On March 27, 2018 Moleculin Biotech, Inc., (NASDAQ: MBRX) ("Moleculin" or the "Company"), 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, reported that it has entered an agreement with The University Hospitals Cleveland Medical Center, which includes the Seidman Cancer Center and the Cleveland Clinic, to participate in its U.S. Phase I/II clinical trial of Annamycin for the treatment of relapsed or refractory acute myeloid leukemia (AML) and that patient enrollment has begun (Press release, Moleculin, MAR 27, 2018, View Source [SID1234525011]).

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"This is an important milestone in establishing the efficacy of Annamycin in the treatment of AML in a U.S. trial," commented Walter Klemp, Chairman and CEO of Moleculin. "Coupled with the impending Annamycin clinical trial in Poland, we believe we are at an important inflection point to demonstrate the safety and effectiveness of our leading drug candidate. We have worked hard to get to this point, and we are gratified with the opportunities to move Annamycin forward."

On March 27, 2018 RedHill Biopharma Ltd. (NASDAQ:RDHL) (Tel-Aviv Stock Exchange:RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company primarily focused on late clinical-stage development and commercialization of proprietary drugs for gastrointestinal diseases and cancer, reported that two abstracts1 related to the successful Phase III study with BEKINDA (RHB-102)2 24 mg for acute gastroenteritis and gastritis (the GUARD study) have been accepted for oral presentations at the Society for Academic Emergency Medicine (SAEM) 2018 Annual Meeting, May 16-17, 2018, at the JW Marriott Hotel in Indianapolis, IN (Press release, RedHill Biopharma, MAR 27, 2018, View Source [SID1234525013]).

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The randomized, double-blind, placebo-controlled Phase III GUARD study with BEKINDA 24 mg successfully met its primary endpoint of efficacy in the treatment of acute gastroenteritis and gastritis, and BEKINDA 24 mg was found to be safe and well tolerated in this indication3. If approved for marketing by the FDA, BEKINDA 24 mg could become the first 5-HT3 antiemetic drug in the U.S. indicated for the treatment of acute gastroenteritis and gastritis.

The first presentation, entitled ‘Treatment of Acute Gastroenteritis-Related Emesis with Bimodal Release Ondansetron (RHB-102)’, will be presented by Robert Silverman, MD, MS, Associate Professor of Emergency Medicine, Zucker School of Medicine at Hofstra/Northwell; Northwell Health, and Lead Investigator of the BEKINDA Phase III GUARD study, on Wednesday, May 16, 2018, at 3:00 PM EDT. The abstract concludes that the Phase III GUARD study is the first study of acute gastroenteritis-related emesis showing benefit from any ondansetron preparation in adolescents and adults and suggests that acute gastroenteritis can be treated with a long-acting, bimodal release tablet, potentially avoiding the need for intravenous access.

The second presentation, entitled ‘A 24 mg bimodal-release ondansetron pill (RHB-102) shows no evidence of QT interval prolongation’, will be presented by Joseph Miller, MD, MS, Associate Clinical Professor, Emergency Medicine, Henry Ford Hospital and Investigator of the BEKINDA Phase III GUARD study, on Thursday, May 17, 2018, from 9:00 AM EDT. The abstract concludes that in patients with normal baseline corrected QT interval (QTc), 24 mg bimodal extended-release ondansetron caused no QTc prolongation in comparison to placebo.

About BEKINDA (RHB-102):
BEKINDA is a proprietary, bimodal extended-release (24 hours) oral pill formulation of ondansetron, covered by several issued and pending patents and targets several gastrointestinal indications. A first Phase III clinical study with BEKINDA 24 mg for the treatment of acute gastroenteritis and gastritis (the GUARD study) successfully met its primary endpoint. A Phase II study with BEKINDA 12 mg for the treatment of diarrhea-predominant irritable bowel syndrome (IBS-D) successfully met its primary endpoint.

On March 27, 2018 Fennec Pharmaceuticals Inc. (NASDAQ:FENC; TSX: FRX), a specialty pharmaceutical company, reported that the U.S. Food and Drug Administration (FDA) has granted PEDMARK (a unique formulation of sodium thiosulfate) Breakthrough Therapy designation for prevention of cisplatin-related ototoxicity in pediatric patients with standard risk hepatoblastoma (SR-HB) (Press release, Fennec Pharmaceuticals, APR 27, 2018, View Source [SID1234525799]).

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"The decision by the FDA to grant PEDMARK the first Breakthrough Therapy designation for the prevention of cisplatin ototoxicity reflects a recognition of the promising efficacy and safety data generated from SIOPEL 6 and COG ACCL0431 studies. We believe the recent receipt of Fast Track designation, and today, Breakthrough Therapy designation highlights the current lack of safe and effective treatments and overwhelming need to address this serious condition," said Rosty Raykov, President and Chief Executive Officer of Fennec. "This designation is another significant milestone for the advancement of PEDMARKTM, as we work closely with the Agency to expedite the NDA filing."

According to FDA, Breakthrough Therapy designation is given when preliminary clinical evidence has been provided to show that a treatment effect may represent substantial improvement over available therapies for the treatment of a serious condition. The designation includes all of the Fast Track program features, as well as more intensive FDA guidance on an efficient drug development program. Additional information is available under the FDA guidance for Industry Expedited Programs for Serious Conditions – Drugs and Biologics:

View Source

About PEDMARK (Sodium Thiosulfate (STS))

Cisplatin and other platinum compounds are essential chemotherapeutic components for many pediatric malignancies. Unfortunately, platinum-based therapies cause ototoxicity in many patients, and are particularly harmful to the survivors of pediatric cancer.

In the U.S. and Europe there is estimated that over 10,000 children may receive platinum based chemotherapy. The incidence of hearing loss in these children depends upon the dose and duration of chemotherapy, and many of these children require lifelong hearing aids. There is currently no established preventive agent for this hearing loss and only expensive, technically difficult and sub-optimal cochlear (inner ear) implants have been shown to provide some benefit. Infants and young children at critical stages of development lack speech language development and literacy, and older children and adolescents lack social-emotional development and educational achievement.

STS has been studied by cooperative groups in two Phase 3 clinical studies of survival and reduction of ototoxicity, The Clinical Oncology Group Protocol ACCL0431 and SIOPEL 6. Both studies are completed. The COG ACCL0431 protocol enrolled one of five childhood cancers typically treated with intensive cisplatin therapy for localized and disseminated disease, including newly diagnosed hepatoblastoma, germ cell tumor, osteosarcoma, neuroblastoma, and medulloblastoma. SIOPEL 6 enrolled only hepatoblastoma patients with localized tumors.

On March 27, 2018 i2020 Accelerator reported that Stelvio Therapeutics has joined its early drug discovery ecosystem (Press release, Stelvio Therapeutics, MAR 27, 2018, View Source [SID1234555715]). i2020 aims to accelerate research programs with differentiated biology and established development paradigms towards advanced leads and clinical candidates. The i2020 Accelerator deploys a world-wide network of well-established R&D resources, financial and BD&L capabilities to help Stelvio Therapeutics advance its proprietary epigenetic platform for glioblastoma therapies.

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i2020 received a startup funding commitment of $30 million from the specialty life science investor, Torrey Pines Investment. "With the risk of taking on projects at early development stages being very significant, i2020 has to be reasonably selective with the programs it supports," comments Nikolay Savchuk, Managing Director at Torrey Pines. "Stelvio Therapeutics’ AI-driven epigenetic signature-based platform, which identifies compounds that trigger differentiation of cancer stem cells into benign cell types, matches i2020’s target profile well. It is a first-in-class project with strong clinical hypothesis, a well-defined product profile and clear development milestones."

"i2020 aligns well with our overall goals, since it provides a robust network of relevant R&D, business strategy and scientific resources, together with an agile business model and flexible partnering options," comments Attila Hajdu, CEO at Stelvio Therapeutics. "This exciting partnership is a tremendous step towards our shared mission of delivering innovative medicines of value to the patients that need them. With our combined technology and resources, the traditional approaches of chemo and radiotherapy would be toppled and we could see a cure for glioblastoma within our lifetime."

On March 27, 2018 Bavarian Nordic A/S (OMX: BAVA, OTC: BVNRY) reported that Paul Chaplin, President & Chief Executive Officer will provide a corporate presentation at Needham & Company’s 17th Annual Healthcare Conference in New York City on Tuesday, March 27, 2018 at 4:00 PM EDT (Press release, Bavarian Nordic, 27 27, 2018, View Source [SID1234525016]).

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A live and archived webcast of the presentation will be available at http://bit.ly/2DZQgOi.

Contacts
U.S.: Seth Lewis, Vice President, Investor Relations. Phone: +1 978 341 5271
Europe: Rolf Sass Sørensen, Vice President Investor Relations & Communications. Phone +45 61 77 47 43