Advancing Clinical Trials for Leukemia Patients is Helping Improve Survival Rate

PALM BEACH, Florida, March 14, 2019 /PRNewswire/ -- According to the Leukemia & Lymphoma Society, the world's largest voluntary health agency dedicated to blood cancer, In 2018, 60,300 people are expected to be diagnosed with leukemia and that there are an estimated 381,774 people living with or in remission from leukemia in the US. In 2010 to 2014, leukemia was the sixth most common cause of cancer deaths in both men and women.  However, the overall picture has been improving over the last decade. The overall five-year relative survival rate for leukemia has more than quadrupled since 1960. From 1960 to 1963, the five-year relative survival rate among whites (only data available) with leukemia was 14 percent. From 1975 to 1977, the five-year relative survival rate for the total population with leukemia was 34.1 percent, and from 2007 to 2013, the overall relative survival rate was 63.7 percent.   Acute myeloid leukemia (AML), the most common type of adult leukemia, is a cancer of the blood-forming cells of the bone marrow. Currently, most patients with AML are treated with standard chemotherapy. But recent scientific advances have revealed that there are many forms of the disease, each with different specific genetic changes that may affect cancer growth and treatment.   Active biotech and pharma companies in the markets this week include Moleculin Biotech, Inc. (NASDAQ:MBRX), Akari Therapeutics, Plc (NASDAQ: AKTX), Eli Lilly and Company (NYSE: LLY), Celgene Corporation (NASDAQ: CELG), Geron Corporation (NASDAQ: GERN).

The society says that: "Taking part in a clinical trial may be the best treatment choice for some acute myeloid leukemia (AML) patients. Clinical trials are under way for patients at every treatment stage and for patients in remission… Virtually all of today's standard treatments for cancer are based on previous clinical trials."

Moleculin Biotech, Inc. (NASDAQ:MBRX) BREAKING NEWS :  Moleculin Biotech, a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors, today announced the first patients have been treated in the Company's second clinical trial to study Annamycin for the treatment of relapsed and refractory adults with acute myeloid leukemia.  The Company further reported that the initial treatment of the first patient appeared to be well tolerated.

"We are encouraged to see such ready access to qualified patients in Poland," commented Walter Klemp, Moleculin's Chairman and CEO.  "We consider it a positive indication to have completed the treatment of the first European patient so soon after beginning recruitment.  In addition, we have already begun treatment of the second patient. We also believe that the higher starting dosage in the European trial as compared to the US trial may be contributing to a faster rate of recruitment."  Read this and more news for MBRX at:  https://www.financialnewsmedia.com/news-mbrx/   

Other recent developments in the biotech industry include:

Akari Therapeutics, Plc

(NASDAQ: AKTX) On March 13, the company, a biopharmaceutical company focused on innovative therapeutics to treat orphan autoimmune and inflammatory diseases where the complement and/or leukotriene systems are implicated, announced that it had a successful Type B, pre-IND meeting with the Food and Drug Administration (FDA) regarding Akari's proposed pivotal clinical trial program for pediatric hematopoietic stem cell transplant-related thrombotic microangiopathy (HSCT-TMA). HSCT-TMA is an orphan condition with an estimated fatality rate of more than 80% in children with the severe disease.

A framework for the trial design was agreed to with the FDA in which the response to Coversin of selected, clinically meaningful treatment variables would be the primary endpoint in the proposed pivotal trial. These responder endpoints were based on work done by Sonata Jodele, M.D., a world-leading expert in treating pediatric HSCT-TMA.

Eli Lilly and Company (NYSE: LLY) On March 12 the company announced that its Phase 3 RELAY study of CYRAMZA^®(ramucirumab) met its primary endpoint of progression-free survival (PFS), demonstrating a statistically significant improvement in the time patients lived without their cancer growing or spreading after starting treatment. The Phase 3 global, randomized, double-blind trial is evaluating CYRAMZA in combination with erlotinib, compared to placebo in combination with erlotinib, as a first-line treatment in patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have activating EGFR mutations.

"Despite recent treatment advances in metastatic EGFR-mutated non-small cell lung cancer, prognosis remains poor and there is an ongoing need for additional first-line treatment options to help patients with this deadly disease," said Maura Dickler, M.D., vice president of late phase development, Lilly Oncology.

Celgene Corporation (NASDAQ: CELG) On March 11, the company announced that the Company has submitted a Marketing Authorization Application to the European Medicines Agency (EMA) for ozanimod for the treatment of adults with relapsing-remitting multiple sclerosis (RRMS). Ozanimod is an oral, sphingosine 1-phosphate (S1P) receptor modulator, which binds with high affinity selectively to S1P subtypes 1 (S1P₁) and 5 (S1P₅).

The pivotal efficacy and safety data provided in the application result from the SUNBEAM™ and RADIANCE™ Part B phase 3, multicenter, randomized, double-blind, double-dummy, active-controlled trials.

Geron Corporation (NASDAQ: GERN) recently reported financial results for the fourth quarter and full year ended December 31, 2018 and recent events. As of year-end 2018, the Company had approximately $182 million in cash and marketable securities, which is sufficient to commence the planned Phase 3 clinical trial of imetelstat in lower risk myelodysplastic syndromes (MDS) by mid-year 2019.

"We expect 2019 to be a pivotal year," said John A. Scarlett, M.D., Chairman and Chief Executive Officer. "We are making good progress in the transition of the imetelstat program and expect to assume sponsorship of the imetelstat clinical trials by the end of the second quarter. We continue planning to open the Phase 3 clinical trial of imetelstat in lower risk MDS for enrollment by mid-year, as well as evaluating the potential for late-stage development in MF. In addition, we expect to further expand our team with individuals who have strong development expertise that will enable us to build a robust hematology-oncology franchise."

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