Stewart Lyman of Lyman BioPharma Consulting posted a great article in today's Xconomy summarizing some key points and links to more information about the rules governing the Therapeutic Discovery Project Credit which have now been released by the US Treasury Department. Today, a detailed fact sheet was released about the tax credit program and it seems almost perfectly designed for most cell therapy companies.

Lyman points out a few important details about the application schedule including:

1. The Formal IRS applications (Form 8942) will not be available until June 21st or thereabouts.

2. The application period opens on June 21 and ends on July 21. The postmark on the application is deemed to be the date of delivery. Preliminary review of the applications is to be completed by Sept. 30; this is to ensure that applicants are eligible taxpayers and that their applications are complete. Applicants will receive determinations as to whether or not they qualify for credits and/or grants, and how much they will receive, by Oct. 29.

By way of a little more background, the following is excerpted from a March Forbes.com article by Dean Zerbe:

What does the credit cover?

The credit/grant covers research in tax years beginning in 2009 and 2010. The taxpayer is provided a 50% credit/grant for qualified investments in "qualifying therapeutic discovery projects." What expenses count as qualified investments? The aggregate amount of costs paid or incurred in the taxable year for expenses necessary for and directly related to the conduct of a qualifying discovery project. What doesn't count? The pay of employees covered by 162(m)(3) of the tax code--think CEOs--doesn't count. Other excluded items: interest expenses; facility maintenance expenses (e.g. mortgage or rent payments, insurance, utility and maintenance and costs of employment of maintenance personnel); and certain indirect costs (basically general and administrative costs) as defined in the Treasury Regulations at 1.263A-1(e)(4).

What is a qualifying therapeutic discovery project?

According to the legislation, it's a project designed to do one of three things:

--Treat or prevent diseases or conditions by conducting pre-clinical activities, clinical trials and clinical studies, or carrying out research protocols for the purpose of securing federal government approval by the FDA.

--Diagnose diseases or conditions or to determine molecular factors related to diseases or conditions by developing molecular diagnostics to guide therapeutic decisions.

--Develop a product, process or technology to further the delivery or administration of therapeutics.

Finally, to qualify, a venture may not have more than 250 employees in all businesses of the taxpayer--meaning a small biotech project at a big company wouldn't qualify.

Which biotech companies might benefit?

Those that are investing significant resources in pre-clinical or clinical studies, which may take years to come to fruition to ultimately satisfy FDA requirements, could now recoup a significant portion of their expenses. Additionally, biotech start-ups focusing on the development of diagnostic assays or applications to advance therapeutics and treatments can also benefit. Finally, companies currently engaged in basic or applied research which may ultimately contribute to curing caner within the next 30 years may also be excellent candidates. Along these lines, companies studying signal transduction pathways, gene therapy and stem cell research seem like prime candidates.

The Cell Therapy Group will be collecting more information about the tax credit and service providers who might be recommended to assist in the application if needed. Contact CTG for more details or watch here for more information.

http://www.celltherapyblog.com hosted by http://www.celltherapygroup.com

An evolving concept of cancer stem cells in tumor biology: a lecture (34:38 min) by Jeremy N Rich. Webcast of the initial presentation at an Educational Session on Cancer Stem Cells and Treatment Resistance, AACR 101st Annual Meeting, April 17, 2010. [FriendFeed entry].

Comment: Dr. Rich's research has a primary emphasis on Glioma Cancer Stem Cell and Brain Tumors. An example of a recent publication: Integrin Alpha 6 Regulates Glioblastoma Stem Cells by Justin D Lathia and 10 co-authors, including Jeremy N Rich, Cell Stem Cell 2010(May 7); 6(5): 421-32. [PubMed citation][FriendFeed entry].

Aspirin May Increase Risk of Crohn's Disease

(HealthDay News) -- A new British study finds that people who take aspirin every day have a higher risk of developing Crohn's disease, a potentially devastating digestive illness.

But it's still not very likely that aspirin users will develop the condition, and the study's lead author said patients should keep in mind that aspirin lowers the risk of heart disease.

"If the link with aspirin is a true one, then only a small proportion of those who take aspirin -- approximately one in 2,000 -- may be at risk," said study author Dr. Andrew Hart, a senior lecturer in gastroenterology at University of East Anglia School of Medicine. "If aspirin has been prescribed to people with Crohn's disease or with a family history by their physician, then they should continue to take it. Aspirin has many beneficial effects and should be continued." Read more...

Ayurtox for Body Detoxification

OCEANSIDE, CA – May 18, 2010 – International Stem Cell Corporation (ISCO.OB), http://www.intlstemcell.com, announced today that it had entered into a strategic alliance with The Automation Partnership (TAP), http://www.automationpartnership.com, to automate and scale up the production of stem cell-derived human corneal tissue. The alliance has been formed to create instrumentation for ISCO and its partners and affiliates to produce development and commercial volumes of donor tissue for cornea transplantation and to reduce the use of animals and animal eyes in safety testing of drugs, chemicals and consumer products.

Cornea-related loss or reduction of vision can be caused by physical injury, infections and degenerative diseases. In cases where cornea replacement is indicated, current medical practice typically involves a one-two hour outpatient procedure under local anesthesia using full or partial corneas from healthy human cadavers. 10 million people worldwide are candidates for such treatment, primarily in Asia and Europe where there is significant quantitative and qualitative shortage of human cornea donation.

Global efforts are underway to transition from the use of live animals and excised animal eyes to test drugs, chemicals and consumer products. For example, Europe’s Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) estimates a need to spend €270M and use 160,000 animals for eye safety testing alone to catch up with the back-log of insufficiently tested agents. In the US, the National Institutes of Health (NIH) and the Environmental Protection Agency (EPA) have launched a five-year program dedicated to finding new, non-animal technologies for toxicity testing of chemical compounds.

ISCO has discovered and filed for patents on a cell culture process for the synthesis of standardized, human, corneal tissue using stem cells. Histology, permeability and optical testing has demonstrated compatibility with natural corneas. Efforts are ongoing to further characterize this tissue and standardize and scale up its synthesis. Automation is necessary to produce sufficient, reproducible tissue for development and commercialization of the therapeutic and toxicity testing applications.

Brian Lundstrom, ISCO’s President, says: “Given the substantial unmet therapeutic and toxicology testing needs for human corneal tissue, ISCO has embarked on a focused effort to advance this technology with international investors, eye clinics, and development and commercialization partners. After reviewing a range of potential cell culture automation companies, we are very pleased that TAP has agreed to contribute their over twenty years of experience towards this goal.”

David Newble, TAP’s CEO says: “TAP has successfully installed and supported over 160 automated cell culture systems worldwide and continues to design new and customize existing equipment for cell culture and other emerging life science applications. The opportunity to join forces with ISCO in the cornea tissue area will enable us to contribute solutions for clear biomedical needs while also creating new technology and knowhow that will be useful in other applications downstream.”

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 (hpSCs) 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.

About The Automation Partnership
The Automation Partnership (TAP) provides advanced automation systems and services to improve productivity in life science research, development and production.

For over 20 years TAP has been the leader in the design and development of automated cell culture and processing systems with applications in regenerative medicine, discovery research, bioprocess development and biologics production. Systems include SelecT, CompacT SelecT and Cellmate.

In addition, TAP has a strong track record in providing a range of custom automation solutions for biobanking, biological sample management, compound management and advanced high throughput screening applications.

TAP is a privately-owned company with headquarters near Cambridge, UK and a sales and support facility near Wilmington, Delaware, USA.

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

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
Or
The Automation Partnership
Matthew Walker
Head of Communications
+44 1763 227 200
Matthew.walker@automationpartnership.com

Isolation and use of solid tumor stem cells, United States Patent 7,713,710. [FreePatentsOnline][PatentStorm].
Publication Date: May 11, 2010.
Inventors: Clarke; Michael F. (Ann Arbor, MI), Morrison; Sean J. (Ann Arbor, MI), Wicha; Max S. (Ann Arbor, MI), Al-Hajj; Muhammad (Ann Arbor, MI).
Assignee: The Regents of the University of Michigan (Ann Arbor, MI) .
Appl. No.: 11/753,191
Filed: May 24, 2007
Abstract:

A small percentage of cells within an established tumor have the properties of stem cells. These solid tumor stem cells give rise both to more tumor stem cells and to the majority of cells in the tumor that have lost the capacity for extensive proliferation and the ability to give rise to new tumors. The solid tumor heterogeneity reflects the presence of tumor cell progeny arising from a solid tumor stem cell. This discovery is the basis for solid tumor stem cell compositions, methods for distinguishing functionally different populations of tumor cells, methods for using these tumor cell populations for studying the effects of therapeutic agents on tumor growth, and methods for identifying and testing novel anti-cancer therapies directed to solid tumor stem cells.

Parent Case Text:

CLAIM OF PRIORITY
This application is a Continuation of U.S. patent application Ser. No. 11/150,073, filed Jun. 10, 2005, which is a Continuation of U.S. patent application Ser. No. 09/920,517, filed Aug. 1, 2001, now U.S. Pat. No. 6,984,522, which claims priority to U.S. provisional applications Ser. No. 60/222,794, filed Aug. 3, 2000, and Ser. No. 60/240,317, filed Oct. 13, 2000, all of which are herein incorporated by reference in their entireties.

Google patents entry for Application Number 11/753,191 (The application that led to patent 7,713,710. The filing date was 24 May 2007).

Google patents entry for Application Number 11/150,073 (See Parent Case Text above: the filing date was 10 June 2005).

Google patents entry for Patent Number 6,984.522 (See Parent Case Text above: the filing date was 1 August, 2001 and the issue date was 10 Jan 2006). [FreePatentsOnline][PatentStorm].

Comment:

Not mentioned in the Parent Case Text above is United States Patent 7,115,360. [FreePatentsOnline][PatentStorm]. This patent was issued October 3, 2006 and filed on August 2, 2001.

The Parent Case Text for patent 7,115,360:

CLAIM OF PRIORITY
This patent is the United States national stage of PCT patent application PCT/US01/24243, published Feb. 14, 2002 as WO 02/12447, which is a continuation of U.S. Ser. No. 09/920,517, filed Aug. 1, 2001, now U.S. Pat. No. 6,984,522. This patent also claims priority to provisional patent applications U.S. Ser. Nos. 60/222,794, filed Aug. 3, 2000, and 60/240,317, Oct. 13, 2000.

Information about this patent was found via a Google search for "Isolation and use of solid tumor 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).

Preventing Heart Disease

Heart disease is the leading cause of death in the U.S. Like most illness, it is strongly related to diet and

lifestyle and is highly preventable.

Everybody knows that cholesterol is related to heart disease, but the connection is complex. While high

cholesterol increases heart disease risk in younger people, many people who die from it have normal cholesterol, and many with high cholesterol don't get heart disease. Cholesterol can deposit on artery walls to cause blockage, but in order for this to occur, there needs to be inflammation of the artery wall and the cholesterol must be oxidized.

Lowering cholesterol may reduce coronary risk in younger people. Most doctors don't know that in people 65 and older high cholesterol is correlated with increased lifespan and that low cholesterol in the

elderly is associated with risk of death.

Doctors are increasingly relying on a group of prescription drugs called statins to lower cholesterol, but they commonly cause many side effects including muscle pain and weakness, neuropathy, impaired Read more...

Cardiofy Heart Care Supplement