First Patient Enrolled in Delcath Amended Registration Trial in Metastatic Ocular Melanoma

On August 21, 2018 Delcath Systems, Inc. (OTCQB: DCTH), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, reported that the first patient has been enrolled under the amended protocol for its registration trial in ocular melanoma liver metastases (Press release, Delcath Systems, AUG 21, 2018, View Source;p=RssLanding&cat=news&id=2364273 [SID1234529754]). Stanford University Medical Center is the first trial site to enroll a patient under the amended protocol.

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The trial, A Single-arm, Multi-Center, Open-Label Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Melphalan/HDS Treatment in Patients with Hepatic-Dominant Ocular Melanoma (The FOCUS Trial), will enroll a minimum of 80 patients with ocular melanoma metastatic to the liver. Patients previously enrolled in the Melphalan/HDS arm of the trial under the prior randomized protocol will continue to be treated and evaluated as part of the amended trial.

"We are very pleased that the team at Stanford were able to begin enrolling patients in the amended trial so quickly," said Jennifer K. Simpson, PhD, MSN, CRNP, President and Chief Executive Officer of Delcath Systems. "We look forward to rolling out the amended protocol to additional centers in the coming months and are working hard to achieve our goal of completing trial enrollment by the end of the first half of 2019."

BerGenBio ASA: Results for the Second Quarter and First Half 2018

On August 21, 2018 BerGenBio ASA (OSE: BGBIO), a clinical-stage biopharmaceutical company developing novel, selective AXL kinase inhibitors for multiple cancer indications, reported its results for the second quarter and first half 2018 (Press release, BerGenBio, AUG 21, 2018, View Source [SID1234529421]). A presentation of the results by the Company’s management will take place today at 10.00 am CET in Oslo – details below.

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Richard Godfrey, Chief Executive Officer of BerGenBio, commented: "We are pleased with the progress of our clinical development programme for bemcentinib in the first half 2018. The emerging results in several clinical trials, which we showcased at our successful satellite reception coinciding with the ASCO (Free ASCO Whitepaper) meeting in June, are very encouraging and continue to support our view that bemcentinib could become a cornerstone of future cancer therapy. These data provide further evidence of bemcentinib’s activity in patients whose cancer progression is mediated by AXL. In addition, we are making good progress with our studies to identify predictive biomarkers that could be developed as companion diagnostics for personalized therapy with bemcentinib. We look forward to advancing these studies to completion and defining the future development strategy of bemcentinib with the greatest value for patients."

Highlights – Second Quarter & First Half 2018
Advanced lung cancer (NSCLC): First stage fully recruited, and first efficacy endpoint met in trial of bemcentinib in combination with KEYTRUDA. Clinical responses seen following treatment with bemcentinib/KEYTRUDA in patients negative for PD-L1 for whom KEYTRUDA monotherapy is not effective.
Advanced leukaemia (AML/MDS): Encouraging single agent activity in hard to treat relapsed / refractory (R/R) leukaemia: Superior response rates of > 40% observed in biomarker subgroup analyses.
Triple negative Breast cancer (TNBC): First stage fully recruited, patients negative for Axl and PDL1 and first efficacy endpoint not met.
Tissue- and blood-based biomarkers with potential for development as companion diagnostics: AXL IHC method reporting encouraging correlation data. Low plasma soluble AXL predicts patient benefit in R/R AML/MDS.
Pipeline update: AXL antibody preparing for Phase I clinical trial.
Cash position NOK441m.
Presentation and Webcast Details
A presentation by BerGenBio’s senior management team will take place at 10.00 am CET at:

Felix Konferansesenter, Bryggetorget 3, 0125 Oslo

The presentation will webcast live and the link will be available at www.bergenbio.com in the section Investors/ Financial Reports. A recording will be available shortly after the webcast has finished.

The results report and the presentation will be available at www.bergenbio.com in the section: Investors/ Financial Reports from 7:00 am CET the same day.

Medtronic Reports First Quarter Financial Results

On August 21, 2018 Medtronic plc (NYSE: MDT) reported financial results for its first quarter of fiscal year 2019, which ended July 27, 2018 (Press release, Medtronic, AUG 21, 2018, View Source;p=RssLanding&cat=news&id=2364225 [SID1234529340]).

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The company reported first quarter worldwide revenue of $7.384 billion, a decrease of 0.1 percent as reported, or an increase of 6.8 percent on an organic basis, which adjusts for the divestiture of its Patient Care, Deep Vein Thrombosis (Compression), and Nutritional Insufficiency businesses to Cardinal Health that occurred in the second quarter of fiscal year 2018, and a $78 million positive impact from foreign currency. As reported, first quarter GAAP net income and diluted earnings per share (EPS) were $1.075 billion and $0.79, respectively. As detailed in the financial schedules included through the link at the end of this release, first quarter non-GAAP net income and diluted EPS were $1.601 billion and $1.17, respectively, both increases of 4 percent. Adjusting for the divestiture and a positive 5 cent impact from foreign currency, first quarter non-GAAP diluted EPS increased 9 percent.

First quarter U.S. revenue of $3.864 billion represented 52 percent of company revenue and decreased 4.4 percent as reported, while it increased 6.4 percent on a comparable basis, which adjusts for the divestiture. Non-U.S. developed market revenue of $2.406 billion represented 33 percent of company revenue and increased 4.0 percent as reported and 5.5 percent on a comparable, constant currency basis. Emerging market revenue of $1.114 billion represented 15 percent of company revenue and increased 7.6 percent as reported and 11.2 percent on a comparable, constant currency basis.

"We are executing against our plan, growing our markets and driving share gains across multiple businesses and geographies," said Omar Ishrak, Medtronic chairman and chief executive officer. "Our execution is not only on the top line, but also down the P&L, as we delivered margin expansion through our Enterprise Excellence program while increasing our investment in R&D."

Cardiac and Vascular Group
The Cardiac and Vascular Group (CVG) includes the Cardiac Rhythm & Heart Failure (CRHF), Coronary & Structural Heart (CSH), and Aortic, Peripheral & Venous (APV) divisions. CVG worldwide first quarter revenue of $2.811 billion increased 6.2 percent, or 5.0 percent on a constant currency basis. CVG revenue performance was driven by strong, low-double digit growth in CSH, mid-single digit growth in APV, and low-single digit growth in CRHF, all on a constant currency basis.

– CRHF first quarter revenue of $1.426 billion increased 2.6 percent, or 1.4 percent on a constant currency basis. Arrhythmia Management grew in the low-single digits on a constant currency basis, driven by high-teens constant currency growth in AF Solutions and the high-thirties constant currency growth of TYRX in Infection Control. Results were also driven by mid-single digit growth in Pacing, led by the adoption of the Micra Transcatheter Pacing System and the Azure wireless pacemaker.

– CSH first quarter revenue of $917 million increased 12.2 percent, or 10.9 percent on a constant currency basis, led by high-teens constant currency growth in transcatheter aortic valves on the global strength of the CoreValve Evolut PRO. Coronary grew in the high-single digits on a constant currency basis, driven by double digit constant currency growth of drug-eluting stents and guide catheters.

– APV first quarter revenue of $468 million increased 6.6 percent, or 5.2 percent on a constant currency basis, led by mid-teens constant currency growth in endoVenous on strong demand for the VenaSeal(TM) closure system. Peripheral Vascular grew in the mid-single digits on a constant currency basis, driven by strong PTA balloon growth globally and drug-coated balloon growth in international markets. Aortic grew in the low-single digits on a constant currency basis, driven by growth in thoracic stent grafts.

Minimally Invasive Therapies Group
The Minimally Invasive Therapies Group (MITG) includes the Surgical Innovations (SI) and the Respiratory, Gastrointestinal & Renal (RGR) divisions. MITG worldwide first quarter revenue of $2.052 billion decreased 17.5 percent as reported, or increased 4.9 percent on a comparable, constant currency basis. MITG revenue performance included mid-single digit growth in SI and low-single digit growth in RGR, both on a comparable, constant currency basis.

– SI first quarter revenue of $1.397 billion increased 5.8 percent on a comparable, constant currency basis, driven by low-double digit constant currency growth in Advanced Energy on the strength of the LigaSure(TM) vessel sealing instruments with innovative nano-coating. Advanced Stapling grew in the mid-single digits, driven by strong demand for Tri-Staple(TM) 2.0 endo stapling specialty reloads and the Signia(TM) powered stapler.

– RGR first quarter revenue of $655 million increased 2.9 percent on a comparable, constant currency basis. GI grew in the mid-single digits on a comparable, constant currency basis. Respiratory and Patient Monitoring grew in the low-single digits on a comparable, constant currency basis, with high-single digit constant currency growth in capnography and ventilation.

Restorative Therapies Group
The Restorative Therapies Group (RTG) includes the Spine, Brain Therapies, Specialty Therapies, and Pain Therapies divisions. RTG worldwide first quarter revenue of $1.949 billion increased 7.7 percent, or 6.8 percent on a constant currency basis. Group results were driven by mid-teens growth in Brain Therapies and Pain Therapies, with low-single digit growth in Specialty Therapies and flat results in Spine, all on a constant currency basis.

– Spine first quarter revenue of $652 million increased 0.5 percent, or decreased 0.3 percent on a constant currency basis. When combined with the company’s sales of enabling technology used in spine surgeries, which is recognized in the Brain Therapies division, global Spine revenue increased in the mid-single digits on a constant currency basis, driven by the success of the company’s Surgical Synergy strategy.

– Brain Therapies first quarter revenue of $599 million increased 14.8 percent, or 13.6 percent on a constant currency basis, driven by high-teens constant currency growth in Neurovascular and Neurosurgery. Neurovascular had strong growth in stents, flow diversion, and access products. Neurosurgery growth was led by strong capital equipment sales of the O-arm2 surgical imaging system, StealthStation S8 surgical navigation system, Mazor X(TM) robotic guidance system, and Visualase MRI-guided laser ablation system.

– Specialty Therapies first quarter revenue of $384 million increased 4.1 percent, or 3.3 percent on a constant currency basis. Results were led by mid-single digit constant currency growth in ENT.

– Pain Therapies first quarter revenue of $314 million increased 16.7 percent, or 15.6 percent on a constant currency basis. The division had strong, low-twenties growth in Pain Stimulation on the strength of the recently launched Intellis(TM) platform for spinal cord stimulation, as well as low-double digit growth in Targeted Drug Delivery and high-single digit growth in Interventional Pain, all on a constant currency basis.

Diabetes Group
The Diabetes Group is now organized into the Advanced Insulin Management (AIM) and Emerging Technologies divisions. Diabetes Group worldwide first quarter revenue of $572 million increased 27.4 percent, or 26.3 percent on a constant currency basis. The group is experiencing strong global demand for its new sensor-augmented insulin pump systems.

– AIM first quarter revenue grew in the mid-twenties on a constant currency basis, driven by the ongoing U.S. launch of the MiniMed 670G hybrid closed loop insulin pump system with the Guardian sensor 3 continuous glucose monitor (CGM). In international markets, AIM delivered high-teens constant currency growth on the continued strength of the MiniMed 640G system.

– Emerging Technologies first quarter revenue grew in the high-sixties on a constant currency basis, driven by the U.S. launch of the Guardian Connect CGM system with Sugar.IQ(TM) personal diabetes assistant.

Guidance
The company today updated its fiscal year 2019 revenue growth and EPS guidance.

For fiscal year 2019, the company is increasing its organic revenue growth guidance from a range of 4.0 to 4.5 percent to a range of 4.5 to 5.0 percent. If recent exchange rates hold for the remainder of the fiscal year, the company’s fiscal year 2019 revenue would be negatively affected by approximately $420 million to $520 million.

For fiscal year 2019, the company is increasing its implied constant currency non-GAAP diluted EPS growth forecast from a range of 8 to 9 percent to a range of 9 to 10 percent. At recent rates, foreign exchange is expected to be neutral to fiscal year 2019 EPS versus a 5 cent benefit prior. As such, despite the increased constant currency EPS growth outlook, the company is maintaining its diluted non-GAAP EPS guidance in the range of $5.10 to $5.15.

"We are excited about the growth opportunities in our end markets, and we are bullish about our competitive position," said Ishrak. "Our pipeline of innovation, invention, and disruption has never been stronger. We are also putting the pieces in place to improve free cash flow conversion, creating additional capital that can be returned to shareholders and reinvested to drive future growth, all with a goal of creating long-term shareholder value."

Webcast Information
Medtronic will host a webcast today, August 21, at 8:00 a.m. EDT (7:00 a.m. CDT) to provide information about its businesses for the public, analysts, and news media. This quarterly webcast can be accessed by clicking on the Investor Events link at investorrelations.medtronic.com and this earnings release will be archived at newsroom.medtronic.com. Medtronic will be live tweeting during the webcast on our Newsroom Twitter account, @Medtronic. Within 24 hours of the webcast, a replay of the webcast and transcript of the company’s prepared remarks will be available by clicking on the Investor Events link at investorrelations.medtronic.com.

Financial Schedules
To view the first quarter financial schedules and non-GAAP reconciliations, click here. To view the first quarter earnings presentation, click here. Both documents can also be accessed by visiting newsroom.medtronic.com.

Y-mAbs Receives Breakthrough Therapy Designation for Naxitamab for the treatment of High Risk Neuroblastoma

On August 21, 2018 Y-mAbs Therapeutics, Inc. (YmAbs), an immunotherapy company discovering and developing innovative treatments for patients with cancer, reported that the Company has received a Breakthrough Therapy designation for naxitamab, in combination with GM-CSF, for the treatment of high risk neuroblastoma refractory to initial therapy or with incomplete response to salvage therapy in patients older than 12 months of age with persistent, refractory disease limited to bone marrow with or without evidence of concurrent bone involvement (Press release, Y-mAbs Therapeutics, AUG 21, 2018, View Source [SID1234529164]).

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YmAbs Founder, President and Head of Business Development and Strategy, Thomas Gad said, "We are very pleased that the FDA has granted the Breakthrough Therapy designation to naxitamab and we look forward to continuing to work with the FDA to make this therapy potentially available to children facing an unmet medical need. We believe that Naxitamab provides a new opportunity for pediatric patients otherwise faced with little or no options. This is an important milestone achievement for YmAbs, and we continue to work with the regulatory authorities to advance naxitamab to patients suffering from high risk neuroblastoma as quickly as possible."

Dr. Claus Møller, Chief Executive Officer further notes, "This is the first time naxitamab has earned the distinction of a Breakthrough Therapy Designation. We are pleased that the FDA continues to recognize the potential of naxitamab to help patients with high risk neuroblastoma."

About Breakthrough Therapy Designation:

The Breakthrough Therapy Designation was enacted as part of the 2012 FDA Safety and Innovation Act (FDASIA) and is intended to expedite development of drugs to treat serious and life-threatening medical conditions when preliminary clinical evidence demonstrates that the drug may have substantial improvement on at least one clinically significant endpoint over available therapies. Breakthrough Therapy Designation includes all the features of the Fast Track Designation, as well as more intensive guidance from the FDA on a drug’s clinical development program.

Onconova Therapeutics Announces Plan for Expanding Rigosertib Clinical Trials for Patients with Myelodysplastic Syndromes (MDS) to South America with Pint Pharma

On August 21, 2018 Onconova Therapeutics, Inc. (NASDAQ:ONTX), a Phase 3-stage biopharmaceutical company focused on discovering and developing novel products to treat cancer, with a primary focus on myelodysplastic syndromes (MDS), reported that its commercial partner, Pint Pharma GmbH, will assist in expanding access to clinical trials studying rigosertib, a novel and targeted anti-cancer compound currently in a Phase 3 study for the treatment of MDS, to several selected sites across South America (Press release, Onconova, AUG 21, 2018, View Source [SID1234529071]). Pint Pharma is a European-based pharmaceutical company focused on the development, registration and commercialization of specialty-based treatments for the Latin American market and has successfully participated in clinical trials for hematological cancers.

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"This assistance will help make rigosertib available to cancer patients on a fifth continent, following our ongoing clinical trials in North America, Europe, Asia and Australia. We are delighted to partner with Pint Pharma, which has a wide footprint in South and Central America, with first-hand experience in running clinical trials for malignant hematological disorders," said Dr. Ramesh Kumar, CEO of Onconova Therapeutics, Inc.

"We are excited to start helping Onconova open new clinical sites in Latin America. We are hopeful that Onconova will be able to start recruiting patients as soon as possible to continue the development of IV and Oral Rigosertib," said David Munoz, Chief Executive Officer of Pint Pharma. He added, "Rigosertib is highly complementary to our comprehensive hematology oncology portfolio, and will further strengthen our mission to enable the Latin American population with life-threatening conditions to live better lives by providing early and efficient access to innovative technologies."

Dr. Steven Fruchtman, President and Chief Medical Officer of Onconova, is working closely with Dr. Valnei Canutti, General Manager, Brazil, and Chief Medical Officer of Pint. Dr. Fruchtman commented, "Completion of the INSPIRE Trial and expanding the potential utility of rigosertib for cancer patients are our core objectives and we are delighted that our commercial partner will assist us in recruiting patients in the INSPIRE trial. There is a great medical need and interest to conduct studies in patients with higher risk MDS in this geographical region."

Dr. Canutti added, "We are looking forward to working with Dr. Fruchtman on this important initiative. My prior experience in MDS and our connections with Key Opinion Leaders across this continent will be greatly helpful as we collaborate with Onconova."