Biotech Brief: Growing Number of Ongoing Clinical Trials for Leukemia (AML) Brings New Hope

Tuesday, April 9, 2019 Clinical Trials News
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Financialnewsmedia.com News Commentary

PALM BEACH, Florida, April 9, 2019 /PRNewswire/ -- In the last few years

the number of clinical trials looking for new treatments for Leukemia (AML) has continued to grow. In 2017, a report from ManagedCare said that: "… There are over 400 phase 2 or phase 3 trials currently recruiting or underway for the treatment of
AML…"  As of April 8, 2019 that number had grown to 1,448 according to ClinicalTrials.gov, an arm of the National Institutes of Health: U.S. National Library of Medicine. The ManagedCare article said: "Acute myeloid leukemia (AML), sometimes called acute granulocytic leukemia, is the most common of the four major types of leukemia… This is a cancer that is rarely seen before age 45 with the average age of onset around 65… Treatment for AML can vary based on a number of factors, but in general the first-line therapy consists of induction therapy. The American Cancer Society estimates that about two-thirds of patients who undergo standard induction therapy will achieve remission. About half of patients who achieve remission and undergo consolidation will achieve long-term remission. While those are pretty good odds for remission compared to many other types of cancer, it does leave many who need further options for treatment. Active biotech and pharma companies in the markets this week include Moleculin Biotech, Inc. (NASDAQ:MBRX), CEL-SCI Corporation (NYSE: CVM), Coherus BioSciences, Inc. (NASDAQ: CHRS), Inovio Pharmaceuticals, Inc. (NASDAQ: INO), Insmed Incorporated (NASDAQ: INSM).

With new drug approvals… and over 400 (now 1,448) clinical trials underway in the treatment of AML, it is apparent that there is quite a bit of interest in producing new treatment options for AML. This brings new hope to patients who cannot receive traditional therapies, or who have relapsed despite receiving traditional therapy already. It will be interesting to monitor the impact new therapies will have on the market considering the high cost of treatment with the new therapies and the relatively high success of lower cost traditional chemotherapy for those eligible for treatment. A search on clinicaltrials.gov shows high interest in the continuation of research for additional therapies for AML."

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 it has successfully expanded the clinical supply of Annamycin for its on-going clinical trials via BSP Pharmaceuticals S.p.A. (www.bsppharmaceuticals.com) in Latina, Italy.

"Securing production supply for a liposomal anthracycline like Annamycin is no trivial matter, which is why we partnered last year with a quality supplier like BSP, who will be able to supply Annamycin in commercial quantities going forward," commented Walter Klemp, Moleculin's Chairman and CEO. "They have worked diligently to establish production capability and are now supplying our Annamycin drug for our clinical trials in the U.S. and the EU. We believe having a partnership with a pharmaceutical manufacturer the caliber of BSP mitigates our development risk and better positions us to further advance the clinical development of Annamycin as we work to develop effective solutions for the treatment of acute myeloid leukemia." Read this and more news for MBRX athttps://www.financialnewsmedia.com/news-mbrx/   

Other recent developments in the biotech industry include:

CEL-SCI Corporation (NYSE: CVM) recently announced that the Independent Data Monitoring Committee (IDMC) for the Company's pivotal Phase 3 head and neck cancer study of its investigational immunotherapy Multikine* (Leukocyte Interleukin, Injection) has completed its recent review of the Phase 3 study data. The data from all 928 enrolled patients were provided to the IDMC by the clinical research organization (CRO) responsible for data management of this Phase 3 study.

CEL-SCI's Phase 3 study is the largest Phase 3 study in the world for the treatment of head and neck cancer. Per the study's protocol, newly diagnosed patients with advanced primary squamous cell carcinoma are treated with the Multikine treatment regimen for 3 weeks prior to receiving the Standard of Care (SOC), which involves surgery, radiation and/or concurrent radiochemotherapy. Multikine is designed to help the immune system "see" the tumor at a time when the immune system is still relatively intact and thereby it is better able to mount an attack on the tumor. The aim of treatment with Multikine is to increase the body's immune system against the tumor prior to SOC.

Coherus BioSciences, Inc. (NASDAQ: CHRS) recently announced that UDENYCA™ preliminary unaudited net sales for the quarter that ended March 31, 2019 are expected to be in the range of $36.0 million to $38.0 million. Coherus will not disclose topline gross sales, discounts, or gross-to-net data until these data are reported in its Form 10-Q for the quarter ended March 31, 2019.

Coherus introduced­­ UDENYCA™ (pegfilgrastim-cbqv) in the U.S. marketplace on January 3, 2019 with a comprehensive launch across all segments including 340B hospitals, non-340B hospitals and clinics. As announced, Coherus will provide additional financial updates and business highlights on May 9, 2019 at 4:30 p.m. Eastern Time.

Inovio Pharmaceuticals, Inc. (NASDAQ: INO) recently announced that it achieved a third indication milestone from AstraZeneca resulting from dosing a patient in a Phase 2 combination trial evaluating MEDI0457 (formerly called INO-3112) in combination with durvalumab targeting cervical, anal, penile, and vulvar cancers associated with the human papilloma virus (HPV). The milestone achievement for this multi-indication trial is the third MEDI0457-related Phase 2 milestone from AstraZeneca; two previous milestone payments resulted from initiating Phase 2 combination trials targeting head and neck and cervical cancers. Financial arrangements were not disclosed.

Dr. J. Joseph Kim, Inovio's President and Chief Executive Officer, said, "This Phase 2 milestone stresses the potential breadth of MEDI0457 in treating multiple HPV-associated cancers. Inovio's goal is to lead the HPV-treatment market from pre-cancers with its lead product VGX-3100 to cancers with MEDI0457 along with our partner AstraZeneca."

Insmed Incorporated (NASDAQ: INSM) a global biopharmaceutical company on a mission to transform the lives of patients with serious and rare diseases, recently provided an update on the U.S. launch of ARIKAYCE®(amikacin liposome inhalation suspension), including preliminary net product sales for the first quarter of 2019.  ARIKAYCE was granted accelerated approval by the U.S. Food and Drug Administration (FDA) on September 28, 2018, for the treatment of Mycobacterium avium complex (MAC) lung disease as part of a combination antibacterial drug regimen for adult patients who have limited or no alternative treatment options.

"We continue to be very pleased with the U.S. launch progress of ARIKAYCE and the positive feedback received from the refractory MAC lung disease community," said Will Lewis, Chairman and Chief Executive Officer of Insmed. "Six months into launch, we continue to see steady increases in patients initiating therapy as well as strong support from payers. We remain very encouraged by the early trends in our first two quarters of launch, while carefully monitoring metrics such as patient dropout rates and duration of therapy. We look forward to providing more information and additional guidance on the U.S. launch during our first quarter earnings call in early May."

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