another option is a cream containing both hydrocortisone and the anti-infective agent iodoquinol (Vytone, also available as generic).

To help prevent a recurrence, don’t lick your lips. You want to avoid letting excessive moisture accumulate in the corners of your mouth.

Once the angular cheilitis heals, use a protective lip balm, preferably one that is hypoallergenic. Make sure the mouth corners are dry before applying, and use it often.

If the condition does not clear, see your physician for a prescription anti-yeast cream such as ketoconazole cream.

Cracks in the skin and the excess moisture provide a fertile environment for yeast, which causes a low-grade infection.