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Regenerative Medicine With Stem Cell Therapy Injections at an Arizona pain clinic (602) 507-6550

By NEVAGiles23

Amniotic Fluid Based Stem Cell Injections are being offered at Preferred Pain Center in Arizona. The injections offer an opportunity to harness the body's regenerative potential and exponentially increase it: 1) Anti-inflammation 2) Hyaluronic Acid 3) Stem Cells 4) Non-steroidal, non-embryonic treatment Pain relief plus potential regeneration of cartilage and soft tissues such as rotator cuff and ligaments.

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Regenerative Medicine With Stem Cell Therapy Injections at an Arizona pain clinic (602) 507-6550

To Read More: Regenerative Medicine With Stem Cell Therapy Injections at an Arizona pain clinic (602) 507-6550
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Stem cells acquired from human skin

By daniellenierenberg

Japanese scientists from Kyoto University, led by Professor Shinya Yamanaka and American researchers from the University of Wisconsin, led by James Thomson managed to create multifunctional stem cells from human skin. Earlier, generation of stem cells required cloning or use of human embryos.

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Stem cells acquired from human skin

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Vitamin D deficiency unquestionably linked to bone fractures

By Dr. Matthew Watson

Recent research from Scotland reinforces the longstanding medical opinion that vitamin D deficiency leads to a significantly increased risk of bone fractures.

Among people with hip fractures referred to the Scottish fracture liaison service, 98 percent test positive for serious deficiencies in vitamin D. Supplementation with the vitamin, on the other hand, significantly reduces the risk of repeat fractures.

"Taking a supplement can make a difference quite quickly," said Stephen Gallacher, head of the liaison service. "Bone density can increase by 20 percent in a few months with enough vitamin D."

"We have found we can reduce fractures by something like 30 to 50 percent. It is our belief that we can significantly reduce the risk of fractures in the population by giving people anti-osteoporosis therapy and vitamin D supplements."Read more...

Cardiofy Heart Care Supplement

Source:
http://feeds.feedburner.com/integratedmedicine

To Read More: Vitamin D deficiency unquestionably linked to bone fractures
categoriaIntegrative Medicine commentoComments Off on Vitamin D deficiency unquestionably linked to bone fractures | dataAugust 21st, 2011
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The Cleverness Of The Apes (GALLERY) – Global Animal

By Dr. Matthew Watson


The Guardian (blog)
The Cleverness Of The Apes (GALLERY)
Global Animal
(GREAT APES/ANIMAL SCIENCE) In “Rise of the Planet of the Apes,” experiments with genetic engineering lead to an incredibly intelligent species of ape. In reality, these non-human primates are in fact very smart and have better, faster memories than we ...
Movie Review: Rise of the Planet of the ApesWishaw Press
Rise of the Planet of the Apes – 'Human, all too human'The Guardian (blog)

all 118 news articles »

Source:
http://news.google.com/news?q=genetic-engineering&output=rss

To Read More: The Cleverness Of The Apes (GALLERY) – Global Animal
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2nd International Festival of Biotechnology – India: – Sunday Observer

By Dr. Matthew Watson


Sunday Observer
2nd International Festival of Biotechnology - India:
Sunday Observer
Nalanda College, Colombo won first place at the 2nd International Festival of Biotechnology held at the CMS Rajendra Nagar Campus - 1 Lucknow, India. Fifty-six schools representing Sri Lanka, India, Bangladesh, Nepal, Bhutan, Pakistan and Russia ...

Source:
http://news.google.com/news?q=biotechnology&output=rss

To Read More: 2nd International Festival of Biotechnology – India: – Sunday Observer
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International Stem Cell’s Q2 Revenues Nearly Triple by Deborah Sterescu

By Dr. Matthew Watson

International Stem Cell Corporation (ISCO) (OTCBB:ISCO) reported Wednesday that second quarter sales more than doubled to almost triple, while year-to-date sales jumped a whopping 271%, as the company's operating subsidiaries continue to generate more revenue.
In addition to its hugely potentially valuable stem cell therapy business, the company also two other operations that have reflected revenue growth in the meantime, including Lifeline Cell Technology, which sells its cell-culture products to researchers to grow human cells for pre-clinical research, and Lifeline Skin Care, which sells skin care products based on its parent's stem cell technology.
For the three months ending June 30, International Stem Cell saw revenues rise to $1.1 million, from $0.44 million a year earlier.
Year-to-date revenues totaled $2.6 million, versus $0.7 million for the same period in 2010, helped by a $1.7 million contribution from Lifeline Skin Care, and a $0.9 million addition from Lifeline Cell.
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 ISCO plans to continue.
Meanwhile, the company's skin care business is coming off a highly successful launch at the end of last year, exceeding its plans to sell 1,000 products, with 7,000 products sold initially. Lifeline Skin plans to aggressively kick start major marketing initiatives again in September.
While these two subsidiaries are busy chalking up revenues, ISCO, 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. Like embryonic stem cells, they 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.
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. It has also started pre-clinical animal trials to create neuronal cells in the brain, to potentially cure Parkinson's disease.
Unsurprisingly, all this work to progress the company's technology has increased expenses, contributing to a $2.5 million loss in the second quarter, or a 3 cent loss per share.
Research and development costs grew on account of greater scientific projects, while general and administrative costs leapt on increased headcount as the company bulks up its management team.
International Stem Cell, with $3.6 million in the bank at the end of the quarter, said that it has not ruled out future capital raising, but it already has a facility that allows it to draw equity as necessary to secure its planned growth.

Source:
http://intlstemcell.blogspot.com/feeds/posts/default?alt=rss

To Read More: International Stem Cell’s Q2 Revenues Nearly Triple by Deborah Sterescu
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International Stem Cell Corporation Announces Second Quarter 2011 Financial Results and Corporate Events

By Dr. Matthew Watson


International Stem Cell Corporation (OTCBB: ISCO), a biotechnology company that developed a powerful new stem cell technology called "parthenogenesis" which promises to significantly advance the field of regenerative medicine, today announced financial results for the quarter ended June 30, 2011 and for the first six months of the fiscal year and provided an update on corporate events.

ISCO reported year-to-date revenues of $2.6 million compared to $0.7 million for the same time period in 2010, representing an increase of 271%. The increase in our revenues relates to sales generated by ISCO's wholly-owned subsidiaries Lifeline Skin Care (LSC) which contributed $1.7 million and Lifeline Cell Technology (LCT) which contributed $0.9 million of revenues.

Total year-to-date expenses, excluding cost of sales increased $2.0 million or 38%, compared to the first six months of the previous year. The most significant reasons for the increase in total expenses related to increases in R&D and G&A. Research & Development expenses increased primarily due to increased activity on our scientific projects. General & Administrative expenses increased primarily due to increased headcount, non-cash stock-based compensation and increased expenses related to business development activity and general corporate expenses.
Our cash balance at June 30, 2011 was $3.6 million. Net cash used in operating activities for the six months ended June 30, 2011 was $3.0 million.

Second Quarter 2011 Highlights:
-- The first U.S.-based donor was enrolled in ISCO's program to establish a bank of clinical-grade human parthenogenetic stem cells (hpSCs) capable of being immune-matched to millions of patients.

-- We strengthened our senior management team to assist in the continued development of the Company. Kurt May was appointed Senior Vice President responsible for mergers and acquisitions and development of new international collaborations. Donna Queen was added to the management team as Vice President of LSC, where she is responsible for marketing and business development.

-- We started a series of preclinical animal studies of neuronal cells derived from hpSCs. The studies will evaluate the in vivo safety and tumorigenicity of neuronal cells as well as their ability to develop into functioning dopaminergic neuron–like cells to treat Parkinson's disease.

-- We successfully completed the first series of preclinical testing of hepatocytes derived from hpSCs. In the transplantation mouse model, inoculated cells were capable of engrafting and surviving in specific niches within the liver, and were further developing into cells with essential hepatocyte-like features.

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 and Subsidiaries
(A Development Stage Company)
Condensed Consolidated Statements of Financial Condition
June 30,
2011
December 31,
2010
(Restated)(1)
(Unaudited)
Assets
Cash and cash equivalents
$
3,581,933
$
5,782,027
Accounts receivable
341,666
738,506
Inventory
1,329,433
856,083
Prepaid expenses and other current assets
290,196
228,338
Total current assets
5,543,228
7,604,954
Property and equipment, net
1,495,916
1,295,328
Patent licenses, net
1,056,562
986,714
Deposits and other assets
16,279
39,812
Total assets
$
8,111,985
$
9,926,808
Liabilities and Stockholders' Equity
Accounts payable
$
1,032,531
$
582,824
Accrued expenses
855,315
545,781
Deferred revenue
137,834
759,667
Advances
250,000
250,000
Warrants to purchase common stock
1,027,171
2,399,605
Total current liabilities
3,302,851
4,537,877
Commitments and contingencies
Stockholders' Equity
Common stock, $.001 par value, 200,000,000 shares authorized, 76,599,928 shares and 74,771,107 shares issued and outstanding at June 30, 2011 and December 31, 2010, respectively
76,600
74,771
Convertible preferred stock, $.001 par value, 20,000,000 shares authorized, 2,800,043 shares issued and outstanding at June 30, 2011 and December 31, 2010, respectively
2,800
2,800
Subscription receivable on common stock
-
(4,875
)
Additional paid-in capital
59,780,363
56,170,006
Deficit accumulated during the development stage
(55,050,629
)
(50,853,771
)
Total stockholders' equity
4,809,134
5,388,931
Total liabilities and stockholders' equity
$
8,111,985
$
9,926,808

(1)
The Company restated its financial statements for the year ended December 31, 2010, and the quarter ended March 31, 2011.
International Stem Cell Corporation and Subsidiaries
(A Development Stage Company)
Condensed Consolidated Statements of Operations
(Unaudited)
Three Months Ended
June 30,
Six Months Ended
June 30,
Inception
(August 2001)
through
June 30,
2011
(Restated)(1)
2011
2010
(Restated)(1)
2011
(Restated)(1)
2010
(Restated)(1)
Revenues
Product sales
$
1,114,309
$
441,118
$
2,629,225
$
713,744
$
5,728,390
Royalties and license
-
-
-
-
135,000
Total revenue
$
1,114,309
$
441,118
$
2,629,225
$
713,744
$
5,863,390
Development expenses
Cost of sales
362,131
214,330
791,125
360,706
2,506,597
Research and development
1,128,869
754,000
2,132,279
1,338,069
15,992,557
Marketing
345,800
291,576
664,006
424,994
3,063,155
General and administrative
2,135,732
2,033,615
4,368,470
3,408,821
27,692,292
Total development expenses
3,972,532
3,293,521
7,955,880
5,532,590
49,254,601
Loss from development activities
(2,858,223
)
(2,852,403
)
(5,326,655
)
(4,818,846
)
(43,391,211
)
Other income (expense)
Settlement with related company
-
-
-
-
(92,613
)
Miscellaneous expense
(12,040
)
(256
)
(11,140
)
(20,649
)
(28,652
)
Dividend income
-
350
-
25,999
92,875
Interest expense
-
(6,805
)
-
(14,079
)
(2,225,074
)
Sublease income
2,450
2,125
4,650
3,525
303,083
Change in market value of warrants
478,669
7,083,365
1,349,518
(1,347,960
)
(2,380,664
)
Total other income (expense)
469,079
7,078,779
1,343,028
(1,353,164
)
(4,331,045
)
Income (loss) before income taxes
(2,389,144
)
4,226,376
(3,983,627
)
(6,172,010
)
(47,722,256
)
Provision for income taxes
-
-
-
-
6,800
Net income (loss)
$
(2,389,144
)
$
4,226,376
$
(3,983,627
)
$
(6,172,010
)
$
(47,729,056
)
Dividends on preferred stock
$
(107,203
)
$
-
$
(213,231
)
$
(1,238,067
)
$
(7,751,380
)
Net income (loss) attributable to common stockholders
$
(2,496,347
)
$
4,226,376
$
(4,196,858
)
$
(7,410,077
)
$
(55,480,436
)
Basic earnings per common share
$
(0.03
)
$
0.06
$
(0.06
)
$
(0.11
)
Diluted earnings per common share
$
(0.03
)
$
0.04
$
(0.06
)
$
(0.11
)
Share used in per share calculations:
Weighted average shares outstanding
76,340,016
68,676,504
75,842,071
64,789,250
Weighted average shares outstanding on a Fully Diluted Basis
76,340,016
114,797,830
75,842,071
64,789,250
(1)
The Company restated its financial statements for the year ended December 31, 2010, and the quarter ended March 31, 2011.
http://cts.businesswire.com/ct/CT?id=bwnews&sty=20110817005393r1&sid=14230&distro=ftp
International Stem Cell Corporation
Kenneth C. Aldrich, Chairman
760-940-6383
kaldrich@intlstemcell.com
Or
Ray Wood, CFO
760-940-6383
rwood@intlstemcell.com

Source:
http://intlstemcell.blogspot.com/feeds/posts/default?alt=rss

To Read More: International Stem Cell Corporation Announces Second Quarter 2011 Financial Results and Corporate Events
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Part 3: The Ellis Martin Report with Ken Aldrich of Int Stem Cell Corp (ISCO.OB)

By Dr. Matthew Watson


Ellis Martin of The Ellis Martin Report interviews Ken Aldrich of International Stem Cell Corporation (ISCO.OB) on the latest research involving stem cell technology utilizing unfertilized eggs, as a basis for cell generation with a goal toward organ transplants which are immune to rejection by the body...as well as other applications. Mr. Aldrich also discusses neurological applications focusing on reversing Parkinson's disease. Preventing and reversing blindness is another topic covered. 


International Stem cell Corporation is a paid sponsor of The Ellis Martin Report

Source:
http://intlstemcell.blogspot.com/feeds/posts/default?alt=rss

To Read More: Part 3: The Ellis Martin Report with Ken Aldrich of Int Stem Cell Corp (ISCO.OB)
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Cutting edge classes coming to one Tampa high school – Central Florida News 13

By Dr. Matthew Watson


Central Florida News 13
Cutting edge classes coming to one Tampa high school
Central Florida News 13
(BN9 photo/Robert Hahn) Middleton High, a magnet school in Tampa, is offering courses in biomedical science and biotechnology to help prepare students for the 21st century. By Robert Hahn, Reporter An exciting new program is coming to Middleton High ...

Source:
http://news.google.com/news?q=biotechnology&output=rss

To Read More: Cutting edge classes coming to one Tampa high school – Central Florida News 13
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Embryonic stem cell therapy in China (www.esctherapy.com)

By LizaAVILA

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.

Read the original:
Embryonic stem cell therapy in China (www.esctherapy.com)

To Read More: Embryonic stem cell therapy in China (www.esctherapy.com)
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"Bone Marrow Stem Cells" Donald Kohn

By NEVAGiles23

"Bone Marrow Stem Cells: Developing New Therapies in the Fight Against Disease"- Donald Kohn, January 18, 2011 Dr. Donald Kohn, UCLA professor of microbiology, immunology and molecular genetics, his research group at the Kohn Lab focus on developing new therapies for genetic diseases of the blood cells using gene therapy methods to correct hematopoietic stem cells. His laboratory performs studies on gene transfer, expression and immune response and then translates the findings into clinical trials.

View original post here:
"Bone Marrow Stem Cells" Donald Kohn

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Govt panel hand in GM botch-up – Calcutta Telegraph

By Dr. Matthew Watson


Treehugger
Govt panel hand in GM botch-up
Calcutta Telegraph
13: Government agencies have helped a crop biotechnology company involved in genetic engineering of brinjal in its alleged violation of a 2005 law that regulates access to India's biodiversity, a state biodiversity official and environmental groups ...
Bt brinjal: NBA to act against Mahyco, MonsantoIndian Express
NBA may act against Mahyco / Monsanto, company claims all permissions in placefnbnews.com

all 19 news articles »

To Read More: Govt panel hand in GM botch-up – Calcutta Telegraph
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Malaysia Secures RM2 Billion Industrial Biotechnology Investment In ECER – Bernama

By Dr. Matthew Watson


Business Recorder
Malaysia Secures RM2 Billion Industrial Biotechnology Investment In ECER
Bernama
PUTRAJAYA, Aug 12 (Bernama) -- Malaysia has secured a RM2 billion industrial biotechnology investment in the East Coast Economic Region (ECER). South Korea's CJ Cheiljedang Corporation and France's Arkema SA today announced the setting up of the ...
Malaysia Receives US$660 Million Biotech Investment From S Korea & FranceAsian Scientist Magazine
Korea, France to invest RM2b in ECER biotech sectorThe Edge Malaysia
ECER gets RM2bil boostMalaysia Star
The Malaysian Insider -Business Times - Malaysia -AFP
all 19 news articles »

To Read More: Malaysia Secures RM2 Billion Industrial Biotechnology Investment In ECER – Bernama
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Good Data? $100. Good Product Development? $100. Good Commercialization Strategy? Priceless.

By Dr. Matthew Watson

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)



To Read More: Good Data? $100. Good Product Development? $100. Good Commercialization Strategy? Priceless.
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International Stem Cell Corporation: A Company with Scores of Potential by Deborah Sterescu

By Dr. Matthew Watson

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

To Read More: International Stem Cell Corporation: A Company with Scores of Potential by Deborah Sterescu
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Part Two: The Ellis Martin Report – Interview with Ken Aldrich of International Stem Cell Corp.

By Dr. Matthew Watson

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

To Read More: Part Two: The Ellis Martin Report – Interview with Ken Aldrich of International Stem Cell Corp.
categoriaStem Cell Therapy commentoComments Off on Part Two: The Ellis Martin Report – Interview with Ken Aldrich of International Stem Cell Corp. | dataAugust 14th, 2011
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The Ellis Martin Report: Interview with Ken Aldrich of International Stem Cell Corp.

By Dr. Matthew Watson

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"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

To Read More: The Ellis Martin Report: Interview with Ken Aldrich of International Stem Cell Corp.
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Reminder: International Stem Cell Holding Business Update Conference Call on August 10

By Dr. Matthew Watson

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

To Read More: Reminder: International Stem Cell Holding Business Update Conference Call on August 10
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Stroke Victim Improved With Stem Cell Therapy. More at http://www.stemcellfusion.com

By raymumme

To Read More: Stroke Victim Improved With Stem Cell Therapy. More at http://www.stemcellfusion.com
categoriaUncategorized commentoComments Off on Stroke Victim Improved With Stem Cell Therapy. More at http://www.stemcellfusion.com | dataAugust 12th, 2011
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Dr. Craig Saunders Adult Stem Cell Therapy

By Sykes24Tracey

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

To Read More: Dr. Craig Saunders Adult Stem Cell Therapy
categoriaUncategorized commentoComments Off on Dr. Craig Saunders Adult Stem Cell Therapy | dataAugust 11th, 2011
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