On December 18, 2017 NanOlogy LLC, a clinical-stage pharmaceutical development company, reported the first patient has been enrolled in a clinical trial of NanoPac (nanoparticle paclitaxel) sterile suspension administered intratumorally in patients with locally advanced pancreatic adenocarcinoma (Press release, NanOlogy, DEC 18, 2017, View Source [SID1234522699]). The Phase 2a dose-rising trial will evaluate the safety and preliminary efficacy of NanoPac delivered directly into the tumor by endoscopic ultrasound-guided fine needle injection in patients who have completed current standard of care treatment prior to trial entry.

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!

NanoPac is part of an extensive submicron technology platform developed by NanOlogy. Gere diZerega, MD, VP of Medical Affairs, will present an overview of the platform and an update of the clinical program at Biotech Showcase, on January 8, 2018 at 3:45PM in Franciscan room D (Ballroom Level) of the Hilton San Francisco Union Square.

In 2017, an estimated 54,000 new cases of pancreatic cancer will be diagnosed in the U.S. and 43,000 people will die from the disease. Despite being relatively rare, pancreatic cancer is the third leading cause of cancer death in the USA with a survival rate of only 25% at one year and less than 10% at five years. Pancreatic cancer is so deadly because it is rarely diagnosed at an early stage while it is still local, and the disease tends to be aggressive and resistant to systemic chemotherapy. Recent advances in abdominal imaging techniques hold the promise for earlier diagnosis of pancreatic cancer and the ability to treat the disease before it spreads to other parts of the body.

"The advanced endoscopy team at Baylor College of Medicine and St Luke’s Medical Center performed the first endoscopic ultrasound-guided intratumoral injection of NanoPac for locally advanced pancreatic cancer last Friday," said Dr. Mohamed Othman, MD, Director of Advanced Endoscopy and Associate Professor of Medicine at Baylor College of Medicine in Houston, TX. "The team is hopeful that this approach may offer a more potent and less toxic alternative for patients with locally advanced disease."

"The targeted administration of submicron particle paclitaxel sterile suspension [NanoPac] by endoscopic ultrasound (EUS) represents an important step in the fight against pancreatic cancer," said Jacques Van Dam, MD, PhD, Professor of Medicine and Clinical Scholar at the University of Southern California’s Keck School of Medicine, and Principle Investigator for this multicenter trial. "Pancreatic cancer patients, their families, and their physicians recognize all too well the limitations of current therapies. Delivering NanoPac directly into the tumor may eliminate many of the toxic side effects of standard chemotherapy, while providing a higher concentration of drug directly to its intended target."

NanOlogy has a broad clinical development program underway for NanoPac sterile suspension, including clinical trials in ovarian cancer (with orphan drug designation), prostate cancer, pancreatic cancer, and pancreatic mucinous cysts. In addition, NanOlogy and affiliate DFB Soria are progressing clinical trials for Soria-developed SOR007 (nanoparticle paclitaxel) ointment in cutaneous metastases and actinic keratosis. Clinical trials for NanoDoce (nanoparticle docetaxel) are planned in 2018 pending IND approval. An inhaled version of NanoPac has shown evidence of tumor reduction in a preclinical lung cancer study after PK studies demonstrated retention of drug in lung tissues for more than 14 days following nebulized inhalation and no abnormalities within the trachea or lung upon gross and histologic exam.

Starting with the world’s most prescribed systemic chemotherapeutic agents, the patented NanOlogy submicron particle production technology reduces the size of paclitaxel and docetaxel API crystals by up to 400 times into patented, stable, naked submicron particles with exponentially increased surface area and unique geometry. Unlike conventional nanoparticles, which use coating or carrier agents for stability, NanoPac and NanoDoce particles are stable in their naked form and suspended prior to use without such agents for local delivery to the site of disease.

On December 18, 2017 ONCODESIGN (Paris:ALONC) (ALONC – FR0011766229), a biopharmaceutical company specializing in precision medicine, and CYCLOPHARMA, a company developing leading molecular imaging solutions, in cooperation with Centre Georges François Leclerc (CGFL), the regional cancer research and treatment center for Burgundy, reported promising results for the Phase 1 study of the first radiotracer 1 to come out of the IMAkinib program (Press release, Oncodesign, DEC 18, 2017, View Source [SID1234522715]).

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 radiotracer, labelled with radioactive 18F-fluorine, is a molecule generated using Oncodesign’s Nanocyclix technology whose use as a companion biomarker in targeted EGFR inhibitor therapy2 is being assessed in patients with lung tumors.

The current clinical study has as its primary objective the assessment of the clinical advantages of the radiotracer using PET3, by determining its sensitivity and specificity in patients with pulmonary tumors treated with targeted anti-EGFR therapy. It is the product of cooperation between Centre Georges François Leclerc, Cyclopharma and Oncodesign as part of the Dijon-based Pharmimage cluster.

The first stage of the clinical trial, in 8 patients with EGFR mutations, has produced very encouraging results in terms of product safety, dosage and fixing on pulmonary tumors expressing mutated EGFR. These results allow the launch of the second stage of the clinical study, with the inclusion of 6 new patients with non-mutated EGFR receptors. The aim of this second stage is to demonstrate the radiotracer’s specificity.

Full results from the Phase 1 study are expected in the first half of 2018. Positive results would directly allow the design of a Phase 3 clinical study, with the final objective of application for Marketing Authorization.

"Measuring EGFR receptor activity in lung cancer enables early detection of tumor resistance to anti-EGFR therapies, and thus better care for patients," said Philippe Genne, founder, Chairman and CEO of Oncodesign. "In comparison with other types of companion biomarkers, using liquid or solid biopsy techniques, the advantage of a PET-based approach is that it gives clinicians an idea of the heterogeneity of the disease in the whole of the patient’s body. Together with our partners we have been pioneers in this approach."

Activating mutations for EGFR kinase are a cause of non-small cell pulmonary adenocarcinomas, which represent between 10% and 15% of lung cancers in the Caucasian population and between 30% and 50% of those in patients of Asian origin. This type of cancer affects nearly 6,000 patients in France each year, with a projection of 1.3 million patients worldwide by 2022 (up 22% in 10 years). The main treatments for this pathology include tyrosine kinase inhibitors that target EGFR, meaning that the use of a biomarker that can help clinicians in their selection of treatments is a major step forward in precision medicine.

On December 17, 2017 Spectrum Pharmaceuticals, Inc. (NasdaqGS:SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in Hematology and Oncology, reported that its Board of Directors has terminated Rajesh C. Shrotriya, MD without cause from his position as Chief Executive Officer, and announced leadership changes under which Joseph W. Turgeon, the current President and Chief Operating Officer, has been named President and Chief Executive Officer and elected to the Board of Directors, and current Director Stuart M. Krassner, ScD, PsyD, has been named Chairman of the Board (Press release, Spectrum Pharmaceuticals, DEC 17, 2017, View Source [SID1234522672]). In addition, Thomas J. Riga, who currently serves as Executive Vice President, Chief Commercial Officer and Head of Business Development, has been named Chief Operating Officer. These changes are effective immediately.

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 Board of Directors thanks Dr. Shrotriya for his contributions to Spectrum over the past fifteen years," said Dr. Krassner, Chairman. "The Board believes that now is the right time to effect these leadership changes. Mr. Turgeon and Mr. Riga have nearly 50 years of combined industry experience and the Board believes that they are the right leaders for Spectrum as the Company enters its next chapter."

"I am honored to serve as Spectrum’s next CEO and appreciate the confidence the Board has placed in me to guide the Company forward," said Mr. Turgeon, President and CEO. "We are at an exciting point in Spectrum’s history, and I look forward to driving the operation forward as we maintain our focus on our product pipeline."

Mr. Turgeon brings more than 30 years of experience in the pharmaceutical industry, including various executive leadership roles at Amgen Inc. He had served as Spectrum’s President and Chief Operating Officer since April 2014, and had previously served as the Company’s Senior Vice President and Chief Commercial Officer from October 2012 to April 2014. Prior to joining Spectrum, Mr. Turgeon spent 22 years at Amgen Inc. as Vice President of Sales.

Mr. Riga brings over 15 years of pharmaceutical sales and management experience in various positions at Amgen, Eli Lilly and Dendreon, including as Vice President of Sales at Dendreon. He had served as Spectrum’s Executive Vice President, Chief Commercial Officer and Head of Business Development since June 2017, and previously served as Spectrum’s Senior Vice President and Chief Commercial Officer from August 2014 to June 2017, and Vice President, Corporate Accounts from July 2013 to August 2014.

Dr. Krassner has served as a director of Spectrum since December 2004, and was previously a member of Spectrum’s Scientific Advisory Board from 1996 to 2001. Dr. Krassner’s career spans nearly four decades of experience in positions of increasing responsibility at the University of California at Irvine, most recently as Professor of Developmental and Cell Biology at the School of Biological Sciences. Dr. Krassner is Professor Emeritus, University of California, Irvine and has also been retained by pharmaceutical, medical device and other companies, including Allergan Pharmaceuticals, Lasermed Corporation, Automated Microbiology Systems, and In Vitro International, among others, to provide scientific and regulatory advisory services, including FDA compliance. He is a past member of the American Academy for the Advancement of Sciences, and the American Society of Tropical Medicine and Hygiene, among others.

On December 16, 2017 Celltrion, Inc. (KOSDAQ: 068270) reported that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion recommending that Herzuma (trastuzumab biosimilar) be granted marketing authorization in the European Union (EU) for the treatment of patients with early breast cancer, metastatic breast cancer, or metastatic gastric cancer whose tumors have either HER2 overexpression or HER2 gene amplification (Press release, Celltrion, DEC 16, 2017, View Source [SID1234522673]). The CHMP’s opinion will now be sent to the European Commission (EC) for final review.

Herzuma is a biosimilar to Herceptin​[i], a breast cancer and gastric cancer treatment antibody biologic drug developed by Genentech and marketed by Roche. Herceptin is a blockbuster drug which had worldwide sales of CHF 6.8 billion[ii] (US$6.8 billion) in 2016, of which CHF 2.1 billion[iii] (US$2.1 billion) was in European sales.

"We welcome the CHMP’s recommendation. By providing more treatment options, biosimilars open more opportunities for greater affordability and improve access to wider use of biotherapeutics. Herzuma could become a cost-effective alternative to biologics for treatment of breast cancer and gastric cancer, since biologics, which cost much more than conventional anticancer drugs, place undue financial burden on patients and the general healthcare system." said Woo Sung Kee, Chief Executive Officer of Celltrion.

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!

About Herzuma
Herzuma is an anticancer monoclonal antibody (mAb) biosimilar used to treat breast cancer and gastric cancer. Similarity of Herzuma to the reference product, Herceptin, was demonstrated in terms of pharmacokinetic, pharmacodynamics, efficacy and safety through multiple global clinical trials covering various indications such as HER2-positive early breast cancer, HER2-positive metastatic breast cancer, and HER2-positive metastatic gastric cancer. Celltrion also submitted the Biologics License Application (BLA) to the US Food and Drug Administration (FDA). In 2017, Celltrion launched Herzuma in Korea.

On December 15, 2017 Aclaris Therapeutics, Inc. (NASDAQ:ACRS), a dermatologist-led biopharmaceutical company, reported that the U.S. Food and Drug Administration (FDA) has approved ESKATA (hydrogen peroxide) topical solution, 40% (w/w) for the treatment of raised seborrheic keratoses, or SKs (Press release, Aclaris Therapeutics, DEC 15, 2017, View Source [SID1234525224]). SKs are non-cancerous skin growths that affect more than 83 million American adults and can be an aesthetic skin concern. SKs tend to increase in size and number with age. The condition is more prevalent than acne, psoriasis and rosacea combined.

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!

Multimedia assets accompanying this release are available at:

View Source

View Source

View Source

View Source

View Source

View Source

View Source

"This achievement delivers on Aclaris’ commitment to bringing innovative therapies to market that address significant unmet needs in dermatology," said Dr. Neal Walker, President and Chief Executive Officer of Aclaris. "For the first time, with the approval of ESKATA, patients will have access to an FDA-approved topical, non-invasive treatment for raised SKs."

ESKATA is a proprietary, high-concentration hydrogen peroxide-based topical solution designed for in-office application by a healthcare provider. It is a targeted treatment applied directly to the raised SK using a pen-like applicator.

"We are proud to offer ESKATA to dermatologists and their patients as a treatment that can clear raised SKs without cutting, burning or freezing the skin. As a clinician, I saw first-hand that patients preferred non-invasive treatments," said Stuart D. Shanler, M.D., Chief Scientific Officer of Aclaris. "We believe ESKATA may appeal to patients who are bothered by the appearance of their raised SKs — especially in highly visible areas such as the face and neck — and that patients are looking for a treatment that is safe and effective."

"Many of my patients begin to notice SKs around age 40 and feel self-conscious about them," said Anne M. Chapas, M.D., FAAD, Founder and Medical Director of Union Square Dermatology; Clinical Instructor of Dermatology, Mount Sinai Medical Center, New York; and a consultant for Aclaris. "With the approval of ESKATA, I am pleased to be able to offer my patients a topical treatment option that is well tolerated and can clear raised SKs with a low risk of scarring."

The FDA approval of ESKATA is based on two pivotal Phase 3 trials that demonstrated the safety and efficacy of ESKATA for the treatment of raised SKs. In these trials, patients received up to two treatments with ESKATA, with one at treatment initiation and a second at week three. Patients treated with ESKATA were more likely to have all four treated SKs completely cleared after two treatments than patients who received placebo. Treatment with ESKATA was generally well tolerated, with the most common side effects being itching, stinging, crusting, swelling, redness and scaling at the site of application.

It is important to see a healthcare provider with expertise in diagnosing skin conditions to confirm the diagnosis of SKs and determine whether ESKATA is an appropriate treatment.

"A recent consumer survey by the American Society for Dermatologic Surgery (ASDS) supports the need for an effective treatment of SKs," said Lisa Donofrio, M.D., ASDS President. "ESKATA provides physicians with the first topical treatment option to satisfy this unmet patient need."

ESKATA will be offered to patients as a self-pay aesthetic treatment and is expected to be commercially available in the spring of 2018. Visit www.ESKATA.com for more information and to view the full Prescribing Information. In addition, Aclaris has submitted a Marketing Authorization Application (MAA) for ESKATA for the treatment of SKs in select countries in the European Union.

Management will conduct a conference call at 8:00 AM ET today to discuss the approval of ESKATA. A live webcast of the event can be accessed on the Events and Presentations page on the Investors section of the Aclaris website at www.aclaristx.com/events-and-webcasts. A replay of the webcast will be archived on the Aclaris website following the event.

To participate on the live call, please dial 844-776-7782 (domestic) or 661-378-9535 (international), and reference conference ID 8793369 prior to the start of the call.

Important Safety Information

ESKATA (hydrogen peroxide) topical solution, 40% (w/w) is for use as an in-office treatment. ESKATA is applied by your healthcare provider and is not for use at home.

Serious eye problems can happen if ESKATA gets into your eyes. If ESKATA accidentally gets into your eyes, your healthcare provider will tell you to flush them well with water for 15 to 30 minutes.

Skin reactions occurred in and around the treatment area after application of ESKATA. Some were severe, including breakdown of the outer layer of the skin (erosion), ulcers, blisters and scarring.

The most common side effects of ESKATA include itching, stinging, crusting, swelling, redness and scaling.

Tell your healthcare provider about any side effects that bother you or do not go away. Tell your healthcare provider right away if ESKATA gets into your eyes, mouth or nose during application.

Approved Use for ESKATA

ESKATA is a prescription medicine used to treat seborrheic keratoses that are raised.

You are encouraged to report negative side effects of prescription drugs to the FDA. Contact the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see ESKATA Full Prescribing Information and Patient Information at www.ESKATA.com.

About Seborrheic Keratoses

Seborrheic keratoses (SKs) are non-cancerous skin growths that affect more than 83 million Americans and are most commonly seen in middle-aged and older adults. SKs vary in color from flesh-colored to pink, yellow, gray, tan, brown, or black; can range in size from a millimeter to a few centimeters wide; and typically have a slightly elevated, waxy or scaly appearance. The number and size of SKs tends to increase with advancing age. SKs frequently appear in highly visible locations, such as the face or neck, but can also appear anywhere on the body, except the palms, soles and mucous membranes.