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This web site is dedicated to the memory of Chris Hollyer, and has been created for those of us with Multiple Myeloma, our caregivers and friends and families to use as a resource. The content is 100% contributed by members.
For many of us who suffer the incurable cancer called multiple myeloma,there was one person we turned to above all for information, guidance and wit, Chris Hollyer. MM took your life, Chris, but it will never take the patient and gentle spirit you left behind.
– Ed Gorman
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BioInvent Presents Positive Data for BI-505 at International Myeloma Congress
Lund, Sweden – 4 April 2013 – BioInvent International AB (OMXS:BINV) announce that the previously communicated positive results from a phase I trial of BI-505 is presented today at The International Myeloma Workshop in Kyoto, Japan. At the same meeting, preclinical data is also presented which demonstrate significantly enhanced efficacy when approved myeloma drugs are combined with BI-505. BI-505 is a human antibody directed against ICAM-1 and is developed for the treatment of multiple myeloma.
The results from the phase I study of BI-505 in patients with advanced multiple myeloma are presented by Associate Professor Markus Hansson at Lund University. The preliminary analysis shows that BI-505 has an advantageous safety profile. In cohorts where extended treatment was available, 24 percent of the patients had stable disease for at least two months, indicating effect of BI-505.
At the same meeting, new preclinical data is also presented showing significantly enhanced anti-myeloma activity when the approved drugs Velcade® or Revlimid® is combined with BI-505 compared to single agent treatment. Combined treatment was evaluated in two different experimental models and the drugs were given in a similar way as to patients with myeloma. In one of the models enhanced survival was observed following combination therapy with BI-505, compared to single agent treatment with the approved drugs. In the second model, complete remission was observed in the majority of animals when combining BI-505 with Revlimid® or Velcade®.
Cristina Glad, CEO for BioInvent, commented: “We believe BI-505 has the potential to address a major unmet medical need in a broad population of patients with multiple myeloma. Based on the results from the phase I trial which are now presented at the international myeloma meeting, we have decided to continue our studies on BI-505 with a new smaller trial in patients with asymptomatic multiple myeloma (called “smoldering multiple myeloma”). The interesting preclinical studies showing enhanced anti-tumor effect when combining BI-505 with approved drugs, support to move forward with a clinical trial in which BI-505 is combined with another drug, representing a logic continuation of the clinical development process for our hitherto most advanced project.”
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The candidate drug BI-505 is a human antibody that specifically binds to the ICAM-1 adhesion protein (also known as CD54). Expression of ICAM -1 is increased on myeloma cells, which makes it a suitable target for a candidate drug. BI-505 exerts its antimyeloma activity by inducing programmed cell death in myeloma cells and by engaging patient´s immune cells to attack myeloma cells. In several animal models, BI-505 has been shown to kill tumor cells more efficiently than existing drugs.
The first results from the phase I study of BI-505 in patients in advanced stages of the malignant disease multiple myeloma were reported earlier this year. The preliminary analysis showed that BI-505 has an advantageous safety profile. In dose groups where extended therapy was offered, 24% of these severely ill patients demonstrated stable disease for at least two months, indicating effect of BI-505.
The number of newly diagnosed patients with multiple myeloma worldwide is estimated to more than 40,000 per year.
BI-505 has received Orphan Drug Designation in both Europe and the US for the indication multiple myeloma. This provides BioInvent with market exclusivity for treatment of multiple myeloma with an antibody against ICAM-1 for up to 10 years after marketing approval is granted.
BioInvent International AB, listed on the NASDAQ OMX Stockholm (BINV), is a research-based pharmaceutical company focused on discovery and development of innovative antibody-based drugs against cancer. The Company’s pipeline currently includes three product candidates for the treatment of cancer.
The company’s competitive position is underpinned by n-CoDeR®, a proprietary antibody development platform. The scope and strength of this platform is also used to develop antibody-based drugs in collaboration with partners who finance the development of the new drug, and provide BioInvent the right to milestone payments and royalties on sales. These partners include Bayer HealthCare, Daiichi Sankyo, Mitsubishi Tanabe and Servier. More information is available at www.bioinvent.com.
For further information, please contact:
President and CEO
+46 (0)46 286 85 51
+46 (0)708 16 85 70
BioInvent International AB (publ)
Co. reg. No. 556537-7263
Visiting address: Sölvegatan 41
Mailing address: 223 70 LUND
Phone: +46 (0)46 286 85 50
FDA NEWS RELEASE
For Immediate Release: July 20, 2012
Media Inquiries: Erica Jefferson, 301-796-4988, firstname.lastname@example.org
Consumer Inquiries: 888-INFO-FDA
FDA approves Kyprolis for some patients with multiple myeloma
The U.S. Food and Drug Administration today approved Kyprolis (carfilzomib) to treat patients with multiple myeloma who have received at least two prior therapies, including treatment with Velcade (bortezomib) and an immunomodulatory therapy.
A form of blood cancer that arises from plasma cells, multiple myeloma usually grows in bone marrow, the soft, spongy tissue found inside most bones. The bone marrow is where normal blood cells are produced. In 2012, an estimated 21,700 people will be diagnosed with multiple myeloma and 10,710 will die from the disease, according to the American Cancer Society.
“The approval of Kyprolis provides a treatment option to patients with multiple myeloma whose disease has progressed despite use of available therapies,” said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in FDA’s Center for Drug Evaluation and Research. “We are encouraged by the continued progress in the development of drugs for multiple myeloma over the past decade, offering improved treatment of this disease.”
The safety and effectiveness of Kyprolis, which is administered directly into a patient’s vein (intravenously), was evaluated in a study of 266 patients with relapsed multiple myeloma who had received at least two prior therapies, including Velcade and Thalomid (thalidomide).
The study was designed to measure the percentage of patients who experienced complete or partial disappearance of tumor after treatment (overall response rate). The overall response rate was 23 percent. The median duration of response was 7.8 months.
The most common side effects observed in more than 30 percent of the study participants were fatigue, low blood cell count and blood platelet levels, shortness of breath, diarrhea, and fever. Serious side effects seen with Kyprolis included heart failure and shortness of breath. Patients should be monitored closely and treatment withheld if these serious side effects occur.
The drug is being approved under the FDA’s accelerated approval program, which allows the agency to approve a drug to treat a serious disease based on clinical data showing that the drug has an effect on a surrogate endpoint that is reasonably likely to predict a clinical benefit to patients. The program is designed to provide patients with earlier access to promising new drugs. The company is required to submit additional clinical information after approval to confirm the drug’s clinical benefit.
Krypolis is marketed by Onyx Pharmaceuticals of South San Francisco, Calif.
For more information:
FDA: Office of Hematology and Oncology Products
FDA: Approved Drugs: Questions and Answers
FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
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Elsevier Global Medical News. 2011 Feb 28, B Bates
ANAHEIM, CALIF. (EGMN) -Highlighting shifting priorities after the recession, nearly half of all recent psychosocial consultations with patients at a leading cancer center involved financial worries, rather than adjustment issues or other pressing mental health concerns.
Among 313 single-episode encounters at the Cleveland Clinic’s Taussig Cancer Institute during one month in late summer 2010, 49% focused on financial issues, according to a study presented at the annual conference of the American Psychosocial Oncology Society.
These included a lack of adequate health insurance, inability to afford medications, housing crises, and/or difficulties in meeting basic financial obligations during cancer treatment, reported Christa Poole, a social worker at the institute. Read More →