Thursday November 22, 2:15 pm Eastern Time

Press Release

SOURCE: Advanced Cell Technology, Inc.

Advanced Cell Technology Reports Clones Are Healthy & Normal

Science Journal Article Evaluates 30 Cloned Cattle

WORCESTER, Mass., Nov. 22 /PRNewswire/ -- Advanced Cell Technology, Inc. (ACT) and its subsidiary Cyagra, Inc. today reported that its proprietary cloning technology has been used to produce healthy and normal adult animals.

ACT evaluated 30 cattle cloned from proliferating skin cells. Twenty-four (80%) of the clones were vigorous and remained alive and healthy one to four years later (by comparison, survival to adulthood normally ranges from 84% to 87%). Results of general health screens, physical examination and immune function were normal for all clones, including laboratory analysis on blood and urine, biochemistry, and behavioral responses.

``We haven't observed any of the genetic defects, immune deficiencies or other abnormalities reported in the popular or scientific press,'' said Robert Lanza, M.D., Vice-President of Medical & Scientific ACT. ``All of the data collected reinforce the view that these animals were clinically and phenotypically normal.''

The report will be published in next week's issue of SCIENCE (November 30, 2001), titled ``Cloned Cattle Can Be Healthy and Normal'' by ACT and its collaborators at the Mayo Clinic, Trans Ova Genetics, Em Tran and the University of Pennsylvania. Prior to publication, the journal requires that the articles be checked by independent experts through a scientific peer review process.

``This information on cloned animals is valuable'' according to Dr. Michael West, President and CEO of ACT`` not only because it assures us in regard to the animal's health and welfare but more importantly its long term medical potential.''

Dr. Jose Cibelli, ACT's Vice President for Research, said ``These findings are exciting; cattle producers can now rely on Cyagra to generate copies of their animals with the confidence that the genetics of their best animals will be intact for as long as they desire.''

To request a copy of the Science paper, contact AAAS News and Information Office at or 202-326-6440.

     Robert Lanza, M.D.
     Advanced Cell Technology, Inc.
     508 756 1212

SOURCE: Advanced Cell Technology, Inc.

Sunday November 25, 9:02 am Eastern Time

Press Release

SOURCE: Mary Ann Liebert, Inc.

e-biomed: The Journal of Regenerative Medicine Publishes Results of Human Somatic Cell Nuclear Transfer And Parthenogenesis

LARCHMONT, N.Y.--(BW HealthWire)--Nov. 25, 2001--A report on research on human somatic cell nuclear transfer and parthenogenesis that provides the first proof that reprogrammed human cells can supply tissue for transplantation was published today in e-biomed: The Journal of Regenerative Medicine, a peer-reviewed journal ( Mary Ann Liebert, Inc.).

The full text is available online at

The paper, ``Somatic Cell Nuclear Transfer in Humans: Pronuclear and Early Embryonic Development,'' is authored by Jose B. Cirelli, Kerrianne Cunniff, Robert P. Lanza, and Michael D. West of Advanced Cell Technology, a biotechnology company in Worcester, MA in collaboration with scientists Ann A. Kiessling and Charlotte Richards of Duncan Holly Biomedical, Somerville, MA.

Human embryonic stem (ES) cells, and other cells derived from the inner cell mass of the preimplantation embryo are totipotent, that is, they are capable of forming any cell or tissue in the human body. While numerous human ES cell lines are now in existence, they are of little value in human transplantation, as they would be rejected by a patient as foreign. Human therapeutic cloning has the potential to solve this problem by providing cells that are an exact genetic match for the patient.

Advanced Cell Technology (ACT) reports preliminary studies on two means of manufacturing such cells. The first method is parthenogenesis. In this technique an egg cell is activated without being fertilized by a sperm cell. A patient in need of a particular cell or tissue type provides the egg cell, the activated egg cell forms a preimplantation embryo, and the resulting stem cells are differentiated into the type of tissue the patient needs. The paper reports success in activating egg cells in this manner to form many-celled embryos resembling blastocysts. The paper does not report data on stem cell isolation.

In a second series of studies, the company performed somatic cell nuclear transfer (cloning) to form preimplantation embryos. In this instance, human egg cells were prepared by removing their DNA and adding the DNA from a human somatic (body) cell. The paper reports that the somatic nuclei showed evidence of reprogramming to an embryonic state as evidenced by pronuclear development (a type of nucleus observed only in the fertilized egg) and by early embryonic development to the six-cell stage. Again, the company did not report on stem cell isolation.

``This is indeed a milestone in therapeutic cloning,'' said Mary Ann Liebert, publisher of the online journal, e-biomed: The Journal of Regenerative Medicine. ``These preliminary results, which add to the weight of evidence that human cell reprogramming is possible, are very significant given the importance of the growing field of regenerative medicine. They underscore the urgent imperative for federal funding and acceleration of stem cell research. The implications for lifesaving therapies for age related disease and conditions such as stroke, cancer, AIDS, and neurodegenerative disorders such as Parkinson's and Alzheimer's disease hold enormous promise,'' she emphasized.

The editor in chief of ebiomed: The Journal of Regenerative Medicine is William Haseltine, chairman and CEO of Human Genome Sciences (NASDAQ: HGSI - news). Dr. Haseltine is the chairman of the 2nd Symposium on Regenerative Medicine, which will take place December 2-4 at the Renaissance Hotel in Washington, D.C. (full program at . Dr. Haseltine is also the president of the newly formed Society of Regenerative Medicine and Stem Cell Biology.

Mary Ann Liebert, Inc. Two Madison Avenue, Larchmont, New York 10538, also publishes Genetic Engineering News and peer-reviewed journals including Human Gene Therapy; Tissue Engineering; Cloning and Stem Cells; and AIDS Research and Human Retroviruses. Journals are available in print and online.

Additional information at the following links:


     Mary Ann Liebert, Inc.
     Mary Ann Liebert, 914/834-3100 ext. 622
     cell, 914/584-7751

Sunday November 25, 9:19 am Eastern Time

Press Release


SOURCE: Scientific American

Scientific American Describes First Human Embryo Cloned

-Potential Therapies for Damaged Spinal Cords, Diabetes and Other Ailments within Reach-

NEW YORK, Nov. 25 /PRNewswire/ --

    WHAT:     In an article just released by Scientific American magazine on
              its web site, scientists at Advanced Cell
              Technology (Worcester, Massachusetts) describe how they
              succeeded in generating, for the first time anywhere, cloned
              human embryos.  The report will also be in the upcoming January
              Scientific American, which will be available in mid-December.

    WHO:      With Scientific American Editor Carol Ezzell present, the team
              of scientists sought to create human embryos through cloning.
              Their goal: to use stem cells derived from such embryos as the
              "starter stock" for replacement tissues that might one day treat
              patients suffering from a variety of diseases.

              "Doctors Jose Cibelli, Robert Lanza and Michael West describe in
              their own words the process, the challenges and the ethical
              considerations that were involved in this monumental scientific
              undertaking," said John Rennie, Editor in Chief, Scientific
              American magazine.

    AT STAKE: "This is quite possibly the dawn of a new age in medicine as it
              becomes clear that therapeutic cloning is within reach," said
              Ms. Ezzell.  Therapeutic cloning seeks to use patients' own
              genetic material to produce new cells that could treat illness
              or repair injuries without fear of tissue rejection. It is
              distinct from reproductive cloning, which aims to produce a new
              baby who is genetically identical to an adult.

FOR IMMEDIATE IN-PERSON INTERVIEWS: John Rennie, Editor in Chief, Scientific American and * Carol Ezzell, Editor, Scientific American
can explain the process of cloning human embryos and discuss the importance of
its ramifications for medicine. They can also elaborate on how soon
therapeutic cloning may be available.

    In addition, they can address:

    * The ethical issues involved
    * The medical implications of cloning stem cells, in particular for
       diseases of the nervous and cardiovascular systems, diabetes,
       autoimmune disorders and diseases of the blood or bone marrow
    * The history of cloning: how we've gotten this far
    * The race to clone -- which companies and researchers are in the game?

SOURCE: Scientific American

Monday November 26, 10:19 am Eastern Time
Cloning As A Treatment: Pricey
By Matthew Herper

The scientists who announced yesterday that they had cloned a human embryo--a first--want to eventually use cloning as a therapy for diseases like AIDS and Parkinson's. But one thing evident from their research: Such therapeutic cloning could be a very expensive treatment, more costly than even the priciest drugs.

These researchers, working at privately held Advanced Cell Technology (ACT) in Worcester, Mass., have no intention of creating cloned babies. Instead, they want to use somatic cell nuclear transfer, the same process used to clone Dolly the sheep in 1997, to create embryonic stem cells. The cloned cells would be genetically identical to the patient's own, so they could replace part of an ailing brain or heart without touching off a full-scale attack from the patient's immune system.

At least, that's the theory. But creating a cloned embryo requires human egg cells, and egg cells aren't cheap. In vitro fertilization clinics will generally pay an egg donor $3,000 to $5,000, and Advanced Cell Technology took 71 eggs from seven women.

Each of these women had to be treated with drugs, first to stop their ovary production, then to kickstart it into overdrive so that she could provide the scientists with about ten eggs each. Removing the eggs requires a serious medical procedure that can scar.

The process looks at least as inefficient as cloning in animals. Nineteen eggs underwent nuclear transfer. Their genetic material was removed and replaced with similar material from a donor. They then began to divide into embryos, but none grew past the six-cell stage. Stem cells are taken from embryos with more than 100 cells.

Researchers working with animals don't have to worry about getting enough eggs. Cow eggs, for instance, can be bought cheaply from slaughterhouses that would otherwise discard them. For a recent paper on cloning in Science, Peter Mombaerts, a scientist at Rockefeller University in New York City who clones mice, ran through 4,000 mouse oocytes--he estimates that might be $2,000 worth of mice. Doing the same work in humans, he estimates, could cost $2 million.

Scientists will almost certainly use fewer eggs if therapeutic cloning is used on people. But even if it required a mere 100 eggs, taken from ten donors, the cost of simply paying the donors could easily reach $50,000. On top of that, there would be medical costs involved in procuring the egg. Mombaerts believes it could cost more than $1,000 per egg when all is said and done. That means costs to treat one patient could conceivably soar above $100,000.

That would make eggs the limiting factor in using nuclear transfer to treat human diseases. Such high costs are not unheard of in biotechnology--for instance, treating a patient for a year with a rare joint disorder called Gaucher's disease with Genzyme 's Cerezyme can cost $170,000.

ACT Chief Executive Michael West has in the past expressed a belief that if the cure works, it will be paid for. But West was once worried enough about the problem that ACT tried to create human stem cells using cow eggs. Geron , the stem-cell company he founded before moving to ACT, has often talked of nuclear transfer as a way of figuring out how to make stem cells. Geron's current CEO, Thomas Okarma, believes the first uses of embryonic stem cells as a therapy will have to make use of powerful drugs that suppress the immune system.

Another limiting factor on cloning: expertise. Mombaerts calls his former colleague Teru Wakayama, who is now at ACT, "the Tiger Woods of the micropipette." The inference is that, like golf, cloning mouse cells is a skill that involves exactly how the requisite tool is held and used--an art as much as a science. "That's one reason scientists think it will be a decade or two before this technology reaches the clinic."

Nonetheless, ACT's paper, published yesterday in the Journal of Reproductive Medicine, provides a guidebook to groups that want to clone human embryos to make babies. The steps at the beginning are the same. That is likely to spook lawmakers who already voted in the House of Representatives to make all human cloning, including the therapeutic kind, illegal. If the Senate passes a similar bill, President George W. Bush will surely sign it.

Whatever the lawmakers decide, though, this work will almost certainly continue--if not on U.S. soil, then elsewhere. "They've bitten the bullet now," Mombaerts says. "We can't go back."

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