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  1. 1. ACTION ALERT April – June 2005 Coalition for Pulmonary Fibrosis Announces 2005 National IPF Awareness Week Activities Third Annual National IPF Awareness Week to be Held Sept. 25 – Oct. 1, 2005 The Coalition for Pulmonary Fibrosis (CPF) recently announced plans for the third annual National IPF Awareness Week, to be held Sept. 25 – Oct. 1, 2005. During IPF Week, for the third consecutive year, a delegation of CPF representatives will travel to Washington, D.C. to meet with lawmakers and raise awareness of idiopathic pulmonary fibrosis (IPF) on Capitol Hill. The CPF will also be introducing its new Fundraising Tool Kit for patients, families and friends who want to help raise much-needed funds for IPF research, patient support and education. IPF patients and CPF representatives will meet with Members of Congress in Washington, D.C. on Sept. 27-29 to improve awareness of IPF in the Congressional community, to discuss the importance of increased funding of IPF-related research, and to encourage Members to advance IPF-related legislation currently before Congress, including the “Ending the Medicare Disability Waiting Period Act of 2005.“ The Act would waive the current 24-month waiting period for Medicare benefits for people with life-threatening diseases such as IPF. The CPF is also supporting two major stem cell bills that have captured the attention of Congress — one bill allows federal funding for embryonic stem cell research and another establishes a network for optimizing umbilical cord stem cell research. “IPF patients and CPF representatives are really making a difference on Capitol Hill by raising awareness of the importance of legislation in Congress that has the potential of impacting IPF patients and families, and the health care professionals who treat them,“ said Mark Shreve, chief executive officer of the CPF. “This advocacy effort is a crucial part of our campaign and provides a great source of hope to our members that their viewpoints are being represented at a national level.“ Last year during the 2004 National IPF Awareness Week, CPF representatives and IPF patients met with more than 60 Members of Congress, including successful meetings with Rep. Charlie Norwood (R-GA), who, weeks before, announced he had IPF, Rep. Joe Barton (R-TX), Chair of the Energy and Commerce Committee, and Rep. Ted Strickland (D-OH). The CPF is also publishing its first Fundraising Tool Kit during National IPF Awareness Week to encourage community-based fundraising activities all year round. The Fundraising Tool Kit will serve as a guide for those interested in organizing events and
  2. 2. activities to help support those affected by IPF, and advance IPF-related research. The kit will provide organizations and individuals the opportunity to make a difference in the lives of IPF patients by offering ideas and guiding them through the process of organizing their own fundraising events and initiatives, while at the same time raising awareness of IPF in their local communities. Funds raised can help advance the CPF’s patient programs and services, continue awareness and education programs around the country, and provide resources for research to find a cure for IPF. The CPF will also be offering commemorative pins in support of IPF Week. The pins will be available on the CPF Web site beginning in July 2005. For additional information about National IPF Awareness Week 2005 activities, or to contribute to CPF-sponsored fundraising events, visit www.coalitionforpf.org. CPF Awarded $25,000 Grant from Fred J. Brotherton Charitable Foundation to Improve Awareness of IPF in New Jersey Clinical Community The CPF is excited to announce that it has been awarded a $25,000 charitable gift from the Fred J. Brotherton Charitable Foundation for the purposes of improving clinical understanding of idiopathic pulmonary fibrosis (IPF). Understanding that early detection of IPF is crucial, the CPF will be sending an educational tool kit to primary care physicians in the State of New Jersey in the coming months thanks to the support of the Brotherton Foundation. Data from the CPF's Basic Research Questionnaire - completed by more than 1,600 patients or family members of patients with IPF - reinforce the need for improved education and awareness of IPF. The questionnaire's data indicates that two thirds of IPF patients reported being misdiagnosed with another form of respiratory illness before being diagnosed with IPF. Further, while 45 percent of patients reported being diagnosed within one year of the onset of symptoms, an estimated 15 percent cited a lapse of two to three years and 21 percent three to five years between the onset of respiratory symptoms and being diagnosed with IPF. Data also show that while 86 percent of patients consult a pulmonologist as part of their treatment, 85 percent of patient report consulting with their primary care physician as well. The CPF hopes to improve early and accurate detection of IPF by providing primary care physicians a copy of “A Physician's Guide to IPF“ - a peer-reviewed monograph to improve clinical understanding of symptoms and diagnostic strategies for IPF - as well as copies of the CPF's “Let's Talk About IPF“ patient educational pamphlets for distribution in their offices. The CPF and its entire membership would like to thank the Fred J. Brotherton Foundation for their commitment to the IPF community through their charitable gift!
  3. 3. Coalition for Pulmonary Fibrosis Partners with the David Geffen School of Medicine at UCLA and the University of Chicago to Raise Funds to Find a Cure for IPF B.I.G. (Breathing Is Glorious!) Ball and B.I.G. Butterfly Ball 2005 fall gala events will provide hope for thousands of IPF patients around the country The Coalition for Pulmonary Fibrosis (CPF) announced in June that it will partner with two nationally recognized medical centers to raise funds for research efforts to find a cure for idiopathic pulmonary fibrosis (IPF), a fatal lung disease, affecting more than 83,000 Americans with no known cause, no cure, and no FDA-approved treatment. The B.I.G. (Breathing is Glorious!) Ball on Friday, Oct. 21, 2005, will be held at the Peggy Notebaert Nature Museum in Chicago to benefit the University of Chicago, and The B.I.G. Butterfly Ball on Saturday, Oct. 22, 2005, will be held at a private beach club in Santa Monica, Calif., to benefit The David Geffen School of Medicine at UCLA. Proceeds will also benefit the education, awareness, advocacy and support services offered by the CPF to patients and families nationwide. “We are pleased to partner with the University of Chicago and UCLA medical centers who clearly share our mission of unifying efforts to help all those affected by IPF,“ said Mark Shreve, chief executive officer of the CPF. “This is a unique opportunity to raise funds to benefit these highly regarded IPF treatment and research centers, while also supporting the programs and services of the CPF.“ UCLA is one of the country's premier IPF treatment and research centers, with more than 500 IPF patients among 1,800 of those suffering from interstitial lung diseases at the clinic. “UCLA is pleased to partner with the nation's largest nonprofit organization supporting IPF patients. These events are a critical source of funding to continue the important research that we do at UCLA,“ said Dr. Robert Strieter, chief, Division of Pulmonary and Critical Care Medicine, and professor of medicine at UCLA. The University of Chicago's Division of Pulmonary and Critical Care Medicine is also a leading institution actively involved in IPF research. “We are happy to be a part of this exciting IPF fundraising event. Funding for research into novel therapeutic approaches to treat – and hopefully cure – IPF is desperately needed. It is important to get everyone involved in this effort,“ said Imre Noth, M.D., co- director, Respiratory Clinical Research Group at the University of Chicago. Although IPF is approximately three times more common than cystic fibrosis, it is often misdiagnosed and receives a fraction of the research funding. The B.I.G. Ball and B.I.G.
  4. 4. Butterfly Ball galas will not only raise important funds for research, but will also provide a channel to increase awareness of this little-known disease. Guests at each of the B.I.G. events will enjoy an evening of fine dining, live and silent auctions, and an opportunity to provide hope for thousands of patients around the country suffering from IPF and the physicians who treat them. For more information on the CPF or to learn more about each of these groundbreaking events, please visit www.coalitionforpf.org or call 888-222-8541. Ron Rakos to Participate in IronMan Triathlon to Raise Funds for the CPF Ron Rakos is taking the concept of riding for a cause to a whole new level. Ron will be participating in the Janus Charity Challenge Ironman Triathlon on Sept. 11, 2005, in honor of his mother, Ida Mae, who is battling idiopathic pulmonary fibrosis (IPF). Ron's dedication to his mother and the sport will send him on a phenomenal athletic challenge. The Ironman consists of a 2.4-mile swim, 112-mile bike race and a 26.2-mile run. The Janus Charity Challenge allows participants to raise funds on behalf of a nonprofit organization of their choosing, and we are excited to announce that Ron has chosen the CPF to be his designated beneficiary. Ron will be swimming, biking and running to raise funds for the Coalition for Pulmonary Fibrosis (CPF). Ron's fundraising efforts will help to find a cure for patients like his mother, suffering from idiopathic pulmonary fibrosis (IPF), a devastating lung disease that affects approximately 83,000 people in the United States, with 31,000 new cases diagnosed each year. The CPF is the nation's largest nonprofit organization (8,500 members and growing) dedicated to helping those affected by IPF. The CPF offers education, awareness, advocacy, and support programs and services, while funding research efforts to find a cure. Like many people, Ron had never heard of IPF when his mother was diagnosed in 2002. She developed a persistent cough and was misdiagnosed with pneumonia, allergies and bronchitis on multiple occasions until a surgical lung biopsy performed in 2002 confirmed that she had IPF. This diagnosis was a huge shock to the Rakos family. Ida Mae comes from a family with a history of longevity, with the previous generation all living into their nineties. “We'd never heard of IPF before, and it took my mother six months to get a proper diagnosis. There is not enough awareness of IPF. We need to educate the public and primary care physicians about this disease to help improve diagnosis and increase research funding,“ said Ron.
  5. 5. The experience of supporting his mother's fight with IPF has made Ron and his family more aware of life's vulnerabilities. Ida Mae is on oxygen support 24-7 and at her recent clinic visit her diagnosis moved from a “moderate“ to a “severe“ case of IPF. Ron is racing to raise awareness of this little-known disease and raise funds to find a cure. “My mother is my inspiration for this challenge. She is my motivation every day when I train.“ Ron’s fundraising goal for this event is $15,000. Help support his efforts with a donation on his Web site at: www.active.com/donate/imwisconsin/rakos. Janus makes additional contributions to the beneficiaries of the top 30 fundraisers at the race. Help Ron utilize this matching gift! The first place fundraiser receives an additional $10,000 for their designated cause. We are deeply grateful to Ron for designating the CPF as his charity, and we hope you will consider contributing to his incredible fundraising effort. For more information on the CPF, visit our Web page at www.coalitionforpf.org, email us at info@coalitionforpf.org, or call (888) 222-8541. Research and Clinical Trial Update CPF Supports Stem Cell Research The Coalition for Pulmonary Fibrosis (CPF), on behalf of the community of 83,000+ patients fighting idiopathic pulmonary fibrosis (IPF), continues to support legislation advancing stem cell research. Recently two major stem cell bills have captured the attention of Congress. One bill (the Stem Cell Research Enhancement Act, H.R. 810) allows federal funding for embryonic cell research and another (the Stem Cell Therapeutic and Research Act, H.R. 2520) establishes a network for optimizing umbilical cord stem cell research. President Bush is opposed to embryonic stem cell research and has promised to veto any such legislation that reaches his desk. The umbilical cord stem cell bill has more widespread support and could be passed into law this year. It is the position of the CPF that stem cell research has great potential in treating - or possibly curing - a wide range of diseases, including IPF. The CPF strongly believes that physicians and scientists, with proper ethical oversight, should be allowed to explore new approaches to treating, and ultimately curing diseases through stem cell research. We urge CPF members to continue expressing their support for stem cell legislation - including both of these bills – by contacting your elected officials in Congress. For more information and to view a sample letter, please visit our campaign ACT home page at www.coalitionforpf.org/campaignact.
  6. 6. FibroGen Completes $100 Million Equity Financing: Plans Phase II Study of FG-3019 in IPF for Mid-2005 FibroGen, Inc. recently announced the completion of a placement of convertible preferred stock generating approximately $100 million in net proceeds. “The primary purposes of this financing were to obtain funds to expand our clinical trial activities and to introduce FibroGen's therapeutic programs to the U.S. institutional investor community,“ said Thomas B. Neff, chief executive officer. Funds are expected to be used to increase staffing and the scope of FibroGen's clinical activities including expansion of anemia programs and continuation of studies in idiopathic pulmonary fibrosis and diabetic nephropathy.Data from FibroGen’s Phase I clinical trial investigating the safety and tolerability of FG-3019 - a human monoclonal antibody against Connective Tissue Growth Factor (CTGF) - in patients with mild to moderate IPF were presented at the American College of Chest Physicians Annual Meeting in October 2004. FG-3019 was found to be safe and well tolerated in IPF patients. (Citation: Mageto et al. (2004) CHEST 126 (4): 773S.). According to the company, a Phase II clinical trial of FG-3019 in IPF will be initiated in mid-2005. For further information about clinical trial participation, including trial sites and patient eligibility, please contact FibroGen at (650) 866-7828 or visit www.fibrogen.com. Source: FibroGen, Inc. InterMune Anticipates Initiating Phase III Clinical Trial of Pirfenidone for IPF During First Half of 2006 InterMune, Inc. recently provided its promised first quarter update on its development plans for pirfenidone. A recent end-of-Phase II meeting with the U.S. Food and Drug Administration (FDA) focused on the completed development work supporting the design and initiation of a Phase III program in idiopathic pulmonary fibrosis (IPF). Following that meeting, InterMune is now working with the FDA to finalize details of a Phase III development program in IPF. As previously disclosed, InterMune also plans to conduct a Phase III pirfenidone development program for Hermansky-Pudlak Syndrome (HPS), a rare genetic disorder often complicated by pulmonary fibrosis.
  7. 7. Prior to initiating a Phase III pirfenidone program for either IPF or HPS, InterMune must first finalize the details of the Phase III IPF program with U.S. and European regulatory authorities and manufacture sufficient quantities of drug product to complete the Phase III trials for both indications. “Assuming we reach agreement in a timely manner with U.S. and European regulatory authorities on an acceptable Phase III program in IPF, we expect to initiate both the IPF and HPS programs in the first half of 2006,“ said Dan Welch, president and CEO of InterMune. “As our regulatory and manufacturing efforts progress, we are also exploring European partnering opportunities for this promising compound.“ About Pirfenidone Pirfenidone is an orally active, small molecule that shows a wide range of biologic activity. In-vitro evidence has shown that pirfenidone inhibits collagen synthesis, down- regulates profibrotic cytokines and decreases fibroblast proliferation. Data presented from Phase II clinical trials suggest that pirfenidone may impact disease progression in patients with IPF. In these clinical experiences, pirfenidone was generally well tolerated with the most frequent side effects reported being photosensitivity rash and gastrointestinal symptoms. In 2004, the FDA and European Medicines Agency (EMEA) granted pirfenidone orphan drug designation for the treatment of IPF. InterMune has worldwide rights, excluding Japan, Korea and Taiwan, to develop and commercialize pirfenidone for all fibrotic diseases. Source: InterMune, Inc. Living With PF Educational Seminar at UCLA Draws 170 Patients and Family Members On Friday, April 22, 2005, the UCLA Division of Pulmonary, Critical Care Medicine & Hospitalists held an free IPF educational seminar entitled “Living with Pulmonary Fibrosis“ at the UCLA Faculty Center. The panel of speakers included UCLA physicians David Zisman, M.D., John Belperio, M.D., Michael Keane, M.D. and David Ross, M.D. The topics featured during the event included “Overview on Interstitial Lung Diseases,“ “Practical Approach to Diagnosis,“ “Promising New Agents,“ “Lung Transplantation: When, Why and How“ and “Life Management Issues for Pulmonary Fibrosis Patients.“ More than 170 patients and families attended the program. UCLA is planning a similar program for Fall 2005. The CPF is grateful to UCLA for their committment to the IPF community through their ongoing IPF treatment and research efforts, and educational programs to improve awareness of IPF in their community. For more information about future seminars, please contact Susan Golleher, R.N. at (310) 206-8950, or visit the CPF's Web page at www.coalitionforpf.org.
  8. 8. University of Minnesota Pulmonary Fibrosis and Interstitial Lung Disease Education Day Draws 270 Patients from 20 States On April 30, 2005, the University of Minnesota held its first annual “Minnesota Pulmonary Fibrosis and Interstitial Lung Disease Education Day.“ This seminar for patients, families and healthcare professionals was held at the Radisson Hotel Metrodome in Minneapolis. The Coalition for Pulmonary Fibrosis was proud to be the largest single sponsor of this event, making it possible for the University of Minnesota to offer this education day to patients and their families free of charge. The Minnesota Pulmonary Fibrosis and Interstitial Lung Disease Education Day was a huge success, with more than 270 attendees from 20 states, and as far away as Alberta, Manitoba and Ontario, Canada. The day featured faculty from the University of Minnesota's Interstitial Lung Disease Clinic, led by Tim Whelan, M.D., Assistant Professor and Director of the University's Interstitial Lung Disease Program. Dr. Whelan served as host of the event and presented “Updates in Clinical Therapies.“ Guest speaker Talmadge E. King, Jr., M.D., chief of Medical Services, San Francisco General Hospital, and chairman of the Department of Medicine, UCSF, was a highlight of the day with an informative, engaging overview of IPF diagnosis and treatment. This event was part of a series of educational days planned and sponsored by the Center for Advanced Lung Disease at the University of Minnesota. The Center for Advanced Lung Disease is an interdisciplinary center focusing on diseased-based education, treatment and research. Due to the great success of this year's event, a 2nd annual Education Day focused on pulmonary fibrosis is being planned for Spring of 2006. Be on the lookout for this event, more news about the Center, and future educational offerings for pulmonary fibrosis and interstitial lung disease at the University of Minnesota. For more information please contact Joslyn R. Biever, administrative director of the Center for Advanced Lung Disease at (612) 628-7741 or (800) 646-9255. Recommended Reading for IPF Patients and Caregivers The following books offer information on lung disorders, and are available at major booksellers nationwide: Breathe Better, Live in Wellness: Winning Your Battle Over Shortness of Breath By Jane M. Martin Healing After Loss: Daily Meditations for Working Through Grief By Martha Whitmore Hickman
  9. 9. The Breathing Disorders Sourcebook By F.V. Adams, M.D. Shortness of Breath: A Guide to Better Living and Breathing By A.L. Ries, et al The Lung Transplantation Handbook By K.A. Coulture Coping with Prednisone By E. Zukerman and J.R. Ingelfinger, M.D. The Official Patient’s Source Book on Idiopathic Pulmonary Fibrosis By J.N. Parker & P. Parker Share the Care: How to Organize a Group to Care for Someone Who Is Seriously Ill By C. Capossela & S. Warnock Taking Flight - Inspirational Stories of Lung Transplantation Compiled by Joanne Schum, Authored by lung recipients around the world CoTherix Initiates Phase II Trial for Ventavis(R) in IPF Patients with Associated Pulmonary Hypertension CoTherix, Inc. announced recently that it has initiated a Phase II trial for its marketed product, Ventavis(R) (iloprost) Inhalation Solution, to potentially expand the indication to include pulmonary hypertension (PH) associated with idiopathic pulmonary fibrosis (IPF). Ventavis was approved by the Food and Drug Administration in December 2004 for the treatment of pulmonary arterial hypertension (PAH) (World Health Organization Group I) in patients with NYHA Class III or IV symptoms. The primary objective of the double-blind, placebo-controlled trial, known as the ACTIVE trial (Aerosolized iloprost a Clinical Trial in IPF to Improve Ventilation and Exercise), is to determine the safety of Ventavis in patients with PH associated with mild
  10. 10. or moderate IPF. The study will also assess other clinically relevant measures including, the six-minute walk test, NYHA class change and hemodyamic parameters. The study will be conducted in approximately 50 patients at 15 sites in the United States. "Ventavis is an ideal candidate to investigate for IPF patients with pulmonary hypertension. Since Ventavis is inhaled, we believe it targetsonly the non-fibrotic portions of the diseased lung, increasing vasodilation only in the ventilated areas and reducing the potential for mismatched ventilation and pulmonary blood flow, which can lead to heart strain and fainting," said James Pennington, M.D., executive vice president and chief medical officer of CoTherix, Inc. "With Ventavis already on the market in the United States for PAH, this trial underscores our strategy to continue our leadership position in inhaled therapies for pulmonary diseases." "Treatment options for these patients are extremely limited," said Richard Channick, M.D., associate professor of Medicine at the University of California, San Diego. "There is a significant need for new therapies to treat the pulmonary hypertension complications of this progressive disease. I am very excited about the potential for Ventavis in IPF and look forward to participating in the study." Source: CoTherix, Inc. (www.cotherix.com) CPF Supports New NIH Policy on Public Access to Federally Funded Research The National Institutes of Health (NIH) announced recently a new policy designed to accelerate the public's access to taxpayer-funded research. The policy - the first of its kind for NIH - calls on scientists to release to the public manuscripts from research supported by NIH as soon as possible, and within 12 months of final publication. CPF believes this new policy is a good first step toward a more cooperative sharing of information that could benefit researchers and patients fighting a variety of diseases. The NIH is the largest funder of medical research in the world, and the largest funder of non-classified research in the U.S. federal government. The research will be made available through an online digital library maintained by the NIH called PubMed Central (www.pubmedcentral.nih.gov). The new policy went into effect in May 2005. Amarillo Biosciences, Inc. Reports on Clinical Trial of Interferon Therapy in IPF Amarillo Biosciences, Inc. recently announced that the company has been supplying its low-dose orally administered interferon alpha (IFNa) to a pilot clinical trial in the treatment of idiopathic pulmonary fibrosis (IPF). The study, is being conducted by
  11. 11. Lorenz O. Lutherer, M.D., Ph.D. and Cynthia Jumper, M.D., professors of internal medicine at Texas Tech University Health Sciences Center. The study, which commenced in 2001 and is ongoing, was funded by a grant from the State of Texas Higher Education Coordinating Board, Applied Technology Program. “IFNa was selected as a potentially effective therapy for IPF for a number of reasons,“ said Dr. Lutherer. “There exists a low level of interferon in the lungs of IPF patients. IFNa is known to stimulate the body's interferon production; modify immune responses; prevent activation of fibroblasts and deposition of collagen (scarring process); and, activate aquaporins in lungs, thereby preventing drying of the tissue across which oxygen enters the blood.“ The study has enrolled 17 of 20 planned subjects who are being administered 150 units of IFNa three times daily in the form of orally dissolving lozenges. Originally designed for one year, subsequent FDA approval was obtained to continue the IFNa treatment in those subjects who demonstrate stabilization of IPF. The subjects are evaluated with pulmonary function tests quarterly and chest x-rays and high resolution computed tomography (HRTC) annually. Results to date suggest that while IFNa treatment has not reversed existing damage, it appears to be arresting the progression of the disease, and the duration of the stability is impressive given the short expected survival time after diagnosis. The stability – arrest of IPF – was confirmed by pulmonary function tests in six of seven patients treated at least one year, including one subject who has been on IFNa treatment for three years. “Subjects also experienced a marked decrease in cough and have expressed a positive response to the lack of progression of the disease,“ said Dr. Lutherer. Accordingly, ABI, in conjunction with Dr. Lutherer, will continue to follow those on treatment; use current data to apply for Orphan Drug Designation from the Food and Drug Administration (FDA); and, submit a Phase II development program to FDA. Additional information is available on the ABI Web site at www.amarbio.com. Source: Amarillo Biosciences, Inc. Cambridge Antibody Technology and Genzyme to Initiate Phase I Clinical Trial of GC-1008 in IPF C ambridge Antibody Technology (Cambridge, England) recently announced that it has received approval from the US Food and Drug Administration (FDA) to begin a Phase I clinical trial of GC-1008 in patients with idiopathic pulmonary fibrosis (IPF). Preparations for this trial are now underway, and the trial is expected to commence during the second quarter of 2005. GC-1008 is a pan-specific fully human anti-TGF (transforming growth factor)-beta monoclonal antibody. The drug is being developed
  12. 12. through an alliance with Genzyme Corporation (Cambridge, Mass.). The full text of this information can be found at www.cambridgeantibody.com. Further information about this clinical trial will be posted to our Web page at www.coalitionforpf.org as it becomes available. Source: Cambridge Antibody Technology InterMune Posts Positive Trial Data: Company Says Actimmune Appears to Fight Fatal Lung Disease Pulmonary Fibrosis InterMune Inc. announced recently that an analysis of trial data suggests its Actimmune drug effectively prolongs survival for patients suffering from pulmonary fibrosis, a fatal lung disorder. The results were presented at the annual International Conference of the American Thoracic Society (ATS), in San Diego. Other data presented at ATS 2005 included an independent investigator-initiated meta analysis that evaluated the effect of Actimmune treatment in prolonging survival in patients with IPF, results of the use of the Composite Pulmonary Index (CPI) in predicting mortality in IPF patients, and preclinical findings on the mechanism of action of interferon gamma-1b in IPF. “The Actimmune efficacy, safety and mechanism of action data presented at the ATS conference provide further support for the design and objective of our INSPIRE trial, an ongoing 600-patient randomized Phase III trial that evaluates the effect of Actimmune treatment in prolonging survival in patients with IPF,“ said Dan Welch, InterMune's president and CEO. “We are encouraged that our investment in and commitment to this trial is validated by these important and supportive data. We plan to complete study enrollment by the end of 2005.“ Long-Term Use of Interferon Gamma-1b in Patients with IPF To assess the outcomes of long-term use of interferon gamma-1b in patients with IPF, researchers at Vanderbilt University in Nashville and at InterMune analyzed efficacy and safety data from 70 patients who had completed both GIPF-001, InterMune's randomized, placebo-controlled, Phase III trial of interferon gamma-1b, and GIPF-004, a 48-week open-label safety study. After receiving interferon gamma-1b treatment for an average of 2.5 years, the cohort of 70 patients showed relatively stable lung function as measured by three standard measures of disease progression. Mean percent predicted forced vital capacity (FVC) decreased by 5 percent from baseline, mean percent predicted DLco decreased by 5 percent, and mean alveolar-arterial gradient increased by 2 mm Hg. Serious adverse events (SAEs) occurred in 29 patients (41 percent). Of these, 10 (14 percent) were deemed possibly or probably related to interferon gamma-1b. Twenty- seven respiratory SAEs occurred in 20 patients (29 percent), of which seven (10 percent)
  13. 13. were deemed possibly related to interferon gamma-1b. During the initial eight weeks of therapy, no acute respiratory failures and no respiratory SAEs were reported. The authors concluded that these safety findings are consistent with those from published reports of randomized-controlled trials of interferon gamma-1b in IPF. Interferon gamma-1b Therapy in IPF: A Meta Analysis In an oral presentation at ATS 2005, Ednan K. Bajwa, M.D., Research Fellow in Medicine at Harvard Medical School presented results from a meta analysis conducted to determine whether interferon gamma-1b treatment prolongs survival in patients with IPF. Dr. Bajwa and his colleagues at Brigham and Women's Hospital and Harvard Medical School together with researchers at the Mayo Clinic and Vancouver General Hospital analyzed pooled data from three long- term, randomized controlled trials of interferon gamma-1b that included a total of 390 patients with IPF. The investigators calculated the pooled differences in survival rates between the interferon gamma-1b group and the control group and compared them at five time points (6 months, 1 year, 18 months, 650 days and 2 years). Interferon gamma-1b was found to be associated with prolonged survival overall (p=0.0003). When survival was evaluated at specific time points, interferon gamma-1b was associated with significantly prolonged survival at 1 year (p=0.0063), 18 months (p<0.0001), 650 days (p<0.0001) and 2 years (p<0.0001). Although safety data was not included in this abstract, adverse events typically associated with the use of interferon gamma-1b include headache, fatigue, fever, myalgia, and rigors. Association of the Composite Pulmonary Index (CPI) with Mortality in a Phase 3 Trial of Patients with IPF In another oral presentation, Athol U. Wells, M.D., of the Interstitial Lung Disease Unit at Royal Brompton Hospital in London, U.K., who helped develop the CPI, presented data on the value of the CPI in predicting mortality. Dr. Wells and colleagues used data from 315 patients with IPF who participated in a large, randomized, placebo-controlled, Phase III trial of interferon gamma-1b. The data suggest that the CPI, which is readily calculable using a formula that uses pulmonary function test results, may be an independent predictor of mortality in IPF patients. The CPI also appears to be a better predictor of survival in IPF than conventional measures, such as isolated lung function tests. Analysis of the data also suggests that, in this study, randomization to interferon gamma-1b and extent of lung fibrosis on CT scan are independent predictors of survival. Interferon Gamma 1-b Inhibits Interleukin-4 (IL-4) Up-Regulation in Activated T- Cells and IL-4-Induced Collagen Synthesis in Cellular Models of Lung Fibrosis In a preclinical study conducted by InterMune researchers, the potential mechanism of action of interferon gamma-1b in IPF was evaluated by measuring its effect on interleukin-4 (IL-4) synthesis in purified CD4 T-cells from healthy volunteers and on IL-4-induced collagen synthesis in human lung fibroblasts. IPF is thought to result from epithelial cell injury followed by aberrant wound healing and excessive accumulation of collagen. Results of this in vitro study showed that interferon gamma-1b significantly reduced the production of IL-4 in CD4
  14. 14. cells and collagen synthesis in healthy donor samples. These results suggest that interferon gamma-1b may be beneficial in the treatment of patients with IPF by reducing IL-4 levels and inhibiting IL-4's ability to induce type I collagen in human lung fibroblasts. Sources: Associated Press (AP) and InterMune, Inc. Sea Puffers Group Offers Oxygen Services for Cruise Travel Celeste Belyea, founder and editor of The Pulmonary Paper, recently found that readers continually are concerned about traveling with oxygen. Celeste, who is also on the CPF board of directors, asked her sister-in-law, Pam Mackenzie, who owns a travel agency in Rochester, NY, if she could arrange cruises for oxygen dependent people. This service became known as the Sea Puffers, and the result has been fulfilling and exciting. Together, the Sea Puffers have traveled to Hawaii, Mexico, the Caribbean, the Panama Canal, to London and around the British Isles and many times to everyone's favorite trip, Alaska. In September 2005, they will go from New York to Canada and New England and are planning a trip to Rome and a 10-day cruise around the Mediterranean in May 2006. The Sea Puffers provide support and arrange each passenger's oxygen and other medical needs. During the days at sea, they meet and discuss tips on dealing with lung disease. Vendors generously donate products to demonstrate and give away, such as the LifeStyle portable oxygen concentrator, Aerochambers, OxyView glasses and printed material. They try to have dinner at the same time each night and talk about how everyone’s day is going, much like a family dinner table. They have a full infirmary on each ship that is capable of ventilating a patient if need be. The Sea Puffers are just a small part of the cruise ship and everyone is free to go their own way, on their own excursions and activities aboard ship. Many venture into the casino and have been very lucky, winning thousands of dollars on the slots machines and craps table. If you are interested in joining a Sea Puffers cruise, you may contact Pam Mackenzie at (877) 473-2726 or visit www.seapuffers.com. Campaign ACT Update CPF Member Visits Capitol Hill Trudy Vanderbeck, an IPF patient and active CPF member, recently visited Washington, D.C. for a family event and made good use of her time on Capitol Hill to raise awareness of IPF. Trudy is a great example of how CPF members can be advocates for IPF and the CPF and have an impact in a few short hours.
  15. 15. In one afternoon Trudy met with three Congressional Members’ offices; Sen. Evan Bayh (D-IN), Sen. Richard Lugar (R-IN) and Rep. Charlie Norwood (R-GA), who received a lung transplant for IPF last October. Trudy’s visits were productive, and she was greeted at some offices with many questions about IPF. She was able to follow up on meetings she had last year during National IPF Awareness Week, and continue to reinforce IPF awareness and the need for important legislation to be passed to help support patients and fund research to find a cure. “Although I was in Washington, D.C. for a family trip, I made the time to visit Members of Congress,“ said Vanderbeck. “It's important for all of us to remind our elected officials about IPF because they can forget about us so quickly.“ She also stressed, “Patients, caregivers, doctors and family members, all need to write to members of Congress. They need to be reminded that patients are suffering and that there is no known cause or cure for this disease.“ We encourage you to visit your U.S. Representative and Senators if you are visiting our nation's Capitol. You can make a difference by spending an hour or so on Capitol Hill. The process is simple. Visit your Senators’ and Representative’s Web site to find out how to call and schedule meetings with them or their health aides. Go in with a plan and have specific requests for their assistance and support. If you can, carry information about IPF with you to leave behind for them to review, as you may not have enough time to cover everything. The CPF can provide helpful ideas for your meetings. If you are planning a visit to Capitol Hill, please contact the CPF at (888) 222-8541. IPF Seminars CPF Partners with National Jewish Medical & Research Center to Host “Living With IPF“ Educational Seminar July 23 The Coalition for Pulmonary Fibrosis (CPF) in partnership with National Jewish Medical and Research Center in Denver is hosting a free seminar on Saturday, July 23, 2005, for patients and families living with idiopathic pulmonary fibrosis (IPF). The seminar will feature lung specialists, Gregory Cosgrove, M.D. and Steven K. Frankel, M.D. from the National Jewish Medical and Research Center's Interstitial Lung Disease Program. The seminar will address IPF diagnosis, current standards of care, lung transplantation, oxygen management and pulmonary rehabilitation for the IPF patient, life management issues, and resources and support services for those fighting this disease. This is a unique opportunity for patients, family members, caretakers – anyone affected by IPF – to learn about the latest in IPF diagnosis, research and treatment from the National Jewish Medical and Research Center's leading IPF researchers and pulmonary
  16. 16. experts. For more information, or to register, please contact the CPF at (888) 222-8541 or visit www.coalitionforpf.org. Oxygen is available upon request. Please indicate on your RSVP if you require oxygen. See next page for more details. CPF Introduces New Fundraising Tool Kit for Members The CPF has published a Fundraising Tool Kit to encourage community-based fundraising activities all year round. This new Tool Kit is designed for patients, families and friends who want to help raise much-needed funds for IPF research, patient support and education. The Fundraising Tool Kit will serve as a guide for those interested in organizing events and activities to help support all those affected by IPF. The kit will provide organizations and individuals the opportunity to make a difference in the lives of IPF patients by offering ideas and guiding them through the process of organizing their own fundraising events and initiatives, while at the same time raising awareness of IPF in their local communities Funds raised can help advance the CPF's patient programs and services, continue awareness and education programs around the country, and provide resources for research to find a cure for IPF. Tool kits will be available beginning July 2005 by calling us at (888) 222-8541 or emailing us at info@coalitionforpf.org. Members can immediately view or download the Tool Kit via the CPF Web site at www.coalitionforpf.org (high speed internet required). New Support Groups in Arkansas and California CPF and Arkansas Asthma & Lung Center Establish Support Group in Little Rock The Coalition for Pulmonary Fibrosis is pleased to announce a new support group has been established for idiopathic pulmonary fibrosis (IPF) patients and their loved ones in partnership with the Arkansas Asthma & Lung Center. The support group is coordinated by Boo Domingue of the Arkansas Asthma & Lung Center, and the CPF is deeply grateful to him for volunteering his time for this worthy cause. The first meeting was held April 30, 2005. Attendance is open to patients, their families, caregivers and anyone interested in sharing and learning about IPF. The focus of this support group is to provide IPF patients and their loved ones with essential educational resources and support. Meetings are in Little Rock, within the office building of the Arkansas Heart Hospital, 1701 S. Shackleford R., which is handicapped accessible. Signs will be posted the day of meetings. Should you have any questions or to inquire about future meeting dates, please
  17. 17. contact Boo Domingue, RRT, at (501) 541-2729 or by email at arasthma@sbcglobal.net. New IPF Support Group in California Thanks to the efforts of our local volunteers, the CPF is pleased to announce a new support group near Los Angeles for IPF patients and their families. The CPF encourages attendance by patients, their families, caregivers and anyone interested in sharing and learning about interstitial lung disease. IPF Support Group for Idiopathic Pulmonary Fibrosis Location: Charitable Foundation 16716 Bear Valley Rd. Victorville, CA 92392 Meetings: First Wednesday of every month. For additional information or to RSVP, please contact: Steve Clemons (760) 246-7711 or Teresa Hackett (760) 956-8817. About the CPF Board of Directors Each quarter the CPF profiles a member of the CPF board of directors or scientific advisory board, many of whom are nationally recognized thought leaders in the treatment and research of IPF, family members of patients with IPF and advocates for all those fighting the disease. Celeste Belyea Celeste Belyea, RN, RRT, is founder and editor of The Pulmonary Paper, a newsletter for pulmonary patients that is distributed worldwide. She strives to provide timely information and supportive resources to people affected by chronic lung diseases, including pulmonary fibrosis. Her work in home healthcare taught her that many pulmonary patients were lacking the education and support structure that would help them battle their illness. In 1992, while working as a respiratory therapist, Celeste decided to branch out by forming Health Smart, a mobile occupational testing company. The genesis of the company was driven primarily by her determination to promote preventive health by performing risk assessments and health screenings and providing educational materials to employees in an effort to keep them out of respiratory rehabilitation departments. Health Smart was later purchased by HealthSouth. Celeste holds a degree in respiratory therapy from the State University of New York Upstate Medical Center in Syracuse, NY, as well as a nursing degree from Broome Community College in Binghamton, NY. With more than 30 years of experience in pulmonary medicine, Celeste has worked in various respiratory therapy departments at
  18. 18. hospitals in New York, Alabama, New Hampshire and Florida. She is a member of the board of directors for the National Home Oxygen Patient Association and a member of the American Association of Respiratory Care, which honored her as an “Outstanding Practitioner.“ CPF Board of Directors Marvin I. Schwarz, M.D. CPF Chairman & The James C. Campbell Professor of Pulmonary Medicine & Head, Division of Pulmonary Sciences and Critical Care Medicine University of Colorado Health Sciences Center Gregory Tino, M.D. Associate Professor of Medicine, Director, Pulmonary Outpatient Practice, Pulmonary, Allergy and Critical Care Division, University of Pennsylvania Medical Center Shirley Becker Family member of IPF patients Paul W. Noble, M.D. Professor of Medicine, Yale University School of Medicine Deirdre R. Roney Family member of eight IPF patients Celeste Belyea, RN, RRT Editor, The Pulmonary Paper Teresa Barnes Family member of four IPF patients Supporting the CPF The Coalition for Pulmonary Fibrosis relies on the contributions of individuals, corporations and associations who share our commitment to improving awareness and education of IPF, and improving the quality of life for patients fighting IPF nationwide. Through your generous support, the CPF will continue to provide information, resources, and support to more than 83,000 IPF patients, caregivers and families, and to the healthcare professionals who treat them. Should you wish to make a tax-deductible contribution to the CPF, we encourage you to send your check or money order to:
  19. 19. Coalition for Pulmonary Fibrosis c/o PNC Bank POB 31001-0943 Pasadena, CA 91110-0943 Any contributions mailed by overnight delivery or by special couriers should be sent to: PNC Bank 465 North Halstead, Suite 160 Pasadena, CA 91107 Ref: Coalition for Pulmonary Fibrosis Lockbox #910943 Contributions are also accepted online by bank transfer or by using any major credit card safely and securely through PayPal. The CPF’s PayPal ID is info@coalitionforpf.org. Contributors can visit our secure PayPal link at http://www.coalitionforpf.org/AboutUs/contribute, or by visiting www.paypal.com. If you have any questions about your contribution to the CPF, or if you would like to make a restricted donation to advance a specific CPF program such as our educational materials, seminars, support services or research efforts, please contact us at 888-222- 8541. About the Coalition for Pulmonary Fibrosis The Coalition for Pulmonary Fibrosis (CPF) is a 501(c)(3) nonprofit organization, founded in 2001 to further education, patient support and research efforts for interstitial lung disease, and specifically pulmonary fibrosis. The CPF is governed by the nation's leading pulmonologists, individuals affected by pulmonary fibrosis, medical research professionals and advocacy organizations. With more than 8,500 members nationwide, the CPF is the largest nonprofit organization in the country dedicated to helping those with pulmonary fibrosis. The CPF's nonprofit partners include the Caring Voice Coalition, the Genetic Alliance, the Mary D. Harris Memorial Foundation, the National Coalition of Autoimmune Patient Groups, the National Organization for Rare Disorders (NORD), The Pulmonary Paper, the Second Wind Lung Transplant Association, and more than 30 leading medical and research centers nationwide. For more information please visit www.coalitionforpf.org or call (888) 222-8541.