Category Archives: Stem Cells

DCA research on brain cancer, EurekAlert, May 12, 2010. [FriendFeed entry]. Excerpt: "... the orphan generic drug Dichloroacetate (DCA) may hold promise as potential therapy for ... a form of brain cancer called glioblastoma". Another excerpt:

By extracting glioblastomas from 49 patients over a period of 2 years and studying them within minutes of removal in the operating room, the team showed that tumors respond to DCA by changing their metabolism. Then, the team treated 5 patients with advanced glioblastoma and secured tumor tissues before and after the DCA therapy. By comparing the two, the team showed that DCA works in these tumors exactly as was predicted by test tube experiments. This is very important because often the results in non-human models tested in the lab do not agree with the results in patients. In addition, the team showed that DCA has anti-cancer effects by altering the metabolism of glioblastoma cancer stem cells, the cells thought responsible for the recurrences of cancer.

And,

No conclusions can be made on whether the drug is safe or effective in patients with this form of brain cancer, due to the limited number of patients tested by the study's leads Drs Michelakis and Petruk. Researchers emphasize that use of DCA by patients or physicians, supplied from for-profit sources or without close clinical observation by experienced medical teams in the setting of research trials, is not only inappropriate but may also be dangerous. ...

See also: Generic drug may be potential treatment for deadly brain cancer: U of A medical study by Noreen Remtulla and Julia Necheff, ExpressNews, University of Alberta, May 12, 2010.

And: Potential brain-cancer drug shows promise, CBC News, May 12, 2010. [CBC video].

And: Cancer drug trial raises hopes by Elise Stolte, Edmonton Journal, May 13, 2010.

These news reports are about the publication: Metabolic Modulation of Glioblastoma with Dichloroacetate by Evangelos D Michelakis and 12 co-authors, including Kenneth C Petruk, Sci Transl Med 2010(May 12); 2(31): 31ra34.

See also an editorial: Targeting Cell Metabolism in Cancer Patients by Matthew G Vander Heiden, Sci Transl Med 2010(May 12); 2(31) :31ed1. From the TOC: "Dichloroacetate can safely modify glucose metabolism in aggressive brain tumors when administered to patients". Last sentence of the editorial: "Time will tell whether this strategy constitutes an effective cancer therapy".

Comments: After an initial research publication in January 2007 [PubMed citation], DCA attracted much attention. See, for example, the Wikipedia entry for Dichloroacetic acid. And, Cancer society warns of untested drug, CBC News, March 22, 2007.

The Official University of Alberta DCA Website provides FAQs about DCA. It includes, in the News & Updates section, DCA Research Team publishes results of Clinical Trials (dated May 12, 2010) and an earlier Letter from Dr. Evangelos Michelakis (dated October 2008).

Other Tests Show Tissue's Ability to Focus Light, Pointing to Potential Therapeutic Applications

OCEANSIDE, Calif. – May 10, 2010 – International Stem Cell Corporation (OTCBB: ISCO), http://www.internationalstemcell.com/, the first company to perfect a method of creating human "parthenogenetic" stem cells from unfertilized eggs, announces the results of a second set of experiments confirming that its lab-grown corneal tissue closely mimics the drug absorption and drug metabolism characteristics found in normal corneal tissue. Other tests show that the stem cell derived corneal tissue refracts light, thus providing a further indication of its potential therapeutic value in treating corneal injury and disease.

Two sets of collaborative experiments between ISCO and Absorption Systems have now shown that corneal tissue cultured by ISCO exhibits topical drug absorption barrier properties and tissue-appropriate enzymatic activity, making it a promising model for studying human ocular drug absorption as an alternative to live animal testing. ISCO's human corneal tissue is created in the laboratories of its wholly owned subsidiary, Lifeline Cell Technology (Walkersville, MD).

In a second set of tests conducted by a third party expert, a beam of diverging light was projected through the corneal tissue from different distances, becoming more or less refracted with the changing distance, showing that the corneal tissue was clear and had optical properties that allow the focusing of light. Additional experiments will be conducted to better define these optical characteristics.

According to Jeffrey Janus, Senior VP of ISCO and CEO of Lifeline, "We are very excited to confirm our initial results showing drug absorption that correlates with animal models and add to these results the observation of enzymatic activity. This not only advances our plans to manufacture a product that can be used to reduce the need for tests that use living animals, but it also is one more step toward the potential therapeutic use of this tissue as a treatment for human corneal injury or disease. This has implications, not only in the US, but also in India and Asia, where millions of people suffer from corneal blindness that now goes untreated. The experiments showing light refraction are a tempting indication that this tissue will have therapeutic application."

"There is a large commercial need for a predictive and reproducible non-animal method for testing the safety of ophthalmic drugs and consumer products," said Patrick M. Dentinger, President and CEO of Absorption Systems. "The combined knowledge and expertise of ISCO and Absorption Systems have allowed us to take a step forward toward addressing an unmet need in the field of ophthalmology by creating a unique in vitro model to study human ocular drug absorption without using animals. Our collaboration with ISCO underscores our commitment to helping bring safe drugs to market."

The collaboration between Absorption Systems and ISCO uses Absorption Systems' know-how in creating and characterizing assay systems to develop superior preclinical methods of testing drugs. Such methods can also reduce the use of laboratory animals currently necessary for other tests, including safety testing of consumer products.

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/.

ABOUT ABSORPTION SYSTEMS:

Absorption Systems, founded in 1996, assists pharmaceutical, biotechnology and medical device companies in identifying and overcoming ADMET (Absorption, Distribution, Metabolism, Excretion and Toxicity) barriers in the development of drugs, biologics and medical devices. The company's mission is to continually develop innovative research tools that can be used to accurately predict human outcomes or to explain unanticipated human outcomes when they occur. The CellPort Technologies® platform, a suite of human cell-based tests systems for drug transporter characterization, exemplifies Absorption Systems' commitment to innovation. Absorption Systems has facilities near Philadelphia, PA, and in San Diego, CA, and serves customers throughout the world. For information on the company's comprehensive contract services and applied research programs, please visit http://www.absorption.com/.

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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," "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

CONTACTS:
International Stem Cell Corporation
Kenneth C. Aldrich, Chairman
760-940-6383
kaldrich@intlstemcell.com
Or
Brian Lundstrom, President
760-640-6383
bl@intlstemcell.com

For links to recent news items about CSC, visit this [Topsy] page. Examples of two news items that have received attention in the past week:?

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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For links to recent news items, visit these [Twitter] or [FriendFeed] pages. Examples of two news items that have received attention:?

• Distinct expression levels and patterns of stem cell marker, aldehyde dehydrogenase isoform 1 (ALDH1), in human epithelial cancers by Shan Deng and 15 co-authors, including George Coukos and Lin Zhang, PLoS ONE, 2010(Apr 21); 5(4): e10277 [Connbotea bookmark][PubMed Citation][OA full text]. Last sentence of the abstract:
  

  As a novel cancer stem cell marker, ALDH1 can be used for tumors whose corresponding normal tissues express ALDH1 in relatively restricted or limited levels such as breast, lung, ovarian or colon cancer.

• AACR: Are Cancer Stem Cells Vulnerable to Trastuzumab? By Ed Susman, MedPage Today (Apr 19) [FriendFeed entry][AACR10 abstract]. Excerpt:
  

  Mathematical modeling suggests that even in women whose breast cancer does not overexpress the HER-2 gene, treatment with trastuzumab (Herceptin) in the adjuvant setting could wipe out cancer stem cells, researchers reported here.

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.