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Press Release: Alex’s Lemonade Stand Foundation awards Phase I/II Infrastructure Grants to assist in expediting the process of enrolling children with cancer in clinical trial

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Philadelphia, PA (January 14, 2014) – In an effort to bring the latest treatments to more children with cancer now, Alex’s Lemonade Stand Foundation (ALSF) has announced the awarding of six new Phase I/II Infrastructure Grants to researchers at leading hospitals and institutions across the country. The grants, which are intended to accelerate early phase research efforts to increase patient participation and speed up completion of studies, will provide $625,000 over the course of five years to six institutions. Additionally, to sustain the momentum, at the close of the five-year period, the Foundation will match the project’s institutional fundraising for a subsequent five years.

The grants will extend to Robin Norris, MD at CASE Western Reserve University; Lia Gore, MD at theChildren’s Hospital Colorado; Julia Glade-Bender, MD at Columbia University Medical Center; Timothy Cripe, MD/PhD atResearch Institute at Nationwide Children’s Hospital; Julie Park atSeattle Children’s Hospital and Regional Medical Center; and Regina Jakacki, MD at Children’s Hospital of Pittsburgh of UPMC; (full lay summaries can be found on the following page).

Since inception, the primary focus of Alex’s Lemonade Stand Foundation has been to find better treatments and ultimately cures for all kids with cancer. While doctors and researchers work to find these treatments and cures, the Foundation is dedicated to speeding up the process of clinical trials, and working to provide more access for patients in need. With funding from the Infrastructure Grants, hospitals and institutions are able to employ essential support personnel specifically focused on providing this imperative access to clinical trials and in turn bring the latest treatments to more children.

“When my daughter Alex was battling neuroblastoma, the traditional treatment protocol proved to be ineffective,” said Jay Scott, Co-Executive Director of Alex’s Lemonade Stand Foundation. “It was through access to the latest treatments in clinical trial that Alex was able to survive to the age of 8 and create what has now become a leading national nonprofit to find cures for all kids with cancer. We know firsthand how important these trials are to children and their families facing childhood cancer, and we want to ensure they have access to them.”

"We are deeply grateful to Alex's Lemonade Stand Foundation and the Scott family for their investment in our program,” said Children’s Colorado grant recipient Lia Gore, MD. “From the beginning, we have worked to provide the best care and treatment options to our patients. This extraordinary funding will allow us to increase our work and bring new, exciting therapies to the children and families who need these promising options most. We can expand our reach both scientifically and with human capital, and this translates directly into innovative, high-quality care for patients.”

“We owe a debt of gratitude to a little Pennsylvania girl named Alex for her tenacious desire to raise money for childhood cancer research by selling lemonade,” said Timothy Cripe, MD, PhD, division chief of Hematology/Oncology/Blood and Marrow Transplant at Nationwide Children’s Hospital.

In addition to Infrastructure Awards, Alex’s Lemonade Stand Foundation has recently announced the awarding of several other grants to researchers on the front lines of the childhood cancer fight. For more information on recently funded grants, visit: www.ALSFgrants.org.

2014 Funded Infrastructure Phase I/II Grants

 

Robin Norris, MD at CASE Western Reserve University, Cleveland, OH

The Phase I/II Trials Collaborative for Children, Adolescents, and Young Adults at UH Rainbow Babies & Children's Hospital and the Case Comprehensive Cancer Center

Innovative pediatric developmental therapeutic programs are critical to the identification of novel agents that offer the prospect of more effective and less toxic therapies for pediatric cancers.

The pediatric phase I/II trials collaborative for children, adolescents, and young adults at Rainbow Babies & Children's Hospital (RB&C) and the Case Comprehensive Cancer Center (Case CCC) is a unique partnership among the pediatric oncology team at RB&C, the medical oncology team at Case CCC, and translational scientists at Case Western Reserve University (CWRU). The pediatric phase I/II program has been designed to leverage the outstanding science and clinical research expertise of the CWRU and the adult Developmental Therapeutics (DVL) Program at Case CCC and extend the established opportunities and successes in the care of young adults with relapsed/refractory cancer to children and adolescents.

The organization of the pediatric phase I/II program draws from both the existing infrastructure of the adult DVL Program at the Case CCC as well as the existing infrastructure that supports phase II/III pediatric oncology trials at RB&C. Over the next 5 years, we anticipate significant growth in our program as a result of increased trials (consortia, industry, investigator-initiated) as well as the formation of a NE Ohio pediatric phase I/II network consisting of five regional children's hospitals. Central to the growth and success of the pediatric DVL Program is consistent financial support such as that provided in this ALSF Infrastructure Award. Together, we can transform scientific discovery into clinical success for children, adolescents, and young adults with cancer.

 

Lia Gore, MD at Children’s Hospital Colorado, Aurora, CO

Children's Colorado Experimental Therapeutics Program

Most children diagnosed with cancer today will be cured. Unfortunately, for some with very difficult-to-treat cancers, standard therapy is ineffective. The Experimental Therapeutics Program (ETP) within the Center for Cancer and Blood Disorders at Children's Hospital Colorado was created to support the development of and enhance the access to the most promising new therapies for children, adolescents and young adults.

We are the only program of this type in a 12-state region, and conduct phase I and II trials of new cancer treatments that are promising in early studies, but not yet widely available. We actively participate in Children's Oncology Group (COG), Pediatric Oncology Experimental Therapeutics Investigators' Consortium (POETIC), Treatment Advances for Leukemia and Lymphoma Consortium (TACL), and New Agents for Neuroblastoma Treatment (NANT) Consortium clinical trials.

Our program was developed in response to the need to bring new therapies to children who need them the most -- those with cancers with the poorest prognosis. Since inception, we have drawn patients from 40 states and 19 foreign countries for consultation and treatment and have one of the largest and most active phase I portfolios in North America. At present, the demand for consults and enrollments to our open trials exceeds our staffing capacity. ALSF funding will help us support the infrastructure needed to meet the increasing demands for enrolling more children on our trials with the ultimate goal of improving their prognosis and advancing treatment options.

Julia Glade-Bender, MD at Columbia University Medical Center, New York, NY

Columbia University Developmental Therapeutics Program: Striving for Excellence

Survival following chemotherapy for pediatric malignancy remains one of the most stunning successes of modern medicine. Nevertheless, there remains a subset of patients with aggressive disease for whom novel therapies are required.

The Pediatric Cancer Foundation Developmental Therapeutics Program (PCFDTP) at Columbia University (CU) is the only National Cancer Institute-sponsored Children's Oncology Group Phase I center serving the New York, Northern New Jersey and Connecticut tri-state region and a population in excess of 20 million. The PCFDTP also serves as the administrative home for Therapeutic Advances for Childhood Leukemia consortium trials, pharmaceutical industry studies and selective academic collaborations. Since its inception in August 2006, and due to early support from the Alex's Lemonade Stand Foundation (ALSF), the PCFDTP has seen an increase of nearly 50% in early phase trial patient accrual and an increase of more than 100% in outside referrals.

As we strive for excellence, it is an explicit goal of the PCFDTP to develop the independent capability to lead multicenter investigator-initiated industry-sponsored trials both scientifically and administratively. The PCFDTP will use the next 5 years of ALSF infrastructure funding to:

1) Expand the capacity of project coordination and data management to support a substantially increased developmental therapeutics trial portfolio and accrual volume. 2) Translate the rich pipeline of basic and preclinical research ongoing at CU into evidence driven investigator-initiated trials with strong correlative biology. 3) Integrate Precision in Pediatric (PIPseq) comprehensive tumor profiling into standard practice for patient selection and recruitment to biologically targeted early phase trials.

 

Timothy Cripe, MD/PhD at Research Institute at Nationwide Children’s Hospital, Columbus, OH

Nationwide Children's Hospital Phase I/II Infrastructure

The ALSF Infrastructure funding will help support the second phase of the Clinical Research Office growth: successful launching of investigator initiated and early phase protocol to the kids at Nationwide Children's Hospital.

The support that is needed to successfully launch early phase trials is different from the cooperative group trials. The Division of Hematology, Oncology & BMT Clinical Research Office is ready to expand in the areas of patient care for early phase research, information technology and compliance to the protocol to ensure the aims of the study are met in a timely manner.

The ALSF Phase I/II Infrastructure grant will specifically support the critical positions that it takes to successfully launch and run Phase I/II trials. These positions will be Phase 1 Research Nurse, Phase 1 Lead CRC, and Phase 1 Lead Data CRC. The current expansion of the clinical research office infrastructure includes pre-clinical research developmental support, protocols launch support, and active working protocols support to help catalyze the investigator-initiated projects through the entire approval system. This staff supports the multiple existing strengths of the current faculty who have protected time to develop investigator-initiated studies.

Julie Park at Seattle Children’s Hospital and Regional Medical Center, Seattle, WA

Accelerating Access to Cellular Therapies for the Treatment of Childhood Malignancies

The outcome for some of the most common childhood cancers remains unacceptable and for those who survive, long-term medical complications of therapy are a reality.

Our pediatric oncology program at Seattle Children's Hospital (SCH)/Seattle Children's Research Institute (SCRI) is committed to investigate new therapies for childhood cancers. Investigators at SCH/SCRI and within the Seattle Cancer Consortium (SCH/SCRI, University of Washington, Fred Hutchinson Cancer Research Center) have a strong record of translating preclinical laboratory investigations into early phase clinical trials and further successful transition of these therapies to national consortia for definitive assessment. We are committed to further our efforts by now translating laboratory research into developing therapies that will utilize the patient's immune system to target and eliminate cancer.

Our long-term vision is to eradicate childhood cancer while minimizing the long term effects of therapy that childhood cancer survivors of today must endure. Funding from the Alex's Lemonade Stand Foundation (ALSF) is critical to our ability to fulfill our mission. The funding will support the research personnel necessary to complete clinical immunotherapy trials initiated at our program and to maximize our collaboration with pediatric centers worldwide. We pledge to expand our current clinical research personnel and ensure the rapid development and implementation of our clinical trials to ensure that novel immunotherapies will be available to families and patients fighting cancer.

 

Regina Jakacki, MD at Children’s Hospital of Pittsburgh of UPMC, Pittsburgh, PA

Children's Hospital of Pittsburgh of UPMC Phase 1-2 Infrastructure Support Grant - Reapplication

Children's Hospital of Pittsburgh of UPMC has a long tradition of participation in pediatric oncology research. Children’s Hospital is one of 21 institutions in the Children's Oncology Group (COG) Phase 1 Consortium and 1 of 10 in the Pediatric Brain Tumor Consortium (PBTC). We enrolled the largest number of patients to PBTC trials and are the third highest enroller to COG Phase I studies this year. The Neuro-Oncology program at Children’s has two, and soon to be three, innovative vaccine trials open for children with central nervous system tumors and serves as the coordinating center for a multi-institutional Phase II trial of pegylated interferon for patients with plexiform neurofibromas.

Increasing patient numbers and regulatory burden, and the need to coordinate multiple evaluations, including pharmacokinetic analyses, are placing significant stress on our limited infrastructure of one research nurse, one CRA and one regulatory administrator. Budgetary constraints resulting from inadequate financial support provided by COG, PBTC and the institution have precluded hiring additional personnel. Additional clinical trials building on the experience from our initial vaccine studies are planned, including collaborative studies with pharmaceutical companies investigating combination studies with immunomodulatory agents. However, progress has been impeded by lack of research personnel.

We will utilize the ALSF Program Infrastructure Award to hire a second research nurse. With improved staffing in place, we will increase the number of available Developmental Therapeutic clinical trials and total patient accrual, and assure the future integrity of a Developmental Therapeutics Program at Children’s.

About Childhood Cancer

Childhood cancer is a general term used to describe cancer in children occurring regularly, randomly and sparing no ethnic group, socioeconomic class, or geographic region. Childhood cancer extends to over a dozen types of cancers and a countless amount of subtypes. Just a few of these cancer types include: Ewing’s sarcoma, glioma, leukemia, lymphoma, medulloblastoma, neuroblastoma, osteosarcoma, retinoblastoma, rhabdomyosarcoma and Wilm’s tumor. In the United States, childhood cancer is the leading cause of death by disease in children under the age of 15. Every day, approximately 250 kids around the world die from cancer, accounting for 91,250 losing their lives to the disease every year.

 

About Alex’s Lemonade Stand Foundation
Alex's Lemonade Stand Foundation (ALSF) emerged from the front yard lemonade stand of cancer patient Alexandra “Alex” Scott (1996-2004). In 2000, 4-year-old Alex announced that she wanted to hold a lemonade stand to raise money to help find a cure for all children with cancer. Since Alex held that first stand, the Foundation bearing her name has evolved into a national fundraising movement, complete with thousands of supporters across the country carrying on her legacy of hope. To date, Alex’s Lemonade Stand Foundation, a registered 501(c)3 charity, has raised more than $75 million toward fulfilling Alex’s dream of finding a cure, funding over 375 pediatric cancer research projects nationally. For more information on Alex’s Lemonade Stand Foundation, visit AlexsLemonade.org.

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