Seattle Genetics and Millennium Initiate Global Phase III Clinical Trial of ADCETRIS® ; Pfizer Announces Top-Line Efficacy Results From A Phase 4 Study Of PRISTIQ® Print E-mail
By Mary Davila   
Thursday, 24 January 2013 20:29
Below is a look at some of the headlines for companies that made news in the healthcare sector on January 24, 2013.

Genetics (Nasdaq: SGEN)
and Millennium: The Takeda Oncology Company, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited (TSE:4502), announced the initiation of a global phase III clinical trial evaluating ADCETRIS (brentuximab vedotin) in combination with chemotherapy for the treatment of newly diagnosed CD30-positive mature T-cell lymphoma (MTCL) patients, including patients with systemic anaplastic large cell lymphoma (sALCL) and other types of peripheral T-cell lymphomas. The trial, also known as ECHELON-2, is being conducted under a Special Protocol Assessment (SPA) agreement from the U.S. FDA and also received scientific advice from the European Medicines Agency (EMA). ADCETRIS is an antibody-drug conjugate (ADC) directed to CD30. ADCETRIS is currently not approved for use in the front-line treatment of MTCL.

“The standard of care for newly diagnosed MTCL, a chemotherapy regimen called CHOP, has not changed in more than three decades, and there is a significant need to identify enhanced treatment options for these patients,” said Clay B. Siegall, Ph.D., President and Chief Executive Officer at Seattle Genetics. “Recent phase I data from 26 patients presented at the ASH annual meeting showed that adding ADCETRIS to CHP resulted in compelling antitumor activity, with 100 percent of the patients experiencing a response, and a manageable safety profile. Our goal with this phase III trial is to redefine the standard of care for front-line treatment of MTCL.”

“This is the third global phase III trial with ADCETRIS to be initiated in the past nine months,” said Karen Ferrante, M.D., Chief Medical Officer, Millennium. “This trial represents another major achievement in our aspiration to bring important new therapies to patients with CD30-expressing malignancies by evaluating ADCETRIS in the front-line setting.”

The ECHELON-2 study is a randomized, double-blind, placebo-controlled multi-center global phase III trial designed to investigate ADCETRIS in combination with cyclophosphamide, doxorubicin and prednisone (A+CHP) versus cyclophosphamide, doxorubicin, vincristine and prednisone (CHOP) as front-line therapy in patients with CD30-expressing MTCL. The primary endpoint is progression-free survival (PFS) per independent review facility assessment using the Revised Response Criteria for malignant lymphoma (Cheson, 2007). Secondary endpoints include overall survival (OS), complete remission (CR) rate and safety. The trial will be conducted in North America, Europe and Asia and is expected to enroll approximately 300 patients (approximately 150 patients per treatment arm). A molecular companion diagnostic test will be used in this trial to identify eligible patients based on CD30 expression. The companion diagnostic test is being developed under a previously announced collaboration agreement with Ventana Medical Systems, Inc. (Ventana), Millennium and Seattle Genetics.

At the recent 54th American Society of Hematology (ASH) Annual Meeting and Exposition held December 8-11, 2012 in Atlanta, GA, encouraging phase I data were presented from an abstract titled “Brentuximab Vedotin Administered Concurrently with Multi-Agent Chemotherapy as Front-line Treatment of ALCL and Other CD30-Positive Mature T-Cell and NK-Cell Lymphomas” (Abstract #60). The clinical trial was conducted to evaluate ADCETRIS in combination with chemotherapy for the treatment of newly diagnosed MTCL patients, including patients with sALCL. Data were reported from 26 previously untreated patients who received the combination regimen of ADCETRIS plus CHP.

After completing a combination regimen of ADCETRIS plus CHP, 26 of 26 patients (100 percent) treated with ADCETRIS plus CHP had an objective response, including 23 patients (88 percent) with a complete remission. The most common treatment-emergent adverse events of any grade regardless of relationship occurring in more than 30 percent of patients were nausea (62 percent), peripheral sensory neuropathy (62 percent), diarrhea (58 percent), fatigue (54 percent) and alopecia (46 percent). The most common Grade 3 or 4 treatment-emergent adverse events regardless of relationship included Grade 3 febrile neutropenia, peripheral sensory neuropathy, nausea and dyspnea and Grade 4 nausea and diarrhea. The abstract can be found at www.hematology.org.


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Pfizer (NYSE: PFE)
announced a Phase 4 study evaluating the efficacy of PRISTIQ® (desvenlafaxine) Extended Release Tablets met its primary endpoint. The study supports the efficacy of 50 mg/day and 100 mg/day doses of PRISTIQ compared with placebo over eight weeks of treatment in adult patients with major depressive disorder (MDD) as measured by the 17-item Hamilton Rating Scale for Depression (HAM-D17) total score.1

In this study, the most common treatment-emergent adverse events observed were consistent with the known safety and tolerability profile of PRISTIQ.1

"These positive top-line results add to the growing body of evidence that supports PRISTIQ as a treatment option for adults with major depressive disorder," said Steven J. Romano, M.D., senior vice president, head of Medicines Development Group, Global Primary Care Business Unit, Pfizer Inc. “We know how challenging it can be to treat and manage major depressive disorder. We continue to study PRISTIQ in order to provide clinicians with more information that can better guide their treatment decisions for MDD patients.”

The Phase 4 study was designed as a multi-center, randomized, double-blind, placebo-controlled, eight-week, parallel group study in adult patients with MDD.1 The primary efficacy endpoint was the change from baseline in HAM-D17 total score at week eight.1 The HAM-D17 is a validated assessment tool used to rate the severity of a patient's major depressive symptoms.2 The study enrolled 924 patients who were randomized in a 1:1:1 ratio to one of the following treatment arms: PRISTIQ 50 mg/day, PRISTIQ 100 mg/day or placebo.1

Results from this PRISTIQ Phase 4 study will be submitted for presentation at upcoming scientific congresses and for publication in a peer-reviewed medical journal.



Also Thursday:



Acorda Therapeutics, Inc. (Nasdaq: ACOR)
today announced that the U.S. Army Medical Research and Material Command (USAMRMC) has awarded the Company a $2.67 million research contract to support development of AC105, a propriety magnesium formulation being studied as a treatment for acute spinal cord injury (SCI).

AmerisourceBergen Corporation (NYSE:ABC)
today reported that in its fiscal year 2013 first quarter, ended December 31, 2012, diluted earnings per share from continuing operations were $0.69, a 13 percent increase. Revenue in the quarter was $21.5 billion, up 6 percent.

Anthera Pharmaceuticals, Inc. (Nasdaq: ANTH)
today announced that it intends to offer and sell shares of its common stock in an underwritten public offering.

AVEO Pharmaceuticals, Inc. (NASDAQ: AVEO)
today reported that it has closed its recently announced public offering of common stock.

Baxter International Inc. (NYSE:BAX)
today announced financial results for the fourth quarter of 2012, and provided its financial outlook for the first quarter and full-year 2013.

Baxter International Inc. (NYSE:BAX)
announced today that it has agreed to acquire the investigational hemophilia compound OBI-1 and related assets from Inspiration BioPharmaceuticals, Inc. as well as certain other OBI-1 related assets, including manufacturing operations, from Ipsen Pharma S.A.S. in conjunction with Inspiration’s ongoing bankruptcy proceedings. The transaction is subject to bankruptcy court and regulatory approvals.

Biogen Idec (NASDAQ: BIIB)
released the primary efficacy analysis and safety data from its Phase 3 pivotal clinical trial, ADVANCE.

Bristol-Myers Squibb Company (NYSE: BMY)
today announced results for the fourth quarter of 2012 highlighted by regulatory approvals for Eliquis® and Forxiga®.

Capital Group Holdings, Inc. (OTCQB: CGHC)
today announced the launch of their television advertising campaign for OneHealth Urgent Care, the Company's wholly owned urgent care division.

Celgene Corporation (NASDAQ: CELG)
reported net product sales of $1,416 million for the fourth quarter 2012, a 14 percent increase from the same period in 2011.

China Botanic Pharmaceutical Inc. (NYSE AMEX: CBP)
("China Botanic" or the "Company"), a developer, manufacturer and distributor of botanical products, bio-pharmaceuticals and Traditional Chinese Medicines ("TCM") in China, today announced the appointment of Mr. Jack Zhao as a member of the Company's Board of Directors.

Elekta (NSE: EKTAb)
and Royal Philips Electronics (NYSE: PHG, AEX: PHIA) announced today that The University of Texas MD Anderson Cancer Center (Houston, Texas) has signed an agreement to join a research group to advance the development of an innovative image-guided treatment technology for cancer care.

Exelixis, Inc. (NASDAQ: EXEL)
today announced the commercial availability of COMETRIQ® (cabozantinib) for the treatment of patients with progressive, metastatic medullary thyroid cancer (MTC).

Gilead Sciences, Inc. (Nasdaq: GILD)
today announced the initiation of the first of two Phase 3 clinical trials (Study 104) evaluating a single tablet regimen containing tenofovir alafenamide (TAF) for the treatment of HIV-1 infection in treatment-naïve adults.

Incyte Corporation (Nasdaq: INCY)
announced today that it has scheduled its fourth quarter/year-end 2012 financial results conference call for 8:30 a.m. ET on Thursday, February 14, 2013.

MediSwipe Inc. (OTCBB: MWIP)
, a patient security solutions and financial products company for the health care industry, today announced that the Company has reached an agreement with the first of several medical dispensaries in the Detroit, Michigan area to offer its digital patient identification cards and MediPay kiosks.

mPhase Technologies, Inc. (OTCBB: XDSL)
reported today that it has received a Notice of Allowance from the U.S. Patent & Trademark Office (USPTO) of a Key Smart Surface Patent.

Nano Mask, Inc., (PINKSHEETS: NANM)
, a materials technology development company focused on health and wellness related markets, today announced that it has appointed Hassan Bennani, MD, to its Board of Directors.

Novadaq® Technologies Inc. (TSX:NDQ)(NASDAQ:NVDQ)
, a developer of clinically-relevant fluorescence imaging solutions for use in surgical procedures, will announce its fourth quarter and full year 2012 financial results before the market opening on Thursday, February 7, 2013.

Pfizer Inc. (NYSE: PFE)
announced today that a Phase 4 study assessing the efficacy and safety of Toviaz® (fesoterodine fumarate) 8 mg once daily in patients with overactive bladder (OAB) compared to Toviaz 4 mg once daily or placebo met its primary endpoint.

Pfizer Inc. (NYSE: PFE)
announced today that a Phase 4 study evaluating the efficacy of PRISTIQ® (desvenlafaxine) Extended Release Tablets met its primary endpoint.

Pfizer Inc. (NYSE: PFE)
announced today that a post-marketing study assessing the efficacy and safety of varenicline (CHANTIX®/CHAMPIX®) in a population of smokers who had made a previous attempt to quit smoking with CHANTIX, and either did not succeed in quitting or relapsed after treatment, met its primary endpoint.

Provectus Pharmaceuticals, Inc. (OTCQB: PVCT)
, a development-stage oncology and dermatology biopharmaceutical company, has launched a free mobile shareholder investor relations application.

ReliaBrand Inc. (OTCBB:RLIA)
announced today Walmart Canada will be the exclusive national retailer of the new Adiri® NxGen® product line in Canada.

Seattle Genetics, Inc. (Nasdaq: SGEN)
and Millennium: The Takeda Oncology Company, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited (TSE:4502), today announced the initiation of a global phase III clinical trial evaluating ADCETRIS (brentuximab vedotin) in combination with chemotherapy for the treatment of newly diagnosed CD30-positive mature T-cell lymphoma (MTCL) patients, including patients with systemic anaplastic large cell lymphoma (sALCL) and other types of peripheral T-cell lymphomas.

Therapeutic Solutions International, Inc. (OTCQB: TSOI)
announced today the signing of an agreement with Smile Cosmetic SARL for the distribution of Therapeutic Solutions International's AMPSA products in Morocco.



"Featured Content" profiles are meant to provide awareness of these companies to investors in the small-cap and growth equity community and should not in any way come across as a recommendation to buy, sell or hold these securities. BiomedReports is not paid or compensated by newswires to disseminate or report news and developments about publicly traded companies, but may from time to time receive compensation for advertising, data, analytics and investor relation services from various entities and firms. Full disclosures should be read in the 'About Us Section'.

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