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Isis Pharmaceuticals, Inc. Release: ISIS-APOCIII Rx Phase 2 Study In Patients With Familial Chylomicronemia Published In The New England Journal of Medicine
CARLSBAD, Calif., Dec. 3, 2014 /PRNewswire/ –Isis Pharmaceuticals, Inc. (NASDAQ: ISIS) announced today that data from a Phase 2 study of ISIS-APOCIIIRx in patients with familial chylomicronemia syndrome (FCS) were published in The New England Journal of Medicine. The paper, titled “Targeting…
SAN DIEGO, Dec. 3, 2014 /PRNewswire/ — Halozyme Therapeutics, Inc. (NASDAQ: HALO) will be presenting at the 25th Annual Oppenheimer Healthcare Conference in New York on Wednesday, December 10, 2014 at 1:00 p.m. ET/10:00 a.m. PT. David Ramsay, Vice President and Chief Financial Officer, will provide a corporate overview.
The presentation will be webcast through the “Investors” section of Halozyme’s corporate website at www.halozyme.com, and a recording will be made available for 90 days following the event. To access the live webcast, please log on to Halozyme’s website approximately 15 minutes prior to the presentation to register and download any necessary audio software.
About HalozymeHalozyme Therapeutics is a biopharmaceutical company dedicated to developing and commercializing innovative products that advance patient care. With a diversified portfolio of enzymes that target the extracellular matrix, the Company’s research focuses primarily on a family of human enzymes, known as hyaluronidases, which increase the dispersion and absorption of biologics, drugs and fluids. Halozyme’s pipeline addresses therapeutic areas, including oncology, diabetes and dermatology that have significant unmet medical need today. The Company markets Hylenex® recombinant (hyaluronidase human injection) and has partnerships with Roche, Pfizer and Baxter. Halozyme is headquartered in San Diego, CA. For more information on how we are innovating, please visit our corporate website at www.halozyme.com.
Investor Contact:Schond GreenwayHalozyme Therapeutics858firstname.lastname@example.org
Media Contact:Susan Neath Francis212email@example.com
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SOURCE Halozyme Therapeutics, Inc.
SAN FRANCISCO, Dec. 3, 2014 /PRNewswire/ – Kindred Biosciences, Inc. (NASDAQ: KIN), a biopharmaceutical company focused on saving and improving the lives of pets, today announced that it has re-assessed its atopic dermatitis program and the atopic dermatitis market and has decided to discontinue its AtoKin study in favor of directing resources toward other programs in its portfolio.
“While the market for atopic dermatitis is large, the space has recently undergone a major transition. The rapid uptake and success of a recently-launched atopic dermatitis product, while confirming the large size of the market, has substantially raised the bar for future atopic dermatitis products,” stated Richard Chin, Chief Executive Officer of KindredBio. “Our goal is to develop products that are superior or clearly differentiated from other products and that have profiles that will lead to leadership positions in the markets. Given that, and given that we are in the position of having a number of other very promising product candidates we would like to pursue, we have made a business decision to discontinue our AtoKin program. This will allow us to redirect resources to other programs, including advancing additional novel drugs and biologics into development. While discontinuing a program is always difficult, we believe that an important part of good drug development is discipline in managing the product portfolio and prioritization of drugs that will lead to maximal return on investment and deliver maximal benefit to our patients.”
About Kindred Biosciences
Kindred Biosciences is a development stage biopharmaceutical company focused on saving and improving the lives of pets. Its mission is to bring to pets the same kinds of safe and effective medicines that human family members enjoy. The Company’s strategy is to identify compounds and targets that have already demonstrated safety and efficacy in humans and to develop therapeutics based on these validated compounds and targets for dogs, cats and horses. The Company has a deep pipeline of novel drugs and biologics in development across many therapeutic classes.
This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, but not limited to, statements regarding our expectations about the trials, regulatory approval, manufacturing, distribution and commercialization of our current and future product candidates, and statements regarding our anticipated revenues, expenses, margins, profits and use of cash.
These forward-looking statements are based on our current expectations. These statements are not promises or guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results to be materially different from any future results expressed or implied by the forward-looking statements. These risks include, but are not limited to, the following: our limited operating history and expectations of losses for the foreseeable future; the absence of revenue from our product candidates for the foreseeable future; our potential inability to obtain any necessary additional financing; our substantial dependence on the success of our lead product candidates, which may not be successfully commercialized even if they are approved for marketing; the effect of competition; our potential inability to obtain regulatory approval for our existing or future product candidates; our dependence on third parties to conduct some of our development activities; our dependence upon third-party manufacturers for supplies of our product candidates; uncertainties regarding the outcomes of trials regarding our product candidates; our potential failure to attract and retain senior management and key scientific personnel; uncertainty about our ability to develop a satisfactory sales organization; our significant costs of operating as a public company; our potential inability to obtain patent protection and other intellectual property protection for our product candidates; potential claims by third parties alleging our infringement of their patents and other intellectual property rights; our potential failure to comply with regulatory requirements, which are subject to change on an ongoing basis; the potential volatility of our stock price; and the significant control over our business by our principal stockholders and management.
For a further description of these risks and other risks that we face, please see the risk factors described in our filings with the U.S. Securities and Exchange Commission (the SEC), including the risk factors discussed under the caption “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2013 and any subsequent updates that may be contained in our Quarterly Reports on Form 10-Q filed with the SEC. As a result of the risks described above and in our filings with the SEC, actual results may differ materially from those indicated by the forward-looking statements made in this press release. Forward-looking statements contained in this press release speak only as of the date of this press release and we undertake no obligation to update or revise these statements, except as may be required by law.
ContactDenise BeversKindredBiodenise.firstname.lastname@example.org (650) 701-7909
SOURCE Kindred Biosciences, Inc.
FDA Approves BLINCYTO™ (Blinatumomab) Immunotherapy for the Treatment of Relapsed or Refractory B-Cell Precursor Acute Lymphoblastic Leukemia
THOUSAND OAKS, Calif. and SOUTH SAN FRANCISCO, Calif., Dec. 3, 2014 /PRNewswire/ — Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has granted approval of BLINCYTO™ (blinatumomab) for the treatment of patients with Philadelphia chromosome-negative (Ph-) relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). This indication is approved under accelerated approval. Continued approval for this indication may be contingent upon verification of clinical benefit in subsequent trials. With this approval, BLINCYTO becomes the first FDA-approved bispecific CD19-directed CD3 T-cell engager (BiTE®) antibody construct product, and the first single-agent immunotherapy to be approved for the treatment of patients with Ph- relapsed or refractory B-cell precursor ALL, a rare and rapidly progressing cancer of the blood and bone marrow.1-3
“The FDA’s breakthrough therapy designation and accelerated approval of BLINCYTO underscores the critical need for new treatment options for patients with relapsed or refractory B-cell precursor ALL, who are often young adults,” said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. “BLINCYTO is the first clinical and regulatory validation of the BiTE® platform, a new and innovative approach that helps the body’s own immune system fight cancer.”
The BLINCYTO approval is based on results of Amgen’s ’211 trial, a Phase 2, multicenter, single-arm open-label study. Eligible patients were > 18 years of age with Ph- relapsed or refractory B-cell precursor ALL. Relapsed or refractory was defined as relapsed with first remission duration of < 12 months in the first salvage, or relapsed or refractory after first salvage therapy, or relapsed within 12 months of allogeneic hematopoietic stem cell transplantation (HSCT), and had > 10 percent blasts in bone marrow. Of the 185 patients evaluated in the trial, 41.6 percent (77/185; 95 percent CI: 34.4-49.1) achieved complete remission or complete remission with partial hematologic recovery (CR/CRh*) within two cycles of treatment with BLINCYTO, which was the primary endpoint of the study. The majority of responses (81 percent [62/77]) occurred within the first cycle of treatment. Among patients who achieved CR/CRh*, 39 percent (30/77) went on to HSCT, and 75.3 percent (58/77 95 percent CI: 64.2-84.4) achieved minimal residual disease (MRD) response, a measure of eradication of residual disease at the molecular level.
“The approval of BLINCYTO represents a significant milestone in immunotherapy research, providing clinicians the opportunity to offer a new single-agent therapy to patients fighting this highly aggressive cancer with previously limited options,” said Anthony S. Stein, M.D., clinical professor, Hematology/Oncology at City of Hope.
BLINCYTO has a BOXED WARNING in its product label regarding Cytokine Release Syndrome (CRS) and Neurological Toxicities.
Cytokine Release Syndrome (CRS), which may be life-threatening or fatal, occurred in patients receiving BLINCYTO. Interrupt or discontinune BLINCYTO as recommended. Neurological toxicities, which may be severe, life-threatening, or fatal, occurred in patients receiving BLINCYTO. Interrupt or discontinue BLINCYTO as recommended.
BLINCYTO is contraindicated to patients with known hypersensitivity to blinatumomab or to any component of the product formulation.
Monitor patients for signs and symptoms of infection and treat appropriately.
Advise patients to refrain from driving and engaging in hazardous occupations or activities such as driving, operating heavy or potentially dangerous machinery while BLINCYTO is being administered.
It is important to strictly follow instructions for preparation (including admixing) and administration to prevent overdose and underdose.
The most common adverse reactions (≥ 20 percent) were pyrexia (62 percent), headache (36 percent), peripheral edema (25 percent), febrile neutropenia (25 percent), nausea (25 percent), hypokalaemia (23 percent), rash (21 percent), tremor (20 percent) and constipation (20 percent). Serious adverse reactions were reported in 65 percent of patients. The most common serious adverse reactions (≥ 2 percent) included febrile neutropenia, pyrexia, pneumonia, sepsis, neutropenia, device-related infection, tremor, encephalopathy, infection, overdose, confusion, Staphylococcal bacteremia and headache.
The FDA has also approved a risk evaluation and mitigation strategy (REMS) for BLINCYTO. The purpose of the BLINCYTO REMS is to inform healthcare providers of the serious risks of CRS, neurological toxicities, and preparation and administration errors. Additional information about the BLINCYTO REMS program can be found at http://www.BLINCYTOREMS.com.
Please contact Amgen Medinfo at 800-77-AMGEN (800-772-6436) regarding BLINCYTO availability.
Amgen and its subsidiary Onyx Pharmaceuticals, Inc., which will commercialize BLINCYTO in the U.S., have announced the availability of Onyx Pharmaceuticals 360™ (Onyx 360), to patients receiving BLINCYTO in the U.S. Onyx 360 is a comprehensive patient and caregiver support and services program designed to help patients navigate the treatment journey, including reimbursement and payment support, treatment support and referrals to third-party organizations for day-to-day needs and emotional support. Dedicated Oncology Nurse Advocates are available Monday through Friday from 9 a.m. to 8 p.m. Eastern Standard Time at 1-855-ONYX-360 (1-855-669-9360) to assist patients, caregivers and healthcare providers.
Patients diagnosed with adult ALL are often young adults, with a median age at diagnosis of 34-39.4 In adult patients with relapsed or refractory ALL, median overall survival is just three to five months.5
About BLINCYTO™ (blinatumomab) BLINCYTO is the first BiTE® antibody construct and the first single-agent immunotherapy to be approved by the U.S. Food and Drug Administration (FDA).3 BLINCYTO was granted breakthrough therapy and priority review designations by the FDA, and is now approved in the U.S. for the treatment of Philadelphia chromosome-negative (Ph-) relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).
About BiTE® TechnologyBispecific T cell engager (BiTE®) antibody constructs are a type of immunotherapy being investigated for fighting cancer by helping the body’s immune system to detect and target malignant cells. The modified antibodies are designed to engage two different targets simultaneously, thereby juxtaposing T cells (a type of white blood cell capable of killing other cells perceived as threats) to cancer cells. BiTE® antibody constructs help place the T cells within reach of the targeted cell, with the intent of allowing T cells to inject toxins and trigger the cancer cell to die (apoptosis). BiTE® antibody constructs are currently being investigated for their potential to treat a wide variety of cancers. For more information, visit www.biteantibodies.com.
Important U.S. Product InformationBLINCYTO is indicated for the treatment of Philadelphia chromosome-negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).
This indication is approved under accelerated approval. Continued approval for this indication may be contingent upon verification of clinical benefit in subsequent trials.
IMPORTANT SAFETY INFORMATION
WARNING: CYTOKINE RELEASE SYNDROME and NEUROLOGICAL TOXICITIES
Cytokine Release Syndrome (CRS), which may be life-threatening or fatal, occurred in patients receiving BLINCYTO™. Interrupt or discontinue BLINCYTO™ as recommended.
Neurological toxicities, which may be severe, life-threatening or fatal, occurred in patients receiving BLINCYTO™. Interrupt or discontinue BLINCYTO™ as recommended.
ContraindicationsBLINCYTO™ is contraindicated in patients with a known hypersensitivity to blinatumomab or to any component of the product formulation.
Warnings and Precautions
Cytokine Release Syndrome (CRS): Life-threatening or fatal CRS occurred in patients receiving BLINCYTO™. Infusion reactions have occurred and may be clinically indistinguishable from manifestations of CRS. Closely monitor patients for signs and symptoms of serious events such as pyrexia, headache, nausea, asthenia, hypotension, increased alanine aminotransferase (ALT), increased aspartate aminotransferase (AST), increased total bilirubin (TBILI), disseminated intravascular coagulation (DIC), capillary leak syndrome (CLS), and hemophagocytic lymphohistiocytosis/macrophage activation syndrome (HLH/MAS). Interrupt or discontinue BLINCYTO™ as outlined in the Prescribing Information (PI).
Neurological Toxicities: Approximately 50% of patients receiving BLINCYTO™ in clinical trials experienced neurological toxicities. Severe, life-threatening, or fatal neurological toxicities occurred in approximately 15% of patients, including encephalopathy, convulsions, speech disorders, disturbances in consciousness, confusion and disorientation, and coordination and balance disorders. The median time to onset of any neurological toxicity was 7 days. Monitor patients for signs or symptoms and interrupt or discontinue BLINCYTO™ as outlined in the PI.
Infections: Approximately 25% of patients receiving BLINCYTO™ experienced serious infections, some of which were life-threatening or fatal. Administer prophylactic antibiotics and employ surveillance testing as appropriate during treatment. Monitor patients for signs or symptoms of infection and treat appropriately, including interruption or discontinuation of BLINCYTO™ as needed.
Tumor Lysis Syndrome (TLS): Life-threatening or fatal TLS has been observed. Preventive measures, including pretreatment nontoxic cytoreduction and on treatment hydration, should be used during BLINCYTO™ treatment. Monitor patients for signs and symptoms of TLS and interrupt or discontinue BLINCYTO™ as needed to manage these events.
Neutropenia and Febrile Neutropenia, including life-threatening cases, have been observed. Monitor appropriate laboratory parameters during BLINCYTO™ infusion and interrupt BLINCYTO™ if prolonged neutropenia occurs.
Effects on Ability to Drive and Use Machines: Due to the possibility of neurological events, including seizures, patients receiving BLINCYTO™ are at risk for loss of consciousness, and should be advised against driving and engaging in hazardous occupations or activities such as operating heavy or potentially dangerous machinery while BLINCYTO™ is being administered.
Elevated Liver Enzymes: Transient elevations in liver enzymes are associated with BLINCYTO™ treatment. The majority of these events were observed in the setting of CRS. The median time to onset was 15 days. Grade 3 or greater elevations in liver enzymes occurred in 6% of patients outside the setting of CRS and resulted in treatment discontinuation in less than 1% of patients. Monitor ALT, AST, gamma-glutamyl transferase (GGT), and TBILI prior to the start of and during BLINCYTO™ treatment. BLINCYTO™ treatment should be interrupted if transaminases rise to > 5 times the upper limit of normal (ULN) or if TBILI rises to > 3 times ULN.
Leukoencephalopathy: Although the clinical significance is unknown, cranial magnetic resonance imaging (MRI) changes showing leukoencephalopathy have been observed in patients receiving BLINCYTO™, especially in patients previously treated with cranial irradiation and anti-leukemic chemotherapy.
Preparation and administration errors have occurred. Follow instructions for preparation (including admixing) and administration in the PI strictly to minimize medication errors (including underdose and overdose).
The most commonly reported adverse reactions (≥ 20%) in clinical trials were pyrexia (62%), headache (36%), peripheral edema (26%), febrile neutropenia (26%), nausea (25%), hypokalemia (23%), rash (21%), tremor (20%) and constipation (20%).
Dosage and Administration Guidelines
BLINCYTO™ is administered as a continuous intravenous infusion at a constant flow rate using an infusion pump which should be programmable, lockable, non-elastomeric, and have an alarm.
It is very important that the instructions for preparation (including admixing) and administration provided in the full Prescribing Information are strictly followed to minimize medication errors (including underdose and overdose).Please see full Prescribing Information and medication guide for BLINCYTO at www.BLINCYTO.com.
About AmgenAmgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people’s lives. A biotechnology pioneer since 1980, Amgen has grown to be the world’s largest independent biotechnology company, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
For more information, visit www.amgen.com and follow us on www.twitter.com/amgen.
About Onyx Pharmaceuticals, Inc.Based in South San Francisco, California, Onyx Pharmaceuticals, Inc., an Amgen subsidiary, is a global biopharmaceutical company engaged in the development and commercialization of innovative therapies for improving the lives of people with cancer. The company is focused on developing novel medicines that target key molecular pathways. For more information about Onyx, visit the company’s website at www.onyx.com. Onyx Pharmaceuticals is on Twitter. Sign up to follow our Twitter feed @OnyxPharm at http://twitter.com/OnyxPharm.
Forward-Looking StatementsThis news release contains forward-looking statements that are based on the current expectations and beliefs of Amgen Inc. and its subsidiaries (Amgen, we or us) and are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those described. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including estimates of revenues, operating margins, capital expenditures, cash, other financial metrics, expected legal, arbitration, political, regulatory or clinical results or practices, customer and prescriber patterns or practices, reimbursement activities and outcomes and other such estimates and results. Forward-looking statements involve significant risks and uncertainties, including those discussed below and more fully described in the Securities and Exchange Commission (SEC) reports filed by Amgen Inc., including Amgen Inc.’s most recent annual report on Form 10-K and any subsequent periodic reports on Form 10-Q and Form 8-K. Please refer to Amgen Inc.’s most recent Forms 10-K, 10-Q and 8-K for additional information on the uncertainties and risk factors related to our business. Unless otherwise noted, Amgen is providing this information as of Dec. 3, 2014, and expressly disclaims any duty to update information contained in this news release.
No forward-looking statement can be guaranteed and actual results may differ materially from those we project. Discovery or identification of new product candidates or development of new indications for existing products cannot be guaranteed and movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate or development of a new indication for an existing product will be successful and become a commercial product. Further, preclinical results do not guarantee safe and effective performance of product candidates in humans. The complexity of the human body cannot be perfectly, or sometimes, even adequately modeled by computer or cell culture systems or animal models. The length of time that it takes for us and our partners to complete clinical trials and obtain regulatory approval for product marketing has in the past varied and we expect similar variability in the future. We develop product candidates internally and through licensing collaborations, partnerships and joint ventures. Product candidates that are derived from relationships may be subject to disputes between the parties or may prove to be not as effective or as safe as we may have believed at the time of entering into such relationship. Also, we or others could identify safety, side effects or manufacturing problems with our products after they are on the market. Our business may be impacted by government investigations, litigation and product liability claims. If we fail to meet the compliance obligations in the corporate integrity agreement between us and the U.S. government, we could become subject to significant sanctions. We depend on third parties for a significant portion of our manufacturing capacity for the supply of certain of our current and future products and limits on supply may constrain sales of certain of our current products and product candidate development.
In addition, sales of our products (including products of our wholly-owned subsidiaries) are affected by the reimbursement policies imposed by third-party payers, including governments, private insurance plans and managed care providers and may be affected by regulatory, clinical and guideline developments and domestic and international trends toward managed care and healthcare cost containment as well as U.S. legislation affecting pharmaceutical pricing and reimbursement. Government and others’ regulations and reimbursement policies may affect the development, usage and pricing of our products. In addition, we compete with other companies with respect to some of our marketed products as well as for the discovery and development of new products. We believe that some of our newer products, product candidates or new indications for existing products, may face competition when and as they are approved and marketed. Our products may compete against products that have lower prices, established reimbursement, superior performance, are easier to administer, or that are otherwise competitive with our products. In addition, while we and our partners routinely obtain patents for our and their products and technology, the protection of our products offered by patents and patent applications may be challenged, invalidated or circumvented by our or our partners’ competitors and there can be no guarantee of our or our partners’ ability to obtain or maintain patent protection for our products or product candidates. We cannot guarantee that we will be able to produce commercially successful products or maintain the commercial success of our existing products. Our stock price may be affected by actual or perceived market opportunity, competitive position, and success or failure of our products or product candidates. Further, the discovery of significant problems with a product similar to one of our products that implicate an entire class of products could have a material adverse effect on sales of the affected products and on our business and results of operations. Our efforts to integrate the operations of companies we have acquired may not be successful. Cost savings initiatives may result in us incurring impairment or other related charges on our assets. We may experience difficulties, delays or unexpected costs and not achieve anticipated benefits and savings from our recently announced restructuring plans. Our business performance could affect or limit the ability of our Board of Directors to declare a dividend or our ability to pay a dividend or repurchase common stock.
CONTACT: Amgen, Thousand OaksDanielle Bertrand, 650-266-2114 (Media) Kristen Davis, 805-447-3008 (Media)Arvind Sood, 805-447-1060 (Investors)
References1. Mayo Clinic. “Acute lymphocytic leukemia.” Available at: http://www.mayoclinic.com/health/acute-lymphocytic-leukemia/DS00558. Accessed on October 30, 2014. 2. BLINCYTO™ Draft US Prescribing Information.3. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®): Acute Lymphoblastic Leukemia. Version 1.2014. Available at: https://www.nccn.org/store/login/login.aspx?ReturnURL=http://www.nccn.org/professionals/physician_gls/pdf/all.pdf. Accessed on November 24, 2014.4. Seer 2014 data. Available at: http://seer.cancer.gov/statfacts/html/leuks.html. Accessed on November 4, 2014. 5. Advani A.S. New immune strategies for the treatment of acute lymphoblastic leukemia: Antibodies and chimeric antigen receptors. Hematology Am Soc Hematol Educ Program. 2013;2013:131-7. Retrieved from: http://asheducationbook.hematologylibrary.org/content/2013/1/131.long.
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Impatient Cancer Patients Help Drive First Ever Crowdfunding Initiative For Multiple Myeloma Research
SAN FRANCISCO, Dec. 3, 2014 /PRNewswire-USNewswire/ — The CrowdCare Foundation is announcing the first crowd funding initiative for myeloma research at the American Society of Hematology 2014 conference. The Myeloma Crowd Research Initiative (MCRI) is a new approach to funding cancer research; combining the skill and knowledge of leading myeloma specialists with the patient perspective and supportive patient social communities to select and fund promising research projects in myeloma.
Research proposals will be accepted on the www.myelomacrowd.org website beginning February 1, 2015. As an initial phase of the MCRI project, both a Scientific Advisory Board and Patient Advisory Board will work together with various research communities to source the most promising research projects in myeloma. The MCRI panel will filter the various projects and initially select two new projects to receive funding. Once chosen, the Myeloma Crowd will launch a crowdfunding campaign for each project in April 2015. All proceeds for each campaign will be donated to the two final projects. Donors will know exactly how their donation is being applied.
Leading this initiative are expert researchers and patient advocates. The founding members of the MCRI Scientific Advisory Board include: Dr. Ola Landgren, MD, PhD (MSKCC), Dr. Guido Tricot, MD, PhD (University of Iowa), Dr. Irene Ghobrial, MD, PhD (Dana Farber Cancer Institute), Dr. Rafael Fonseca, MD (Mayo Clinic Scottsdale) and Dr. Noopur Raje, MD, PhD (Massachusetts General Cancer Center). The MCRI Patient Advisory Board includes Pat Killingsworth (multiplemyelomablog.com), Gary Petersen (myelomasurvival.com), Jack Aiello (well-known myeloma patient advocate) and Jenny Ahlstrom (www.myelomacrowd.org, www.mpatient.org.)
“Patients with terminal cancers cannot sit by as idle spectators, waiting patiently for the next big discovery or cure,” says myeloma patient activist, Jenny Ahlstrom, and founder of the patient-driven CrowdCare Foundation and Myeloma Crowd Radio.
With a drop in NCI-funded research, alternative approaches are needed. “Although we have come a long way in improving outcomes for myeloma patients, we still need to do better, says Dr. Tricot. “Further progress will arise from excellent and diverse research initiatives supported via federal and private funds. It is therefore exciting to see a new funding mechanism like the Myeloma Crowd Research Initiative take shape at a time of reduced federal funding for research.”
“I am delighted to work with an organization whose commitment is to further advances in our management of myeloma patients,” says Dr. Fonseca. “Simply put, today’s best is not good enough.”
“Giving patients a seat at the table to drive new research is a new and exciting opportunity for the patient community. I’m excited to help myeloma patients and caregivers give input into what research is done–and how it’s funded,” says popular myeloma blogger and patient activist Pat Killingsworth. “Crowdfunding and the MCRI is a potential game-changer where new, exciting initiatives can be funded without the crippling limitations of the existing process,” says Gary Petersen.
Building a connected community to drive outcomes is a key component of the complete solution to find a cure. “The Myeloma Crowd Research Initiative is an innovative effort to help improve research and therapy for patients with myeloma in the new era of connectivity,” says Dr. Ghobrial.
The simple goal for the joint quest is a cure. “The Myeloma Crowd Research Initiative is an outstanding project devoted to fund research designed to ultimately establish a cure for myeloma. I am honored to be part of this effort,” says Dr. Landgren and Dr. Raje echoes the sentiment. “This is a novel and exciting approach to funding research in multiple myeloma and I am honored to be a part of it.”
About Myeloma Crowd/CrowdCare FoundationThe Myeloma Crowd is a division of the CrowdCare Foundation, a patient-driven 501(c)3 non-profit organization. The Myeloma Crowd provides patient education, advocacy and now research funding for multiple myeloma. Ahlstrom founded the CrowdCare Foundation, Myeloma Crowd and also hosts online radio interviews with top myeloma specialists worldwide to educate patients and promote clinical trial participation. www.myelomacrowd.org
SOURCE CrowdCare Foundation
Biotechs pool patents on non-invasive prenatal testing, Sequenom shares jump.
Biotechs pool patents on non-invasive prenatal testing, Sequenom shares jump.
Polaris Group Announces Treatment of First Patient in Phase 1 Study of ADI-PEG 20 plus nab-Paclitaxel and Gemcitabine in Advanced Pancreatic Cancer
SAN DIEGO, Dec. 3, 2014 /PRNewswire/ – Polaris Group announced today that the first patient has been dosed in its Phase 1 trial of ADI-PEG 20 in combination with nab-paclitaxel and gemcitabine, a current first line therapy, for the treatment of advanced pancreatic cancer. Polaris Group is currently conducting clinical trials on ADI-PEG 20 in combination with cisplatin in melanoma and ovarian cancer, in combination with doxorubicin in HER2 negative breast cancer, and in combination with cisplatin and pemetrexed in malignant pleural mesothelioma and non-small cell lung carcinoma.
“Combination of ADI-PEG 20 with gemcitabine has been shown to have greater inhibition of pancreatic tumor growth than either treatment alone in a mouse xenograft study,” said John Bomalaski, M.D., Executive Vice President of Medical Affairs at Polaris. “We are excited to start this new trial and explore potential benefits of the combination in the clinical setting.”
About ADI-PEG 20
ADI-PEG 20 is a biologic being developed by Polaris Group to treat cancers, especially those carrying a major metabolic defect that renders such cancer cells, unlike normal cells, unable to internally synthesize arginine. Because arginine is one of the 20 amino acids that are essential for protein synthesis and survival of cells, it is believed these cancer cells become dependent upon the external supply of arginine to survive and grow. ADI-PEG 20 is designed to deplete the external supply of arginine, which causes arginine-dependent cancer cells to die while leaving the patient’s normal cells unharmed. Multiple cancers have been reported to have a high degree of arginine-dependency.
About Polaris Group
Polaris Group is a privately held biopharmaceutical company that specializes in the research and development of protein drugs to treat cancer and other debilitating diseases. The company’s lead therapeutic, ADI-PEG 20, is currently being evaluated in a pivotal Phase 3 trial for hepatocellular carcinoma. Polaris Group is also investigating ADI-PEG 20 as a treatment for other cancers, such as leukemia, lymphoma, melanoma, mesothelioma, non-small cell lung cancers, sarcoma, breast, ovarian, and pancreatic cancer. In addition to the ADI-PEG 20 program, Polaris Group is researching and developing other biotherapeutic agents and is advancing a small molecule drug program that utilizes a rational structure-based approach to design novel compounds that inhibit the biological function of cancer-related protein targets.
For additional information please visit www.polarispharma.com
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SOURCE Polaris Group
$24.7 billion direct and indirect losses from identity theft in 2012
$24.7 billion direct and indirect losses from identity theft in 2012