WCTF.org Transplant News

MILAN, April 26/PRNewswire/ --

- Advances in Virology Translate Into New Promising Drugs to Combat
Hepatitis C

- Clarification of Oncogenic Pathways Aids Liver Cancer Research

- Stem Cells of Potential Benefit in Liver Transplantation

- Systems Biology Helps to Solve Complex Liver Diseases

At today's sessions of the 43rd Annual Meeting of the European
Association for the Study of the Liver (EASL), experts reported advances in
basic research that have important implications for the eventual treatment of
people with chronic liver diseases.

The goal of basic or "fundamental" biomedical science is to
gain knowledge and understanding for its own sake, without reference to a
particular practical problem. "Translational" science transforms basic
knowledge into practical terms. "Applied" research, such as "clinical
trials," takes the discoveries of basic research even further and uses them
to solve specific, clearly defined medical problems. Basic, translational,
and applied research are each necessary to progress in medicine, including
Hepatology.

In virology, for example, notable progress has been made in
clarifying the structure of the Hepatitis C virus (HCV), leading to the
development of new experimental drugs such as protease inhibitors and
polymerase inhibitors, drugs that inhibit virus production. Some of these
drugs have been extensively tested and some are currently in phase II trials.
Based on results to date, it is clear that these drugs can be highly
effective in combination with pegylated Interferon and Ribavirin. Phase III
trials are planned.

Important basic science advances in genetics and systems
biology have also been reported, offering potential progress for strategies
to treat hepatocellular carcinoma (HCC). Using genomics and microarrays to
determine gene expression, scientists have discovered that there are
different biological pathways - called "oncogenic pathways" -- that result in
HCC. This discovery corrects a past, widely held but mistaken assumption that
all cases of HCC arise from a single type of disease process. On the basis of
the new discovery, researchers can now classify and explore differing
subtypes of HCC, as well as designing and experimentally testing targeted
treatments for patients based on their respective cancer subtype. According
to Professor Michael Trauner, Professor of Medicine and Molecular Hepatology
at the Medical University, Graz, Austria, "It is extremely interesting to
look at different gene expression profiles of patients with the same disease
and realize that there are different clusters which may be associated with
differentially aggressive disease. For example, in the field of cancer,
varying gene expression profiles are linked to better and worse prognoses for
hepatocellular carcinoma." In addition to genetic signatures, new protein and
metabolic markers are also being developed to detect cancer at an early stage
among patients considered at risk. Most importantly, new drugs are now
available that are able to target signal transduction cascades which, under
pathological conditions, help tumor cells to grow and proliferate. These
novel drugs include multikinase inhibitors such as Sorafenib, which has
recently been shown to delay progression of HCC. Additional small molecules
targeting tumor cell proliferation will be available for clinical trials in
the near future.

A third area in which basic science offers the potential for
clinical progress in hepatology is in the use of embryonic stem cells for
liver repair. One of the major limitations for the development of liver cell
therapy programs is the shortage of human hepatocytes. Many laboratories have
therefore focussed on stem cells as a renewable source of hepatocytes
(although extensive liver tissue formation/replacement has not yet been
achieved with either adult or embryonic stem cells). Immortalized hepatocytes
could engraft, proliferate and correct a disease phenotype of a recipient
liver, but safety issues (e.g. tumor formation) still remain a concern. To
date, in the laboratory, stem cells have been found to differentiate into
hepatocyte-like cells and other liver cell types and used to restore liver
function in mice with liver failure. For some researchers, this is a
potential treatment that, if successfully applied to humans, will allow
correction of inborn errors of metabolism or allow patients to live long
enough for a donated organ to become available. Some scientists believe that
stem cells might even enable the liver to completely heal itself so a
transplant is no longer needed. In Professor Trauner's view, although the
latter application is interesting, its success may be limited due to severe
disturbances of liver architecture in advanced liver diseases such as
cirrhosis, which limits the function of newly transplanted cells. However, in
the future, stem cells perhaps could also be used to reverse fibrous scars in
liver cirrhosis.

A fourth promising area is the application of systems biology
-- which focuses on interactions in biological systems -- to clinical
problems in hepatology. As such, the systematic exploration of RNA, protein
and metabolic profiles in hepatitis, fatty liver and cancer may help to
identify patients at particular risk for developing severe forms of these
diseases, help to predict prognoses, and may unravel potential therapeutic
targets in individual patients. This approach brings us a major step toward
personalized, individualized medicine with better prediction of individual
prognosis and better selection of the best therapy for each individual
patient.

About EASL

The European Association for the Study of the Liver (EASL)
aims to promote investigation into liver disease and improve the treatments
that currently exist for these conditions. The association, through its
annual meetings, seeks to inform and educate both the scientific community as
well as society in general about the increasing occurrence of liver diseases
along with the importance of understanding these conditions in order to treat
and prevent them. Since its creation in 1966, the EASL congress has been
hosted in 20 different European countries. Currently the association has over
1400 members and the annual congress attracts over 6000 delegates from over
65 countries each year.

Source: EASL - European Association for the Study of the Liver

For more information: Carolina Annand / Karine Elkobbi /Melisa Corrigan, Carolina.annand@eurorscg.com / karine.elkobbi@eurorscg.com / melisa.corrigan@eurorscg.com, Tel. +33-617-43-03-38 / +33-6-61-17-44-77 / +39-328-411-01-38, Euro RSCG Life

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Profile: Transplant News

Advances in Virology Translate Into New Promising Drugs to Combat Hepatitis C

Clarification of Oncogenic Pathways Aids Liver Cancer Research

Stem Cells of Potential Benefit in Liver Transplantation

MILAN, April 26/PRNewswire/ --

- Systems Biology Helps to Solve Complex Liver Diseases

At today's sessions of the 43rd Annual Meeting of the European
Association for the Study of the Liver (EASL), experts reported advances in
basic research that have important implications for the eventual treatment of
people with chronic liver diseases.

The goal of basic or "fundamental" biomedical science is to
gain knowledge and understanding for its own sake, without reference to a
particular practical problem. "Translational" science transforms basic
knowledge into practical terms. "Applied" research, such as "clinical
trials," takes the discoveries of basic research even further and uses them
to solve specific, clearly defined medical problems. Basic, translational,
and applied research are each necessary to progress in medicine, including
Hepatology.

In virology, for example, notable progress has been made in
clarifying the structure of the Hepatitis C virus (HCV), leading to the
development of new experimental drugs such as protease inhibitors and
polymerase inhibitors, drugs that inhibit virus production. Some of these
drugs have been extensively tested and some are currently in phase II trials.
Based on results to date, it is clear that these drugs can be highly
effective in combination with pegylated Interferon and Ribavirin. Phase III
trials are planned.

Important basic science advances in genetics and systems
biology have also been reported, offering potential progress for strategies
to treat hepatocellular carcinoma (HCC). Using genomics and microarrays to
determine gene expression, scientists have discovered that there are
different biological pathways - called "oncogenic pathways" -- that result in
HCC. This discovery corrects a past, widely held but mistaken assumption that
all cases of HCC arise from a single type of disease process. On the basis of
the new discovery, researchers can now classify and explore differing
subtypes of HCC, as well as designing and experimentally testing targeted
treatments for patients based on their respective cancer subtype. According
to Professor Michael Trauner, Professor of Medicine and Molecular Hepatology
at the Medical University, Graz, Austria, "It is extremely interesting to
look at different gene expression profiles of patients with the same disease
and realize that there are different clusters which may be associated with
differentially aggressive disease. For example, in the field of cancer,
varying gene expression profiles are linked to better and worse prognoses for
hepatocellular carcinoma." In addition to genetic signatures, new protein and
metabolic markers are also being developed to detect cancer at an early stage
among patients considered at risk. Most importantly, new drugs are now
available that are able to target signal transduction cascades which, under
pathological conditions, help tumor cells to grow and proliferate. These
novel drugs include multikinase inhibitors such as Sorafenib, which has
recently been shown to delay progression of HCC. Additional small molecules
targeting tumor cell proliferation will be available for clinical trials in
the near future.

A third area in which basic science offers the potential for
clinical progress in hepatology is in the use of embryonic stem cells for
liver repair. One of the major limitations for the development of liver cell
therapy programs is the shortage of human hepatocytes. Many laboratories have
therefore focussed on stem cells as a renewable source of hepatocytes
(although extensive liver tissue formation/replacement has not yet been
achieved with either adult or embryonic stem cells). Immortalized hepatocytes
could engraft, proliferate and correct a disease phenotype of a recipient
liver, but safety issues (e.g. tumor formation) still remain a concern. To
date, in the laboratory, stem cells have been found to differentiate into
hepatocyte-like cells and other liver cell types and used to restore liver
function in mice with liver failure. For some researchers, this is a
potential treatment that, if successfully applied to humans, will allow
correction of inborn errors of metabolism or allow patients to live long
enough for a donated organ to become available. Some scientists believe that
stem cells might even enable the liver to completely heal itself so a
transplant is no longer needed. In Professor Trauner's view, although the
latter application is interesting, its success may be limited due to severe
disturbances of liver architecture in advanced liver diseases such as
cirrhosis, which limits the function of newly transplanted cells. However, in
the future, stem cells perhaps could also be used to reverse fibrous scars in
liver cirrhosis.

A fourth promising area is the application of systems biology
-- which focuses on interactions in biological systems -- to clinical
problems in hepatology. As such, the systematic exploration of RNA, protein
and metabolic profiles in hepatitis, fatty liver and cancer may help to
identify patients at particular risk for developing severe forms of these
diseases, help to predict prognoses, and may unravel potential therapeutic
targets in individual patients. This approach brings us a major step toward
personalized, individualized medicine with better prediction of individual
prognosis and better selection of the best therapy for each individual
patient.

About EASL

The European Association for the Study of the Liver (EASL)
aims to promote investigation into liver disease and improve the treatments
that currently exist for these conditions. The association, through its
annual meetings, seeks to inform and educate both the scientific community as
well as society in general about the increasing occurrence of liver diseases
along with the importance of understanding these conditions in order to treat
and prevent them. Since its creation in 1966, the EASL congress has been
hosted in 20 different European countries. Currently the association has over
1400 members and the annual congress attracts over 6000 delegates from over
65 countries each year.

Source: EASL - European Association for the Study of the Liver

For more information: Carolina Annand / Karine Elkobbi / Melisa Corrigan, carolina.annand@eurorscg.com / karine.elkobbi@eurorscg.com /
melisa.corrigan@eurorscg.com, Tel. +33-617-43-03-38 / +33-6-61-17-44-77 / +39-328-411-01-38, Euro RSCG Life

-------
Profile: Transplant News

SAN DIEGO, April 25 /PRNewswire/ -- SynergEyes, Inc., of Carlsbad, CA, recently launched a revolutionary hybrid contact lens designed for people who need further vision correction after undergoing refractive vision surgery. SynergEyes(R) PS (post-surgical) is also designed for patients who have experienced some type of corneal trauma or suffer from certain degenerative vision conditions.

Every year, millions of people undergo LASIK or other types of vision correction surgery to restore vision and eliminate the need for glasses or contact lenses. But according to the U.S. Food and Drug Administration (FDA), approximately 5 percent of LASIK patients are dissatisfied with their outcome and experience post-operative conditions like eye pain, blurred or double vision and difficulty driving at night.

Because LASIK permanently alters the shape of the eye, traditional contact lenses and glasses often cannot provide the additional vision correction needed. This is why SynergEyes has developed a revolutionary contact lens designed specifically to address the technical challenges of restoring vision to these patients offering them consistent, predictable vision, even at night.

Approved for marketing by the FDA, SynergEyes(R) PS hybrid contact lenses combine two materials -- a rigid gas permeable center with a soft lens outer skirt. The "hybrid" design bonds a "hard" and "soft" contact lens together resulting in a one-of-a-kind vision correction option that provides crisp, clear vision for surgically altered corneas in a comfortable, healthy contact lens.

"The SynergEyes(R) PS lens has proven to be a safe, effective and comfortable lens for the restoration of post-surgical vision loss," says Dr. Edward Boshnick of Miami, FL. "It has become my first choice lens for the treatment of patients who have lost quality vision and comfort due to refractive and corneal transplant surgery."

Until being fit with SynergEyes(R) PS, Gabriel Meneses, a patient of Dr. Boshnick, had been struggling daily with post-LASIK side effects like blurry vision, ghosting and migraines after having the surgery six years ago. His vision could not be adequately corrected with eyeglasses or other contact lenses. "Dr Boshnick gave me the opportunity to be one of the first to try the new SynergEyes(R) PS lens ... all I can say is what a difference! As for vision quality, this lens has definitely offered me the best I've experienced so far."

Incorporating patented HyperBond(TM) technology and HydrolEyes(TM) surface science, the SynergEyes contact lenses with FDA market clearance include SynergEyes(R) A for naturally occurring ametropia, targeting patients with astigmatism, current gas permeable lens wearers, and patients demanding optimized vision; the SynergEyes(R) KC for keratoconus, the SynergEyes(R) Multifocal lens for presbyopia and the SynergEyes(R) PS for post-surgery and post trauma refractive errors.

Contact:
Kellie Kaseburg
Vice President of Global Marketing
kkaseburg@synergeyes.com
877.SEE.2012

http://synergeyes.com/

This release was issued through eReleases(TM). For more information, visit http://www.ereleases.com/.

First Call Analyst:
FCMN Contact:

Source: SynergEyes, Inc.

CONTACT: Kellie Kaseburg, Vice President of Global Marketing for
SynergEyes, Inc., +1-877-SEE-2012, kkaseburg@synergeyes.com

Web site:

http://synergeyes.com/

-------
Profile: Transplant News

Isis to Host Conference Call Today at 8 a.m. EDT

CARLSBAD, Calif. and CAMBRIDGE, Mass., April 25 /PRNewswire/ -- Isis Pharmaceuticals, Inc. (NASDAQ:ISIS) and Genzyme Corp. (NASDAQ:GENZ) announced today that the FDA has provided guidance regarding approval requirements for mipomersen. The FDA has indicated that reduction of LDL-cholesterol is an acceptable surrogate endpoint for accelerated approval of mipomersen for use in patients with homozygous familial hypercholesterolemia (hoFH). The FDA will require data from two ongoing preclinical studies for carcinogenicity to be included in the hoFH filing, which is now anticipated to take place in 2010. A phase 3 study of mipomersen in hoFH is currently enrolling patients.

The companies plan to conduct an outcome trial to support full approval of mipomersen for hoFH and to expand its indication to include other patients with high cholesterol who are at high risk for cardiovascular events. In response to the FDA's guidance, the companies are revising the development plan for mipomersen to accelerate plans for an outcome study. Isis and Genzyme plan to communicate further details of the revised development plan as they are finalized.

"Because our development plan, and our joint plan with Genzyme, has always included outcome studies to maximize the profile and commercial potential of mipomersen, this FDA guidance accelerates these planned studies and simplifies the overall development path for mipomersen," said Dr Stan Crooke, Chairman and Chief Executive Officer of Isis. "Conducting an outcome study in parallel with our continued evaluation of the effects of mipomersen on atherogenic lipids will allow us to submit a much stronger NDA for high risk patients. We are confident that mipomersen will bring benefit to patients with high cholesterol and remain committed to its development and commercialization."

"We are pleased that the FDA has given clear direction on what will be required for the approval of mipomersen, and has acknowledged its potential to help high risk patients whose needs are not being met by current therapies," said Henri A. Termeer, Genzyme's chairman and chief executive officer. "Having outcome data earlier on in the development process will be important to patients and serve to enhance the value of this treatment. We plan to engage in discussions with regulatory agencies in Europe and the rest of the world, and look forward to receiving their feedback."

ABOUT MIPOMERSEN

In early 2008, Isis and Genzyme announced that they had entered into a strategic alliance in which Genzyme will develop and commercialize mipomersen. Final contracts are still being negotiated and are expected to be completed this quarter.

Mipomersen is a second-generation antisense drug that reduces the production of apoB-100, a protein critical to the synthesis and transport of "bad" cholesterol. Cholesterol can be carried in the bloodstream in a variety of forms, with high-density lipoprotein, or HDL-cholesterol, being the good form, and low-density lipoproteins, or LDL-cholesterol, and very low-density lipoproteins, or VLDL-cholesterol, being bad forms directly involved in heart disease. Collectively lowering LDL-cholesterol, VLDL-cholesterol, and other bad forms of cholesterol are a key component in the prevention and management of cardiovascular disease.

Mipomersen is currently in phase 3 development for patients with homozygous familial hypercholesterolemia, a disease which creates a greatly increased risk of premature cardiovascular disease (CVD) and CVD-related death. In phase 2 studies, mipomersen, a weekly injectable therapeutic, was observed to reduce cholesterol and other atherogenic lipids beyond reductions achieved with standard lipid-lowering drugs.

ABOUT ISIS PHARMACEUTICALS, INC.

Isis is exploiting its expertise in RNA to discover and develop novel drugs for its product pipeline and for its partners. The Company has successfully commercialized the world's first antisense drug and has 18 drugs in development. Isis' drug development programs are focused on treating cardiovascular and metabolic diseases. Isis' partners are developing antisense drugs invented by Isis to treat a wide variety of diseases. Ibis Biosciences, Inc., Isis' majority-owned subsidiary, is developing and commercializing the Ibis T5000(TM) Biosensor System, a revolutionary system to identify infectious organisms. Isis is a joint owner of Regulus Therapeutics LLC, a joint venture focused on the discovery, development and commercialization of microRNA therapeutics. As an innovator in RNA-based drug discovery and development, Isis is the owner or exclusive licensee of over 1,500 issued patents worldwide. Additional information about Isis is available at http://www.isispharm.com/.

ABOUT GENZYME

One of the world's leading biotechnology companies, Genzyme is dedicated to making a major positive impact on the lives of people with serious diseases. Since 1981, the company has grown from a small start-up to a diversified enterprise with more than 10,000 employees in locations spanning the globe and 2007 revenues of $3.8 billion. In 2007, Genzyme was chosen to receive the National Medal of Technology, the highest honor awarded by the President of the United States for technological innovation.

With many established products and services helping patients in nearly 90 countries, Genzyme is a leader in the effort to develop and apply the most advanced technologies in the life sciences. The company's products and services are focused on rare inherited disorders, kidney disease, orthopaedics, cancer, transplant, and diagnostic testing. Genzyme's commitment to innovation continues today with a substantial development program focused on these fields, as well as immune disease, infectious disease, and other areas of unmet medical need.

Genzyme's press releases and other company information are available at http://www.genzyme.com/ and by calling Genzyme's investor information line at 1-800-905-4369 within the United States or 1-678-999-4572 outside the United States.

ISIS SAFE HARBOR STATEMENT

This press release includes forward-looking statements regarding the development, activity, therapeutic potential and safety of mipomersen in treating patients with high cholesterol. Any statement describing Isis' goals, expectations, financial or other projections, intentions or beliefs is a forward-looking statement and should be considered an at-risk statement, including those statements that are described as Isis' goals. Such statements are subject to certain risks and uncertainties, particularly those inherent in the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics, and in the endeavor of building a business around such products. Isis' forward-looking statements also involve assumptions that, if they never materialize or prove correct, could cause its results to differ materially from those expressed or implied by such forward-looking statements. Although Isis' forward-looking statements reflect the good faith judgment of its management, these statements are based only on facts and factors currently known by Isis. As a result, you are cautioned not to rely on these forward-looking statements. These and other risks concerning Isis' programs are described in additional detail in Isis' annual report on Form 10-K for the year ended December 31, 2007, which is on file with the SEC. Copies of this and other documents are available from the Company.

Isis Pharmaceuticals is a registered trademark of Isis Pharmaceuticals, Inc. Ibis Biosciences and Ibis T5000 are trademarks of Ibis Biosciences, Inc. Regulus Therapeutics is a trademark of Regulus Therapeutics LLC.

GENZYME SAFE HARBOR STATEMENT

This press release contains forward-looking statements, including without limitation, statements concerning mipomersen's benefits for patients with high cholesterol, the development plan for mipomersen and FDA's requirements for its approval. These statements are subject to risks and uncertainties that could cause actual results to differ materially from those forecasted. These risks and uncertainties include, among others: the timing of further discussions with FDA regarding the approval of mipomersen; the timing and content of submissions to and decisions made by the FDA relating to mipomersen; further analysis of clinical trial data; the results of other studies; the actual efficacy and safety of mipomersen; and the risks and uncertainties described in Genzyme's SEC reports filed under the Securities Exchange Act of 1934, including the factors discussed under the caption "Risk Factors" in Genzyme's 2007 Annual Report on Form 10K. Genzyme cautions investors not to place substantial reliance on the forward-looking statements contained in this press release. These statements speak only as of today's date and Genzyme undertakes no obligation to update or revise the statements.

Genzyme(R) is a registered trademark of Genzyme Corporation. All rights reserved.

CONFERENCE CALL INFORMATION

At 8:00 a.m. Eastern Time Friday, April 25, Isis will conduct a live webcast conference call to discuss the mipomersen regulatory update. Interested parties may access the webcast at http://www.isispharm.com/ or listen to the call by dialing 877-604-9669. A webcast replay will be available for a limited time.

Isis Pharmaceuticals' Contacts:
Kristina Lemonidis (Investors) Amy Blackley, Ph.D. (Media)
760-603-2490 760-603-2772

Genzyme Contacts:
Patrick Flanigan (Investors) Erin Emlock (Media)
617-768-6563 617-768-6923

First Call Analyst:
FCMN Contact:

Source: Genzyme Corp. and Isis Pharmaceuticals, Inc.

CONTACT: Investors, Kristina Lemonidis, +1-760-603-2490, or Media, Amy
Blackley, Ph.D., +1-760-603-2772, both of Isis Pharmaceuticals; or Investors,
Patrick Flanigan, +1-617-768-6563, or Media, Erin Emlock, +1-617-768-6923,
both of Genzyme Corp.

Web site:

http://www.genzyme.com/
http://www.isispharm.com/

Company News On-Call:

http://www.prnewswire.com/comp/113803.html

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Profile: Transplant News