Cyclosporine Side Effects Linked to Risk of Cancer After Liver Transplant

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A study by Dutch researchers seems to indicate that the organ transplant drug Cyclosporine may increase the risk of cancer among liver transplant recipients.

The findings were published in this month’s issue of the medical journal Liver Transplantation, looking at the rate of new cancer malignancies that occur after patients receive new livers. Researchers say the data they collected indicates that cyclosporine cancer risk is dose-specific, meaning that the more of the medication a patient receives, the higher the risk of cancer.

Cyclosporine is an immunosuppressant that helps prevent the body from rejecting transplanted organs by weakening the immune system. It was approved for use by the FDA in 1983 and was originally developed by Sandoz, now known as Novartis, under the brand name Sandimmune.

In the latest study, researchers performed a retrospective analysis on 385 liver transplant patients between 1986 and 2007. They discovered that 50 of those patients, or 13%, developed a de novo (new) cancer after the transplants. When they looked at the therapies the patients had received, researchers determined that the key risk factor appeared to by the use of cyclosporine.

Researchers also found that the cancer risk was highest in patients who received transplants in recent years, and among those under 50 years of age. They determined that the increase was associated with a change in cyclosporine treatment that increased the amount of the drug they were receiving.

The cancers that followed in the wake of cyclosporine treatments were also more aggressive when compared to patients taking other transplant treatments who developed cancer, researchers said.

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Lung transplant trial of inhaled Cyclosporine now closed to enrollment

Let's hope the clinical trials discussed in this press release prove to be successful in reducing the rate of chronic rejection in lung transplant recipients, the most common reason for the current 3-year post transplant survival rate of 60 percent with average survival overall less than 5 years.

APT Pharmaceuticals Completes Enrollment in Phase III for Inhaled Cyclosporine

Leading medical centers in North America participate in study to evaluate the safety and efficacy of cyclosporine inhalation solution in preventing chronic rejection in lung transplant recipients.

Burlingame, CA, APT Pharmaceuticals February 24, 2010

APT Pharmaceuticals, a specialty drug development company focused on the development of inhaled cyclosporine, announced today that it has completed enrollment in its Phase III CYCLIST trial. The multi-center, randomized, controlled study enrolled 288 recent lung transplant recipients across 19 leading centers in North America, including the Cleveland Clinic; the University of Pittsburgh; and the University of California, San Francisco.

The objective of the CYCLIST trial is to evaluate the safety and efficacy of cyclosporine inhalation solution in improving bronchiolitis obliterans syndrome (BOS)-free survival following lung transplantation. Lung transplantation is a life-saving procedure for people with end-stage lung diseases who have exhausted all other available treatment options. However, average survival post-lung transplant is less than five years -- significantly less than all other forms of solid organ transplant. Poor long-term outcomes in lung transplant patients appear to relate to BOS, a manifestation of chronic rejection, which remains a persistent problem despite administration of multi-drug systemic immunosuppressive regimens.

"We appreciate the broad support provided by the community of lung transplant centers, advocacy groups, patients and caregivers," said Dr. Charlie Johnson, chief medical officer of APT Pharmaceuticals. "They have exceeded our expectations by enrolling this trial in just over a year."

About Cyclosporine Inhalation Solution

Cyclosporine Inhalation Solution (CIS) is an inhaled formulation of cyclosporine A, an oral medication that has been widely used for over 25 years to prevent rejection in solid organ transplant recipients. Preliminary clinical studies of CIS in lung transplant recipients have been conducted, including a placebo-controlled study that was published as the lead article in the New England Journal of Medicine in January 2006 (Iacono et al 2006). This small, single-center, randomized, controlled, Phase II study showed that administration of inhaled cyclosporine, initiated soon after transplantation, reduced chronic rejection and improved survival while not increasing the risk of infection. This study led to the multi-center, APT Phase III CYCLIST study.

About APT Pharmaceuticals, Inc.

APT Pharmaceuticals, Inc. is focused on the development of cyclosporine inhalation solution (CIS) for the prevention and treatment of chronic rejection in lung transplantation. The company has successfully enrolled a large, multi-center Phase III clinical trial evaluating the effect of CIS on chronic rejection. APT is preparing for study data and commercialization of the product in the US and Europe. Leading life sciences investors Charter Life Sciences, Great Point Partners, InterWest Partners, Pinnacle Ventures, Research Corporation Technologies, Three Arch Partners, Versant Ventures and Vivo Ventures back APT.

Disclaimer

Cyclosporine Inhalation Solution (CIS) is an investigational drug and is not currently approved by the FDA.

For more information about APT, please visit http://www.aptbio.com.

For more information about the CYCLIST trial, please visit http://www.cycliststudy.com.

“You Have the Power to Save Lives – Register to be an organ and tissue donor & Tell Your Loved Ones of Your Decision”

Register to be a donor in Ontario or Download Donor Cards from Trillium Gift of Life Network. NEW for Ontario: recycleMe.org - Learn The Ins & Outs Of Organ And Tissue Donation. Register Today! For other Canadian provinces click here

In the United States, be sure to find out how to register in your state at ShareYourLife.org or Download Donor Cards from OrganDonor.Gov

In Great Britain, register at NHS Organ Donor Register

In Australia, register at Australian Organ Donor Register

Your generosity can save up to eight lives with heart, kidneys, liver, lungs, pancreas and small intestine transplants. One tissue donor can help up to 100 other people by donating skin, corneas, bone, tendon, ligaments and heart valves

Has your life been saved by an organ transplant? "Pay it forward" and help spread the word about the need for organ donation - In the U.S. another person is added to the national transplant waiting list every 11 minutes and 18 people die each day waiting for an organ or tissue transplant.

Organ Transplants Linked to Cancer

(Ivanhoe Newswire) -- Organ transplants can save lives, but new research shows they might also put recipients at risk of developing cancer.

New research at the Harvard Medical School revealed the immunosuppressive drug cyclosporine ramps up vascular endothelial growth factor (VEGF), causing new blood vessels to grow and feed tumors. Tumors that develop after a transplant can come from three sources: viruses from the organ donor, pre-existing cancer or recurrence of previous cancer.

The study revealed a potential treatment: anti-VEGF therapy, which could inhibit cancerous cell growth. For the 15 to 20 percent of patients who develop cancer in the decade that they received transplants, this could be great news. Researchers found the anti-VEGF therapy drastically reduced tumor growth in mice implanted with human kidney cancer cells.

VEGF expression is necessary in the immediate stage after transplantation, but after organ stabilization, lowering VEGF expression is important to “prevent tumor growth and keep cancer at bay,” Soumitro Pal, Ph.D., an assistant professor at Harvard Medical School’s Transplantation Research Center at Children’s Hospital in Boston, was quoted as saying. He added, “We would need to figure out how to balance benefit and risk to keep cancer at bay.”

SOURCE: Cancer Research, 2008;68,5689-5698

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For other Canadian provinces click here

In the United States, be sure to find out how to register in your state at ShareYourLife.org or Download Donor Cards from OrganDonor.Gov

Your generosity can save up to eight lives through organ donation and enhance another 50 through cornea and tissue donation