-- Trial is First Application of Company's Proprietary Cell Therapy Product--

WARREN, N.J.--(BUSINESS WIRE)--Nov. 10, 2008--Celgene Cellular Therapeutics (CCT), a wholly owned subsidiary of Celgene Corporation (NASDAQ: CELG), today announced the U.S. Food and Drug Administration (FDA) has accepted the company's investigational new drug application to initiate a clinical trial using PDA001, an immunomodulatory therapy utilizing human placenta-derived stem cells obtained via CCT's proprietary processes. Clinical development will begin by the end of the year with the initiation of this Phase I, multi-center clinical trial in the U.S. for patients with moderate-to-severe Crohn's disease, who are refractory to oral corticosteroids, such as prednisone, and immune suppressants.

PDA001 is a novel culture expanded stem cell population that has broad therapeutic potential in areas such as immunology, inflammation, hematology and oncology. Pre-clinical evaluation of PDA001 has demonstrated its safety and potent immune-suppressive properties. A placenta-derived stem cell therapy, PDA001 has several potential significant benefits in that the cells are derived from a safe and almost unlimited source and are scalable to a traditional pharmaceutical level.

CCT owns an array of proprietary technologies directed to novel placental cell types and cell populations, as well as methods for collecting, processing and storing many types of stem cells from the placenta. PDA001 is the first product to be developed as a result of this expanding portfolio.

"This first placental-derived stem cell clinical trial is of vital importance given the significant number of people suffering from this debilitating disease," said lead investigator Dr. Lloyd F. Mayer, Professor and Director of the Immunology Institute, Professor of Medicine and Chief of the Divisions of Clinical Immunology and Gastroenterology at Mount Sinai in New York City. "With the positive results from in vivo biodistribution and safety studies, our hope is that PDA001 will suppress the atypical immune and inflammatory reactions involved in the pathogenesis of Crohn's disease, thereby resulting in a decrease in symptoms and improved quality of life for patients."

Crohn's disease, a chronic inflammatory condition of the gastrointestinal tract, impacts almost one million people in the United States alone. Traditional treatment for Crohn's disease has focused on non-specific anti-inflammatory or immunosuppressive agents. Unfortunately, a considerable proportion of patients develops intolerable side-effects, requires surgery or becomes unresponsive to therapy.

"This is the first step in our program to initiate clinical evaluations in a range of indications including not only Crohn's disease, but other serious inflammatory and autoimmune diseases, such as multiple sclerosis and rheumatological disorders as well," said Robert Hariri, M.D., Ph.D., CEO of Celgene Cellular Therapeutics. "By creating a novel cell therapy from a readily available source that does not require human leukocyte antigen-matching, we are hopeful that we can treat a large number of patients with a variety of devastating diseases."

About Celgene Cellular Therapeutics
At Celgene Cellular Therapeutics (CCT) we discover and develop therapeutics from stem cells derived from the human placenta as well as from the umbilical cord. CCT is a state-of-the-art research and development organization dedicated to fulfilling the promise of cellular therapeutics by developing cutting-edge products and therapies that will significantly benefit patients. Our goal is to develop proprietary cell therapy products for the treatment of unmet medical needs. Stem cell based therapies offer the potential to provide disease-modifying or even curative outcomes for serious diseases, which today lack adequate therapy.

About Placenta-Derived Stem Cells
Human Placenta-Derived Cells (PDA001) is a cellular immune modulatory agent with significant therapeutic potential. PDA001 is a novel cell population derived from normal, full-term human placental tissue. PDA001 is a culture-expanded plastic adherent cell, undifferentiated in vitro cell population that expresses the nominal phenotype CD34-, CD10+, CD105+ and CD200+. PDA001 cells constitutively express moderate levels of HLA Class I and undetectable levels of HLA Class II, and they do not express the co-stimulatory molecules CD80 and CD86. PDA001 is genetically stable, displaying a normal diploid chromosome count, normal karyotype and exhibit normal senescence after prolonged in vitro culture. PDA001 is capable of immunomodulation and suppresses T-cell proliferation. PDA001 also exhibits immunomodulatory effects on other cell types involved in an immune response such as T-cell subsets, macrophages and dendritic cells.

This release contains forward-looking statements which are subject to known and unknown risks, delays, uncertainties and other factors not under the Company's control, which may cause actual results, performance or achievements of the Company to be materially different from the results, performance or other expectations expressed or implied by these forward-looking statements. These factors include results of current or pending research and development activities, actions by the FDA and other regulatory authorities, and other factors described in the Company's filings with the Securities and Exchange Commission such as our 10K, 10Q and 8K reports.

CONTACT:
Celgene Cellular Therapeutics
Robert Hariri, M.D., Ph.D., 732-564-3503
Chief Executive Officer
or
Celgene Corporation
Greg Geissman, 908-673-9854
Associate Director, Public Relations

Unlike companies that only preserve cord blood, LifebankUSA is the first and only cord blood bank in the United States to store and release placenta-derived stem cells for transplant. LifebankUSA’s goal is to help medical professionals educate their patients about cord blood banking options and the fact that not all cord blood banks are the same.  

Cedar Knolls, NJ, August 4, 2008 – LifebankUSA has provided thousands of parents and healthcare professionals with education and peace of mind by offering a revolutionary stem cell banking service known as Placenta-Cord banking. Expecting parents choose Placenta-Cord banking because of the potentially significant increase in CD34+ stem cells banked compared to cord blood alone.  More and more health care professionals are recommending to potential cord blood banking patients that if they are planning to bank their babies’ stem cells they should strive to bank as many CD34+ stem cells (blood forming cells that matter most for treatment success) as possible.

Expecting parents can now bank the most stem cells possible through this leading cord blood banking option that enables them to bank stem cells from 2 sources: the placenta and the cord blood. This unique placenta-derived stem cell and cord blood banking option can provide expecting parents with the potential to bank the most CD34+ stem cells possible—and more CD34+ stem cells have been shown to improve transplant success and patient survival in the treatment of potentially life-threatening diseases and conditions. Recently, the older brother of a baby whose placenta-derived stem cells and cord blood stem cells were banked with LifebankUSA in 2007 underwent a transplant using both placenta-derived and cord blood units to treat a potentially fatal type of leukemia. “The patient is doing extremely well and, in fact, was discharged from the hospital one-to-two weeks earlier compared to traditional cord blood transplants,” said Lolie C. Yu, M.D., who led this groundbreaking Placenta-Cord transplant. 

Collecting stem cells from both the cord blood and the intact placenta is a simple process that a health care provider initiates immediately following delivery. The initial process takes about 5 minutes following delivery and poses no risk to either the mother or the newborn. 

The chance that a child will use his/her own stored cells during their lifetime is estimated at 1 in 400 (J.J. Nietfeld and F. Verter). These odds may increase if there is a family history of certain blood disorders or cancers. The potential risks and benefits of stem cell transplantation vary and depend on many factors, such as the amount and quality of the stem cells collected, the HLA compatibility between recipient and donor, and the client’s overall health. Talk with your health care provider. For more information, call 1-877-LIFEBANKUSA (1-877-543-32266) or visit www.lifebankusa.com.

LifebankUSA, industry leading placenta-derived stem cell and cord blood banking company, offers hope for parents looking to provide increased stem cell treatment options for their families.  

Cedar Knolls, NJ, July 14, 2008 – Expecting a newborn is both a fearful and exhilarating time for many parents. Feelings of worry and anxiety for the well-being of the newborn are often greater for an expecting parent who has a family history of medical problems. While all children can potentially benefit from cord blood banking, families of children with histories of certain medical conditions should especially consider cord blood banking as their chances of using stem cells may be greater.

Many of these soon-to-be parents seek the peace of mind offered by cord blood banks that collect, process, and store their newborns’ stem cells as a precautionary measure should the stem cells be needed for potentially lifesaving treatments. Parents who save their newborns’ stem cells in cord blood banking facilities have the peace of mind knowing that an exact stem cell match, for the child whose cells were banked, is readily available to treat potentially life-threatening diseases and conditions. However, does cord blood banking alone offer the best treatment options for their families’ potential future health needs? 

Medical professionals recommend collecting the most CD34+ stem cells (blood forming cells that matter most for treatment success) to patients considering cord blood banking.  Using more stems to treat potentially life-threatening diseases and conditions has been shown to improve treatment success and patient survival. Expecting parents can collect the most stem cells possible by banking from two sources: the placenta and cord blood. This procedure, which is known by the medical community as Placenta-Cord banking, increases the total number of stem cells banked and yields two separate stem cell collections, which improves and increases the treatment options offered by cord blood banking alone. For example, if the stem cells were needed, one collection could potentially be used for the baby and the other for another biological family member, assuming a suitable match. Another advantage of collecting placenta-derived stem cells in addition to traditional cord blood banking is that the placenta is up to 15 times richer in CD34+ stem cells, which studies have shown are the cells that matter most for transplant success and patient survival in the treatment of potentially life-threatening diseases and conditions. LifebankUSA is currently the only cord blood bank that collects, processes, and stores stem cells from two of the richest sources of blood forming stem cells: the placenta and the cord blood.

Placenta-derived stem cell and cord blood banking may become even more valuable in the future with exciting research under way to find new medical uses for stem cells in areas such as diabetes, heart disease, liver disease, muscular dystrophy, Alzheimer’s disease, Parkinson’s disease, stroke, and even spinal cord injury.  Many parents see this cord blood bank option as a valuable tool to help them obtain increased lifesaving treatment options for their families’ potential future health needs.

The chance that a child will use his/her own stored cells during their lifetime is estimated at 1 in 400 (J.J. Nietfeld and F. Verter). These odds may increase if there is a family history of certain blood disorders or cancers. The potential risks and benefits of stem cell transplantation vary and depend on many factors, such as the amount and quality of the stem cells collected, the HLA compatibility between recipient and donor, and the client’s overall health. Talk with your health care provider. For more information, call 1-877-LIFEBANKUSA (1-877-543-32266) or visit www.lifebankusa.com.

First Application is Pediatric Patient with Acute Lymphoblastic Leukemia (ALL). Study in Collaboration with Louisiana State University Children’s Hospital and Morgan Stanley Children’s Hospital of NewYork-Presbyterian and Columbia University Medical Center
Warren, NJ â?? May 2, 2008 – Celgene Cellular Therapeutics (CCT), a wholly owned subsidiary of Celgene Corporation (NASDAQ: CELG), today announced the clinical application of a human placenta-derived stem cells (HPDSCs) for hematopoietic reconstitution. The groundbreaking transplant occurred at the LSU Health Sciences Center Children’s Hospital (LSU) on March 28, 2008 to treat a pediatric patient with Acute Lymphoblastic Leukemia (ALL), a cancer of the bone marrow and blood.  Following the birth of the patient’s sibling in December 2007, HPDSCs, along with cord blood, were collected and cryo-preserved and both products were used in the transplant.

CCT owns proprietary technologies for collecting, processing, and storing HPDSCs.  HPDSCs are immature and versatile stem cells with potentially broad therapeutic applications in, for example, leukemia and other hematological malignancies, solid tumor cancers, and autoimmune diseases.  CCT is also conducting research on other types of stem cells derived from the placenta that are obtained via additional proprietary methodologies. 

The transplant is part of a multicenter clinical trial being conducted at LSU, together with Morgan Stanley Children’s Hospital of NewYork-Presbyterian and Columbia University Medical Center using HPDSCs for patients with a range of disorders including cancers and non-malignancies.  It is a single-arm study with a primary objective of assessing the safety of transplantation of umbilical cord blood augmented with HPDSCs from the same donor, with a secondary objective of assessing potential restoration of normal hematopoiesis and immune function with this combination of cells.  Patients will be monitored carefully post-transplant for up to 24 months to monitor safety outcomes, engraftment, and survival.

“The patient is doing extremely well and, in fact, was discharged from the hospital one-to-two weeks earlier compared to traditional cord blood transplants,” said Lolie C. Yu, M.D., Professor of Pediatrics, Division Chief of the Pediatric Heme-Onc Program, Director of the BMT Program at LSUHSC/Children’s Hospital. “Neutrophil engraftment occurred earlier than anticipated in this proof-of-principle study further raising our hopes regarding the benefits of this treatment.”

There is considerable anticipation around the potential of HPDSCs. An independent study headed by researchers from UCLA published earlier this year declared that blood-forming stem cells originate in the placenta in laboratory animals.  

“We are excited to advance our study of the placenta as a source of stem cells that have the ability to effectively treat patients worldwide,” said Robert Hariri, M.D., Ph.D., CEO of Celgene Cellular Therapeutics. “We are pleased with this first positive step in our effort to bring this cutting-edge therapy to the clinic to treat sufferers with a variety of devastating diseases.”

“For the first time, we are transplanting human placenta-derived stem cells to treat patients with a variety of cancers and non-malignant diseases,” said Mitchell Cairo, M.D., who leads the clinical trial at Morgan Stanley Children’s Hospital and Columbia University Medical Center, and is Chief of the Pediatric Blood and Marrow Transplantation Division at Morgan Stanley Children’s Hospital of NewYork-Presbyterian and Professor of Pediatrics, Medicine and Pathology at Columbia University College of Physicians and Surgeons.  “Our hope is that HPDSCs, in conjunction with cord blood stem cells, will expedite engraftment and improve treatment for patients.”

Expectant parents can cryo-preserve HPDSCs for future use through Celgene’s cord blood bank, LifebankUSA. For more information visit www.LifebankUSA.com or call 1-877-LifebankUSA toll-free.

About LifebankUSA
LifebankUSA, a Celgene company, is one of the largest cord blood banks in the world, and has provided cord blood banking services for tens of thousands of families worldwide.  It has released dozens of stem cell units for transplant worldwide to treat numerous life-threatening diseases. LifebankUSA is also the first bank to allow families to collect and preserve stem cells derived from the placenta, as well as the umbilical cord (Placenta-Cord banking), to rebuild blood and the immune system, including red blood cells, white blood cells, and platelets. What further sets LifebankUSA apart is an active involvement in research along with its parent company Celgene, in a commitment to further the science of stem cells to help ensure a more promising future for both placenta-derived and umbilical cord blood stem cell therapeutics.

About Celgene Cellular Therapeutics
Celgene Cellular Therapeutics, a wholly owned subsidiary of Celgene Corporation, is an innovative leader in stem cell therapy and biomaterials. CCT has a laboratory devoted to research on stem cells derived from the human placenta and umbilical cord – both of which are non-controversial sources of stem cells. Research on placental stem cells by CCT has uncovered a variety of critical biological activities creating opportunities in regenerative medicine. Cell-based therapy offers the possibility of providing disease-modifying outcomes that could potentially treat currently incurable diseases. This release contains forward-looking statements which are subject to known and unknown risks, delays, uncertainties and other factors not under the Company’s control, which may cause actual results, performance or achievements of the Company to be materially different from the results, performance or other expectations expressed or implied by these forward-looking statements. These factors include results of current or pending research and development activities, actions by the FDA and other regulatory authorities, and other factors described in the Company’s filings with the Securities and Exchange Commission such as our 10K, 10Q and 8K reports.