Palm Beach, FL – (June 12, 2018) – Clinical trial data is an important catalyst as well as trial results or any positive updates on the clinical studies are often received well these days in the pharma and biotech market. The industry as whole has bounced back in the past month as it rose 6.8%, better than the S&P 500’s increase of 2.9% making it one of the best-performing industries in the U.S. stock market. On the bright side of things, indications are the demand for drugs is rising worldwide due to increasing ailing and elderly population, frequent approval of new drugs as well as line extensions of already marketed drugs and increased healthcare spending. In addition another positive indication for the biotech industry is the U.S. Food and Drug Administration is taking steps to streamline the approval process for cancer drugs, reviewing clinical trial data up front to make sure applications companies submit are complete. Active companies in the markets today include: Moleculin Biotech, Inc. (NASDAQ:MBRX), Aptose Biosciences Inc. (NASDAQ:APTO), Cardiome Pharma Corp. (NASDAQ:CORV), Pfizer Inc. (NYSE:PFE), Endocyte Inc. (NASDAQ:ECYT).
Moleculin Biotech, Inc. (NASDAQ:MBRX) BREAKING NEWS: Moleculin Biotech, a clinical stage pharmaceutical company focused on the development of oncology drug candidates, all of which are based on license agreements with The University of Texas System on behalf of the M.D. Anderson Cancer Center, today announced that it has entered into an agreement with the Jagiellonian University in Krakow, Poland, for the development of its STAT3 inhibitor, WP1732, for the treatment of ocular tumors.
“Today there are very limited options for the treatment of ocular tumors," commented Walter Klemp, Chairman and CEO of Moleculin. “And, these tumors are believed to involve a significant upregulation of the activated form of STAT3. It is important to note that, in addition to the ability of WP1732 to inhibit the proliferation and survival of cancer cells in preclinical studies, as STAT3 inhibitor, it is designed to potently block cancer stem cells and induce immune system function to overcome tumor-induced immune tolerance. This could make WP1732 an ideal candidate for targeting these unique and highly metastatic tumors.”
Mr. Klemp continued: “we remain committed to targeting accelerated approval pathways for WP1732 by focusing on significant unmet needs. This includes niche indications like ocular tumors and AML, as well as high-profile indications like pancreatic cancer.” Read this and more news for Moleculin Biotech at: http://www.marketnewsupdates.com/news/mbrx.html
In other pharma and biotech developments in the markets:
Aptose Biosciences Inc. (NASDAQ:APTO) came to a close up 6.39% on Monday at $4.33 trading over 1 million shares by the market close. The company also recently annnounced the publication of preclinical data elucidating the mechanism of action of APTO-253, the company’s clinical stage anticancer product candidate. The data are published in two separate articles in the June 2018 issue (Volume 17, Number 6) of Molecular Cancer Therapeutics, a peer-reviewed journal of the American Association for Cancer Research (AACR). The first publication, entitled “APTO-253 stabilizes G-quadruplex DNA, inhibits MYC expression and induces DNA damage in acute myeloid leukemia cells,” demonstrates that the APTO-253 small molecule anticancer agent inhibits expression of the MYC oncogene and depletes cells of the MYC protein, triggers the DNA repair and stress response pathways, and promotes programmed cell death (apoptosis) in acute myeloid leukemia (AML) cell lines and fresh bone marrow samples derived from patients with AML and other hematologic malignancies that often depend on MYC upregulation.
Cardiome Pharma Corp. (NASDAQ:CORV) closed up 48.08% on Monday at $3.08 trading oved 5.7 million shares by the market The company also announced that it has received a response from the U.S. Food and Drug Administration (FDA) regarding the regulatory path forward in the US for BRINAVESS® (vernakalant hydrochloride, IV), Correvio's antiarrhythmic drug for the rapid conversion of recent onset atrial fibrillation (AF). In its written reply, the FDA informed Correvio that it would be permissible to resubmit the BRINAVESS New Drug Application (NDA) and agreed that the Company may schedule a Pre-NDA meeting. Correvio currently expects that the Pre-NDA meeting with the FDA will take place in the fourth quarter of 2018. "In our most recent communication with the FDA, we asked the Agency if the Division of Cardiovascular and Renal Products would be willing to meet to discuss a regulatory path forward for Brinavess," said William Hunter, MD, CEO and President of Correvio. "We are pleased that the Agency has agreed to discuss Brinavess in a pre-NDA meeting, which we will seek to have in the fourth quarter."
Pfizer Inc. (NYSE:PFE) recently announced that the U.S. Food and Drug Administration accepted for filing and granted Priority Review designation to the company’s New Drug Application for talazoparib. The submission is based on results from the EMBRACA trial, which evaluated talazoparib versus chemotherapy in patients with germline (inherited) BRCA-mutated (gBRCAm), HER2-negative locally advanced or metastatic breast cancer (MBC). Talazoparib is an investigational, once-daily, oral poly ADP ribose polymerase (PARP) inhibitor. The European Medicines Agency has also accepted the Marketing Authorization Application for talazoparib in this patient population. “Women with a hereditary BRCA mutation are typically diagnosed with breast cancer at a younger age than the overall breast cancer population and have limited treatment options when they develop advanced disease,” said Mace Rothenberg, M.D., chief development officer, Oncology, Pfizer Global Product Development.
Endocyte Inc. (NASDAQ:ECYT) last week announced the enrollment of the first patient in its global phase 3 VISION trial of 177Lu-PSMA-617 in prostate cancer by Dr. Luke Nordquist at Urology Cancer Center in Omaha, NE, a member of Precision Cancer Research. The international, prospective, open-label, multicenter, randomized phase 3 study is evaluating patients with progressive prostate specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC), who have received at least one novel androgen axis drug (abiraterone or enzalutamide) and at least one taxane regimen. “We are pleased to announce the initiation of this important clinical trial so quickly following our end-of-phase 2 meeting with the FDA. This speed of execution is a result of the enthusiasm of participating physicians and the focus and urgency of our clinical operations team,” said Mike Sherman, president and CEO of Endocyte. “Having collaborated with several of the key opinion leaders in prostate cancer around the world, we are confident in the robustness of the VISION trial design and eager to complete enrollment.”
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