International Stem Cell Corporation Obtains Exclusive Rights in the US and Canada to Distribute Approved Human Skin Model for Toxicity Testing
OCEANSIDE, California, April 29, 2008
International Stem Cell Corporation (OTCBB: ISCO) announced today that it has entered into an exclusive agreement with CellSystems Biotechnologie to distribute laboratory-cultured models of human skin useful for testing the hazardous properties of consumer products and for dermatological and pharmaceutical research. Such testing is likely to be soon required for certain types of consumer products sold into the European Union.
According to International Stem Cell’s (ISCO) President Jeffrey Janus, “This agreement is another positive step in ISCO’s strategic plan to become the primary source of high quality human cells for the therapeutic and research markets by leveraging its manufacturing and distribution resources.”
ISCO’s human cell and cell culture research products are manufactured and distributed under the “Lifeline” brand by wholly-owned subsidiary Lifeline Cell Technology, LLC, based in Walkersville, Maryland (www.lifelinecelltech.com).
The laboratory-cultured models of human skin, called EST-1000 and AST-2000 were developed by CellSystems and contain cells manufactured by Lifeline. These three dimensional skin cell models are used as alternative methods to animal testing in the field of Skin Corrosion, Skin Irritation, Skin Sensitization, Genotoxicity and Phototoxicity.
“We have worked with the Lifeline staff and know their abilities to provide excellent
customer service and their ability to consistently produce high quality products; a critical factor for researchers that depend on human cells for the success of their research,” said Horst W. Fuchs, President of CellSystems Biotechnologie. This agreement between our companies opens a distribution channel for CellSystems’ skin model products to scientific researchers throughout the United States and Canada.”
“While the sale of these Lifeline stem cell and research products provides ISCO
immediate cash flow, it also helps embed ISCO’s products into successful therapeutic and quality control procedures worldwide, providing a revenue stream of shared royalties beyond traditional sales,” added Janus.
Archive for April, 2008
Posted by Jim H on April 29, 2008
Posted by Jim H on April 29, 2008
Yes, I know this is supposed to be a blog about Frederick County Biotech. This story is neither about Fred Co nor biotech, but it’s my blog and I can rant when I want to.
I am at a loss for words. Hold on, they’re coming back to me. In waves, kinda like diarrhea. Maybe this can be my inaugural BPSDB post?
The Global Warming conspiracy, in Nature no less, reports that the ozone-hole recovery is threatening the Antarctic Ice cap. Yes brothers and sisters, the Ozone hole, so widely attributed to be the demise of the planet in the 80′s, a tell-tale, doomsday prophecy of humans ruining the universe due to gluttony and lust of chlorofluorocarbons and exhaust from burning of fossil fuels, the ozone hole shrinketh.
From the article ( a drum roll please):
Antarctic ice threatened by ozone-hole recovery
Global winds could accelerate melting.
The ozone hole may have delayed Antarctic warming
Recovery of the ozone hole above Antarctica could warm the Antarctic and cause more ice to melt in coming decades, researchers say. As the ozone hole heals, wind patterns that shield the interior of the polar region from warm air may break down, causing warming in the Antarctica as well as warmer and drier conditions in Australia.
Despite global temperatures rising, the interior of Antarctica has experienced a unique cooling trend during its summer and autumn over the last few decades. Scientists attribute this cooling to the hole in the ozone layer, which alters atmospheric circulation patterns and strengthens the westerly winds that swirl around the continent. These winds have isolated the Antarctic interior from the warming patterns seen on the continent’s peninsula and throughout the rest of the world.
“The warming of the Antarctic may have been delayed because of the ozone hole,” says atmospheric scientist Judith Perlwitz, a climate scientist at the of the University of Colorado at Boulder and the National Oceanic and Atmospheric Administration.
Let it be said, as real climatologists have been telling us for decades, there is no consensus that we are in a period of global warming. As this article supports, the Antarctic (the Southern Hemisphere in general) has been experiencing a “unique cooling trend”.
Sounds like we’re heading for an Ice Age, to me.
Ok. Rant accomplished. I hope my invite to SciFoo ’08 isn’t retracted. I’ll overblog this with something good I just read about FredCoBio…
Posted by Jim H on April 28, 2008
I ran across this article last week in medicalphysicsweb.com, so might as well post it. All kinds of news from the Fort this week:
Apr 15, 2008
A new take on MRI contrast
The US National Cancer Institute (NCI) has given the go-ahead for preclinical characterization of a nanomaterials-based contrast agent that’s being billed, at least by developers in industry, as “a completely new approach to enhancing contrast during MRI procedures”.
The modified fullerene compound comes from the labs of Luna Innovations, a Roanoke, VA-based technology-transfer company with interests in healthcare, telecoms, energy and defence markets.
Studies of the MRI contrast candidate will include characterization of its physical attributes, its in vitro biological properties and its in vivo compatibility using animal models. Researchers will also examine critical parameters related to distribution, metabolism, elimination and toxicity.
The study programme is expected to take a year from receipt through the in vivo phase. Evaluation will be carried out at the NCI’s Nanotechnology Characterization Laboratory (NCL) in Frederick, MD. The NCL’s remit is to standardize preclinical characterization of nanomaterials intended for therapeutic and diagnostic applications.
“The outcome of this characterization study is the report necessary for an Investigational New Drug application,” said Chris Kepley, nanoimmunology group leader at Luna and principal investigator on the study. “The process of getting a new drug to market can be a lengthy one. However, with the NCL behind us we hope to move forward more quickly bringing to market a next-generation solution for MRI contrast agents.”
Posted by Jim H on April 27, 2008
I ran across an article in Medical News Today from 18 Feb:
Disfigured Wounded US Soldiers To Get New Skin, Ears And Fingers
Article Date: 18 Apr 2008 – 9:00 PDT
The US Department of Defense has announced the launch of a five year collaborative program to make use of cutting edge medical technology to treat service members who are badly disfigured from injuries received while serving in wars.
Giving an example of the type of innovative treatment the new initiative would be developing, Lt Gen Eric Schoomaker, who is Surgeon General of the US Army told a press conference held at the Pentagon yesterday, Thursday 17th April, about one case of a badly burned Marine who was going to receive a new ear grown from his own stem cells.
Using the patient’s own stem cells to regenerate replacement skin, tissue and other body parts is an area currently being explored by the new Armed Forces Institute of Regenerative Medicine (AFIRM) said Schoomaker.
AFIRM will come under the US Army’s leading medical research, development and acquisitions agency for related supplies, the US Army Medical Research and Material Command at Fort Detrick in Frederick, Maryland, which ultimately reports to Schoomaker in his capacity as Army Surgeon General.
I’m not clear from this article exactly how much of the research will occur at the Fort, but the possibilities are exciting to me, especially since I am working in the field. I knew that there was a bit of this research going on through DARPA funding, but I am glad that “RegMed 2.0″ has made it to the mainstream and Frederick is, once again, leading the pack.
For the initial five year period, AFIRM will be funded by an overall budget of around 250 million dollars, 80 of which will come from the Department of Defense, and the rest from organizations like the National Institutes of Health, the Department of Veterans Affairs, and matching funds from other public and private organizations.
Posted by Jim H on April 27, 2008
I’ve enjoyed Jason Balog’s write-ups about Biotech in the FNP. I believe this is the second one. He seems to have an interesting angle on the events of the times and certainly has a good grasp of the local Biotech scene.
Among the interesting points:
- approximately two dozen lawmakers were forming a biotechnology and life sciences caucus to promote the industry throughout the state.
- The Biotechnology Investment Incentive Tax Credit remained intact and was again funded in the budget at the amount of $6 million
- The Md Stem Cell Research fund “did suffer a cut, I am happy to report that lawmakers settled on $19 million for the fund with $1 million more possible, depending on the availability of extra money from the Cigarette Restitution Fund.”
- My Rant here: Funding Stem Cell research with tobacco money? Oh, the horror. In case you forgot, a vast majority of MdSCRF funding went to Hopkins who, by the way, already make a boat load of cash treating patients who use tobacco.
And the summary paragraph:
It was a quiet year in the legislature on the life sciences front. The current budget situation did not allow for the expansion of current programs or the initiation of new programs. However, momentum continues to build for the life sciences industry in the state as reflected by the creation of the new biotechnology and life sciences caucus. Many anticipate that the next two legislative sessions are going to be critical for the industry to grow in Maryland, and assuming that the economy cooperates I would expect to see new and exciting initiatives to help Maryland become the premier location for the life sciences industry.
Posted by Jim H on April 25, 2008
I have been busy the past few days and haven’t been able or motivated enough to put a real post together. So this morning, after being reminded that I had left MedImmune off the Companies list (which is one of the most popular Pages on the Blog in terms of hits), I wanted to take a step back to a press release from Feb. 6th from a new company started in Frederick County named Vaccinogen. This could be a really big story if they are able to demonstrate this process is effective.
Here’s the blurb from their web site:
Frederick, MD – February 6, 2008 – Cancer research pioneer Michael G. Hanna Jr. Ph.D., also Vaccinogen, Inc.’s Founder, Chairman and CEO has acquired the rights to OncoVAX®, a vaccine with the potential to prevent colon cancer from recurring in many patients.
“This agreement represents a major step forward in defeating cancer by increasing the body’s immunity to it,” said Dr. Hanna, who has been working on cancer vaccines for more than 30 years.
“This agreement represents a major step forward in defeating cancer by increasing the body’s immunity to it.”
In the agreement, Vaccinogen obtained exclusive license to OncoVAX® Active Specific Immunotherapy as well as an important component of the product TICE BCG. The vaccine is made from the patients’ own tumor and is injected back into the patient to effect an immune response against recurrence of that cancer.
The FDA views Stage II colon cancer as an unmet medical need. When colon cancer recurs after surgery it is frequently fatal. OncoVAX® prevents that recurrence and thereby reduces recurrence and deaths by over 50%. Vaccinogen is currently preparing to commercialize the vaccine in Switzerland.
I should also post an update off their web site from Feb 27th, that announces the availability of the vaccine in Europe:
Frederick, MD – February 27, 2008 –Vaccinogen, Inc. announced that its new vaccine to block colon cancer from recurring will be commercially available in Europe starting June 2008.
“This makes OncoVAX® the world’s first commercially viable vaccine for colon cancer,” said Dr. Michael G. Hanna, Jr., Ph.D., Chairman & CEO of Vaccinogen. “It is the beginning of our worldwide strategy of profitable distribution. Questions of the feasibility of patient specific anti-cancer therapies have been raised and this new European initiative will obviate these issues.”
Pro Vaccine AG, a leading Swiss-based pharmaceutical distributor, will begin distributing OncoVAX® throughout Switzerland starting with Zurich and Neuchâtel by June 2008. “We are very excited about the prospects of offering OncoVAX® to Swiss and foreign patients,” said Renato Duckeck, GM of Pro Vaccine.
Pharmacenter Hungary, a rapidly growing oncology company that commercializes a broad portfolio of oncology treatments, will begin distributing the vaccine in Hungary, Czech Republic, Slovakia, Poland, Romania, Bulgaria and Slovenia starting in the third quarter of 2008. Dr. Christian Galli, Director of Business Development of Pharmacenter Hungary noted, “We recognize the excellent opportunity OncoVAX® provides us and the growing population of colon cancer patients in Eastern Europe.”
And I also wanted to go waay back to an article I started a post about in January that ran in the FNP when Vaccinogen first started. From the FNP, 1/22/08:
A company that uses a unique system to fight colon cancer has opened in Frederick.
Vaccinogen, located at 5300 Westview Drive, uses some of the patient’s own cancer cells to help cure the disease.
The company is headed by Michael Hanna, director of the National Cancer Research Center in Frederick from 1975 to 1983.
“At that time, I headed the entire operation,” he said of the cancer center. “We went from a small center to 50 buildings.”
After he left, the center’s operations were broken into several divisions, each headed by a different director, he said.
Although a resident of Bethany Beach, Del., Hanna said he is happy to be back in Frederick. It seemed the perfect place to locate the headquarters for his company.
Vaccinogen has a manufacturing plant in Emmen, Holland.
Although still undergoing studies here for approval, Vaccinogen’s system is being used in Switzerland.
“It is considered a transplant there,” Hanna said.
The immunotherapy, known as OncoVAX, follows surgery for removal of Stage II colon cancer. The tumor cells are processed in the facility in the Netherlands.
A specific vaccine is created using those cells and injected into the patient in four doses during a six-month period. The vaccine unleashes the body’s own immune system to fight cancer cells.
“It is the first time a patient-specific therapy has been successful,” Hanna said.
“We have done all the hard work. There are final clinical trials that need to be done,” he said.
Even though it was put on the fast track by the federal Food and Drug Administration, it will be four years before OncoVax could be on the market in the United States, Hanna said.
He said he would like to eventually build a manufacturing plant in the U.S., most likely in Baltimore.
“It is truly a Frederick product,” Hanna said. Research for the process began at the Frederick Cancer Research Center.
When he left the local cancer research center, Hanna ran a research institute for Litton Bionetics on individualized targeted therapy. That institute was later acquired by Azko Nobel. At that time, Hanna’s research team also developed a treatment for bladder cancer that is considered the standard for today.
Hanna acquired the OncoVaX technology and formed a company called PerImmune in 1997. In 1998, PerImmune merged with Intracel Corp., but Hanna continued to hold OncoVAX assets and formed Vaccinogen.
More than $300 million has been spent on research during the 35 years of OncoVax’s development.
Besides Switzerland, and eventually the U.S., Hanna said the company is working to market the product in Eastern Europe and other locations.
I knew a bit about the history of Vaccinogen before this story came out because we were doing a little work with their predecessor, Intracel, as they were closing up operations. Intracel also made HDL and LDL, which I believe Vaccinogen also acquired and is making today. Anyway, they have real nice History and TimeLine pages, with nostalgic pictures scrolling across the top of their About Us page.
So here’s where the story gets real interesting. The whole thing started in the 60′s with the formation of Litton Bionetics, which became a popular target of the conspiracy theorists in the 90′s due to their links with the military and germ warfare. It is a documented fact that Litton Bionetics was a major Defense Contractor of the time and the recipient of a1970 Dept. of Defense appropriations request for 10 million dollars for a 5 year study to develop immune system targeted micro-organisms for germ warfare. What they did with the money is where people get excited.
This research was overseen by Dr. Hanna the likes of emerging giants in the field such as Dr Robert Gallo, working at the National Cancer Institute at the time. To make a long story short, the conspiracy theorists claim, amongst other things, that this group is responsible for introducing AIDS & Ebola as a contaminant in a polio or small pox vaccine used in Africa in the 70′s. The allegation is that the vaccine was contaminated with monkey retrovirus that were used in germ warfare experiments.
Quite frankly, I was expecting to do a brief post on he topic, but my research took a strange turn towards the bizarre I had not anticipated. A long, unsubstantiated rumor, or maybe just a bit more Frederick County Biotech folklore?
And I thought Stem Cells were controversial……
Posted by Jim H on April 24, 2008
With an endorsement from my “info-friend” Attila @ PIMM I am very happy to be invited this year to attend “SciFoo” camp at the Googleplex somewhere in California. It’s like the ultimate achievement of my blogging ScienceGeek career!
We’d like to invite you to join us on the weekend of August 8-10 for Science Foo Camp (or “Sci Foo”), a unique, invitation-only gathering organized by Nature, O’Reilly Media, and Google, and hosted at the Googleplex in Mountain View, CA.
Now in its third year, Sci Foo is already achieving cult status among those with a passion for science and technology. The Economist said that it “capture[s] the essence of innovation”; in a photo essay for Edge (http://tinyurl.com/3o9sam), George Dyson wrote of the “the impossible choice” when deciding which sessions to attend; another attendee described it simply as “The best gathering ever. Period.”
As before, we will be inviting about 200 people from around the world who are doing groundbreaking work in diverse areas of science and technology.
Participants will include not only researchers, but also writers, artists, investors, and other thought-leaders.
The format is highly informal: all delegates are also presenters and demonstrators; the schedule is determined collaboratively on the first evening; and sessions continue to be organized and re-organized throughout the weekend. This creates a unique opportunity to explore topics that transcend traditional boundaries, and discussions are of a kind that happens at the best conferences during breaks and late into the night.
Of course, there will also be time to have fun and relax at Google’s legendary campus.
Sci Foo 2008 will run from about 6pm on Friday, August 8 until after lunch on Sunday, August 10. Campers need to make their own way to and from the event, but Google will provide accommodation and meals, and there is no registration fee. For those who don’t have cars, there will also be free shuttle buses between the hotel and the Googleplex.
Please RSVP by replying to this email. We do have space restrictions, so if you’d like to attend please be sure to reply as soon as possible, and in any case by May 16.
We hope to see you at the Googleplex in August!
Tim O’Reilly, O’Reilly Media
Chris DiBona, Google
Timo Hannay, Nature
Nature Publishing Group (NPG) is dedicated to serving the information and communication needs of scientists and medics. NPG’s flagship title, Nature, first published in 1869, has now been joined by over 80 other titles, among them the Nature research journals, Nature Reviews, Nature Clinical Practice and a range of prestigious academic journals including society-owned publications. It also operates the leading scientific website, Nature.com, and a range of innovative online services, from databases to collaboration tools and podcasts. For more information, see http://www.nature.com.
O’Reilly Media spreads the knowledge of innovators through its books, online services, magazines, and conferences. Since 1978, O’Reilly has been a chronicler and catalyst of leading-edge development, homing in on the technology trends that really matter and spurring their adoption by amplifying “faint signals” from the alpha geeks who are creating the future. Whether it’s delivered in print, online, or in person, everything O’Reilly produces reflects the company’s unshakeable belief in the power of information to spur innovation. An active participant in the technology community, the company has a long history of advocacy, meme-making, and evangelism. For more information, see http://www.oreilly.com.
About Foo Camps
The “Foo Camp” meeting format has been pioneered by O’Reilly (see http://xrl.us/b9sv). In this context, “Foo” originally stood for “Friends Of O’Reilly”, but it is also a meaningless ‘placeholder word’
commonly used by computer programmers, rather like the term ‘X’ in algebra. The success of O’Reilly’s original technology Foo Camps has stimulated a wide range of similar events, from Science Foo Camp to Disney’s Pooh Camp.
Posted by Jim H on April 22, 2008
Some more good news today coming out of the “Incubator“. According to the Baltimore Business Journal, Frederick’s own ChromoTrax was awarded a $50K grant from TEDCO for a collaboration with UMB for the “diagnosis and treatment of people with genetic-based diseases”.
I wonder if this means and end to androgenic alopecia?
Posted by Jim H on April 22, 2008
Every once in a while, I can be bribed enticed to post something happening outside Frederick County. Even though I had promised to do this last week, it is still not too late to let you know that Horiba and Microfluidics are cosponsoring a seminar in the Rockville, Maryland on April 24th. The Seminar will cover Particle Characterization and Bioprocessing. The review of the core Microfluidics technology will include new drug delivery applications.
More details from the Website:
Particle Characterization and Processing Seminar and Workshop – CA
Thursday, April 24, 2008, 8:30 AM – 3:30 PM
The Legacy Hotel and Meeting Center
1775 Rockville Pike
Microfluidizer High-Shear Fluid Processing: Core Technology and BioPharmaceutical Applications
by Mimi Panagiotou, Ph.D., Microfluidics
High Level Expression Through Pichia Pastoris Fermentation
by Ben Woodard, University of Maryland
Process Development of a Novel Malaria Vaccine Candidate
by Richard Shimp, National Institute of Health, NIAID
Size Specifications in the Pharmaceutical Industry
by Mark Bumiller, HORIBA Instruments
Particle Size Method Development and Validation Support of NanoCrystal Colloidal Dispersion Formulation Characterization.
by Joost Straster, Elan Pharmaceuticals
Particle Characterization Applications in the Pharmacetuical Industry
by Mark Bumiller, HORIBA Instruments
There is no fee for this seminar, but reservations are required. Call 1-800-370-5452 x 234 or email Christian Beer to secure your reservation.
Posted by Jim H on April 21, 2008
I am being pestered to place more pictures of BioBeers III on the web site. Thus far, only 7 people have figured out that by clicking the photo below, you would be exposed to a whole gamut of BioBeers II photos. So, here are a couple for those not capable of advancing their IT degrees…
I’ll try to post a couple other stories later.