On June 3, 2015 AVEO Oncology reported that, following pre-submission advisory meetings to discuss the potential submission of a Marketing Authorization Application (MAA) for tivozanib in Europe for the treatment of renal cell carcinoma (RCC), it has received written confirmation of support from the Rapporteur and co-Rapporteur for the filing of such an application (Press release, AVEO, JUN 3, 2015, View Source;p=RssLanding&cat=news&id=2056290 [SID:1234505227]). The Rapporteur (from Portugal) and Co-Rapporteur (from the United Kingdom) are the two appointed members of the Committee for Medicinal Products for Human Use (CHMP) who would lead the evaluation of the MAA, if submitted.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The application would be based on the Company’s existing dataset, which includes results from the Phase 3 TIVO-1 study of tivozanib in the first-line treatment of RCC in which tivozanib demonstrated a significant improvement over sorafenib in the study’s primary endpoint of progression free survival. At the advisory meetings, AVEO provided data demonstrating that the discordance in overall survival (OS), the secondary endpoint of the study, was very likely attributable to the crossover design of the study. The final meeting minutes reflect that the Rapporteurs "did not see a ‘blocking issue’ with the OS trend" and that AVEO "clearly presented a credible story for the Rapporteurs to assess but one which would need to be supported with very careful reasoning." AVEO was also reminded that the Rapporteurs "cannot advise on [the] final outcome of the review."

"We are pleased that both the Rapporteur and Co-Rapporteur were supportive of an MAA filing for tivozanib in RCC using TIVO-1 as the pivotal study," said Michael Bailey, president and chief executive officer of AVEO. "We believe tivozanib may provide an important addition to the clinical armamentarium in the treatment of this disease. Based on our assessment of the economic and infrastructure requirements associated with filing an MAA and subsequently launching tivozanib in Europe, we are evaluating partnership opportunities to take tivozanib forward in this important market as we continue to prepare for a filing."

On June 3, 2015 Varian Medical Systems reported Varian Medical Systems is expanding in the Middle East with the creation of a strategic operating entity in Saudi Arabia. Varian Medical Systems Arabia, the result of a joint venture with El Seif Development Group, was officially launched today at a ceremony attended by local dignitaries and Varian’s chief executive officer Dow Wilson (Press release, InfiMed, JUN 3, 2015, View Source [SID:1234505221]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"This move represents the next step in our commitment both to cancer patients and the medical community in Saudi Arabia," said Dow Wilson. "Radiotherapy plays a vital and cost effective role in treating cancer and we are committed to making more advanced treatment systems available to more patients across the region."

Varian Medical Systems Arabia will be home to 35 sales, service and administrative employees supporting Varian’s three business segments: Oncology Systems, Imaging Components and Particle Therapy. Varian has also established a spare parts depot in Riyadh.

"We look forward to supporting the ministry of health in Saudi Arabia as well as with the other healthcare service providers in the military sector, independent organizations and private hospitals," said Mazyad Al Utaibi, managing director of VMS Arabia. "Our expertise, experience, strengths and capabilities ensure we are well placed to continue offering our partners the latest technology and local service to fight cancer and help save lives."

Varian is the leading provider of radiotherapy systems to Saudi hospitals. The first Varian linear accelerator was installed in Saudi Arabia over 30 years ago and the company now has 22 systems operating across the country. Varian was also selected to equip the Middle East’s first proton therapy center, which is under construction at King Fahad Medical City in Riyadh.

On June 3, 2015 Varian Medical Systems reported that it has been selected to equip and service the new multi-room HollandPTC in Delft with the Varian ProBeam proton therapy system. The company will book the equipment part of the order in its fiscal 2015 third quarter (Press release, Varian Medical Systems, JUN 3, 2015, View Source [SID:1234505220]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

HollandPTC is a key part of Medical Delta, the medical-technological collaboration of the universities and university medical centers of Leiden, Delft and Rotterdam. When completed, the center will feature two proton therapy treatment rooms with full rotational gantries as well as facilities for fixed-beam eye treatments and research. Equipment installation is expected to take place in mid-2016, with patient treatments expected to begin in the second half of 2017.

"We are pleased to be selected to supply our ProBeam system for this prestigious project," said Moataz Karmalawy, managing director of Varian’s particle therapy business. "As well as offering pencil-beam scanning, the most advanced form of proton therapy, HollandPTC will be a key research site feeding into a national program to study the efficacy of protons."

Varian’s ProBeam system with Dynamic Peak Scanning is uniquely capable of high-speed intensity modulated proton therapy (IMPT) which is the most precise form of proton therapy available.

Proton therapy makes it possible to treat certain types of cancer more precisely and with potentially fewer side effects than is possible with conventional radiation therapy. With proton therapy, the risk of damage to healthy tissues and potential side effects is reduced because the beam is designed to stop and deposit dose within the tumor site rather than passing all the way through the patient. Proton therapy can be used for many of the most common types of cancer.

Varian’s ProBeam technology is being used to treat patients at the Scripps Proton Therapy Center in San Diego, the Rinecker Proton Therapy Center in Munich, and at the Paul Scherrer Institute in Switzerland. Varian also has contracts for system installations at eight other sites around the world.

On June 3, 2015 Celator Pharmaceuticals reported that enrollment is complete in a Phase 2 pharmacokinetic and pharmacodynamics (PK/PD) study evaluating the effects of CPX-351 (cytarabine:daunorubicin) Liposome Injection on cardiac repolarization in adult patients with acute hematologic malignancies, including acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), and myelodysplastic syndrome (MDS) (Press release, Celator Pharmaceuticals, JUN 3, 2015, View Source [SID:1234505218]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The open-label, single-arm, Phase 2 study is a thorough PK/PD assessment designed to: (1) measure the effects of CPX-351 on cardiac repolarization following the first induction cycle of CPX-351, and (2) correlate changes in cardiac repolarization with plasma pharmacokinetic data for cytarabine and daunorubicin and their metabolites. The study began enrolling patients in August 2014. Each patient received a first induction of CPX-351 on days 1, 3 and 5 and, if necessary, a second induction for patients with reduced leukemia/MDS burden not yet achieving a disease-free state. Responding patients were eligible for up to four consolidation courses. Analysis of treatment impact on cardiac electrophysiology, as measured by the QTc interval, and PK assessments were performed following the first induction course.

The study enrolled patients with newly diagnosed de novo and high-risk (secondary) AML, relapsed/refractory AML and relapsed ALL. Fifteen of the 26 patients enrolled are evaluable for response at this time. Six of the 15 patients responded to CPX-351 (defined as CR-complete response or CRi-complete response with incomplete hematologic recovery) including 2 of 3 patients (67%) with high-risk (secondary) AML, the study population of the ongoing Phase 3 trial. Responses were also seen in patients with de novo AML, relapsed AML, and relapsed ALL.

"We are happy to report that this study confirms the broad activity of CPX-351 in multiple populations of acute leukemia patients," said Tara Lin, M.D., Assistant Professor of Medicine at The University of Kansas Cancer Center, the lead investigator of this study, "and will report cardiac repolarization and pharmacokinetic data necessary for the registration of CPX-351 later this year."

The Phase 2 study was conducted to support the U.S. Food and Drug Administration (FDA) requirements of a New Drug Application (NDA) for CPX-351. Our Phase 3 study comparing CPX-351 to the current standard of care, known as 7+3, is being conducted in patients with high-risk (secondary) AML. The Phase 3 study completed enrollment in November 2014. Initial data from a secondary endpoint, induction response rate, is expected by the end of June 2015. The primary endpoint data, of overall survival, is expected in the first quarter of 2016.

"We continue to work expeditiously to bring CPX-351 before the FDA as a potential new treatment option for patients with acute hematologic malignancies," said Scott Jackson, Chief Executive Officer of Celator Pharmaceuticals. "Clinical pharmacology studies are required by the FDA for new drugs in development, so we are pleased to have completed enrollment in this Phase 2 study to support a NDA submission for CPX-351. We expect to report top-line results from this study by the end of the year."

On June 3, 2015 RedHill Biopharma reported an update on its development pipeline and anticipated key milestones (Press release, RedHill Biopharma, JUN 3, 2015, View Source [SID:1234505217]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

RHB-105 – for H. pylori bacterial infection

Top-line results from the first Phase III clinical study with RHB-105 are expected in the third week of June 2015. The Phase III study (the ERADICATE Hp study) is currently ongoing in the U.S. for the treatment of H. pylori bacterial infection, a major cause of chronic gastritis, peptic ulcer disease, gastric cancer, and mucosa associated lymphoid tissue (MALT) lymphoma

RHB-105 was designated by the FDA as a Qualified Infectious Disease Product (QIDP) under the Generating Antibiotic Incentives Now (GAIN) Act, allowing RedHill to benefit from fast-track development status for RHB-105, priority review, and, if ultimately approved by the FDA, an additional five years of marketing exclusivity, for a total of 8 years

The 2015 global and U.S. market potential for H. pylori eradication therapies, at current branded prices, were recently estimated at approximately $4.83 billion and $1.45 billion, respectively, and could potentially grow with increasing awareness of the health risks associated with H. pylori infection and the benefits of its eradication1

BEKINDA (RHB-102) – for gastroenteritis and gastritis, and for chemotherapy and radiotherapy-induced nausea and vomiting (CINV and RINV, respectively)

Top-line results from the Phase III study with BEKINDA for acute gastroenteritis and gastritis (the GUARD study), currently ongoing in the U.S., are expected either in the fourth quarter of 2015 or the first quarter of 2016. The results are intended to support potential future submissions of marketing applications in both the U.S. and Europe, targeting an estimated potential worldwide market exceeding $650 million annually2

A meeting with the FDA is planned during the third quarter of 2015 to discuss the regulatory path of BEKINDA for the indications of acute gastroenteritis and gastritis, as well as a potential filing of a New Drug Application (NDA) for CINV

RedHill recently received feedback from European regulatory agencies regarding the European Marketing Authorization Application (MAA) submitted by RedHill in December 2014 for the oncology support indications of CINV and RINV. Clinical and manufacturing-related comments have been discussed with the UK Medicines and Healthcare Products Regulatory Agency (MHRA) and a six-month extension was agreed to, in principle, with the MHRA

A Phase IIa Proof of Concept study for a new undisclosed indication is planned to commence in the second half of 2015

RHB-104 – for Crohn’s disease, multiple sclerosis and other inflammatory diseases

Interim analysis of the Phase III study with RHB-104 for Crohn’s disease (the MAP US study) is expected in the second half of 2016, after half of the 270 patients expected to be enrolled in the study have completed 26 weeks of treatment. The primary endpoint is remission at week 26 of treatment

The Phase III MAP US study is currently enrolling patients in approximately 80 sites in the U.S., Canada, Israel and New Zealand, with new sites in Australia, New Zealand and Europe currently being added, for a total of up to 120 clinical sites

Clinical trial applications have been submitted in Europe, and initial comments received and responded to, for RHB-104’s second Phase III Crohn’s disease study (the MAP EU study) with potential European regulatory clearance expected in the third quarter of 2015

RedHill recently received a Notice of Allowance from the U.S. Patent and Trademark Office (USPTO) for two new patents covering RHB-104. Once granted, the patents are expected to be valid until at least 2029

The last patient has been screened in the ongoing Phase IIa Proof of Concept study with RHB-104 for the treatment of multiple sclerosis (MS) (the CEASE-MS study), with interim results expected either in the fourth quarter of 2015 or the first quarter of 2016

ABC294640 – for multiple inflammatory-GI diseases and related oncology indications

ABC294640 is a proprietary, first-in-class, orally administered, new chemical entity (NCE) sphingosine kinase-2 (SK2) inhibitor, which has successfully completed numerous pre-clinical studies and a Phase I study in cancer patients with advanced solid tumors.

ABC294640 targets multiple inflammatory, gastrointestinal and oncology indications within RedHill’s therapeutic focus.

A Phase Ib/II study of ABC294640 for refractory/relapsed diffuse large B cell lymphoma, primarily funded by the National Cancer Institute/STTR, is planned to commence either in the second or third quarter of 2015

A Phase II study in multiple myeloma is planned, subject to a pending National Cancer Institute/SBIR grant

A Phase II study to assess ABC294640 as a radio-protectant and radiation enhancer in cancer patients receiving radiotherapy is being planned by RedHill

RHB-106 – bowel cleanser pill

In February 2014, RedHill and Salix Pharmaceuticals, Inc. ("Salix") entered into a license agreement under which Salix acquired worldwide exclusive rights to RHB-106 and other purgative developments. In April 2015, Valeant Pharmaceuticals International, Inc. ("Valeant") announced the completion of its acquisition of Salix. The RHB-106 program is under review by Valeant following its acquisition of Salix

MESUPRON – for pancreatic cancer and other solid tumors

RedHill is preparing nonclinical studies to further evaluate the mechanism of action and define the patient population for MESUPRON, a Phase II orally-administered small molecule drug targeting pancreatic cancer and other solid tumors. MESUPRON is a first-in-class urokinase-type plasminogen activator (uPA) inhibitor

RP101 – for pancreatic cancer and other solid tumors

RedHill is preparing nonclinical studies to further evaluate the mechanism of action and define the patient population for RP101, a Phase II orally-administered small molecule drug targeting pancreatic cancer and other solid tumors. RP101 is a first-in-class heat shock protein 27 (Hsp27) inhibitor

Ebola virus disease – early stage development program

As part of a previously disclosed nonclinical research collaboration with a U.S. government agency, initial nonclinical studies have been completed, and RedHill is currently planning the next stage of development

RIZAPORT (RHB-103) – for acute migraines

Regulatory feedback regarding the MAA submitted in October 2014 is expected either in the fourth quarter of 2015 or the first quarter of 2016

RedHill and its Canadian co-development partner IntelGenx Corp. continue to work with the FDA to address the remaining Chemistry, Manufacturing and Controls (CMC) matters, and to secure a compliant source of raw material. The existing source of raw material for RIZAPORT has been successfully audited in recent months by non-U.S. regulatory agencies, as well as an independent auditor on behalf of RedHill, and is currently awaiting another FDA inspection, after which, and subject to a successful audit, a new FDA PDUFA date is expected