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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, email@example.com
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.
“This study was a result of the [social work] team noticing a trend in increased consultation requests and interventions related to financial need,” Ms. Poole said in an interview.
Among patients’ presenting concerns were losses of benefits from layoffs, high COBRA premiums, and housing foreclosures, with these challenges often taking precedence over the more existential struggles faced by patients facing life-altering or life-threatening cancer diagnoses.
In the study, mental health distress – including coping challenges, adjustment to the diagnosis or treatment, and acute risk assessment for suicidality – constituted 37% of social work consultations, followed by other issues, including coordination of family meetings to discuss goals of care or decision making (5%), and domestic or family violence (2%).
The institute’s five social workers are now very often placed in a position of having to focus immediate attention on patients’ basic needs, while staying attuned to their depression, anxiety, grief, and changes in life roles and self-image, according to Ms. Poole.
“Cancer care, in most cases, cannot wait. These financial worries cause significant distress and when not addressed, may cause barriers to quality care,” she said.
At times, money woes are now directly impinging on medical care, she added, affecting choices patients and families make about cancer treatment regimens or symptom management. “Unfortunately, some patients choose care or treatment that will avoid debt or hardship for their loved ones,” even when those choices may affect their survival or comfort, said Ms. Poole.
“We don’t want to see patients in situations where they are choosing between paying an electric bill and paying for a drug to control nausea, when we know that patients need both.”
Financial burdens influence adherence as well, she noted: “When patients can’t afford gas or copays, they often cancel or ‘no-show’ for appointments.”
The “devastation of financial recession” has not only jolted the priorities of cancer patients, but also has taxed the institutional and external philanthropic assistance programs that once addressed such needs, said Ms. Poole.
“Resources are continuing to dwindle. Programs are simply running out of funding and are much less able to extend financial assistance,” she said. “This issue deserves continued attention and investigation, as the problem may worsen. How will hospital policies and programs respond to absorbing unpaid medical debt?”
Ms. Poole said her department continues to track trends in consultation, “as the full impact of the economic crisis continues to unfold in health care.”
Investigators reported no relevant financial disclosures.
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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I’ve been taking thalidomide for the past 4 years, and putting up with the gradually increasing neuropathy. The sudden-onset muscle cramping, however, does get downright annoying, especially when one of my super exciting dreams is interrupted by a golf-ball sized muscle cramp hitting in the calf of one leg. An interesting question comes up: does the activity in my dreams (leaping from building to building a la Spiderman) cause the cramp, or does the onset of the cramp influence what I am dreaming? I should mention that I have always had really great dreams – now that I’m 71 years old, it’s the only real excitement that I get. LOL
I will put up with my fingers getting twisted into weird positions. That is merely annoying, especially if I am trying to hold a pen or a pencil. What really hurts though, and what I find the most distressful, is a cramp in the arch of one or both feet just before bedtime. Nothing seems to work – heat, vibration, massage, NSAIDs. For years, I have read about people using tonic water (quinine water) to treat muscle cramping, and I have always scoffed. “How can a miniscule amount of quinine possibly influence muscle cramping?” sayeth I. ” It must be in their imagination!” Well, one evening I was ready to try anything, and found a bottle of quinine water in my larder. Ice in the glass, and glug, glug. Within five minutes the cramping in the arch of my foot was GONE. I believe that my reaction was, “Son of a gun!” or something like that.
The next night, same thing: cramps start, drink a glass of tonic water, cramps stop and I get a good night’s sleep. Great dreams: no cramps in the middle of the night, either. Being skeptical, the third night, I went cold-turkey: no tonic water. At two in the morning, while climbing a hillside carrying my trusty 7mm Remington Magnum on a bear hunt, my leg knotted up with nasty cramp. Sudden-End to a really great dream.
Gentle readers, I am not one to leap to conclusions, but every night for the next 2 weeks I drank the tonic water (yes, I went to the grocery and stocked up on a generic brand, some with lime and some “straight”). No cramps. If I skipped the tonic water, I got cramps. Therefore, I must come to the conclusion that tonic (quinine) water has a miraculous ability to stop and/or prevent muscle cramping caused by long term dosage of thalidomide.
There is an additional benefit. Both my Family Physician and my VA physician advocate taking 1½ oz of spirits, or a glass of wine, before bedtime. (a little ethyl alcohol IS good for the human body). This is a marvelous excuse, then, to imbibe a vodka n’ tonic before climbing into my P-47D Thunderbolt, and zooming off to fight a bunch of Me-109’s at 25 thousand feet.
Best regards, Bob Oberle, Chantilly, VA aged 71, dx 5/02 IgG lamda stage 2A, SCT 3/03, in CR since, thalidomide q36hrs for maintenance.
In March of 2007 I was at my monthly oncologist appt for routine labs. I had previously had creatinine levels in the 0.8-1.0 range. Looking back in my records my creatinine on January 2, 2007 was 0.9. January 30th it was 1.0. February 27th it was 1.5. March 30th it jumped to 4.0. At this last level my doctor advised me he was going to admit me to the hospital.
At this time I had been on Biaxin, Revlimid and Dexamethasone for three months with not a very dramatic response. I had also received Zometa recently and had been on Ibuprofen. While in the hospital I was diagnosed with Acute Renal Failure (ARF). I was put on i.v. fluids and my chemotherapy was changed to Velcade. I also had a kidney biopsy performed which revealed I had “myeloma kidney”. My doctors call was to have me receive plasmapheresis treatments.
I first had to have a catheter inserted near my collar bone. The catheter had two lumens. One took the protein out and the other replaced it with albumin (I think Beth, I’m not 100% sure). I had five treatments, two as a hospital patient and the other three as an out-patient. It was an amazing experience. I was connected to this fairly large machine that had buttons, dials and lights along with the tubes that were connected to my catheter. The process took between 60-90 minutes. They can adjust the speed of the machine and it was necessary to do this a little at a time.
The process was painless. I do remember I was chilly during the transfer. They warmed the albumin before it was introduced to my system. They did tell me I might experience tingly sensations around my mouth but I never did.
During the process you could read, watch tv, listen to tapes or sleep. The nurse was there with me during the total procedure.
Each day I had treatment they took my labs and my creatinine continued to improve.
In September I did a SCT and my creatinine is now at 1.9.
MM (Multiple Myeloma)
MDS (Myelodysplastic Syndrome)
Patients & Caregivers
Clinical research study on a newly launched medical product. The purpose is to gain insight and gather opinions from patients and their caregivers that are diagnosed with MM or MDS. It is not necessary to be taking medications to participate. All information is completely confidential and used for research purposes only.
In person 45-50 minute interview
Locations & Dates -Philadelphia, PA – 5/10,5/11,5/12
Fort Lauderdale, FL – 5/14,5/15
Phoenix, AZ – 5/16, 5/17, 5/18
Participants receive $150 cash.
Please contact to schedule or ask questions.
Jan Mallery-Groom RN
212-217-0407 / 201-284-8201
When my hair started to fall out I prevented a big mess by shaving my head. For men in SoCal a completely bald head is a fashion statement, so I never felt out of place. However, my sons and grandson decided to make sure I was OK with being bald: they went and shaved their heads too! I quickly found out that a nice soft wool beret was the most comfortable way of keeping my head warm. Since it was winter I took to sleeping with it on. I also had a stylish Safari style straw hat that served well in sunny weather, but the beret was the best. When my hair came back in it was the same wavy medium brown as before, with just enough gray at the temples to prove I don’t dye it. My old HS classmates are mostly all gray or bald and seem to be jealous. My family doesn’t go gray much. My Mom didn’t have much gray until she was 85. My Sis had treatment for Hodgkin’s and lost her hair. It had been dark brown and very wavy. It came back black and quite curly.
When my hair started to fall out I prevented a big mess by shaving my head. For men in SoCal a completely bald head is a fashion statement, so I never felt out of place. However, my sons and grandson decided to make sure I was OK with being bald: they went and shaved their heads too!
I quickly found out that a nice soft wool beret was the most comfortable way of keeping my head warm. Since it was winter I took to sleeping with it on. I also had a stylish Safari style straw hat that served well in sunny weather, but the beret was the best.
When my hair came back in it was the same wavy medium brown as before, with just enough gray at the temples to prove I don’t dye it. My old HS classmates are mostly all gray or bald and seem to be jealous. My family doesn’t go gray much. My Mom didn’t have much gray until she was 85.
My Sis had treatment for Hodgkin’s and lost her hair. It had been dark brown and very wavy. It came back black and quite curly.