Year: 2017

Janssen Submits New Drug Application to U.S. FDA for Apalutamide (ARN-509) to Treat Men with Non-Metastatic Castration-Resistant Prostate Cancer

On October 11, 2017 Janssen Biotech, Inc. reported that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for apalutamide, an investigational, next generation oral androgen receptor (AR) inhibitor for men with non-metastatic castration-resistant prostate cancer (CRPC) (Press release, Johnson & Johnson, OCT 11, 2017, View Source [SID1234520847]). Currently, there are no FDA approved treatments for patients with non-metastatic CRPC.

This submission is based on Phase 3 data from the pivotal ARN-509-003 (SPARTAN) clinical trial, which assessed the safety and efficacy of apalutamide versus placebo, in men with non-metastatic CRPC who have a rapidly rising prostate specific antigen (PSA) despite receiving continuous androgen deprivation therapy (ADT).1 Men with non-metastatic CRPC with a rapidly rising PSA are at high risk for developing metastatic disease.2,3 The primary endpoint of this study was metastasis free survival (MFS).1 MFS is the time from randomization to first evidence of confirmed metastasis, or time to death.4 The SPARTAN study results will be presented at a future medical meeting.

“The SPARTAN data lead the path towards a new approach to treating men with prostate cancer earlier in the disease course. We have demonstrated that treating patients before the disease has metastasized improves outcomes,” said Peter Lebowitz, M.D., Ph.D., Global Therapeutic Area Head of Oncology at Janssen. “We are thrilled to have completed our submission of the SPARTAN data to the FDA and we look forward to a promising treatment that can provide new hope and expectations for men facing this disease.”

Prostate cancer is the most common cancer among American men, other than skin cancer.5 According to the American Cancer Society, more than 161,000 men are estimated to be diagnosed with prostate cancer in 2017.5 Patients with non-metastatic prostate cancer receiving ADT will eventually become resistant to ADT, developing castration-resistant prostate cancer (CRPC). Data has estimated 10% to 20% of patients diagnosed with prostate cancer may develop CRPC within approximately 5 years.6

Non-metastatic castration-resistant prostate cancer refers to patients with CRPC who lack detectable distant metastatic disease.7,8 These individuals have a rising PSA, testosterone level below 50 ng/dl and bone scan and CT scans that show no evidence of spread to bones or visceral organs.9 Men with rapidly rising PSA have a high unmet medical need, as these patients are at high risk for developing metastatic disease.10

About Apalutamide (ARN-509)
Apalutamide is an investigational, next generation oral androgen receptor inhibitor that inhibits the action of testosterone in prostate cancer cells and works by preventing androgen from binding to the androgen receptor.

Integra LifeSciences to Host Third Quarter 2017 Earnings Results Conference Call on October 26, 2017

On October 11, 2017 Integra LifeSciences Holdings Corporation (NASDAQ:IART), a leading global medical technology company, reported that it will release 2017 third quarter financial results on Thursday, October 26, 2017, prior to market open. In conjunction with the earnings release, the company will host a conference call at 8:30 a.m. ET (Press release, Integra LifeSciences, OCT 11, 2017, View Source [SID1234520895]).

Peter J. Arduini, president and chief executive officer, and Glenn G. Coleman, chief financial officer and corporate vice-president of International, will review 2017 third quarter results during the call.

The live call is accessible by dialing (323) 794-2551 and using the passcode 6660907. A simultaneous webcast of the call will be available via the Company’s website at www.integralife.com.

A replay of the call will be available for five days via telephone stating at approximately 12:00 p.m. ET on Thursday, October 26, 2017. The replay is available by dialing (719) 457-0820 and using the passcode 6660907.

NanoString Announces Preliminary Revenue for Third Quarter of Fiscal Year 2017

On October 11, 2017 NanoString Technologies, Inc. (NASDAQ:NSTG), a provider of life science tools for translational research and molecular diagnostic products, reported preliminary total revenue of approximately $25.9 million to $26.9 million for the third quarter, including product and service revenue of approximately $16.9 million and collaboration revenue of $9.0 million to $10.0 million (Press release, NanoString Technologies, OCT 11, 2017, View Source [SID1234520896]). This unaudited estimate, based on management’s preliminary financial analysis, is lower than the company’s previous guidance for product and service revenue of $19.5 million to $21.5 million for the third quarter of 2017.

“We are in the process of transforming our business, by strengthening our commercial channel to drive growth on an increasing scale, while setting the stage for the launch of multiple innovative products currently in development,” said Brad Gray, president and chief executive officer of NanoString Technologies. “While we are disappointed that softness in our instrument and consumable sales drove a shortfall in our product and service revenue in the third quarter, we believe that initiatives underway will strengthen the value proposition of our products and enhance the growth of the business over time.”

The Company will release detailed operating results for third quarter of 2017 after the close of trading on Thursday, November 2, 2017. Company management will host a conference call beginning at 4:30pm ET to discuss those results, and provide updated 2017 financial guidance and a business update.

Individuals interested in listening to the conference call may do so by dialing (888) 793-9492 for domestic callers, or (734) 385-2643 for international callers. Please reference Conference ID: 88331168. To listen to a live webcast, please visit the investor relations section of the company’s website at: www.nanostring.com.

A replay of the call will be available beginning November 2, 2017 at 7:30pm ET through midnight on November 9, 2017. To access the replay, dial (855) 859-2056 or (404) 537-3406 and reference Conference ID: 88331168. The webcast will also be available on the Company’s website for one year following the completion of the call.

Regeneron to Report Third Quarter 2017 Financial and Operating Results and Host Conference Call and Webcast on November 8, 2017

On October 11, 2017 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) reported that it will report its third quarter 2017 financial and operating results on Wednesday, November 8, 2017, before the U.S. financial markets open (Press release, Regeneron, OCT 11, 2017, View Source [SID1234520897]). The Company will host a conference call and simultaneous webcast at 8:30 AM Eastern Time that day.

Conference Call Information
To access this call, dial (800) 708-4539 (U.S.) or (847) 619-6396 (International). A link to the webcast may be accessed from the ‘Events and Presentations’ page of Regeneron’s website at www.regeneron.com. A replay of the conference call and webcast will be archived on the Company’s website and will be available for 30 days.

GT BIOPHARMA ANNOUNCES COMPLETION OF FIRST FOUR PATIENTS IN FDA PHASE 2 TRIAL OF CANCER DRUG OXS-1550

On October 10, 2017 GT Biopharma Inc. (OTCQB: GTBP) (Euronext Paris: GTBP.PA) reported that the first four patients have completed treatment in their Food and Drug Administration-approved (FDA) Phase 2 clinical trial of its promising cancer therapy, OXS-1550 (Press release, GT Biopharma , OCT 10, 2017, View Source [SID1234539538]). Additional patient enrollment is ongoing.

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!

GT Biopharma owns the worldwide rights to commercialize OXS-1550. The targeted immuno-oncology company is focused on novel antibody constructs that provide alternative treatments to cancer patients for whom existing therapies have failed.

The Phase 2 clinical trial is being conducted with GT Biopharma’s partner, the University of Minnesota’s Masonic Cancer Center. Earlier this year, researchers at the University of Minnesota completed a Phase 1 trial of OXS-1550 to determine the safe highest tolerated dose of the drug. A seamless Phase 2 trial followed and began in April. Topline results of the Phase 2 trial are expected to be released in the first quarter of 2018.

Anthony Cataldo, Executive Chairman of GT Biopharma said, "We are pleased with the progress of our four patients in the Phase 2 trial as we continue to move forward with this promising technology."

Dr. Kathleen Clarence-Smith said, "The product performed well in Phase 1 studies of blood cancers, enrollment in the Phase II study is advancing rapidly, and we look forward to providing a targeted immunotherapy product that has the capability of treating a number of different liquid tumors."

OXS-1550 is an ADC (Antibody Drug Conjugate) drug. ADCs, such as ADCETRIS (brentuximab vedotin) from Seattle Genetics (SGEN), a first-in-class FDA approved antibody-drug conjugate, have paved the way for this type of next-generation platform drug.

OXS-1550 uses a proprietary immunoconjugate platform technology as a treatment for leukemia and other blood-born cancers. What sets OXS-1550 (DT2219ARL) apart from other treatments, such as chemotherapy, is that it is designed to specifically target and kill cancer cells while minimizing damage to normal tissues.

Dr. Daniel Vallera, director of the section on Molecular Cancer Therapeutics at the University of Minnesota Masonic Cancer Center, helped develop OXS-1550.

"The initiation of Phase 2 patient treatment is a key opportunity to demonstrate the effectiveness of this promising cancer therapy," Dr. Vallera said.

The clinical progress for OXS-1550 brings the company closer to an important alternative to toxic and poorly tolerated chemotherapies and to costly cell therapies, such as those from Kite Pharma, Inc. (KITE), and from Juno Therapeutics (JUNO), for cancer patients.

The news about OXS-1550 follows another major corporate development about GT Biopharma, Inc. with the announcement that it had completed its merger with GTP (Georgetown Translational Pharmaceuticals, Inc.), a move that brought in new management and a class of close-to-market Central Nervous Systems (CNS) products to GT Biopharma.

The inclusion of products and new management can be accessed thru the company’s website (gtbiopharma.com) which highlights several benefits of the acquisition for its shareholders.