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Life extension is funding study of therapy that cured cancer in 100% of mice.

In a discovery that made headline news around the world, Dr. Zheng Cui of the Wake Forest University School of Medicine developed a colony of mice with super-charged granulocytes that successfully fight off any form of virulent transplanted cancer. (1) These super-charged granulocytes infiltrate tumor cells and destroy them. The mice given these potent granulocytes are healthy, cancer free, and have a normal life span.

This research project started serendipitously in 1999 when Dr. Cui was testing the effects of administering cancer cells to mice. He found that one mouse did not develop tumors no matter how many cancer cells he administered. Further investigation led Dr. Cui to discover that the mouse that appeared to be immune from cancer had an extra amount of potent granulocytes for specifically killing cancer cells without harming normal cells. When Dr. Cui administered these potent granulocytes to mice with cancer, he cured them. (2)

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This discovery was heavily publicized in 2007-2008, yet no one stepped forward to fund a clinical study to see if this immune-augmentation therapy could cure cancer in humans. When the Life Extension Foundation[R] learned that this potential breakthrough was not being funded, we immediately made a $200,000 grant to help fund a human clinical trial at the South Florida Bone Marrow/Stem Cell Transplant Institute located in Boynton Beach, Florida.

The rationales behind this human study are laboratory experiments showing that some people's immune cells can be almost 50 times more effective in fighting cancer than others. (3) It is now possible to harvest these super-charged granulocytes from healthy young donors and infuse them into cancer patients with curative intent.

This clinical trial will test this approach in humans with advanced cancer, including metastases, who have not been helped by conventional cancer therapies. The trial has received an IND (investigational new drug) status from the FDA and Institutional Review Board approval. The principal investigator/lead physician for this trial is Dipnarine Maharaj, MD, who has in-depth experience in stem cell transplantation, including transfusion of blood products, hematology, and oncology.

In January of this year, Dr. Maharaj notified the Life Extension Foundation that progress was being slowed because expected funding sources had dried up. Life Extension responded with additional funding commitments to facilitate this critical research.

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Dr. Maharaj, the Director of the South Florida Bone Marrow/Stem Cell Transplant Institute, stated, "It would have been impossible for this project to exist without funding from the Life Extension Foundation."

According to William Faloon, who co-founded the Life Extension Foundation in 1980, "These research grants have been awarded to help find a cure for cancer ... Life Extension has no financial interest in the outcome of this research ... Life Extension does have an interest in being able to recommend a validated cure for cancer to its millions of supporters worldwide."

Cancer patients who want further information about participating in this new study can contact Dr. Dipnarine Maharaj, Principal Investigator at 561-752-5522 or Dr. Steven Hirsh of the Life Extension Foundation at 954-766-8433 or log on to Dr. Maharaj's website www.bmscti.org.

The clinical trial expenses include donor costs and building a healthy Donor Registry which is crucial as these donors are the 'medicine' for the cancer patients. There are tremendous costs involved in screening and testing donors, for which Life Extension has provided the main initial funding. However, the clinical trial requires an additional $5 million in order to treat the study's quota of patients (up to 29 allowed by the protocol). Until such funding is available, patients who wish to get onto the study's waiting list are encouraged to visit Dr. Maharaj's website at www.bmscti.org to learn more about the study and fill out an application. Those wishing to contribute financially can also find information about donations on the website.

The following article describes the unique methods used by Dr. Maharaj to treat hematological cancers at his clinic.

THE IMMUNE SYSTEM: A NEW ALLY IN CANCER WAR, BY STEPHEN LAIFER

Hematologist/Oncologist Dipnarine Maharaj, MD, medical director of the South Florida Bone Marrow Stem Cell Transplant Institute, utilizes bone marrow stem cell transplants to combat several common forms of cancer. (4-8) One aspect that makes his approach unique is that the body's own immune system is conscripted into the fight. "Bone marrow stem cell transplant is a procedure whereby we treat patients suffering from different types of blood cancers," explains Dr. Maharaj. "The essence of the treatment is to repair the body's immune system using its own healthy stem cells."

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Dr. Maharaj has been involved in bone marrow stem cell research and its possible applications since 1984. (4) His roots as an innovator go back to childhood: his father and brothers were engineers. His mother and sisters, on the other hand, were nurses. "My mother wanted me to be involved in medicine," he recalls. "She would take me to the clinic when I was younger, and I got used to the idea that doctors do good things. But the engineering influence made me also want to be an innovator."

Medical studies in Glasgow, Scotland led to specializations in stem cell hematology and oncology, which Dr. Maharaj chose because he saw them as an area where he could make a real difference in the quality of cancer care. In Scotland, he was also involved with one of the first groups to explore bone marrow stem cell transplants. (4) Today, aside from running the South Florida Bone Marrow Stem Cell Transplant Institute, he is also a lecturer in biological sciences at Florida Atlantic University. "My education helped shape me as a doctor and as a person. But for me, learning never ends," he says.

CLEAN STEM CELLS

Many of Dr. Maharaj's patients come to the Institute after being told by other doctors there is nothing more that can be done for them. The first step, he says, is to get rid of the cancer in the patient's bone marrow. "Often this requires very high doses of chemotherapy to overcome the tumor cells' resistance to standard doses," (4-8) he says. He favors the analogy of a hammer: "You can crack a nut with a small hammer, meaning standard chemotherapy in this case. But if the nut is resistant, you have to use a sledgehammer."

Stem cell transplants can either be the patient's own, after having been cleaned of cancer cells, or they can be from a donor with the correct tissue match. (9-12) Dr. Maharaj says the ideal situation in many cancers is to identify a compatible donor, because stem cells are then sourced from an individual who has a normal immune system. However, in the conditions which he usually treats--multiple myelomas, non-Hodgkin's lymphomas, Hodgkin's disease and leukemia (13-16)--patients typically have a better outcome when using their own stem cells. "That's because these particular diseases tend to be more prevalent in older patients. Infections, graft rejections and other complications tend to be more frequent in older patients when a donor is involved."

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With a patient's own stem cells, Dr. Maharaj stresses that scouring cancer while the marrow is still in the body is a crucial first step. "Many studies demonstrate that even if you purge the stem cells of the cancer in the lab, if you haven't first gotten the patient to the point where the tumor is basically eradicated, then the outcome isn't as positive," (14) he says. In these studies, cancer treatment centers have typically addressed cleaning the stem cells without considering how much residual cancer is still present in the patient. Patient survival in such cases is unacceptably low. "We have found that we first need to get the tumor load to the point where it is undetectable by conventional methods. (15), (16) Only then will we collect some of the bone marrow and store it, destroy the residual cancer in the patient with high dose chemotherapy and put the stem cells back in."

And here is where the uniqueness of the procedure is clearly demonstrated: Dr. Maharaj says the clean stem cells allow the immune system to undergo what he calls a clonal expansion. (17-22) In effect, the system is "reset" and switched back on; any remaining cancer cells are identified and destroyed by the patient's own recharged immune system. "We're enabling the body's own immunity to fight the cancer. It's exciting," says the oncologist, betraying a bit of the engineer's enthusiasm for innovative solutions.

References

(1.) Hicks AM, Riedlinger G, Willingham MC, et al. Transferable anticancer innate immunity in spontaneous regression/complete resistance mice. Proc Natl Acad Sci U S A. 2006 May 16;103(20):7753-8.

(2.) Available at: http://www.newscientist.com/article/mg19526224.800-cancerresistant-people-lend-out-their-killer-cells.html. Accessed January 18, 2010.

(3.) Benoy IH, Elst H, Philips M, et al. Prognostic significance of disseminated tumor cells as detected by quantitative real-time reverse-transcriptase polymerase chain reaction in patients with breast cancer. Clin Breast Cancer. 2006 Jun;7(2):146-52.

(4.) Burnett AK, Watkins R, Maharaj D, et al. Transplantation of unpurged autologous bone marrow in acute myeloid leukemia in first remission. Lancet. 1984 Nov 10; 324(8411):1068-70.

(5.) Carey PJ, Proctor SJ, Taylor P, et al. Autologous bone marrow transplantation for high-grade lymphoid malignancy using melphalan/irradiation conditioning without marrow purging or cryopreservation. Blood. 1991 Apr 1;77(7):1593-98.

(6.) Reece DE, Bredeson C, Perez WS, et al. Autologous stem cell transplantation in multiple myeloma patients < 60 versus >60 years of age. Bone Marrow Transplant. 2003 Dec;32(12):1135-43.

(7.) Bashey A, Perez WS, Zhang MJ, et al.Comparison of twin and autologous transplants for multiple myeloma. Biol Blood Marrow Transplant.2008 Oct;14(10):1118-24.

(8.) Lazarus HM, Carreras J, Boudreau C, et al. Influence of age and histology on outcome in adult non-hodgkin lymphoma patients undergoing autologous hematopoietic cell transplantation (HCT): a report from the Center for International Blood & Marrow Transplant Research (CIBMTR). Biol Blood Marrow Transplant. 2008 Dec;14(12):1323-33.

(9.) Passweg JR, Walker I, Sobocinski KA, et al. Validation and extension of the EBMT risk score for patients with chronic myeloid leukemia (CML) receiving allogeneic hematopoietic stem cell transplants. Br J Hematol. 2004 Jun; 125(5):613-20.

(10.) Baker KS, Loberiza FR, Yu H, et al. Outcome of ethnic minorities with acute or chronic leukemia treated with hematopoietic stem cell transplantation in the United States. J Clin Oncol. 2005 Oct 1;23(28):7032-42.

(11.) Hari P, Carreras J, Zhang MJ, et al. Allogeneic transplants in follicular lymphoma: higher risk of disease progression after reduced-intensity compared to myeloablative conditioning. Biol Blood Marrow Transplant. 2008 Feb;14(2):236-45.

(12.) Baker KS, Davies SM, Majhail NS, et al. Race and socioeconomic status influence outcomes of unrelated donor hematopoietic cell transplantation. Biol Blood Marrow Transplant. 2009 Dec;15(12):1543-54.

(13.) Crump M, Smith AM, Brandwein J, et al. High-dose etoposide and melphalan, and autologous bone marrow transplantation for patients with advanced Hodgkin's disease: importance of disease status at transplant. J Clin Oncol. 1993 Apr;11(4):704-11.

(14.) Freedman AS, Gribben JG, Neuberg D, et al. High-dose therapy and autologous bone marrow transplantation in patients with follicular lymphoma during first remission. Blood. 1996 Oct 1;88(7):2780-6.

(15.) Harousseau JL, Attal M, Avet-Loiseau H. The role of complete response in multiple myeloma. Blood. 2009 Oct 8;114 (15):3139-46.

(16.) Ladetto M, Pagliano G, Ferrero S, et al. Major tumor shrinking and persistent molecular remissions after consolidation with bortezomib, thalidomide, and dexamethasone in patients with autografted myeloma. J Clin Oncol. 2010 Apr 20;28(12):2077-84.

(17.) Protheroe AS, Pickard C, Johnson PW, et al. Persistence of Clonal T-cell Expansions following High-Dose Chemotherapy and Autologous Peripheral Blood Progenitor Cell Rescue. Br J Haematol. 2000 Dec;111(3):766-73.

(18.) Nieto Y, Shpall EJ, McNiece IK. Prognostic analysis of the early lymphocyte recovery in patients with advanced breast cancer receiving high-dose chemotherapy with an autologous hematopoietic progenitor cell transplant. Clin Cancer Res. 2004 Aug 1;10(15):5076-86.

(19.) Porrata LF, Litzow MR, Tefferi A. Early lymphocyte recovery is a predictive factor for prolonged survival after autologous hematopoietic stem cell transplantation for acute myelogenous leukemia. Leukemia. 2002 Jul;16(7):1311-8.

(20.) Porrata LF, Inwards DJ, Micallef IN, et al. Early lymphocyte recovery post autologous haematopoietic stem cell transplantation is associated with better survival in Hodgkin's lymphoma. Br J Haematol. 2008 Jun;117(3):629-33.

(21.) Gordan LN, Sugrue MW, Lynch JW, et al. Correlation of early lymphocyte recovery and progression-free survival after autologous stem-cell transplant in patients with Hodgkin's and non-Hodgkin's lymphoma. Bone Marrow Transplant. 2003 Jun; 31 (11):1009-13.

(22.) Porrata LF, Gertz MA, Inwards DJ, et al. Early lymphocyte recovery predicts superior survival after autologous hematopoietic stem cell transplantation in multiple myeloma or non-Hodgkin's lymphoma. Blood. 2001 Aug 1;98:579-85.
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Date:Jul 1, 2010
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