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Perifosine Receives “Orphan Medicinal Product Designation” In Europe For Myeloma – On March 1, Aeterna Zentaris announced that it received a positive opinion for orphan medicinal product designation for perifosine for the treatment of multiple myeloma. Perifosine is currently being studied in a Phase 3 trial for myeloma. Orphan medicinal product designation, similar to orphan drug status in the U.S., encourages development of drugs for rare medical conditions. The status gives the drug’s developer assistance with the application for the approval of the drug, waived application fees, and up to ten years of market exclusivity in Europe, if approved for treatment. Perifosine has already been granted orphan drug status in the U.S. For more information, please see the press release on the Æterna Zentaris Web site.

ImmunoCellular Therapeutics To Receive Patent For ICT-69 – On March 2, ImmunoCellular Therapeutics, a biotechnology company that is developing immune-based therapies for cancer treatment, announced that it received a Notice of Allowance on its patent application for ICT-69, a monoclonal antibody that targets multiple myeloma and ovarian cancers. Generally, this notification means that a patent will be issued once the issue fee is paid. For more information, see the ImmunoCellular Therapeutics Web site.

Myeloma Awareness Month Teleconference Series – There are three more teleconferences in the International Myeloma Foundation (IMF) teleconference series celebrating March as Myeloma Awareness Month. Patients, family members, caregivers, and health care professionals are welcome to join. The teleconferences provide up-to-date information regarding multiple myeloma and are held each Friday during March at 7 p.m. EST. Each teleconference will include an hour-long presentation followed by a 30-minute Q&A session on education (March 12), research (March 19), and advocacy (March 26). Please see the IMF Web site for more information.

Living With Myeloma Conference – The Arizona Myeloma Network is hosting its fourth annual “Living With Myeloma” conference on March 27 from 8:30 a.m. to 4:30 p.m. at the Scottsdale Conference Center. Physicians and researchers, including Dr. Robert Kyle, Professor of Medicine at the Mayo Clinic, will be giving invited talks. Patients, family members, caregivers, physicians, researchers, and health care providers interested in myeloma are invited. The conference, including a continental breakfast and hot lunch, is free. Heath care professionals may receive 4.5 continuing medical education credits for attending. Space is limited for the conference, and those interested in attending are urged to register quickly. For registration and more information, visit the Arizona Myeloma Network Web Site.

For a more detailed listing of myeloma related events, please check the Myeloma Beacon Events Calendar.

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Dacetuzumab Shows Some Potential For Multiple Myeloma – Results from a Phase 1 clinical trial show that dacetuzumab (SGN-40), an anti-CD40 monoclonal antibody, has some anti-myeloma effects. The best response observed during the trial was stable disease in 20 percent of patients. The study authors found that doses up to 12 mg/kg per week were well tolerated. Most side effects were mild to moderate and included fatigue, headache, nausea, and anemia. The study authors suggest that dacetuzumab may produce better response rates in combination with other myeloma drugs. Two combination trials (one with Revlimid (lenalidomide) and one with Velcade (bortezomib)) are underway.  For more information, please see the study in The Haematologica Journal (pdf) and the clinical trial descriptions (dacetuzumab with Revlimid or Velcade) .

Myeloma Awareness Month Teleconference Series – Each Friday during the month of March, the International Myeloma Foundation (IMF) will be hosting a teleconference to raise awareness and provide up-to-date information about multiple myeloma. The teleconferences are scheduled for 7 p.m. EST and will include a 60 minute presentation followed by a 30 minute Q&A. Patients, family members, caregivers, and health care professionals are welcome to join. Please see the IMF Web site for more information.

NCI Designs MGUS/Smoldering Myeloma Study – Researchers from the National Cancer Institute (NCI) are in the process of developing a prospective study with the goal of identifying causes of transformation from monoclonal gammopathy of undetermined significance (MGUS) and smoldering myeloma (both asymptomatic, pre-malignant disorders) to multiple myeloma. The study will enroll 350 patients with MGUS or smoldering myeloma in the United States and follow them for up to five years. For more information, please contact the research nurse for this study, Mary Ann Yancey, at (301) 435-9227 or yanceym@mail.nih.gov.

For a more detailed listing of myeloma related events, please check the Myeloma Beacon Events Calendar.

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Innate Pharma And Celgene To Collaborate On Trial Combining Revlimid With IPH 2101 Therapies – Innate Pharma and Celgene will collaborate to evaluate the clinical potential of Celgene’s Revlimid (lenalidomide) plus Innate Pharma’s IPH 2101 in myeloma patients who have failed first-line therapy. In vitro studies on myeloma cell lines have shown that the two drugs may have a synergistic effect. Innate Pharma hopes to submit a request with the Food and Drug Administration in early 2010 to receive authorization to administer the drugs in humans. For more information, please see the Innate Pharma press release.  

Myeloma UK Launches The Innovative Myeloma Clinical Trial Network – The Clinical Trial Network will design and manage a portfolio of early phase trials of myeloma drugs by drawing on a collaboration of clinical specialists, researchers, pharmaceutical companies, and the National Health Service’s regulatory bodies. Eight research centers around the UK will be involved in the trials included in the portfolio. Myeloma patients will be able to take part in the trials at these centers. The first trials are expected to begin recruiting patients in early 2010. For more information, please visit the Myeloma UK Web site.

Peter Boyle Memorial Raises $700,000 For The IMF – The Third Annual Peter Boyle Memorial raised $700,000 for the International Myeloma Foundation. The event was launched three years ago by Boyle’s widow to help fund the battle against multiple myeloma. For more information, please visit the Los Angeles Times Web site.

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Coverage Of Velcade For Myeloma Is Expanded In Scotland – The Scottish Medicines Consortium (SMC) has approved the use of Velcade (bortezomib) for multiple myeloma patients who have relapsed after at least one prior therapy and who have previously undergone or are unable to receive a bone marrow transplant. Previously, Scottish patients were required to fail at least two treatments before being eligible to receive Velcade. Under the deal, Velcade’s manufacturer, Janssen-Cilag, has agreed to cover the cost of Velcade for any patients who do not respond to the treatment. It was announced in March that the National Health Service in Scotland would begin considering such cost sharing deals (related Beacon news). For more information, please visit the SMC Web site.

Kansas City Area Regional Community Workshop – On November 21, the International Myeloma Foundation (IMF) will hold a workshop in Overland Park, KS. The guest speaker, Delva Deauna-Limayo, M.D., a myeloma specialist at the Nevada Cancer Institute in Las Vegas will talk about multiple myeloma, treatment options at diagnosis and relapse, why participation in clinical trials is important, and management of side effects. The program will begin at 8:30 a.m. and end at 3:30 p.m. For more information or to register, please visit the IMF Web site.

For a more detailed listing of myeloma related events, please check the Myeloma Beacon Events Calendar.

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UAMS Receives $19.5 Million Grant For Multiple Myeloma Program – The Myeloma Institute at the University of Arkansas for Medical Sciences (UAMS) will receive $19.5 million over five years from the National Cancer Institute (NCI). The grant is the fourth renewal of continuous funding from the NCI and will allow for continued research on myeloma and the development of new treatments. For more information, please visit the UAMS Web site.

MMRF’s Fall Gala Raises Over $1.8 Million For Multiple Myeloma Research – The Multiple Myeloma Research Foundation (MMRF) raised more than $1.8 million at its annual Fall Gala. The funds will support myeloma research and the development of new treatments. For more information, please visit the MMRF Web site.

3rd Annual Comedy Celebration – The International Myeloma Foundation’s (IMF) 3rd annual Comedy Celebration will take place on November 7 at The Wilshire Ebell Theatre & Club in Los Angeles. It will benefit the Peter Boyle Memorial Fund and will feature Ray Romano, Jimmey Kimmel, and Bob Saget, along with many others. For more information, please visit the IMF Web site.

World Run Day – On November 8, a 5K run will take place in multiple locations around the world. Among the charities which will receive funds from donations is the Multiple Myeloma Research Foundation (MMRF). For more information, please visit the World Run Day Web site.

For a more detailed listing of myeloma related events, please check the Myeloma Beacon Events Calendar.

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FDA Requests Additional Information For Prolia Approval – Amgen Inc. announced on Monday that the U.S. Food and Drug Administration (FDA) has requested additional information needed for the agency to complete its review of Prolia (denosumab).  Amgen has applied to the FDA to have Prolia approved for the treatment and prevention of postmenopausal osteoporosis.  In its recent information request, the FDA asked Amgen for all updated Prolia safety data as well as more details about Amgen's proposed post-marketing surveillance program for Prolia.  The Agency also informed Amgen that a new clinical trial program will be necessary for the FDA to be able to approve Prolia for the prevention of postmenopausal osteoporosis. Prolia is currently being tested in multiple myeloma patients to see if it can delay skeletal events (see related Beacon article). For more information, please see the Amgen press release.

Race For Research 5K Walk/Run – On November 1, the Multiple Myeloma Research Foundation will be sponsoring the Race for Research 5K Walk/Run in Atlanta, Georgia. Registration starts at 7 a.m. and the race beings at 8:30 a.m. The MMRF is looking for participants and donations for this event. For more information, please visit the MMRF Web site.

RHS Open – On November 2, the International Myeloma Foundation is holding the Inaugural RHS open in Mt. Pleasant, SC. This annual golf tournament is held in honor of IMF Board Member, Rich Saletan. For more information, to register, or to sponsor a golfer, please visit the IMF Web site.

For a more detailed listing of myeloma related events, please check the Myeloma Beacon Events Calendar.

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FDA Approves Clinical Trials For Milatuzumab-Doxorubicin Combination – The U.S. Food and Drug Administration (FDA) has approved Immunomedics Inc.'s investigational new drug application for its milatuzumab-based treatment for multiple myeloma.  This drug has doxorubicin (Adriamycin), a chemotherapy drug, bound to milatuzumab, an antibody.  It will be studied in Phase 1/2 clinical trials to evaluate safety and tolerability of the drug in patients with persistent or recurring myeloma.  This drug is also undergoing preclinical studies for the treatment of non-Hodgkin's lymphoma and chronic lymphocytic leukemia. For more information, please see the Immunomedics press release.

IMF Patient And Family Seminar – On August 28-29 the International Myeloma Foundation (IMF) is holding its patient and family seminar in Edina, MN. The seminar includes many presentations by specialists, which focus on managing side effects, standard frontline therapy, and approaches to relapse treatment. For more information, please visit the IMF Web site.

For a more detailed listing of myeloma related events, please check the Myeloma Beacon Events Calendar.