PALM BEACH, Florida, October 3, 2017 /PRNewswire/ --
Moleculin Biotech, Inc., (NASDAQ: MBRX), a clinical stage pharmaceutical company focused on the development of anti-cancer drug candidates, some 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 to conduct its clinical trial to study Annamycin for the treatment of acute myeloid leukemia (AML) with the first of several hospitals desiring to be treatment centers.
"Now that our IND (investigational new drug) application is approved, the race is on to open treatment centers and begin recruiting patients," commented Walter Klemp, Chairman and CEO of Moleculin. "We have identified 14 treatment sites that meet our criteria and have expressed an interest in participating, so there will be much more of this to come." Read this and more news for Moleculin Biotech at: http://www.marketnewsupdates.com/news/mbrx.html
"This first facility is a hematology clinic in a major hospital in Poland," continued Mr. Klemp. "Because of the difference in process in Poland compared with the US, we were able to get this site signed up very shortly following the approval of our IND. We anticipate announcing additional sites over the coming months."
Moleculin entered into this first agreement with a hospital in Poznan, Poland (Hospital of the Transfiguration of the Lord - Medical University in Poznan, Department of Hematology and Marrow Transplantation). The ability to treat patients in this and other Polish sites will require a separate regulatory approval in Poland based on the approved US IND. This is one of seven planned treatment sites in Poland.
In other biotech market developments and positive performances:
Endocyte Inc. (NASDAQ: ECYT) close up over 157% on Monday trading more than 53 million shares by the market close. ECYT was also up in afterhours trading yesterday. The company announced this week the completion of an exclusive worldwide license of PSMA-617 from ABX GmbH. Endocyte intends to move quickly into Phase 3 development of[ 177]Lu-PSMA-617, a radioligand therapeutic (RLT) that targets the prostate-specific membrane antigen (PSMA), present in approximately 80% of patients with metastatic castration-resistant prostate cancer (mCRPC). Lu-PSMA-617 delivers the short-range beta-emitting radioactive isotope lutetium (Lu) selectively to tumor cells while by-passing non-PSMA-expressing healthy cells with encouraging efficacy and safety results. As highlighted in roughly 20 peer reviewed publications of studies in the post-chemotherapy compassionate use setting, Lu-PSMA-617 has consistently demonstrated a PSA response (defined as greater than 50% decline from baseline) in 40% to 60% of patients, and a RECIST response rate in soft tissue disease of between 40% and 50%.
Rigel Pharmaceuticals Inc. (NASDAQ: RIGL) closed up over 32% on Monday trading over 12.6 Million shares by the market close. The company announced that during the company's mid-cycle meeting with the U.S. Food and Drug Administration (FDA) the FDA indicated that, at this point, it is not planning to hold an Oncology Drugs Advisory Committee (ODAC) meeting to discuss the New Drug Application (NDA) for fostamatinib in patients with chronic or persistent immune thrombocytopenia (ITP). Additionally, the FDA indicated that it anticipates meeting the Prescription Drug User Fee Act (PDUFA) action date for the application review, which is April 17, 2018. In an earlier communication, the FDA had conditionally approved the proprietary name Tavalisse[TM]. "Since we submitted our NDA this spring, we have worked collaboratively with the FDA to answer routine questions as they arise," said Anne-Marie Duliege, MD, Executive Vice President and Chief Medical Officer of Rigel. "Our positive interactions with the FDA, including their customary biomedical monitoring (BIMO) inspections at our facilities and clinical sites, are in-line with our expectations and have progressed well."
Arbutus Biopharma Corporation (NASDAQ: ABUS) closed Monday up over 16% on over 1.7 million shares traded by market close as was also up in afterhours trading. Arbutus Biopharma, an industry-leading Hepatitis B Virus (HBV) therapeutic solutions company, announced last week topline results of the bi-weekly dosing segment of Cohort 4 of the Phase II study of its RNAi agent, ARB-1467. In the bi-weekly dosing segment of Cohort 4, twelve HBeAg negative chronically infected HBV patients on stable nucleotide therapy were given five doses of ARB-1467 on a bi-weekly dosing schedule. All twelve patients in Cohort 4 experienced reductions in serum HBsAg levels, with an average reduction in serum HBsAg of 1.4 log10, which was greater than that observed with monthly dosing in Cohorts 1-3. Seven of the twelve patients met the predefined response criteria (at least 1 log10 reduction in serum HBsAg level and a serum HBsAg level below 1000 IU/mL) at or before day 71.
Zogenix Inc. (NASDAQ: ZGNX) came to a close up over 10% on Monday with over 11.2 million shares traded on the day. The company recently announced positive top-line results from its first Phase 3 trial (Study 1) for its investigational drug, ZX008 (low-dose fenfluramine hydrochloride), for the treatment of Dravet syndrome. The trial met its primary objective of demonstrating that ZX008, at a dose of 0.8 mg/kg/day, is superior to placebo as adjunctive therapy in the treatment of Dravet syndrome in children and young adults based on change in the frequency of convulsive seizures between the 6-week baseline observation period and the 14-week treatment period (p<0.001). ZX008 0.8 mg/kg/day also demonstrated statistically significant improvements versus placebo in all key secondary measures, including the proportion of patients with clinically meaningful reductions in seizure frequency and longest seizure-free interval. The same analyses comparing a 0.2 mg/kg/day ZX008 dose versus placebo also demonstrated statistically significant improvement compared with placebo.
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