Cellerant Awarded SBIR Contract Funding to Develop CLT-009 for Treatment of Thrombocytopenia

SAN CARLOS, Calif.--(BUSINESS WIRE)--

Cellerant Therapeutics Inc., a biotechnology company developing novel hematopoietic stem cell-based cellular and antibody therapies for blood disorders and cancer, announced today that it has been awarded a Small Business Innovation Research (SBIR) Phase 1 contract and a Phase 2 option from the National Cancer Institute (NCI) valued up to $1,683,503. The SBIR Contract funds the development of CLT-009, a first-in-class, human allogeneic Megakaryocyte Progenitor Cell therapy for the treatment of thrombocytopenia in cancer patients and allows the Company to conduct studies to enable an Investigational New Drug (IND) Application to be filed with the FDA in the next two years.

Thrombocytopenia is characterized as a significant reduction in the concentration of circulating platelets. Platelets are crucial in the process of coagulation to stop bleeding, and thrombocytopenia can increase the risk of severe bleeding in patients. It is becoming an increasingly common problem among oncology patients and a significant dose-limiting toxicity, especially in the treatment of hematological malignancies. Chemotherapy and radiation therapy are the most common causes of thrombocytopenia because the platelet-producing cells, megakaryocytes, and their precursors are highly sensitive to myelosuppressive cytotoxics and ionizing radiation. Thrombocytopenia typically occurs during the initial cycles of high-dose chemotherapy and radiation therapy, usually 614 days after administration. According to Datamonitor, the estimated incidence of cancer patients who suffer from significant chemotherapy-induced thrombocytopenia worldwide was approximately 200,000 in 2008.

Occurrence of severe thrombocytopenia may require dose reductions for chemotherapy regimens which can impact subsequent disease control and survival, especially in the treatment of hematological malignancies such as acute leukemia and high-risk myelodysplastic syndrome. Current treatment options include platelet transfusions which are costly and labor intensive and are associated with risks such as contamination and transmission of viral and bacterial infections. Recombinant human interleukin-11 is the only approved agent for chemotherapy induced thrombocytopenia but its use is limited and has only modest efficacy and significant side effects. CLT-009, a human Megakaryocyte Progenitor Cell product, would be an alternative treatment option, providing the critical megakayocyte progenitor cellular support to rapidly produce platelets in vivo and shorten the duration of severe thrombocytopenia following chemotherapy treatment.

We are delighted to receive this contract from NCI to support the development of our novel, off-the-shelf, platelet product and address a high unmet need, said Ram Mandalam, Ph.D., President and Chief Executive Officer of Cellerant Therapeutics. This contract allows us to not only leverage our experience in developing cellular therapies but also provides us with the ability to bring CLT-009 closer to the clinic. Our unique product portfolio, which now includes CLT-009, along with our CLT-008 myeloid progenitor cell product and our therapeutic antibodies targeting cancer stem cells, demonstrates our continued commitment to developing novel products for the benefit of cancer patients.

In addition to this SBIR contract, Cellerant has previously received grants from the National Institute of Health (NIH) in 2008 2010 to conduct research studies in platelet recovery which it has successfully completed. In its previous studies, Cellerant demonstrated that megakaryocyte progenitor cells were able to produce human platelets in preclinical models with in vivo functionality similar to that of normal human platelets.

This program is funded with Federal funds from the National Institute of Health, Department of Health and Human Services, under Contract No.HHSN261201200076C.

About CLT-009

CLT-009 is a unique, off-the-shelf, cryopreserved, cell-based therapy that contains human Megakaryocyte Progenitor Cells derived from adult hematopoietic stem cells that have the ability to mature into functional platelets in vivo. Cellerant is developing CLT-009 as an effective treatment for chemotherapy and radiation-induced thrombocytopenia in cancer patients.

About Cellerant Therapeutics

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Cellerant Awarded SBIR Contract Funding to Develop CLT-009 for Treatment of Thrombocytopenia

Stem Cell Discovery Secures Nobel Prize

By: Jenny Marder

Nobel Prize winner Sir John Gurdon talks to reporters on Oct. 8, 2012 in London. Gurdon and Shinya Yamanaka from Japan have both been awarded the Nobel prize for medicine or physiology for their work as pioneers of stem cell research. Photo by Peter Macdiarmid/Getty Images.

In 1962, John B. Gurdon of the United Kingdom discovered that a cell removed from the gut of a frog contained all the genetic information necessary to create the whole frog. More than 40 years later, Shinya Yamanaka of Japan found that by introducing a few genes to a mature mouse cell, he could reprogram it into a stem cell, capable of developing into any cell in the body.

Gurdon and Yamanaka share this year's Nobel Prize in Medicine and Physiology for their work in cellular reprogramming, 50 years after Gurdon's initial discovery. Their work in stem cells has led to a wave of advances, from cloning to allowing scientists to create embryonic cells without having to destroy embryos.

Gurdon was still a graduate student when he first transplanted genetic information from the nucleus of an intestinal cell of one frog into the fertilized egg cell of another. That cell went on to develop into a tadpole, proving that even mature, specialized cells have all the information needed to transform an embryo into an adult.

He relied on a technique called nuclear transfer to transplant the nuclei. The discovery flew in the face of established opinion, since other more established scientists hadn't been able to successfully make such a transfer, and it was thought then that a specialized cell is irreversibly tied to its fate.

"We had to go through a few years, in a sense, of letting the results sink in," Gurdon said in an early morning interview with the Nobel committee.

The same year that discovery was published, Yamanuka was born. And 40 years later, he took the science a big step farther. His research identified the four genes that made it possible to reverse mature stem cells into their embryonic state without using nuclear transfer. The "induced pluripotent embryonic stem cells" could then go on to become nerve cells, heart cells, gut cells.

That finding opened the possibility for skin cells to be reversed to embryonic cells and then reprogrammed into nerve, heart or other tissue cells for medical uses and disease treatment. Such reprogrammed cells have not yet been used to treat patients.

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Stem Cell Discovery Secures Nobel Prize

Church raising funds for pastor's cancer treatment

When modern medicine is unsuccessful in curing diseases, some seek alternative treatments. For Pastor Charles Daugherty, that time has come.

After a year-long battle with multiple myeloma, during which time he has undergone chemotherapy, radiation and stem cell treatment, and then diagnosed with a second type of cancer, liposarcoma, he has decided to try something different.

I dont have anything to lose from trying, he said.

According to the American Cancer Society, normal plasma cells are found in the blood marrow and are a part of the bodys immune system, which is made up of several types of cells, working to fight off infections. One of these types of cells, B cells, transform into plasma in response to infections. When they grow out of control, a tumor is formed. When more than one tumor grows, it is called multiple myeloma.

While the outcomes for those with multiple myeloma have gotten better in recent years, the reality, according to the American Cancer Society, is that the disease never really goes away for most patients.

Its considered terminal. Its considered fatal, Daugherty said.

Since February 2011, the pastor has undergone cancer and radiation treatments. Daugherty also had a stem cell transplant, which he said helped slow the progression of the disease. However, while undergoing chemo, the doctors discovered the liposarcoma, this time in the chest walls. He is now on radiation treatment to shrink it.

It has made it shrink a little bit, but its still there, Daugherty said.

One of his doctors told him about an alternative treatment clinic in Colorado called Eden Valley Lifestyle Center. The center focuses on a holistic approach, using plant-based diets and more natural methods of healing.

Im a firm believer in healing, he said. The problem is that treatment at the center will cost around $10,000, including transportation to and from Colorado.

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Church raising funds for pastor's cancer treatment

Stem Cell Transplant May Spur Heart Disease Risk: Study

WEDNESDAY, Oct. 3 (HealthDay News) -- People who undergo the transplantation of stem cells taken from bone marrow, circulating blood or umbilical cord blood are more likely to develop risk factors for heart disease, such as high blood pressure, diabetes and high cholesterol, a new study contends.

Researchers from the American Society of Hematology noted that patients who were treated with chemotherapy or radiation before such a transplant -- called a "hematopoietic cell transplant," or HCT -- had a significantly higher risk for heart disease later in life.

"While we know that heart disease is a real concern for long-term HCT survivors, small sample sizes and a lack of long-term follow-up in previous studies have only allowed us to look at a small piece of the puzzle of how this chronic condition develops in these patients," the study's first author, Dr. Saro Armenian, medical director of the Pediatric Survivorship Clinic in the Childhood Cancer Survivorship Program at City of Hope in Duarte, Calif., said in a society news release.

"Our study sought to better determine the specific factors before and after transplant that can lead to heart disease in a large group of transplant recipients," Armenian explained.

In conducting the study, the researchers examined the medical records of nearly 1,900 hematopoietic cell transplant recipients to identify factors that could affect their development of risk factors for heart disease. The transplants occurred between 1995 and 2004, and the patients survived for at least one year after the treatment.

The investigators considered the patients' exposure to chemotherapy or radiation before the transplant, the type of hematopoietic cell transplant and whether they were treated for a serious transplant complication known as graft-versus-host disease.

Using the U.S. National Health and Nutrition Examination Survey, the researchers also projected heart disease risk factor rates for the general population.

The study found that high blood pressure, diabetes and high cholesterol were more common among long-term survivors of the blood-forming stem cell transplants.

The risk for developing diabetes was 1.5 times higher for hematopoietic cell transplant survivors who underwent total body radiation. Their risk for high cholesterol was 1.4 times higher. The researchers noted this was true regardless of the type of blood-forming stem cell transplant the patient received.

Although it's unclear why total body radiation increased these patients' risk for diabetes and high cholesterol, previous studies have shown that abdominal radiation may contribute to insulin resistance and an increase in belly fat among cancer patients.

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Stem Cell Transplant May Spur Heart Disease Risk: Study