On January 25, 2017 Advaxis, Inc. (NASDAQ:ADXS), a clinical-stage biotechnology company developing cancer immunotherapies, reported research published in the journal Cancer which underscores the need for more access to screenings, improved clinical care and new therapeutic options for all women with cervical cancer (Press release, Advaxis, JAN 25, 2017, View Source [SID1234517558]).

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!

These important research findings were covered by leading news outlets including The New York Times and CNN, as these data indicate that mortality rates of this deadly form of cancer are significantly higher in the United States than previously reported due to the inclusion of women who have had hysterectomies, highlighting racial and socioeconomic disparities. According to the research, the data revealed a U.S. cervical cancer mortality rate among women without hysterectomies of 10.1 per 100,000 black women and 4.7 per 100,000 white women, up from mortality rates of 5.7 and 3.2, respectively, which were previously reported in research among all women, including those who have had hysterectomies.

The publication of these data coincides with Cervical Health Awareness Month, a national effort designed to promote the need for cervical health education and screenings, which can lead to early detection of cervical cancer when therapies may be most effective.

Advaxis is the only biopharmaceutical company sponsoring global, phase 3 clinical research for advance stage cervical cancer. Last year, the company initiated its Phase 3 AIM2CERV (Advaxis IMmunotherapy 2 prevent CERVical recurrence) trial in high-risk, locally advanced cervical cancer (HRLACC). The company also announced positive, top-line data from the GOG-0265 Phase 2 trial that supports pursuing a global phase 3 study in metastatic recurrent cervical cancer.

"This research highlights disparities in outcomes in the cervical cancer community and underscores the need to work together with policy-makers, providers, academic institutions and the biopharmaceutical industry to raise awareness among minority groups about current treatment options and bring new treatment options forward," said Tamika Felder, Founder of Cervivor. "In doing so, hopefully we can close this gap."

Invasive cervical cancer occurs in women who have been infected by the human papillomavirus (HPV) and is the most common HPV-associated cancer in women. According to the American Cancer Society, approximately 12,000 women in the United States will be diagnosed with cervical cancer in 2017. While vaccines to prevent HPV infection may help prevent cervical cancer if given before exposure, only one-third of the U.S. population has been vaccinated against the virus and the vaccination rate is lower worldwide, which is the main cause of the nearly 500,000 new cases diagnosed each year. Cervical cancer largely affects women who have not received preventative vaccines or regular screenings.

On January 25, 2017 Varian Medical Systems (NYSE:VAR) reported GAAP net earnings of $0.22 per diluted share and non-GAAP net earnings of $0.75 per diluted share for the first quarter of fiscal year 2017, including $76 million in charges almost exclusively relating to a proton facility owned by California Proton Treatment Center, LLC (CPTC) in San Diego (Press release, Varian Medical Systems, JAN 25, 2017, View Source [SID1234517559]). These charges and the associated limited tax deductibility reduced Varian earnings in the first quarter of fiscal 2017 by $0.64 per diluted share on a GAAP basis or $0.34 per diluted share on a non-GAAP basis.

Varian’s first quarter revenues totaled $763 million, up 1 percent from the year-ago quarter in dollars and constant currency. The company ended the quarter with a $3.4 billion backlog, up 2 percent from the end of the first quarter of fiscal year 2016.

"Varian generated strong global order growth and margin gains in our oncology business as well as sales momentum in the imaging components business while recording an impairment of CPTC’s indebtedness to Varian," said Dow Wilson, CEO of Varian Medical Systems. "We remain on track with our previously announced plans to separate and establish the imaging components business as a new public company, Varex Imaging, at the end of this month."

Varian took a $76 million charge in the first quarter in response to certain actions in January by CPTC and its loan agent, ORIX Capital Markets, to address liquidity issues caused by lower than expected patient volumes that are insufficient to support CPTC’s capital structure. This led Varian to reserve $38 million in accounts receivable and to impair $38 million of its $98 million loan to CPTC, of which $29 million was accrued interest. The company is reporting additional information on this matter today in a Form 8-K filing with the Securities and Exchange Commission.

"We believe this center can get on a more solid financial footing by serving a broader patient population with additional healthcare providers locally and regionally," Wilson said. "We remain confident and committed to supporting all of our customers and to building a profitable proton business based on leading technology that is treating patients and performing at a high level. We are continuing to make good progress on 13 other installations and the sales funnel continues to look promising." The company’s Particle Therapy business, recorded first quarter revenues of $30 million.

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!

Varian finished its first quarter of fiscal year 2017 with $815 million in cash and cash equivalents and $607 million of debt. Cash flow from operations was $82 million for the first quarter. During the quarter, the company spent $49 million to repurchase 500,000 shares of common stock.

Oncology Systems
Oncology Systems’ first quarter revenues totaled $581 million, down from the year-ago quarter by 1 percent in dollars and by 2 percent in constant currency. First-quarter Oncology gross orders were $586 million, up from the year-ago quarter by 10 percent in dollars and constant currency. In the Americas, Oncology gross orders increased by 5 percent in dollars and in constant currency, including 7 percent growth in North America. In EMEA, gross orders were up 8 percent in dollars and up 10 percent in constant currency. In APAC, gross orders rose 29 percent in dollars and by 24 percent in constant currency.

"Broad-based demand for new equipment as well as software and services drove the strong gross order growth in our Oncology business during the quarter," Wilson said. "Revenues declined versus a strong year-ago quarter due primarily to the timing of deliveries, but this business did a spectacular job of improving margins with the help of product mix, stable pricing and product cost reductions."

Imaging Components
First quarter revenues from Varian’s Imaging Components business were $152 million, up 7 percent from the year-ago period, and first quarter gross orders for this business were $132 million, up 4 percent from the year-ago period.

"Revenues from Imaging Components rose with gains in both the medical and industrial segments," said Varian Imaging Components President Sunny Sanyal, who will become CEO of Varex Imaging. "With our first quarter performance as well as our previously announced plan to acquire the Medical Imaging business of PerkinElmer this fiscal year, our business is on track to separate from Varian with solid momentum in orders and sales."

Varian Outlook
"Beginning with our fiscal second quarter, Imaging Components will be reflected as a discontinued operation for the first four months of fiscal year 2017," said Wilson. "The company is guiding for continuing operations for the second through the fourth quarters of the fiscal year 2017. For the balance of fiscal year 2017, we believe Varian revenues from continuing operations will grow in the range of 4 to 5 percent, bringing revenue growth for the year to 3 to 4 percent. Non-GAAP earnings per diluted share from continuing operations for the second through fourth quarters of the fiscal year will be in the range of $2.94 to $3.06."

"For the second quarter, we believe Varian revenues from continuing operations will grow in the range of 4 to 5 percent and non-GAAP earnings per diluted share will be in the range of $0.84 to $0.90," Wilson added. The company intends to repurchase 2 million shares of stock in its second quarter of fiscal year 2017. Varian will publish a historical annual breakdown of continuing and discontinued operations for fiscal years 2014-2016 on our website filing shortly following the separation. Separately, the company will make available quarterly pre-tax results for fiscal year 2016.

Please refer to "Discussion of Non-GAAP Financial Measures" below for a description of items excluded from expected non-GAAP earnings.

— more —

Varian Medical Systems Reports Results for First Quarter of Fiscal Year 2017

PTX-200, previously known as TCN-P (triciribine phosphate monohydrate), is a potent small molecule inhibitor of the AKT pathway, which plays a key role in the development of many cancers, including breast, ovarian cancer as well as hematologic cancers such as Acute Myeloid Leukemia.

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!

PTX-200 is currently the subject of two proof of concept trials in breast and ovarian cancer that have commenced at prestigious US Cancer Centers. The first is a Phase 1b/2 study examining PTX-200 in breast cancer patients at the prestigious Montefiore Cancer Center/ Albert Einstein College of Medicine in New York, and the Moffitt Cancer Center and Research Institute in Tampa, Florida. A Phase 1b/2 trial of PTX-200 in combination with current standard of care carboplatin is also underway in patients with recurrent or persistent platinum resistant ovarian cancer at Moffitt Cancer Center. In addition, a Phase 1b/2 trial evaluating PTX-200 in combination with cytarabine in acute myeloid leukemia is scheduled to begin accrual in mid-2016.

PTX-100, is a first in class drug that kills cancer cells by blocking geranylgeranyl transferase-1 (GGT-1), a protein required for the cancer-causing activity of Ral and Rho, that are in turn required for the cancer-causing protein Ras. PTX-100 was well tolerated and achieved stable disease in a Phase 1 trial in advanced solid tumors. Prescient expects to commence Phase 1b/2 clinical trials in breast cancer and multiple myeloma in Q4 2016. At the same time, Prescient plans to develop its novel p27 cancer biomarker as a companion diagnostic that will potentially identify those patients that are most likely to respond to PTX-100 therapy.

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!

On January 24, 2017 Actinium Pharmaceuticals, Inc. (NYSE:ATNM) ("Actinium" or "the Company"), a biopharmaceutical company developing innovative targeted therapies for cancers lacking effective treatment options, reported that recently appointed Chief Medical Officer, Dr. Mark Berger, has been selected to present at the 3rd Annual Think Tank on Integrating New Molecular Targets in Acute Leukemias and Myeloproliferative Neoplasms being held on January 27 – 28, 2017 in Dallas, Texas (Press release, Actinium Pharmaceuticals, JAN 24, 2017, View Source [SID1234517547]). This event is being sponsored by Dava Oncology as part of their Oncology Meeting Innovations program. Dr. Berger’s talk will focus on Actinium’s Iomab-B, which is currently in a pivotal Phase 3 clinical trial and upon approval is intended to simultaneously prepare and condition patients for a bone marrow transplant, also referred to as a hematopoietic stem cell transplant.

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!

"I am looking forward to highlighting Iomab-B to the highly experienced group of physicians that will be attending this event," said Dr. Berger. "Iomab-B has the potential to revolutionize the way we transplant patients with acute leukemia, particularly amongst the most difficult to treat older patients with relapsed or refractory acute leukemia. I believe the attending hematologists and transplant physicians will come away from this event with great enthusiasm for Iomab-B."

About Iomab-B

Iomab-B is Actinium’s lead product candidate that is currently being studied in a 150-patient, multicenter pivotal Phase 3 clinical trial in patients with relapsed or refractory acute myeloid leukemia who are age 55 and above. Upon approval, Iomab-B is intended to prepare and condition patients for a hematopoietic stem cell transplant, also referred to as a bone marrow transplant, which is often considered the only potential cure for patients with certain blood-borne cancers and blood disorders. Iomab-B targets cells that express CD45, a pan-leukocytic antigen widely expressed on white blood cells with the monoclonal antibody, BC8, labeled with the radioisotope, iodine-131. By carrying iodine-131 directly to the bone marrow in a targeted manner, Actinium believes Iomab-B will avoid the side effects of radiation on most healthy tissues while effectively killing the patient’s cancer and marrow cells. In a Phase 2 clinical study in 68 patients with advanced AML or high-risk myelodysplastic syndrome (MDA) age 50 and older, Iomab-B produced complete remissions in 100% of patients and patients experienced transplant engraftment at day 28. Iomab-B was developed at the Fred Hutchinson Cancer Research Center where it has been studied in almost 300 patients in a number of blood cancer indications, including acute myeloid leukemia (AML), chronic myeloid leukemia (CML), acute lymphoblastic leukemia (ALL), chronic lymphocytic leukemia (CLL), Hodgkin’s disease (HD), Non-Hodgkin lymphomas (NHL) and multiple myeloma (MM). Iomab-B has been granted Orphan Drug Designation for relapsed or refractory AML in patients 55 and above by the U.S. Food and Drug Administration and the European Medicines Agency.