International Stem Cell Corporation Signs Financing Agreement
By Dr. Matthew Watson
OCEANSIDE, CA –May 5, 2010 – International Stem Cell Corporation (ISCO.OB), http://www.intlstemcell.com, today announced it has entered into a definitive agreement dated May 4, 2010 (‘the Agreement”) with Socius CG II, Ltd. (“Socius”), pursuant to which Socius has committed to purchase a single tranche of up to $10 million in non-convertible Series F Preferred Stock (the "Preferred Stock") from ISCO. The Company issued a warrant to purchase $13,500,000 worth of the Company’s Common Stock, the exercise price of the warrant being determined by the closing bid price for the Company’s Common Stock on the trading day immediately preceding the date the Company initiates the sale of the Series F Preferred.
The Company anticipates that the Closing of the Preferred Stock sale will take place 20 business days after the issuance of the Warrants. Proceeds from these sales will be used to provide general working capital and to fund additional development of the Company's proprietary Parthenogenetic Stem Cell Lines, development of commercial research products, and other research and development programs and related business activities.
Additional details on the transaction are contained in the Company's Form 8-K filed today with the Securities and Exchange Commission.
A prospectus relating to this offering is available from:
Investor Relations
International Stem Cell Corporation
2595 Jason Court
Oceanside, CA 92056
ABOUT INTERNATIONAL STEM CELL CORPORATION (ISCO.OB):
International Stem Cell Corporation is a California-based biotechnology company focused on therapeutic and research products. ISCO’s core technology, parthenogenesis, results in creation of pluripotent human stem cells from unfertilized oocytes (eggs). 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 sexes, ages and racial groups. This offers the potential to create the first true stem cell bank, UniStemCell™, while avoiding the ethical issue of using fertilized eggs. ISCO also produces and markets specialized cells and growth media for therapeutic research worldwide through its subsidiary Lifeline Cell Technology.
FORWARD-LOOKING STATEMENTS:
Statements pertaining to anticipated future events, including the anticipated closing of the sale of Preferred Stock, along with other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management constitute forward-looking statements. Any statements that are not historical fact (including, but not limited to statements that contain words such as “will,” “believes,” “plans,” “anticipates,” “expects,” “estimates,”) should also be considered to be forward-looking statements. Forward-looking statements involve risks and uncertainties, including, without limitation, risks inherent in satisfying the conditions to closing. Actual results may differ materially from the results anticipated in these forward-looking statements and as such should be evaluated together with the many uncertainties that affect the company's business, particularly those mentioned in the cautionary statements found in the company's Securities and Exchange Commission filings. The company disclaims any intent or obligation to update these forward-looking statements.
Key Words: Stem Cells, Biotechnology, Parthenogenesis
CONTACTS:
International Stem Cell Corporation
Kenneth C. Aldrich, Chairman
760-940-6383
kaldrich@intlstemcell.com
Or
Brian Lundstrom, President
760-940-6383
bl@intlstemcell.com
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More about presentations at AACR10
By Dr. Matthew Watson
Five presentations at the 101th annual meeting of the American Association of Cancer Research were highlighted a news release from Geron Corporation (dated March 3, 2010). One presentation that had an explicit focus on CSC was this poster:
Imetelstat, a telomerase inhibitor in phase I trials in solid tumor and hematological malignancies, has broad activity against multiple types of cancer stem cells [Presentation Abstract].
Also mentioned in the news release was an oral presentation by Jerry W Shay, given as part of the Major Symposium entitled: Role of Telomeres and Telomerase in Chromosomal Stability and Disease [Session Detail]. The presentation was:
Role of telomerase in normal and neoplastic stem cells [Presentation Abstract].
Another poster about the telomerase inhibitor imetelstat (GRN163L) was:
Sensitivity and resistance of non-small cell lung cancer to the telomerase inhibitor imetelstat [Presentation Abstract].
Comments: A search of the ClinicalTrials.gov database for GRN163L revealed 6 trials. Four were ongoing, but not recruiting participants. Two were still recruiting: 1) Safety and Dose Study of GRN163L Administered to Patients With Refractory or Relapsed Solid Tumor Malignancies; 2) A Study of GRN163L With Paclitaxel and Bevacizumab to Treat Patients With Locally Recurrent Or Metastatic Breast Cancer.
An analogous search for imetelstat yielded the same 6 trials. All 6 trials have been sponsored by Geron Corporation.
Sessions on CSC Therapeutics at AACR10
By Dr. Matthew Watson
There were two poster sessions on Cancer Stem Cell Therapeutics at the 101st Annual Meeting of the American Association for Cancer Research (AACR). The sessions, Cancer Stem Cell Therapeutics 1 and Cancer Stem Cell Therapeutics 2, took place on the morning and afternoon of April 20, 2010 [FriendFeed entry].
Two posters presented in the 2nd session have been highlighted in a news release. See: Alchemia’s HyACT Technology Enhances the Killing of Cancer Stem Cell Populations in Breast and Colorectal Cancer, Business Wire, April 20, 2010 [FriendFeed entry]. One of these is Poster #4293: Evaluation of activated CD44 as a biological target in the eradication of breast cancer stem cells, by Vera J Evtimov and Tracey J Brown [Presentation Abstract]. The other is Poster #4278: HA-Irinotecan targeting of activated CD44 is an effective therapy for the eradication of putative colon cancer stem cells [Presentation Abstract].
CSC news links 2010-04-18
By Dr. Matthew Watson
For links to recent news items, visit these [Twitter] or [FriendFeed] pages. Examples of a few news items that have received attention:
- Split ends in CML: divergent roles of Hes1 by Catriona Jamieson, Blood 2010(Apr 8); 115(14): 2726-7 [FriendFeed entry][Connotea bookmark][PubMed citation][Full text PDF]. A comment on: Hes1 immortalizes committed progenitors and plays a role in blast crisis transition in chronic myelogenous leukemia by Fumio Nakahara and 13 co-authors, Blood 2010(Apr 8); 115(14): 2872-81. [Epub 2009(Oct 27)][PubMed citation].
- Metabolism and the leukemic stem cell by Omar Abdel-Wahab and Ross L Levine, J Exp Med 2010(Apr 12); 207(4): 677-80 [Epub 2010(Apr 5)][FriendFeed entry][ResearchGATE entry][CiteULike entry][Connotea bookmark][PubMed citation][Full text].
- A hypoxic niche regulates glioblastoma stem cells through hypoxia inducible factor 2alpha by Sascha Seidel and 13 co-authors, including Till Acker, Brain 2010(Apr); 133(Pt 4): 983-95 [FriendFeed entry][ResearchGATE entry][Connotea bookmark][PubMed citation].
MicroRNA therapy could be a powerful tool to correct the CSC dysregulation?
By Dr. Matthew Watson
Medical Hypothesis: No small matter: microRNAs - key regulators of cancer stem cells by Qing Ji, David Karnak, Ping Hao, Rongquan Wang and Liang Xu, Int J Clin Exp Med 2010(Mar 12); 3(1): 84-7 [FriendFeed entry][Full text via PMC]. PubMed Abstract:
Emerging evidence demonstrates that both tumor suppressor and oncogenic miRNAs play an essential role in stem cell self-renewal and differentiation by negatively regulating the expression of certain key genes in stem cells. It seems logical that they may also be critical players in cancer stem cells. Though small in size, miRNAs play a key role in the epigenetic regulation of cancer stem cells. Specifically, the imbalance of oncogenic vs. tumor suppressor miRNAs may lead to dysregulation of cancer stem cells, thus causing excessive self-renewal and survival of cancer stem cells, and resistance to chemo/radiotherapy. We postulate that restoring the balance of miRNAs will correct this dysregulation via the direct and simultaneous modulation of downstream stem cell pathways involved in cancer stem cell self-renewal and/or differentiation. The resultant restoration of key regulatory pathways could improve therapeutic response. Restoring tumor suppressor miRNAs and/or inhibiting oncogenic miRNAs may provide a novel molecular therapy for human cancers, potentially via modulating cancer stem cells.
International Stem Cell Corporation Engages Leading Immunogeneticists to Advance its Industry-first, Immune-matched Stem Cells
By Dr. Matthew Watson
International Stem Cell Corporation (OTCBB:ISCO), http://www.intlstemcell.com, today added two world-leading immunogeneticists to its scientific advisory board. They and ISCO scientists will study the immune-matching properties of ISCO's human parthenogenetic stem cell (hpSC) technology and the potential for each hpSC-derived therapeutic cell to be an immune-match for millions of people.
Dr. Hans-Dieter Volk, Professor of Immunology and Chair of the Institute of Medical Immunology and Berlin-Brandenburg Center for Regenerative Therapies (BCRT) at Charité Universitätsmedizin in Berlin, and Dr. Matthias von Herrath, Professor at the La Jolla Institute of Allergy and Immunology at University of San Diego, have agreed to join ISCO's scientific advisory board. Both have dedicated their careers to experimental and clinical immunology and are highly regarded immunogenetics experts internationally. They will be most valuable as ISCO attempts to demonstrate the unique immune-matching benefits of the hpSC technology experimentally and in clinical practice.
"We believe that providing human cells that can minimize rejection though immune-matching to the recipient is one of the most important tasks in developing effective regenerative medicine therapies," says Dr. Simon Craw, Vice President at ISCO. "We look forward to Drs. Volk and von Herrath helping us try to demonstrate how that need can be met with our parthenogenetic stem cells."
Embryonic stem cells (hESC) almost invariably have different forms of genes (called "alleles") at each genetic position of the paternal and maternal chromosomes, i.e. they are "heterozygous." This includes the human leukocyte antigen ("HLA") genes that are largely responsible for the distinction between "self" and "foreign," and thus acceptance or rejection of transplants. Since hESC are derived from fertilized embryos, they carry the genes of a unique individual, thus the therapeutic cells derived from hESC will carry HLA alleles that can be recognized as foreign and be rejected by most patients unless they receive immunosuppressive therapy. Such therapy is costly, has significant side effects, and often is disabling in the long term.
Like most individuals in the population, induced pluripotent stem cells ("iPS" cells) and adult stem cells are also predominantly heterozygous because they carry paternal and maternal chromosomes. They are a perfect immune match to the patient they came from and are therefore typically administered back to that same individual ("autologous therapy"). However, they would likely be rejected by most other recipients. Autologous therapy is time-consuming and expensive, which goes against the cost containment pressures globally. In addition, the quality of the therapy is directly related to the ability to secure clinically sufficient numbers of functional cells from the patient, which often poses a significant problem in clinical practice.
In contrast, the hpSCs developed by ISCO are derived from unfertilized eggs ("oocytes") that have been shown in peer-reviewed journals to exhibit unlimited proliferation potential and are pluripotent (can become cells from all three germ layers that form a human being). Most significantly, hpSC can be created in a "homozygous" state, where the alleles, including the HLA alleles, are the same at each genetic position. When these HLA alleles are also found with a high frequency in a population, these "HLA-homozygous" stem cells and their therapeutic derivatives have the potential to be immune matched to millions of people. For example, ISCO's first homozygous stem cell line with high-frequency HLA alleles has the potential to be immune matched to an estimated 75 million people worldwide.
Dr. Volk says: "Using my experience from transplantation immunology and medicine during the past three decades, I am very pleased to help ISCO in their efforts to make its hpSC technology a clinical reality where therapeutic cell derivatives will be immune matches for millions of people worldwide." Dr. von Herrath continues: "While stem cell technologies generally offer great regenerative potential, most clinical applications will be limited by immune rejection. I look much forward to joining ISCO in their quest for making stem cell-derived therapy a practical and attractive clinical option for many degenerative diseases."
Besides the immunogenetic developments, ISCO is advancing its hpSC technology into the differentiation of hpSC into therapeutic cells and tissues and into the establishment of processes and facilities to produce clinical-grade cells. The company is seeking to demonstrate the therapeutic potential of its hpSC technology as a safe, efficient, and superior alternative to other sources of stem cells for human therapy.
ABOUT INTERNATIONAL STEM CELL CORPORATION (ISCO.OB):
International Stem Cell Corporation is a California-based biotechnology company focused on therapeutic and research products. ISCO's core technology, parthenogenesis, results in 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 sexes, ages and racial groups. This offers the potential to create the first true stem cell bank, UniStemCell™, while avoiding the ethical issue of using fertilized eggs. ISCO also produces and markets specialized cells and growth media for therapeutic research worldwide through its subsidiary Lifeline Cell Technology. More information is available at ISCO's website, 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.
FORWARD-LOOKING STATEMENTS
Statements pertaining to anticipated technological developments and therapeutic applications, and other opportunities for the company and its subsidiary, along with other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management constitute forward-looking statements. Any statements that are not historical fact (including, but not limited to statements that contain words such as "will," "should," "believes," "plans," "anticipates," "expects," "estimates") should also be considered to be forward-looking statements. Forward-looking statements involve risks and uncertainties, including, without limitation, risks inherent in the development and/or commercialization of potential products, uncertainty in the results of clinical trials or regulatory approvals, need and ability to obtain future capital, application of capital resources among competing uses, and maintenance of intellectual property rights. Actual results may differ materially from the results anticipated in these forward-looking statements and as such should be evaluated together with the many uncertainties that affect the company's business, particularly those mentioned in the cautionary statements found in the company's Securities and Exchange Commission filings. The company disclaims any intent or obligation to update these forward-looking statements.
Key Words: Stem Cells, Biotechnology, Parthenogenesis
International Stem Cell Corporation
Kenneth C. Aldrich, Chairman
760-940-6383
kaldrich@intlstemcell.com
or
Brian Lundstrom, President
760-640-6383
bl@intlstemcell.com
CSC news roundup 2010-04-11
By Dr. Matthew Watson
- Cancer Stem Cells: Back to Darwin? (review) [FriendFeed entry][Connotea bookmark][PubMed citation] http://bit.ly/csTyxT
- Cancer stem/progenitor cells are highly enriched in CD133+CD44+ population in hepatocellular carcinoma [FriendFeed entry][PubMed citation] http://bit.ly/bwUz7C
- The nuclear receptor tailless induces long-term neural stem cell expansion and brain tumor initiation [FriendFeed entry][News release][PubMed citation] http://bit.ly/cCjVZL
- Hedgehog Signaling and Cancer Stem Cells in Hematopoietic Cell Malignancies (USPTO Application) [FriendFeed entry] http://bit.ly/bSbbTF
- (WO2010037134) Multi-stage stem cell carcinogenesis [FriendFeed entry][WIPO entry] http://bit.ly/cnksOu
- (WO2010037041) Frizzled-binding agents and uses thereof (to target CSC ) [FriendFeed entry] http://bit.ly/aaSJNI
- Epithelial-Mesenchymal Transition (EMT) in Tumor-Initiating Cells and Its Clinical Implications in Breast Cancer (review) [FriendFeed entry][Connotea bookmark][PubMed citation] http://bit.ly/cEcBrJ
- Ovarian cancer stem-like side-population cells are tumourigenic and chemoresistant [FriendFeed entry][Connotea bookmark][PubMed citation] http://bit.ly/cvoGt1
- Emerging strategies for the identification and targeting of cancer stem cells (review) [FriendFeed entry][PubMed citation] http://bit.ly/bGOGfd
- Stem cells in human breast cancer (OA review) [FriendFeed entry][ResearchGATE entry][PubMed citation] http://bit.ly/aF9E8U
- Side-population cells in luminal-type breast cancer have tumour-initiating cell properties, and are regulated by HER2 expression and signalling [FriendFeed entry][PubMed citation] http://bit.ly/92VkLU
- Hypoxia inducible factors in cancer stem cells (minireview) [FriendFeed entry][PubMed citation] http://bit.ly/bGBdxN
- Classic view of cancer challenged by new theory (about the CSC model) [FriendFeed entry] http://bit.ly/decqFe
- New hope in the horizon: cancer stems cells (OA review) [FriendFeed entry][PubGet entry][Full text PDF] http://bit.ly/9HLmV0
International Stem Cell Corporation Provides Strategic Update on its Skin Care Program
By Dr. Matthew Watson
OCEANSIDE, California - April 8, 2010 - International Stem Cell Corporation (ISCO.OB), http://www.internationalstemcell.com, announces today that it’s wholly owned subsidiary, Lifeline Skin Care Inc., has achieved positive results in human safety tests of its cosmetic products and is moving forward with arrangements with Cosmetic Enterprises Ltd. for the manufacture of three cosmetic products. These developments allow Lifeline Skin Care to plan a launch of its cosmetic product line in the late summer or fall of 2010.
Cosmetic face products developed by Lifeline Skin Care Inc., contain extracts from human parthenogenetic stem cells (hpSC) combined with a vitamin complex and other active ingredients. The products utilize a form of nanotechnology to deliver concentrated active ingredients to damaged skin. Laboratory tests show that an active “complex” of stem cell extract has the ability to rejuvenate skin. Also, early human trials show that these cosmetic products moisturize skin and strongly indicate the ability to decrease the depth of wrinkles and provide factors that lead to anti-aging effects.
Lifeline Skin Care is working with Cosmetic Enterprises, Ltd., located in California, to formulate and package its unique skin care product. Cosmetic Enterprises is a well-known OTC drug licensed manufacturer with over 30 years of experience. Lifeline Skin Care’s “parthenogenetic stem cell complex” the product’s active ingredient, is made in Lifeline Skin Care’s laboratory in Oceanside, California.
According to Gregory S. Keller, MD, FACS, “These positive safety studies in human testing are important, especially considering that preliminary human trial data show that products of the production of International Stem Cell’s parthenogenetic stem cells have significant beneficial effects on the skin and might also provide long term benefits in reducing wrinkles and other visible signs of aging. These results are a significant step forward in making this unique product available to the public.” Dr. Keller was named the 2007 “Specialist of the Year in Facial Cosmetic Surgery” in Strathmore’s “Who’s Who”.
The results of recent human safety tests show there were no identifiable signs or symptoms of sensitization (contact allergy). Safety testing is a series of tests to insure the product does not cause negative reactions such as irritation to the skin. This completed round of testing allows Lifeline Skin Care to move forward confidently with its commercial manufacturing plans.
International Stem Cell Corporation is a pioneer in development of a new class of stem cells called “human parthenogenetic stem cells” which avoid critical ethical issues by eliminating the need to use fertilized embryos and can be immune-matched to large segments of the population. As of today, ISCO has successfully derived 10 hpSC lines. One of these lines (hpSC-Hhom-4), carries the most common immune type found across racial groups within the US population and can be immune-matched to millions of people.
ABOUT INTERNATIONAL STEM CELL CORPORATION (ISCO.OB):
International Stem Cell Corporation is a California-based biotechnology company focused on therapeutic and research products. ISCO’s core technology, parthenogenesis, results in 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 sexes, ages and racial groups. This offers the potential to create the first true stem cell bank, UniStemCell™, while avoiding the ethical issue of using fertilized eggs. ISCO also produces and markets specialized cells and growth media for therapeutic research worldwide through its subsidiary Lifeline Cell Technology. More information is available at ISCO’s website, 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.
FORWARD-LOOKING STATEMENTS
Statements pertaining to anticipated technological developments and therapeutic applications, and other opportunities for the company and its subsidiary, along with other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management constitute forward-looking statements. Any statements that are not historical fact (including, but not limited to statements that contain words such as "will," "should," "believes," "plans," "anticipates," "expects," "estimates,") should also be considered to be forward-looking statements. Forward-looking statements involve risks and uncertainties, including, without limitation, risks inherent in the development and/or commercialization of potential products, uncertainty in the results of clinical trials or regulatory approvals, need and ability to obtain future capital, application of capital resources among competing uses, and maintenance of intellectual property rights. Actual results may differ materially from the results anticipated in these forward-looking statements and as such should be evaluated together with the many uncertainties that affect the company's business, particularly those mentioned in the cautionary statements found in the company's Securities and Exchange Commission filings. The company disclaims any intent or obligation to update these forward-looking statements.
Key Words: Skin Care, Stem Cells, Biotechnology, Parthenogenesis
CONTACTS:
International Stem Cell Corporation
Kenneth C. Aldrich, Chairman
760-940-6383
kaldrich@intlstemcell.com
Or
Lifeline Skin Care Inc.
Ruslan Semechkin, PhD, CEO
760-940-6383
ras@intlstemcell.com