On October 17, 2016 Eli Lilly and Company (NYSE: LLY) reported it will contribute cancer research data to the National Cancer Institute’s Blood Profiling Atlas, an open access liquid biopsy database being created in response to Vice President Joe Biden’s call to action and in alignment with the goals of the Cancer Moonshot initiative (Press release, Eli Lilly, OCT 17, 2016, View Source [SID1234515873]). The database is an effort to reduce the development time of effective and safe blood profiling diagnostic technologies. Schedule your 30 min Free 1stOncology Demo! "We are honored to be a part of this unique partnership," said Andrew Schade, M.D., Ph.D., a distinguished medical fellow in Lilly’s clinical diagnostics laboratory. "Liquid biopsies are going to be critical in the future to both identify specific patients for targeted therapies and to follow their treatment to better determine response to therapy. We hope knowledge gained from our research efforts in this area will help to accelerate the development of safe and effective blood profiling diagnostic technologies that help people with cancer."
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In support of this overarching mission, Lilly is studying approaches for the profiling of exosomes for mRNA and non-coding RNA expression and will share sample preparation methods, next-generation quantitative PCR-based methods, and next generation sequencing-based methods along with data related to disease characterization through gene expression analysis.
"Our scientists are dedicated to discovering and developing new cancer treatments to help people living with this disease," said Jan Lundberg, Ph.D., executive vice president of science and technology and president of Lilly Research Laboratories. "In addition to our own research, external partnerships are paramount, and we look forward to collaborating with other experts as part of the Cancer Moonshot initiative."
The Blood Profiling Atlas is part of the Cancer Moonshot initiative, which was established to improve the way research is conducted and expedite the delivery of medicines to patients. Allowing approved researchers access to raw unprocessed datasets in a scalable and reproducible manner, the open database will feature the following data: raw data sets from circulating tumor cells, circulating tumor DNA, and exosome assays, as well as relevant clinical data, sample preparation, and handling protocols from 12 different studies. The Blood Profiling Atlas pilot will be curated by a partnership between the University of Chicago and Seven Bridges, a biomedical data analysis company. For more information about the Blood Profiling Atlas, please click here.
Teva Receives Positive Opinion from European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) to Extend Indication of Trisenox® for First Line Treatment of Low- to Intermediate Risk Acute Promyelocytic Leukemia (APL)
On October 17, 2016 Teva Pharmaceutical Industries Ltd., (NYSE and TASE:TEVA) reported that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending an indication extension of Trisenox (arsenic trioxide) (Press release, Teva, OCT 17, 2016, View Source [SID1234515855]). The indication extension is for use in newly diagnosed low to intermediate risk Acute Promyelocytic Leukemia (APL) in combination with retinoic acid. Trisenox, in combination with retinoic acid, has shown a very high overall survival rate with almost no relapses after more than four years (50 months) of median follow-up. If the European Commission approves this label extension, it would mark the first time that a form of acute leukemia can be effectively treated with a regimen that is entirely chemotherapy-free. Schedule your 30 min Free 1stOncology Demo! APL is a life-threatening type of leukemia as it can cause uncontrollable bleeding and can kill within hours or days if left untreated. In Europe, approximately 1,500 to 2,000 people are diagnosed with APL each year. In light of its rarity, and because most cases present with low blood cell count and low leukemic cells in the blood, diagnosis can be difficult. However, the rapid progression of APL leading to early mortality is a substantial problem, affecting up to 30% of patients. Rapid diagnosis and commencement of treatment is essential to avoid early mortality. Trisenox is currently indicated for second line treatment of patients, who have not responded to treatment with retinoids and chemotherapy, or when their disease has returned after this type of treatment.
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Commenting on the announcement, Francesco Lo-Coco, Professor of Haematology and Head of the Laboratory of Integrated Diagnosis of Oncohematologic Diseases, Department of Biomedicine and Prevention, University of Rome Tor Vergata, Italy said, "This CHMP opinion is very encouraging. Considering it was based on existing published academic data only, this opinion points to a recognition by the EMA that treating low to intermediate risk APL with a chemo-free regimen of Trisenox plus retinoic acid can increase survival rates and dramatically reduce the risk of relapse and chemotherapy-related side effects in patients suffering from this rare and aggressive form of leukemia. In particular, avoiding the risk of life-threatening infection and that of developing secondary leukemias due to chemotherapy is a great gain for patients. The success of this regimen represents a major breakthrough and a paradigm of targeted therapy in oncology and medicine. This is therefore good news, not only for APL patients, but also for the whole medical community."
The CHMP positive opinion is a formal recommendation to grant marketing authorization for an extended indication for first line treatment for Trisenox. The recommendation will now be reviewed by the European Commission, which has authority to approve medicines for use in the 28 countries of the European Union along with Norway, Liechtenstein and Iceland. A final decision by the European Commission is expected by the end of the year.
In commenting on the CHMP positive opinion, Rob Koremans, President & CEO, Teva Global Specialty Medicines said, "As a company committed to providing medicines and solutions that really make a difference in patients’ lives, we’re pleased to reach this important milestone, and hope soon to be able to offer a chemotherapy-free treatment regimen for APL patients at the point of diagnosis. Recognizing the high unmet patient need in this orphan disease, we’ve put everything in place to obtain the label extension for this life-saving treatment. We look forward to receiving an approval from the European Commission for Trisenox as a first line treatment."
About Acute Promyelocytic Leukemia
Acute Promyelocytic Leukemia is a form of acute myeloid leukemia (AML), a cancer of the blood-forming tissue (bone marrow). Approximately 10% to 15% of patients initially diagnosed with AML present with the aggressive sub-type of the condition, APL.
In normal bone marrow, hematopoietic stem cells produce red blood cells (erythrocytes) that carry oxygen, white blood cells (leukocytes) that protect the body from infection, and platelets (thrombocytes) that are involved in blood clotting. In APL, immature white blood cells called promyelocytes accumulate in the bone marrow. The overgrowth of promyelocytes leads to a shortage of normal white and red blood cells and platelets in the body, which causes many of the signs and symptoms of the condition.
People with APL are especially susceptible to developing bruises, small red dots under the skin (petechiae), nosebleeds, bleeding from the gums, blood in the urine (hematuria), or excessive menstrual bleeding. The abnormal bleeding and bruising occur because substances are released that cause excessive blood clotting, and as a consequence lead to a low number of platelets in the blood (thrombocytopenia). The low number of red blood cells (anemia) can cause people with acute promyelocytic leukemia to have pale skin (pallor) or excessive tiredness (fatigue). In addition, affected individuals may heal slowly from injuries or have frequent infections due to the decrease of normal white blood cells that fight infection. Furthermore, the leukemic cells can expand into the bones and joints, which may cause pain in those areas. Other general signs and symptoms may occur as well, such as fever, loss of appetite, and weight loss.
APL is generally diagnosed in much younger patients than in AML (the median age is approximately 40 for APL patients and 70 for AML patients), and can be diagnosed in patients of any age.
About Trisenox
On 5 March 2002, the European Commission granted approval for the Marketing Authorization Application (MAA) for Trisenox. The authorization, which was valid throughout the European Union (EU), was granted to treat patients with relapsed or refractory acute promyelocytic leukemia (APL) and characterized by the presence of the t(15;17) translocation and/or the presence of the Pro-Myelocytic Leukaemia/Retinoic-Acid-Receptoralpha (PML/(RARα) gene. Trisenox, a targeted drug, degrades the PML- RARα fusion protein. Trisenox received marketing authorization in 2000 by the U.S. Food and Drug Administration.
The marketing approval for Trisenox was granted based on results from a multicenter study in which 40 relapsed APL patients were treated with Trisenox 0.15 mg/kg until bone marrow remission or a maximum of 60 days. Thirty-four patients (85 percent) achieved complete remission after two cycles. When the results for these 40 patients were combined with those for the 12 patients in a pilot trial, an overall response rate of 87 percent was observed.
1mL of Trisenox contains 1mg of arsenic trioxide. Trisenox is a concentrate for solution for infusion. It is a sterile, clear, colorless, aqueous solution. Trisenox must be administered under the supervision of a physician who is experienced in the management of acute leukaemias, and special monitoring procedures must be followed.
Study Results
The APL0406 Intergroup GIMEMA-AMLSG-SAL study was a prospective, randomized, multicenter, open-label, phase III non-inferiority study. Eligible patients were adults between 18 and 71 years of age with newly diagnosed, genetically proven low- or intermediate-risk APL (WBC at diagnosis ≤ 103 x 109/L). Overall, 276 patients were randomly assigned to receive ATRA-ATO or ATRA-CHT between October 2007 and January 2013. Of 263 patients evaluable for response to induction, 127 (100%) of 127 patients and 132 (97%) of 136 patients achieved complete remission (CR) in the ATRA-ATO and ATRA-CHT arms, respectively (P = .12). After a median follow-up of 40.6 months, the event-free survival, cumulative incidence of relapse, and overall survival at 50 months for patients in the ATRA-ATO versus ATRA-CHT arms were 97.3%v 80%, 1.9% v 13.9%, and 99.2% v 92.6%, respectively (P , .001, P = .0013, and P = .0073, respectively).
Post-induction events included two relapses and one death in CR in the ATRA-ATO arm and two instances of molecular resistance after third consolidation, 15 relapses, and five deaths in CR in the ATRA-CHT arm. Two patients in the ATRA-CHT arm developed a therapy-related myeloid neoplasm.
RadioMedix and AREVA Med – SBIR NCI Contract awarded to develop targeted alpha-emitter therapy of neuroendocrine tumors with lead-212.
On October 31, 2016 RadioMedix Inc. and AREVA Med (now Orano Med) reported that they have been awarded a collaborative Small Business Innovation Research Contract by the National Institutes of Health, National Cancer Institute to evaluate targeted alpha-emitter therapy of neuroendocrine tumors (NETs) (Press release, RadioMedix, OCT 16, 2016, View Source [SID1234525018]). This is the fourth NIH funding awarded to RadioMedix during the last three years.
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Targeted Peptide Receptor Radionuclide Therapy (PRRT) of NETs is one of the main clinical focuses of RadioMedix, which has long been involved in several clinical studies as a co-sponsor or a collaborator. AREVA Med is focused on the production of lead-212 (212Pb), a rare metal used in TAT, and the development of therapeutics using this metal.
"We have established a very good collaboration with AREVA Med and we are very pleased that this work resulted in the SBIR Contract," said Izabela Tworowska PhD, Principal Investigator and RadioMedix Chief Science Officer." We have got promising preliminary results and we are confident that this contract will accelerate the development of Targeted Alpha Therapy (TAT) agents. I am grateful to NIH NCI agency for selecting this project for contract funding"
"AREVA Med is very excited about its collaboration with RadioMedix that will further support the growth of our pipeline of 212Pb-labeled agents, especially in NETs where we believe we can bring substantial additional efficacy compared to current treatment options" said Julien Torgue, PhD, AREVA Med Scientific Director.
"We are confident that we have secured all resources needed to accelerate translation of targeted alpha therapy agents to clinic," said Dr. Ebrahim Delpassand, CEO and Chairman of RadioMedix. "Our patients are anxiously waiting for this treatment, and we expect to launch a first in human clinical trial by the end of 2017."
10-Q – Quarterly report [Sections 13 or 15(d)]
Burzynski Research Institute has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission .
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Roche announces CHMP recommendation for EU approval of Venclyxto for people with hard-to-treat chronic lymphocytic leukaemia
On October 14, 2016 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported that the EU Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Venclyxto (venetoclax) for the treatment of people with chronic lymphocytic leukaemia (CLL) in the presence of 17p deletion or TP53 mutation who are unsuitable for or have failed a B-cell receptor pathway inhibitor (Press release, Hoffmann-La Roche , OCT 14, 2016, View Source [SID:SID1234515807]). Venclyxto is also recommended for the treatment of people with CLL without 17p deletion or TP53 mutation who have failed both chemo-immunotherapy and a B-cell receptor pathway inhibitor. Based on this positive CHMP recommendation, a final decision regarding the conditional marketing authorisation of Venclyxto is expected from the European Commission in the coming months. Venclyxto is being co-developed by AbbVie and Roche.
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"We are pleased that this positive CHMP opinion brings us closer to providing a much needed new treatment option to people in Europe with this difficult-to-treat disease," said Sandra Horning, M.D., Chief Medical Officer and Head of Global Product Development. "We look forward to continuing the development of this promising medicine in other blood cancers with our partner AbbVie."
Venclyxto is marketed as Venclexta in the United States. Venclexta received accelerated approval from the US Food and Drug Administration (FDA) in April of this year for the treatment of people with CLL with 17p deletion, as detected by an FDA approved test, who have received at least one prior therapy. Venclexta/Venclyxto is the first approved medicine designed to trigger a natural process that helps cells self-destruct, providing a new way to help people who received previous treatment for their CLL or who have a high-risk form of CLL.
About Chronic Lymphocytic Leukaemia (CLL)
CLL is the most common type of leukaemia in the Western world. CLL mainly affects men and the median age at diagnosis is about 70 years. Worldwide, the incidence of all leukaemias is estimated to be over 350,000 and CLL is estimated to affect around one-third of all people newly diagnosed with leukaemia. Although signs of CLL may disappear for a period of time after initial treatment, the disease is considered incurable and many people will require additional treatment due to the return of cancerous cells.
In certain cases of CLL, a part of chromosome 17 is lost and along with it an important gene that controls apoptosis (programmed cell death) called p53. The 17p deletion is found in 3 to 10 percent of previously untreated cases and up to 30 to 50 percent of relapsed or refractory cases.
About Venclexta/Venclyxto
Venclexta/Venclyxto is a small molecule designed to selectively bind and inhibit the BCL-2 protein, which plays an important role in a process called apoptosis (programmed cell death). Overexpression of the BCL-2 protein in chronic lymphocytic leukaemia (CLL) has been associated with resistance to certain therapies. It is believed that blocking BCL-2 may restore the signalling system that tells cells, including cancer cells, to self-destruct. Venclexta/Venclyxto is being co-developed by AbbVie and Roche. Together, the companies are committed to research with Venclexta/Venclyxto, which is currently being evaluated in Phase III clinical trials for the treatment of relapsed, refractory and previously untreated CLL, along with studies in several other cancers. Venclexta/Venclyxto is jointly commercialised by AbbVie and Genentech, a member of the Roche Group, in the United States and commercialised by AbbVie outside of the United States.