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Embryonic stem cell therapy in China (www.esctherapy.com)

Posted: August 16, 2011 at 2:39 am

Since 2002, ESC therapy has treated over 10000 patients with degenerative diseases, injury and cancer, now it has move on to help people to delay ageing as disease usually comes from weaken and aged cells. ESC therapy provides young healthy cells to replace aged and mutated cells in order to prevent disease and delay ageing.

Go here to see the original:
Embryonic stem cell therapy in China (www.esctherapy.com)

Posted in Cell Therapy | Comments Off on Embryonic stem cell therapy in China (www.esctherapy.com)

ACT – Stem Cell Trial for AMD and Stargardt – Phase 1

Posted: August 15, 2011 at 9:44 pm

Advanced Cell Technology starts first two phases for AMD and Stargardt. Each phase will take one year. Phase 1 and Phase 2

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ACT - Stem Cell Trial for AMD and Stargardt - Phase 1

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Stem Cells: Saving Lives or Crossing Lines, Part II: Lessons Learned (Video 2 of 4)

Posted: August 15, 2011 at 9:44 pm

The use of embryonic stem cells in research has become a highly complicated and politically charged issue. This conference will discuss the complexities of this research policy in Texas and examine future policy alternatives by looking at initiatives outside the state. The goal is to introduce a new and more effective dialogue regarding safeguards against reproductive cloning and other unethical practices while advancing research in the state.

Read the original here:
Stem Cells: Saving Lives or Crossing Lines, Part II: Lessons Learned (Video 2 of 4)

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Parkinson’s Disease: Spotlight on Stem Cell Research – Jeff Bronstein

Posted: August 15, 2011 at 9:44 pm

(Part 1 of 3) Jeff Bronstein, MD, Ph.D., spoke at the "Spotlight on Parkinson's Disease," an educational event presented at the CIRM Governing Board meeting on May 7, 2008.

See more here:
Parkinson's Disease: Spotlight on Stem Cell Research - Jeff Bronstein

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Dr. Craig Saunders Adult Stem Cell Therapy

Posted: August 15, 2011 at 3:11 am

Dr. Saunders is one of only a handful of doctors in the country who offer complete on-site adult stem cell retrieval, harvest, and adult stem cell therapy.

Read more:
Dr. Craig Saunders Adult Stem Cell Therapy

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Good Data? $100. Good Product Development? $100. Good Commercialization Strategy? Priceless.

Posted: August 14, 2011 at 4:04 pm

I'm not going to fool anyone into believing I'm a therapeutic product development expert but that's not going to stop me from making a few humble observations in light of the Dendreon "fiasco" of last week which I have no doubt will one day be considered an unfortunate pothole on their road to eventual success.

(though perhaps not before certain current management finds themselves polishing their CVs or retiring to spend their time alternating between their yachts and the courtroom defending their questionable stock trading antics)

I received the following message this morning by email. I don't include it here to promote or endorse or even comment on NWBT, DCVax, Linda Powers, or Toucan Capital in any way -- or in a way that is blind to all the things right or wrong about any of them -- but simply to illustrate the 3 points I want to make below the email.
NWBT HIGHLIGHTS COST EFFECTIVENESS OF DCVAX® IN VIEW OF RECENT IMMUNOTHERAPY PRICING CONCERNS

Northwest Biotherapeutics' (OTC.BB: NWBO)... DCVax® immune therapies for a broad range of cancers (including prostate, brain, ovarian and others) hold the promise, based on available data to date, of being cost effective and priced below other immune therapies while still providing substantial profit margins for the Company and longer survival for patients.

The investor concerns in the news relate to the pricing and reimbursement of Provenge for late stage, metastatic prostate cancer. Provenge is priced at $93,000 for one month of treatment and was approved by the FDA based upon having added 4.5 months of patient survival (to reach overall survival of 25.9 months).

NWBT’s DCVax® will be priced in the range of $37,000 per year for up to 3 years of treatments. In NWBT’s Phase I/II multi-center clinical trial in late stage, metastatic prostate cancer, DCVax® added 18 months of patient survival (to reach overall survival of 38.7 months). DCVax® has previously been cleared by the FDA for a 612-patient, randomized, controlled Phase III trial, although the trial has not yet begun. As is typical before a Phase III trial, the manufacturing processes and product costs have already been determined.
...
...

The key to the substantial pricing advantage of DCVax® is NWBT’s proprietary batch manufacturing process together with its cryopreservation technology for frozen storage of the finished vaccine. NWBT has spent a decade developing and improving its manufacturing and cryopreservation processes. The manufacturing of personalized, living cell products is expensive. But the frozen storage of living cells is quite low-cost – once the specialized freezing technology is worked out for a particular type of cells (the culture conditions, rate of freezing, density of cells and many other factors).

NWBT’s manufacturing methods produce – in a single manufacturing run – a large batch of personalized DCVax® product for 3 years of treatments are much less costly than separate manufacturing runs for each treatment. The technology for freezing the master immune cells (dendritic cells) which comprise DCVax® enables these
cells to remain frozen for years and, when needed, to be thawed and “come back to life” with full potency.

This approach makes DCVax® an "off the shelf” product [for that patient] for several years of treatments after just one manufacturing run. In contrast, Dendreon must do a separate manufacturing run for each one month of treatments. In addition, Dendreon's Provenge product is fresh and not cryopreserved, which limits its shelf life to at most a few weeks.

Another important factor in the cost effectiveness of DCVax® is its simplicity and ease of administration. DCVax® is delivered as a small intra-dermal injection under the skin, similar to a flu shot. As such, it can be administered in any physician’s office or clinic. There is no lengthy intravenous infusion, with the attendant patient discomfort, cost and need for a specialty infusion center. In contrast, Dendreon’s Provenge is delivered by intravenous infusion.

The cost effectiveness of NWBT’s DCVax® is enhanced by the fact that DCVax® is targeting a portion of the prostate cancer market that is 4 times the size of the market segment that Dendreon’s Provenge is currently targeting....

Now this is NWBT clearly blowing their horn - nothing wrong with that - in an attempt to woo back frightened investors. I'm agnostic as to whether any of it is true but it does serve to draw out several points of distinction between what some companies might do to optimize their products for commercial success versus what others might do in an overriding belief that clinical benefit is the only precursor to the happiness of investors, the physician community, patients, and partners.
What I say below is not a commentary, in criticism or praise, on any particular company including NWBT or Dendreon. Many others - Luke Timmerman among the best of them - have provided outstanding and in-depth analysis of the Dendreon story along the way.
I'm only interested in what we as an industry might learn from recent experiences or trends and to perhaps facilitate a useful discussion based on 3 simple observations from someone who has swum in this cell therapy pond for now just over a decade:
1. There is a tendency among some to believe that what we are making (cell-based therapies) are so revolutionary and compelling that the products should almost sell themselves - to investors, partners, regulators, insurers, physicians, and patients.
Of course we know it's not true but sometime we act like it is.
Appligraf and Dermagraft didn't sell themselves to physicians even after regulatory approval. Neither is Provenge apparently-- though they did a good job of selling it to very vocal patient groups. Organogenesis and Advanced Biohealing had to work very long and hard to get profitable reimbursement and market penetration. Dendreon will too.
Investing early in understanding potential clinical adoption hurdles, reimbursement issues, and how the product is and will be perceived not by its champions but by its critics and most importantly, the average agnostic practitioner, is not easy to do because it means spending precious resources long before there is a product to sell but it may mean the difference between a product which eventually sells and one which doesn't.
2. There is a tendency to de-emphasize what I call the "ancillary sciences" around a product -- like lowering the cost of goods, optimizing fresh or frozen storage, cell delivery (e.g., injection/application science) mechanisms, in vivo cell tracking, onsite clinical handling, etc.
Product development science is a science. The science that turns good data into something commercially viable. Not everyone is good at it and certainly this is where a lot of companies fail. PD is not the 'second cousin' in the room of esteemed basic and clinical science.
Take these examples when considering the cellular immunotherapy sector:
Several prominent immunotherapy investigators I have spoken with strongly believe cell-based immunotherapies will require long-term administration to be meaningfully effective -- certainly longer than 3 doses in 3 months. Did Dendreon lock into their clinical protocol too early?
Other immunotherapy companies - like Opexa Therapeutics for instance - create multiple doses for a patient from a single patient collection thus saving considerable expense and creating a better patient experience. Did Dendreon lock into their manufacturing protocol too early?
Other companies are investing heavily in finding ways to extend viable shelf-life of their fresh products or to create cryopreserved versions of their product to optimize its commercial viability.
Imagine a Dendreon that only had to build one manufacturing facility (with a backup CMO) to serve the US market rather than 3 facilities. With a cryopreserved version of the product or a version that had longer than its current limited shelf-life (~72 hours I believe?) that might have been possible.
At every point in clinical development there must be concurrent R&D towards the product's:
  1. science (e.g., MOA, characterization, etc),
  2. clinical effect, and
  3. how to optimize its commercial viability - a big part of which is what we think of as 'product development'.
This is the 3-legged footstool of a commercialization strategy geared for success (credit to Bob Preti of Progenitor Cell Therapy for this analogy).
But 'product development' is also not always about the product strictly speaking and even an expansive definition of product development is only part of a good commercialization strategy.
There is significant component of it that is about studying ways to lower the cost of goods, improving manufacturability and scalability, how hard/easy it is to handle, the patient treatment experience, the physician experience, how it impacts patient's QOL (quality of life), not just what side effects it generates but what side effects it prevents (resulting from other treatments or no treatment) and the cost-savings that generates, etc.
Other cell therapy companies have been more proactive in terms of engaging not only KOLs but average practitioners in a meaningful way that might impact their product and clinical design as well as reimbursement and clinical delivery issues.
3. There is an understandable, largely VC-driven, desire to race forward to the next trial phase when a phase-repeat to optimize or better understand different aspects of the product might be the better way to go.

What's worse? Facing the prospect of not being able to get funding or a partner on the terms one wants for a 2nd phase II or burning through a bunch more money in phase III in an attempt to bring a product to market that isn't market ready? I understand its a tough choice -I'm not saying it's an easy one - but one is certainly more strategic and, as pharma says, is certainly a "de-risking" pathway.
Consider the ratio of products we've seen thus far in the cell therapy industry's short life-span that have been raced to phase III or (worse yet) market only to seriously stumble if not fail when they get there. I can think of 8-10 off the top of my head and there are less than 20 cell or tissue based therapies on the market in US/EU that have received any kind of formal regulatory approval.
Some would argue that this is a prime example of why spinning companies out of academia too early is not beneficial because companies want to minimize exploratory science and lock into a "product" too early. I would argue that this may be true if the problem is understanding the product characterization or mechanism of action but not if your problem is related to how best to develop/optimize the product for commercial viability. Few academics are geared to think this way.
Summary
I certainly don't believe Dendreon failed to identify or consider each and every one of the things they might have done better along the way. I'm sure they did and sure they made calculated judgement-calls about how to approach each one.
Since I'm not a shareholder I don't have to worry myself about being critical of their decisions but rather simply to do what I can to ensure that we as an industry do our best to learn from what - with the benefit of retrospect - may be apparent they did right and wrong.
What are your thoughts? To what extent are the problems that Dendreon has experienced along the way with PROVENGE a predicable result of it being a first-generation product or the result of insufficient focus on critical investigation into the less sexy "ancillary sciences" of product and commercial optimization?
(comment below and/or in the LinkedIn Cell Therapy Industry Group)



Posted in Regenerative Medicine | Comments Off on Good Data? $100. Good Product Development? $100. Good Commercialization Strategy? Priceless.

International Stem Cell Corporation: A Company with Scores of Potential by Deborah Sterescu

Posted: August 14, 2011 at 4:04 pm

International Stem Cell Corp (OTCBB:ISCO) is a company to watch this year, with several promising developments in store, according to a conference call with investors this morning.


The company, whose parthenogenetic stem cell technology can be used to derive pluripotent stem cells, meaning they can be transformed into any cell type in the body, has many important advantages at its fingertips.


Regenerative medicine is a market that is set to boom in the coming years, as more and more companies are developing therapies based on stem cell use. International Stem Cell's long-term goal is to be a universal supplier of stem cells for not just one, but a host of therapies.


The company's parthenogenetic stem cells are derived from unfertilized eggs, avoiding the ethical issues behind the destruction of viable human embryos, and giving cell-therapy companies one big reason to chose International Stem Cell as their supplier of choice when the time is right.
These parthenogenetic cells, like embryonic cells, also have the capacity to become almost any cell type in the body, but have demonstrated they are better in terms of the immune system, as one single stem cell line can be genetically matched to millions of people, reducing the need for immunosuppressants.


The company holds the world's largest collection of research-grade human parthenogenetic stem cell (hpSC) lines, which it uses along with its partners to investigate cellular therapies for a number of incurable human diseases.


Its plan is to establish a US bank of its clinical-grade human parthenogenetic stem cells that will be capable of being immune-matched to millions of patients, so that a physician could call up and request a specific cell type for people. The company, which recently received approvals to enroll around 3 US donors for its bank, already has a collection of ten human parthenogenetic stem cell lines used for research purposes, which were derived outside the US.


These cell lines could potentially be used to cure a number of diseases, including cancer, heart disease, liver disease, among many others. Already, the company has several trials in the works, and has successfully demonstrated in pre-clinical animal studies that its stem cells can be used to create viable liver cells.


Currently, efficacy tests in rat models are in progress for the liver cells, with results anticipated soon. If successful, the company said it plans on aggressively initiating the FDA process, with the aim of beginning first stage clinical trials sometime in 2012. The hope is that International Stem Cell will attain Fast Track designation, as few alternative options are available to patients suffering from liver disease.


The company also has trials in the works for Parkinson's disease and diseases of the eye, and is actively looking for collaborative or joint venture opportunities, as well as in-licensing and out-licensing arrangements.


In addition to its hugely potentially valuable stem cell therapy business, the company also two other operations that are set to generate revenue in the meantime. Lifeline Cell Technology, which saw sales grow by 35% in the first quarter, develops manufactures and markets the Lifeline brand of cell-culture products, which are used by researchers to grow human cells for pre-clinical research.


The subsidiary's products are developed using parent International Stem Cell's technology, and the company expects that as trials for researchers progress into more advanced stages, its technology will be embedded in this progress, potentially generating hundreds of millions of revenue.


In the last quarter, Lifeline Cell gained over 200 new customers due to new product introductions and the development of distribution channels internationally, a strategy it plans to continue.


Lastly, International Stem Cell's Lifeline Skin Care business sells skin care products based on its stem cells, having a very successful launch at the end of last year. The company planned on selling 1,000 products, but sold 7,000 initially, and plans to aggressively kick start major marketing initiatives again in September.


International Stem Cell is a company with scores of upside potential, and though future capital raising has not been ruled out, it has a facility that allows it to draw equity as necessary.
Register here to be notified of future International Stem Cell articles

Posted in Stem Cells, Stem Cell Therapy | Comments Off on International Stem Cell Corporation: A Company with Scores of Potential by Deborah Sterescu

Part Two: The Ellis Martin Report – Interview with Ken Aldrich of International Stem Cell Corp.

Posted: August 14, 2011 at 4:04 pm

International Stem Cell Corporation trades under the symbol ISCO.OB on the Over the Counter Bulletin Board and is based in Carlsbad, California where Ellis Martin had the pleasure of interviewing Executive Chairman Kenneth Aldrich. 


International Stem Cell has developed a process to derive stem cells similar to Embryonic Stem Cells without the need for fertilized embryos and with minimal exposure to non-human cells. These factors provide ISCO a unique leadership role in the field of regenerative cell therapy. Additionally, Lifeline Cell Technology, (a wholly-owned subsidiary of International Stem Cell Corporation (ISCO) develops, manufactures and markets high-quality human primary cells, stem cells, media and reagents for sale to pharmaceutical, academic and government scientists. 

The company's management pioneered the development of the normal human cell culture market through the creation of Clonetics® Corporation in the 1980s and has over 20 years combined experience in research, development, manufacturing, quality control, marketing and sales of human cell culture products. Lifeline's products are distributed in the United States and Europe. http://www.ellismartinreport.comhttp://www.intlstemcell.com contact: martinreports@gmail.com 
International Stem Cell is a paid sponsor of The Ellis Martin Report
Posted in Stem Cells, Stem Cell Therapy | Comments Off on Part Two: The Ellis Martin Report – Interview with Ken Aldrich of International Stem Cell Corp.

The Ellis Martin Report: Interview with Ken Aldrich of International Stem Cell Corp.

Posted: August 14, 2011 at 4:04 pm

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Please click on the arrow above to listen to the complete interview.

"Ken Aldrich of International Stem Cell Corp (ISCO.OB) on the Present and Future of Stem Cell Research and Applications"

The Ellis Martin Report: International Stem Cell Corporation trades under the symbol ISCO.OB on the Over the Counter Bulletin Board and is based in Carlsbad, California where I have the pleasure of interviewing Executive Chairman, Kenneth Aldrich. International Stem Cell has developed a process to derive stem cells similar to Embryonic Stem Cells without the need for fertilized embryos and with minimal exposure to non-human cells. These factors provide ISCO a unique leadership role in the field of regenerative cell therapy. Additionally, Lifeline Cell Technology, a wholly-owned subsidiary of International Stem Cell Corporation (ISCO), develops, manufactures and markets high-quality human primary cells, stem cells, media and reagents for sale to pharmaceutical, academic and government scientists. The company’s management pioneered the development of the normal human cell culture market through the creation of Clonetics® Corporation in the 1980s and has over 20 years combined experience in research, development, manufacturing, quality control, marketing and sales of human cell culture products. Lifeline’s products are distributed in the United States and Europe. Ken Aldrich, welcome to the program.
For the complete text version of this broadcast: http://www.ellismartinreport.com/node/148

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Reminder: International Stem Cell Holding Business Update Conference Call on August 10

Posted: August 14, 2011 at 4:04 pm

International Stem Cell Corporation (OTCBB:ISCO) reminds investors that it is holding a conference call and webcast on Wednesday, August 10, 2011 at 11:00 a.m. Eastern (8:00 a.m. Pacific). Chairman Ken Aldrich will provide an update on the business, including plans for the future development of the skin care line; animal and potential clinical trials for Parkinson's and liver diseases; and the Company's business strategy for 2011 and longer term.


Individuals interested in listening to the conference call may do so by dialing 877-407-8033 for domestic callers, or 201-689-8033 for international callers, or from the webcast on the investor relations section of the Company's Web site athttp://www.intlstemcell.com.


A telephone replay will be available approximately one hour after the conclusion of the call by dialing (877) 660-6853 for domestic callers, or 201-612-7415 for international callers, and entering the account code: 286 and the Conference ID: 376367. The webcast will be available on the Company's Web site for 60 days following the completion of the call.


About International Stem Cell Corporation
International Stem Cell Corporation is focused on the therapeutic applications of human parthenogenetic stem cells and the development and commercialization of cell-based research and cosmetic products. ISCO's core technology, parthenogenesis, results in the creation of pluripotent human stem cells from unfertilized oocytes (eggs). hpSCs avoid ethical issues associated with the use or destruction of viable human embryos. ISCO scientists have created the first parthenogenic, homozygous stem cell line that can be a source of therapeutic cells with minimal immune rejection after transplantation into hundreds of millions of individuals of differing genders, ages and racial background. This offers the potential to create the first true stem cell bank, UniStemCell™. ISCO also produces and markets specialized cells and growth media for therapeutic research worldwide through its subsidiary Lifeline Cell Technology, and cell-based skin care products through its subsidiary Lifeline Skin Care. More information is available at http://www.internationalstemcell.com.


To subscribe to receive ongoing corporate communications, please click on the following link:http://www.b2i.us/irpass.asp?BzID=1468&to=ea&s=0.

International Stem Cell Corporation

Kenneth C. Aldrich, Chairman
760-940-6383
kaldrich@intlstemcell.com
or:
Lippert/Heilshorn & Associates
Don Markley, 310-691-7100
dmarkley@lhai.com

Posted in Stem Cells, Stem Cell Therapy | Comments Off on Reminder: International Stem Cell Holding Business Update Conference Call on August 10

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