Startup Impact Biomedicines Raises $22M to Bring Fedratinib to MF Patients

SAN DIEGO–(Business Wire)–Today, Impact Biomedicines (“Impact”) announced its launch to pioneer the development of life-changing treatments for patients with myeloproliferative neoplasms and other cancers. The Company’s pipeline is centered around fedratinib, a potent and highly selective oral small molecule JAK2 kinase inhibitor that is being developed initially for the treatment of myelofibrosis (MF) and polycythemia vera (PV). In conjunction with this launch, Impact is pleased to share that the U.S. Food and Drug Administration (FDA) has removed the clinical hold placed on fedratinib and that the company has received $22.5 million from Medicxi through a Series A financing.

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Secondary Myelofibrosis Recruiting Phase 1 Trials for DB00493 (Cefotaxime)

This pilot clinical trial studies the side effects of combination chemotherapy, total body irradiation, and donor blood stem cell transplant in treating patients with secondary myelofibrosis. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy x-rays to kill cancer cells and shrink tumors. Giving combination chemotherapy and total body irradiation before a donor blood stem cell transplant helps to stop the growth of cells in the bone marrow, including normal blood-forming cells (stem cells) and cancer cells. When the healthy stem cells from a donor are infused into the patient they may help the patient’s bone marrow make stem cells, red blood cells, white blood cells, and platelets.

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Contemporary Use of Interferon Therapy in the Myeloproliferative Neoplasms

The purpose of this article is to review the current evidence behind interferon therapy in patients with myeloproliferative neoplasms.

Recent Findings

Preliminary analysis suggests that interferon may be non-inferior to hydroxyurea in patients with polycythemia vera and essential thrombocytosis. Responses have been observed regardless of JAK2 mutational status, but the presence of non-JAK2 somatic mutations may negatively influence response rates.

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AMD in Patients With Chronic MPNs

Question  Do patients with chronic myeloproliferative neoplasms have an increased risk of age-related macular degeneration compared with the general population?

Findings  In a large Danish registry-based nationwide cohort study including 7958 patients with myeloproliferative neoplasms and 77 445 age- and sex-matched controls, the risk of age-related macular degeneration was increased for patients with myeloproliferative neoplasms, after adjustment for smoking and risk time.

Meaning  These data suggest that patients with myeloproliferative neoplasms have a higher risk of age-related macular degeneration than the general population, supporting the possibility that systemic alterations may be involved in the pathogenesis of age-related macular degeneration.

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Study Administers IMG-7289 to First Patients with MF

The first patients have been dosed in a Phase 1/2 clinical trial of IMG-7289 for the treatment of myelofibrosis (MF), according to Imago BioSciences.

The clinical-stage pharmaceutical company is developing novel therapies for hematological and inflammatory diseases. Myelofibrosis is characterized by the production of inflammatory cytokines, and IMG-7289 is an investigational lysine-specific demethylase 1 (LSD1) inhibitor intended to suppress that production.

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Women More Likely to Survive Essential Thrombocythemia Than Men

Until now, gender had not been considered a factor in survival rates of individuals with essential thrombocythemia (ET), a type of myeloproliferative neoplasm (MPN). But according to a recent study conducted by researchers at the Mayo Clinic in Rochester, Minnesota and the University of Florence in Italy, being male may lead to inferior overall survival (OS). In other words, women survive more frequently than men with ET. The study was published in the American Journal of Hematology.

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Arthritis Medicine May Move on to PV Treatment Scene

Can a drug used to treat arthritis also be a way to treat polycythemia vera (PV), and save patients with the blood cancer money?

Researchers at the University of Sheffield in England believe that the chemotherapy agent and immune system suppressant, methotrexate (MTX), would benefit tens of thousands of people affected by the disease.

The reason an arthritis treatment may work to treat the rare cancer type is because they both have connections to the Janus kinase/signal transducers and activators of transcription (JAK/STAT) pathway. In patients with arthritis, it sparks up inflammation and an autoimmune response, and for PV, mutations in the pathway account for the majority of diagnoses.

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Registration-Atlanta MPN Patient Program

Atlanta MPN Patient Education Program

Thank you for registering for the MPN Patient/Caregiver Education Program on October 26, 2017 in Atlanta, GA.  We look forward to seeing you.  To complete the registration you can use the link below to pay the registration fee.  Follow the brief instructions to link to the PayPal account.

 NOTE: You do not need a PayPal account to make this payment, you can select the “Pay with Debit or Credit Card” option.  If you are registering for you and a guest or 2 guests please use “Select Registration Option” from the drop down menu provided on the registration page:


Select Registration Option



Mayo Clinic and ASU Seeking MPN Patients for Pilot study in Meditation

Mediation Flyer

During 2015 and 2016, Arizona State University, in partnership with the Mayo Clinic and Udaya Entertainment, successfully conducted two 12-week, home-based, online-streamed yoga interventions in MPN patients. Through these studies, we demonstrated both the feasibility of online yoga in MPN patients as well as the ability for yoga to improve MPN patient symptom burden (e.g., fatigue, anxiety, depression, sleep quality, pain) and quality of life. The data generated from these studies led to the submission of a large effectiveness trial to the National Institutes of Health, National Cancer Institute, which is currently in review. The success of our online yoga studies combined with an interest in meditation amongst MPN patients has led to the expansion of our non-pharmacological research umbrella to include an examination of the effects of meditation on MPN patient symptom burden and quality of life. We are hoping you could share the below information. Note that we don’t mention meditation below as we would like all potential participants to try the intervention and we will determine their perceptions about it afterwards. Here is the information to share:

We are currently conducting a study that explores the practicality and the impact of different strategies (i.e., mobile app, education) to reduce fatigue, MPN-symptom burden and improve quality of life. We are seeking MPN cancer patients, ages 18 and up, to participate. Participants must be willing to be randomized to one of four different groups that includes a combination of materials/resources and/or two different smartphone-based applications to help manage fatigue and stress associated with MPN. Participants will be asked to complete questionnaires at three different time points and wear a Fitbit device throughout the study, which they will keep at the end of the study in gratitude for their participation. This study, much like our previous online health studies, will include a limited number of MPN patients (N=90). The results of this study will provide the data needed to submit a large effectiveness trial to the National Institutes of Health, National Cancer Institute. This research will be conducted through a partnership between Mayo Clinic and Arizona State University (ASU) and may help advance our understanding on the potential role of non-pharmacological complementary approaches to symptom management in MPN patients.

If you are interested in learning more about or joining this study, please contact us by phone (602-827-2314), email mpnpilotapp@asu.edu or visit this link to complete eligibility survey: http://bit.ly/mpnpilotapp (case sensitive)

 

CTI BioPharma Announces First Patient Enrolled in Phase 2 Trial of Pacritinib in Patients with Myelofibrosis who have Thrombocytopenia and who have been Previously Treated with Ruxolitinib

SEATTLE, Aug. 1, 2017 /PRNewswire/ — CTI BioPharma Corp. (NASDAQ and MTA: CTIC) today announced that the first patient has been enrolled in PAC203, a Phase 2 clinical trial of pacritinib in patients with primary myelofibrosis who have failed prior ruxolitinib therapy. PAC203 is designed to evaluate the dose response relationship for safety and efficacy (spleen volume reduction at 12 and 24 weeks) of three dose regimens: 100 mg once-daily, 100 mg twice-daily (BID) and 200 mg BID. The 200 mg BID dose regimen was used in the Phase 3 PERSIST-2 trial of pacritinib in patients with myelofibrosis. The trial is expected to enroll up to approximately 105 patients.

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