Peptimmune Completes Phase I Study With A Novel Peptide Copolymer For The Treatment Of Multiple Sclerosis
March 19, 2008
Peptimmune, Inc. a privately held biotechnology company, announced that it has completed its first clinical trial to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of PI-2301, a novel peptide copolymer for the treatment of multiple sclerosis and other autoimmune diseases.
The Phase I single ascending dose, double blind placebo controlled randomized study involved 56 healthy volunteers who received the drug in eight escalating dose cohorts. All doses were safe and well tolerated, and there were no serious adverse events. Pharmacodynamic assays demonstrated evidence of immune exposure consistent with the pharmacologic mechanism of action for PI-2301, and dose related pharmacokinetics were observed. The Company plans to initiate its first repeat dose study in multiple sclerosis patients in Q2/2008.
“We are pleased to see that PI-2301 was well tolerated and that this trial has provided evidence of single dose priming of healthy subjects. This effect is important as repeated doses in multiple sclerosis patients should lead to therapeutic immune modulation,” stated Thomas P. Mathers, President and CEO of Peptimmune. “We have designed PI-2301 to maximize the therapeutic benefit of a proven, safe compound class in multiple sclerosis as well as increasing patients’ convenience.”
PI-2301 is a second generation peptide copolymer from a similar compound class as Copaxone(R) (Teva Pharmaceuticals). PI-2301 works through immune modulation by enhancing the regulatory response of the immune system to control the pathogenic autoimmune response in certain diseases. PI-2301 has been optimized using Peptimmune’s novel platform peptide chemistry and in pre- clinical studies, has shown to be more potent and effective than Copaxone in treating disease models for multiple sclerosis. PI-2301 has also shown efficacy in pre-clinical models of autoimmune diseases where immune modulation may be effective, such as Crohn’s disease, rheumatoid arthritis and autoimmune uveitis. Peptimmune has also introduced highly reproducible manufacturing methods that allow very strict control and characterization of PI-2301 and should provide a superior level of batch to batch consistency.
Over 400,000 Americans have multiple sclerosis (MS), and worldwide MS may affect over 2.5 million individuals. MS is an autoimmune disease in which the individuals’ immune system responds against multiple components of nerve- insulating myelin. The effects of these immune-mediated attacks can range from relatively benign to somewhat disabling to devastating, as communication between the brain and other parts of the body is disrupted.
About Peptimmune
Peptimmune, Inc. is a privately held clinical stage biotechnology company focused on the development of peptide therapies to improve the management of chronic autoimmune and inflammatory disorders. The Company is in clinical development with second-generation therapeutics that are expected to result in safer and more effective products for multiple sclerosis and pemphigus vulgaris. Current investors include New Enterprise Associates, MPM Capital, Hunt Ventures, Boston Medical Investors, Silicon Valley Bank Capital, and Genzyme Corporation. For additional information, access our website at http://www.peptimmune.com.
Peptimmune, Inc.
http://www.peptimmune.com
Mouse Nerve Cells Protected From Damage By New Drug
March 14, 2008
Multiple sclerosis (MS) is a chronic inflammatory disease of the brain and spinal cord. Individuals with MS develop progressive neurological disability, and this is thought to be caused by degradation of the nerve cells. It is therefore hoped that treatments that protect nerve cells might help individuals with the progressive form of MS. Data to support this hypothesis has now been generated using a chronic progressive EAE mouse model of MS by Howard Weiner and colleagues at the Brigham and Women’s Hospital, Harvard Medical School, Boston.
In the study, treatment of mice after the onset of disease with a water-soluble agent known as ABS-75, which has antioxidant properties and blocks the stimulation of the subset of nerve cells that express the NMDA receptor, markedly reduced disease progression. This beneficial effect was associated with decreased nerve cell degradation, and a similar protective effect was observed for ABS-75 when it was added to cultured nerve cells exposed to damaging reagents. These data led the authors to suggest that agents similar to ABS-75 might provide a new approach to treating individuals with MS and other neurodegenerative disorders.
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TITLE: Reversal of axonal loss and disability in a mouse model of progressive multiple sclerosis
AUTHOR CONTACT:
Howard L. Weiner
Brigham and Women’s Hospital, Harvard Medical School, Boston, Massachusetts, USA.
Source: Karen Honey
Journal of Clinical Investigation
What Will You Do? Join The Movement To End Multiple Sclerosis During MS Awareness Week March 10-17
March 13, 2008
MS Awareness Week March 10 - 17 unites MS organizations and all those living with the effects of multiple sclerosis nationwide in an effort to shine a spotlight on the exciting developments that have occurred this year in treating and understanding MS, a disease where someone is newly diagnosed each hour.
What will you do?
Ways To Join The MS Movement
The National Multiple Sclerosis Society invites people across the county to join the movement to move us closer to a world free of MS by taking simple actions throughout the week, as part of a worldwide “Seven Days of Action.” These activities, just a click away, are designed to be meaningful and easy, whether you are a newcomer or longtime member of the MS Movement. They include:
-Visiting http://www.nationalMSsociety.org daily during MS Awareness Week for new tips and updates on what others are doing to help end MS
-Emailing your members of Congress about the need for increased funding for M S research
-Signing up for a Walk MS or Bike MS event
-Raising awareness by going orange, the color signifying MS and the National MS Society - there are hats, t-shirts, clings, clips and jewelry available for those who want to show they are a part of the MS Movement
-Signing up to volunteer
-Making your mark against MS or sharing your story at http://www.nationalMSsociety.org
-Supporting the Society - every donation brings us closer to a cure
“MS Awareness Week is the perfect time to join the movement to help end MS,” said Joyce Nelson, President and CEO of the National MS Society. “It is also the ideal time to recognize the millions of individuals who are already a part of the movement and each day make a difference in the lives of people who have MS.”
Highlights During MS Awareness Week
Moving Forward MS Film Festival
-The first-ever MS film festival will debut on Second Life on Wednesday March 12 at noon (PT) during MS Awareness Week. The five first-person shorts can also be seen on the Society’s Web site: http://www.nationalMSsociety.org/filmfestival
Launch of a New More Streamlined National Web Site
The Society’s new Web site debuts on March 10. It has been redesigned to make it easier than ever for people with MS and people concerned about MS to find the resources they need.
-Throughout MS Awareness Week, in addition to tips on ways to join the MS Movement, the home page will profile exciting and inspiring volunteers.
-The Society’s online store is introduced where consumers can buy Society items or items from companies and individuals that support the Society
Satellite Media Tour with Jordan Sigalet on March 10
-In collaboration with corporate partner MS Lifelines, live and taped TV interviews have been booked with Providence Bruin hockey star Jordan Sigalet who lives with MS and Society spokesman Dr. Nicholas LaRocca.
Mobility Survey Data To Be Announced
-The Society will release an overview of the first Harris Interactive Poll ever to survey people with MS and their care partners about mobility issues. The initiative was done in collaboration with Acorda Therapeutics. An in-depth media briefing on the survey’s findings will follow on April 8 in New York.
Advocacy Action Alert
-A cross-organizational advocacy alert will be distributed on Tuesday, March 11, to encourage people to ask their federal representatives for increased MS research funding
A Campaign That Moves With You Wherever You Go
The “Join the Movement” campaign has also inspired a wide variety of support from corporations who have donated time, space, creative services and funds to ensure the success of MS Awareness Week and help people with MS move their lives forward. Thanks to the leadership of these corporate supporters, MS Awareness Week 2008 has once again increased the visibility of the MS movement. The National MS Society extends a thank-you to: Bayer HealthCare Pharmaceuticals, Clear Channel Communications, Developers Diversified Realty, EMD Serono and Pfizer Inc, Endless Pools Inc, Genentech/Biogen Idec, Microsoft, Novartis Pharmaceuticals, Teva Neuroscience, The Vitamin Shoppe, and Westfield Shopping Centres.
National MS Chapter Activities
From coast to coast, the Society’s 50-state network of chapters are introducing their own special events to support MS Awareness Week and encourage people to “Join the MS Movement.” They include billboards, banners and displays, “go orange” days, state capitol advocacy days, health fairs, on-the-road MS awareness tours, and alliances with local business and cultural institutions. To find out what is happening in your area, contact your local Society office at 1-800-344-4867 or visit http://www.natonalMSsociety.org to find your chapter.
About Multiple Sclerosis
Multiple sclerosis interrupts the flow of information between the brain and the body and stops people from moving. Every hour in the United States, someone is newly diagnosed with MS, an unpredictable, often disabling disease of the central nervous system. Symptoms range from numbness and tingling to blindness and paralysis. The progress, severity and specific symptoms of MS in any one person cannot yet be predicted, but advances in research and treatment are moving us closer to a world free of MS. Most people with MS are diagnosed between the ages of 20 and 50, with more than twice as many women as men being diagnosed with the disease. MS affects more than 400,000 people in the U.S. and 2.5 million worldwide.
About the National MS Society
MS stops people from moving. The National MS Society exists to make sure it doesn’t. We help each person address the challenges of living with MS. In 2007 alone, through our home office and our 50 state network of chapters, we devoted nearly $126 million to programs that enhanced more than one million lives to move us closer to a world free of MS. The Society also invested more than $46 million to support 440 research projects around the world. We are people who want to do something about MS NOW.
National MS Society
Endless Pools, Inc. And National Multiple Sclerosis Society Raise Awareness For Healthy Living
March 13, 2008
Endless Pools, Inc., the manufacturer of counter-current swimming pools for residential and commercial use, has teamed with the National Multiple Sclerosis Society, the world’s largest MS organization, to highlight the benefits of exercise during MS Awareness Week, March 10-17.
The company, with headquarters in the Philadelphia suburb of Aston, is sponsoring an email communication that the Society will send to half a million households with connections to the MS movement on March 10, kicking off “Seven Days of Action” - a week’s worth of fun, easy activities that anybody can take to boost awareness of multiple sclerosis and the movement to end it. Visit http://www.nationalMSsociety.org to learn more.
Endless Pools also sponsored a Society brochure called Exercise as Part of Everyday Life (.pdf). The 24-page brochure - written by Mary Harmon, a freelance writer who lives with MS - shows how all kinds of exercise, from swimming to yoga to martial arts, can improve physical and mental well-being in people with MS.
“We’ve had a presence for many years in the Society’s national magazine, so expanding this relationship is a natural next step,” said Mark Langan, Marketing Director for Endless Pools, Inc.
“We’re proud to have Endless Pools, Inc. be a part of movement to end MS,” said Joyce Nelson, President and CEO of the National MS Society.
About Endless Pools
Endless Pools, Inc., headquartered in Aston, Pa., a suburb of Philadelphia, was founded in 1988 by James Murdock to manufacture and sell counter-current swimming pools for residential and commercial use. Over the last 20 years, more than 10,000 Endless Pools have been sold and installed in over 50 countries. The 8′ x 15′, temperature-controlled Endless Pool can be installed virtually anywhere, indoors or out. The Endless Pool features an adjustable current that allows you to swim or exercise in place. The current is broad and deep, and is suitable to every swimming ability and therapy need. You can also set the temperature precisely, based on preferences and needs.
About the National Multiple Sclerosis Society
MS stops people from moving. The National MS Society exists to make sure it doesn’t. We help each person address the challenges of living with MS. In 2007 alone, through our home office and 50 state network of chapters, we devoted nearly $126 million to programs that enhanced more than one million lives. To move us closer to a world free of MS, the Society also invested more than $46 million to support 380 research projects around the world. We are people who want to do something about MS NOW. Join the movement at http://www.nationalMSsociety.org.
Studies show that early and ongoing treatment with an FDA-approved therapy can reduce future disease activity and improve quality of life for many people with multiple sclerosis. Talk to your health care professional and contact the National MS Society at http://www.nationalMSsociety.org or 1-800-344-4867 to learn about ways to help manage multiple sclerosis and about current research that may one day reveal a cure.
National Multiple Sclerosis Society
Opexa Therapeutics Announces Completion Of Mid Study Descriptive Analysis On Phase IIb Trial Of Tovaxin(R) For Treatment Of Multiple Sclerosis
March 13, 2008
Opexa Therapeutics, Inc. (NASDAQ:OPXA) announced that the independent Data Safety Monitoring Board (DSMB) of its ongoing 150-patient Phase IIb safety and efficacy study (TERMS) of Tovaxin in multiple sclerosis recommended that the trial be continued as scheduled.
Opexa’s Data Safety Monitoring Board is an independent group of multiple sclerosis experts which is responsible for monitoring the ongoing safety and conduct of the study. At each DSMB meeting, the board may recommend continuing the trial unmodified, continue the trial with modifications or discontinue the trial.
The DSMB meeting reviewed 28-week data for approximately 50% of the patients in the study. The DSMB noted in their report very few dropouts and that the study appears to be proceeding well. In addition, the report indicated that baseline MRI data is consistent with the assumptions used in the design of the study. Edward Fox, M.D., Ph.D. commented, “As the lead investigator of the TERMS trial, I continue to anticipate the conclusion of this experimental protocol, which has been designed to evaluate the efficacy, tolerability, and safety of Tovaxin in the treatment of patients in the early stages of Multiple Sclerosis.”
David McWilliams, president and chief executive officer of Opexa Therapeutics, stated, “I am pleased by the steady progress of the trial and the recommendation of the DSMB. We have delivered all Tovaxin doses to patients in the study and now look forward to presenting 52-week topline results of the TERMS Phase IIb study in September. McWilliams continued, “with this report, we are aggressively moving forward with our regulatory plans and furthering our discussion with potential strategic development partners.”
About TERMS Descriptive Analysis
The descriptive analysis provided to the DSMB included clinical laboratory results, adverse events, vital signs and physical examination data as well as the cumulative number of gadolinium-enhancing lesions on T1-weighted MRI scans, the cumulative number of new gadolinium-enhancing lesions, the change in T2-weighted lesion volume, and annualized relapse rates. Disease progression, as measured by changes in disability scores using the industry-standard Kurtzke Expanded Disability Status Scale (EDSS) along with other select qualitative/quantitative MS-specific instruments, was also assessed.
About TERMS
The Tovaxin Phase IIb clinical study includes 150 patients in a multicenter, randomized, double blind, placebo-controlled trial designed primarily to evaluate the efficacy, safety and tolerability of the Tovaxin T-Cell vaccination with clinically isolated syndrome (CIS) and relapsing-remitting MS (RR-MS) patients. A total of 100 patients will receive Tovaxin, while 50 will receive placebo. The study is designed as a two-arm, 52-week, parallel-group study, whereby patients will be given five subcutaneous injections at 0, 4, 8, 12 and 24 weeks. The analyses will be performed at the end of the 52-week study to assess the safety and efficacy of Tovaxin. The primary efficacy variable is the cumulative number of gadolinium-enhancing lesions on T1-weighted MRI scans summed over the Week 28, 36, 44, and 52 MRIs. The secondary efficacy variables are the cumulative number of new gadolinium-enhancing lesions at Weeks 28-52, the change in T2-weighted lesion volume, and the annualized relapse rate.
About T-cell Vaccination
For a T-cell vaccine to be effective, it should be able to induce T-cell cytotoxic and/or regulatory immune responses against the pathogenic T-cells. Studies of T-cell vaccine have indicated that T-cell vaccination with peripheral blood-derived autologous myelin-peptide selected T-cells in multiple sclerosis patients resulted in the in vivo induction of CD8+ cytotoxic T-cells and CD4+CD25+FoxP3 Tregs specific for T-cell vaccine. The induction of anti-idiotypic cytotoxic CD8+ effector T-cells and anti-ergotypic CD4+CD25+FoxP3 positive Tregs is believed to provide a therapeutically effective dual mechanism of protection to patients treated with Tovaxin. The observed regulatory immune responses have been shown to collectively correlate with clinical improvement in some patients treated in earlier clinical studies.
About Opexa Therapeutics
Opexa Therapeutics develops and commercializes cell therapies to treat autoimmune diseases such as MS, rheumatoid arthritis, and diabetes. The Company is focused on autologous cellular therapy applications of its proprietary T-cell and stem cell therapies. The Company’s lead product, Tovaxin, a T-cell therapy for multiple sclerosis is in Phase IIb trials. The Company holds the exclusive worldwide license for adult multipotent stem cells derived from mononuclear cells of peripheral blood. The technology allows large quantities of monocyte derived stem cells to be produced efficiently for use in autologous therapy, thus circumventing the threat of rejection. The Company is in preclinical development for diabetes mellitus. For more information, visit the Opexa Therapeutics website at http://www.opexatherapeutics.com.
Cautionary Statement Relating to Forward - Looking Information for the Purpose of “Safe Harbor” Provisions of the Private Securities Litigation Reform Act of 1995
This press release contains “forward-looking statements,” including statements about Opexa Therapeutics’ growth and future operating results, discovery and development of products, strategic alliances and intellectual property, as well as other matters that are not historical facts or information. These forward-looking statements are based on management’s current assumptions and expectations and involve risks, uncertainties and other important factors, specifically including those relating to Opexa Therapeutics’ ability to obtain additional funding, develop its stem cell technologies, obtain FDA approval for its therapeutic products, achieve its operational objectives, and obtain patent protection for its discoveries, that may cause Opexa Therapeutics’ actual results to be materially different from any future results expressed or implied by such forward-looking statements. Opexa Therapeutics undertakes no obligation to update or revise any such forward-looking statements, whether as a result of new information, future events or otherwise.
Opexa Therapeutics
Teva Pharmaceutical’s Altered Peptide Ligand Copaxone Boasts The Greatest Patient Share Among First And Second Line Therapies For Multiple Sclerosis
March 12, 2008
Decision Resources, one of the world’s leading research and advisory firms focusing on pharmaceutical and healthcare issues, finds that Teva Pharmaceutical’s Copaxone has the greatest patient share among first- and second-line therapies, and falls short of Merck Serono/Pfizer’s Rebif (by 0.2 percent) in third-line treatment. However, in all three lines of therapy, the interferon-beta drug class (Biogen Idec’s Avonex, Rebif, and Berlex’s Betaseron) outpaces the altered peptide ligand drug class (consisting only of Copaxone) in patient share. Competition between the two drug classes is fiercest in first-line therapy.
“The low volume of patient share attributed to Avonex or Rebif compared with Copaxone in first and second-line treatment illustrates a significant delay on the part of physicians and/or patients to engage in an interferon- beta therapy within a year of a patient’s initial diagnosis for multiple sclerosis,” said Madhuri Borde, analyst at Decision Resources. “However, the magnitudes of Rebif’s first- and second-line patient shares suggest that some physicians are treating the disease more aggressively than might be expected, as this high-dose, high-frequency agent reaches patient shares close to and surpassing Avonex in first- and second-line treatment, respectively.”
According to the new report entitled Treatment Algorithms in Multiple Sclerosis, neurologists note that Copaxone’s better short-term and long-term side-effect/safety profile, together with its lower rate of induction of neutralizing antibodies, are critical reasons for choosing Copaxone instead of Avonex, Rebif and Betaseron. Although Copaxone is administered daily, 23-28 percent of neurologists we surveyed indicate that a key reason to prescribe the drug over any of the interferon-beta therapies is the drug’s ability to foster greater patient compliance, an attribute that is closely tied to the Copaxone’s lower incidence of flulike side effects.
About Treatment Algorithm Insight Series
Decision Resources combines in-depth primary research with the most extensive claims-based longitudinal patient-level data from PharMetrics(R) to provide exceptional insight into physicians’ prescribing trends and the factors that drive therapy product choice, from diagnosis through multiple courses of treatment, for a specific disease.
For each disease examined, Decision Resources’ Treatment Algorithm Insight Series provide the following:
— Summary of U.S. medical practice based on interviews with leading experts in the field.
— Qualitative diagnosis/referral/treatment algorithm for the United States.
— Drug usage by lines of therapy (1st, 2nd, 3rd line).
— Discussion of key freeform combinations by lines of therapy.
— Product share (class and specific compound level) within each line of therapy (1st, 2nd, 3rd line).
— Progression of therapy from key 1st line products.
— Pathway to key therapies from previous therapies.
— Qualitative analysis of two-year forecast incorporating upcoming launches, changes in reimbursement, etc.
About Decision Resources
Decision Resources, Inc., (http://www.decisionresources.com) is a world leader in healthcare market research publications, advisory services, and consulting designed to help clients shape strategy, allocate resources, and master their chosen markets.
All company, brand, or product names contained in this document may be trademarks or registered trademarks of their respective holders.
Decision Resources
http://www.decisionresources.com
MS Society Criticises Producers Of The Bill Over Made-up Drug, UK
March 7, 2008
The MS Society has criticised series producers of The Bill following an episode that featured an entirely made-up drug, which a storyline claimed was available for people with relapsing remitting MS.
The episode, broadcast on 5 March, featured the story of Michael Drummond and ‘Plavitron’ - a drug that viewers were told was available in America.
The MS Society Helpline received a number of calls from people with MS keen to find out more about the ficticious drug, who were disappointed to find out it didn’t exist.
MS Society spokesman, Chris Bentley, said: “There are few effective treatments for MS and any mention of a new drug generates a lot of hope and excitement in people living with and affected by the condition.
“Our Helpline has taken a number of calls from people wanting to know more about the made-up drug Plavitron and we’ve had to tell them it doesn’t exist.
“It was grossly irresponsible of the Bill to make up a drug. People with MS have a tough enough time as it is without being misled over treatments.”
MS Society
Pixantrone To Be Studied In Phase I/II Trial For Aggressive Multiple Sclerosis
March 7, 2008
Cell Therapeutics, Inc. (CTI) (Nasdaq and MTA: CTIC) announced that its investigational drug pixantrone will be studied in a multicenter phase I/II trial initiated by the Fondation Charcot Stichting, in Brussels, Belgium, which sponsors a consortium of centers involved in studying new therapies for the treatment for multiple sclerosis. This study will enroll patients with aggressive relapsing remitting (RR) or secondary progressive (SP) multiple sclerosis (MS). Mitoxantrone, a related compound which is less active in preclinical studies, has been approved by the U.S. Food and Drug Administration (FDA) for the reduction of neurological disability and/or frequency of clinical response in patients with SP MS. A phase III trial with pixantrone in relapsed aggressive non-Hodgkin’s lymphoma (NHL) is near completion.
“Despite the availability of newer biologic agents, drugs such as mitoxantrone remain an important therapy in relapsing MS. Long term cardiotoxicity remains a major drawback to treating multiple sclerosis with mitoxantrone and imposes a limitation both for selection of patients and for the duration of the treatment,” said R.E. Gonsette, M.D., Chairman Fondation Charcot Stichting and principal investigator of the study. “In addition to the potential for lower cardiac toxicity, preclinical studies suggest that pixantrone may provide more effective immune regulation than mitoxantrone, the only currently approved cytotoxic agent for treating MS.”
The investigator-sponsored trial (IST) will enroll 20 patients in Belgium, France and Germany.
About the Study
Twenty patients with aggressive RR MS or SP MS who failed to respond to approved immunomodulatory agents (interferons, glatiramer acetate) will be included. The objectives of the study are to determine the efficacy of pixantrone as an immunosuppressive agent based on its ability to decrease the lymphocyte count and to evaluate efficacy in MS based on gadolinium enhanced magnetic resonance imaging. This trial is an open-label, multi-center, non-comparative study of pixantrone administered at a dose of 120 mg/m2 once every 21 days (3 weeks). Four consecutive three-week courses of pixantrone will be administered in order to determine if this regimen results in lymphopenia of less than or equal to 1000/mm3. The doses and the number of infusions will be adapted to leukocyte, granulocyte and thrombocyte counts and possibly reduced.
About Pixantrone
Pixantrone (BBR 2778) is a novel DNA major groove binder that contains an aza-anthracenedione molecular structure, differentiating it from anthracycline chemotherapy agents. A new chemical compound for the treatment of non-Hodgkin’s lymphoma (NHL), and various other hematologic malignancies, solid tumors, and immunological disorders, pixantrone is being developed by CTI to improve the activity and safety in treating cancers usually treated with the anthracycline family of anti-cancer agents. Anthracyclines have been shown to be very active clinically in a number of tumor types, such as lymphoma, leukemia, and breast cancer. For these diseases, anthracycline-containing chemotherapy regimens are effective in first-line (initial) treatment. However, they may cause cumulative heart damage that limits lifetime dosage and does not allow for retreatment. Pixantrone has been designed to reduce the potential for heart damage compared to currently available anthracyclines or anthracenediones without a loss in anti-tumor or immunomodulatory activities.
About Cell Therapeutics, Inc.
Headquartered in Seattle, CTI is a biopharmaceutical company committed to developing an integrated portfolio of oncology products aimed at making cancer more treatable. For additional information, please visit http://www.cticseattle.com.
This press release includes forward-looking statements that involve a number of risks and uncertainties, the outcome of which could materially and/or adversely affect actual future results. Specifically, the risks and uncertainties that could affect the development of pixantrone and the risks related to this clinical trial include risks associated with preclinical and clinical developments in the biopharmaceutical industry in general and with pixantrone in particular including, without limitation, the potential failure of pixantrone to prove safe and effective for treatment of multiple sclerosis, the identification of new risks or limitations of pixantrone that may be discovered in this Investigator Sponsored Trial, determinations by regulatory, patent and administrative governmental authorities, competitive factors, technological developments, costs of developing, producing and selling pixantrone, and the risk factors listed or described from time to time in the Company’s filings with the Securities and Exchange Commission including, without limitation, the Company’s most recent filings on Forms 10-K, 8-K, and 10-Q. Except as may be required by law, CTI does not intend to update or alter its forward-looking statements whether as a result of new information, future events, or otherwise.
Cell Therapeutics, Inc.
http://www.cticseattle.com
New SSDI Guidebook Available To Individuals With Mutiple Sclerosis
March 5, 2008
During the week of March 10-17, 2008, the National Multiple Sclerosis Society is helping communities and organizations across the country raise awareness and raise funds in the battle against MS. Organizations, including Allsup Inc., which is a national SSDI representation company, are raising awareness about this disease and the resources that are available.
According to the National MS Society, one person every hour is diagnosed with MS, which is an autoimmune disease affecting the central nervous system. This disease affects about 2.5 million people worldwide and 400,000 people in the United States, including many people who must stop working because of the disease.
“Though our efforts to build awareness, understanding and support for the MS cause will certainly continue long past the parameters of this week, we hope by helping to shine a weeklong spotlight on a disease that strikes someone new each hour, we can strengthen the nationwide commitment to unraveling the mysteries of multiple sclerosis,” said Joyce Nelson, president and CEO of the National MS Society.
The National MS Society has developed a new resource to help people who are no longer able to work due to an MS-related disability. The SSDI Guidebook for People with MS is among the materials the society offers on its Web site, http://www.nationalmssociety.org. The guide can be found by clicking on the “Living with MS” link from the home page. The guidebook explains the process of applying for Social Security Disability Insurance (SSDI), which often is a complex and lengthy process.
The MS Society also provides materials to people who are recently diagnosed and working on how to handle the diagnosis, how to communicate with their employers, and how to decide whether to continue working.
Allsup salutes the MS Society and related organizations across the country in recognizing the difficulties facing people who are diagnosed with this disease and the repercussions for their families.
MS Society
Multiple Sclerosis: Prognosis Better Than Expected
March 4, 2008
The authors evaluated data on more than 5000 patients. 60% of MS patients aged 50 years could still walk a distance of 100 meters unaided, as could 40% of patients at age 60. These figures are better than previously assumed. This much more favorable prognosis has also been confirmed by other researchers. On the average, it takes 20 to 29 years from the time of diagnosis for 50% of a collective of MS patients to be able to walk no more than 100 meters. In earlier studies, this stage of disability was generally expected to be reached after only 15 years.
According to the registry data, MS is diagnosed an average of 3.5 years after its clinical onset. For this reason, Flachenecker and coauthors stress that it is important for family practitioners and other physicians in the community to refer any patient with unexplained neurological deficits to a neurologist.
DEUTSCHES AERZTEBLATT
Deutsches Aerzteblatt
Ottostrasse 12
http://www.aerzteblatt.de
