FDA Approves Gilead's Once-Daily Single Tablet HIV-1 Regimen Complera®; Cellular Completes Patient Treatment for Phase I Clinical Trial for Liver Cancer Print E-mail
By Staff and Wire Reports   
Friday, 13 December 2013 19:46
Below is a look at some of the headlines for companies that made news in the healthcare sector on December 13, 2013.

Gilead Sciences (Nasdaq: GILD)
announced the U.S. FDA has approved the single tablet HIV-1 regimen Complera® (emtricitabine/rilpivirine/tenofovir disoproxil fumarate) for use in certain virologically-suppressed (HIV RNA <50 copies/mL) adult patients on a stable antiretroviral regimen in order to replace their current antiretroviral treatment regimen. Complera was first approved in 2011 for patients new to therapy and is now one of the most widely-prescribed HIV regimens in the United States.

“Complera is an effective single-pill therapy with a demonstrated safety profile, and has rapidly become an important option for appropriate HIV patients who are initiating antiretroviral treatment,” said Calvin J. Cohen, MD, M.Sc., Research Director, Community Research Initiative of New England and an investigator on clinical trials of Complera. “The data supporting today's approval demonstrate Complera has the potential to help a broader range of HIV-infected patients who have achieved virologic control on another regimen.”

Complera combines a complete course of three antiretroviral medications into a single, once-daily tablet. The product contains Gilead's Truvada®, which itself is a fixed-dose combination of two HIV medicines, and Janssen R&D Ireland's rilpivirine (marketed as Edurant®). Patients switching to Complera should have no history of virologic failure, have suppressed viral load for at least six months, be on their first or second antiretroviral regimen, and have no current or past history of resistance to Complera components. The efficacy of Complera was established in patients who were virologically suppressed (HIV RNA <50 copies/mL) on a stable ritonavir-boosted protease inhibitor-containing regimen.

Today's approval is supported by clinical data from the Phase 3 SPIRIT (Study 106) clinical trial. In this randomized, open-label study, virologically suppressed patients who were taking multi-tablet HIV therapy containing a ritonavir-boosted protease inhibitor (PI) either switched to Complera or remained on their PI-based regimen. The study found that, after 48 weeks of treatment with Complera, 89 percent (n=283/317) of switch patients had viral load less than 50 copies/mL, compared to 90 percent (143/159) of patients who remained on a PI-regimen for 24 weeks. Complera was well tolerated in SPIRIT and there were few treatment discontinuations due to adverse events. The most common side effects in previous clinical studies of Complera were headache, depressive disorders and insomnia (2 percent for all). No new adverse reactions were identified in SPIRIT, but the frequency of adverse reactions increased from 2 percent to 2.4 percent. Complera has a labeled Boxed Warning on the risks of lactic acidosis/severe hepatotoxicity with steatosis and acute exacerbation of hepatitis B; see below for Important Safety Information.

Marketed as Eviplera® (emtricitabine/rilpivirine/tenofovir disoproxil (as fumarate)) in the European Union, the regimen also was recently granted European regulatory approval for any HIV-infected adult patients without known mutations associated with resistance to the non-nucleoside reverse transcriptase inhibitor (NNRTI) class, tenofovir or emtricitabine, and with a viral load ≤ 100,000 HIV-1 RNA copies/mL.


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Cellular Biomedicine Group, Inc. (OTCQB: CBMG)
,  a biomedicine firm engaged in the development of new treatments for degenerative and cancerous diseases, is pleased to announce that it has treated the final patient of its Phase I clinical trial which evaluates the safety and preliminary efficacy of TC-DC (Tumor Stem Cell Specific Dendritic Cell) therapy for hepatocellular carcinoma (HCC), the most common type of liver cancer.

The Phase I clinical trial for TC-DC therapy for HCC is an open-label clinical trial conducted with Shanghai's PLA 85 Hospital, one of China's largest Liver Disease Centers. The trial evaluated the safety and preliminary efficacy in lowering the incidence of tumor recurrence and metastasis by means of autologous immune cell therapy in primary HCC patients following standard tumor resection and TACE chemotherapy.

"We are very pleased to reach this important milestone in our clinical trial and we look forward to reporting the full data readout early in the new year," said Dr. Wei (William) Cao, PhD, BM, CEO at Cellular Biomedicine Group.

Hepatocellular Carcinoma in China -- Fifty-five percent (55%) of the world's HCC patients are in China, and there are more than 340,000 new patients diagnosed per year in China, according to the journal titled Chinese Clinical Oncology, Mar 2009, Vol. 14, No. 3.  Currently, the most common therapies used to treat most HCC patients are surgery and local chemotherapy, with a 2-year recurrence rate of 51%.


Also Friday:



Amgen (NASDAQ: AMGN)
announced that its Board of Directors today declared a $0.61 per share dividend for the first quarter of 2014.

AxoGen, Inc. (NASDAQ: AXGN)
, a leader in the science and commercialization of surgical solutions for peripheral nerve repair, today announced CEO Karen Zaderej will be interviewed live today at 3:45pm EST on Clear Channel's business talk radio show "The Trader Network" by host Michael Yorba.

Bovie Medical Corporation (NYSE MKT: BVX)
, a manufacturer and marketer of electrosurgical products, announced today that it completed a $7.0 million funding through Great Point Partners LLC (GPP). Gilford Securities Incorporated acted as sole placement agent.

Cellular Biomedicine Group, Inc. (OTCQB: CBMG)
,  a biomedicine firm engaged in the development of new treatments for degenerative and cancerous diseases, is pleased to announce that it has treated the final patient of its Phase I clinical trial which evaluates the safety and preliminary efficacy of TC-DC (Tumor Stem Cell Specific Dendritic Cell) therapy for hepatocellular carcinoma (HCC), the most common type of liver cancer.

Cerner Corporation (Nasdaq:CERN)
today announced that its board of directors approved a stock repurchase program on December 12, 2013, at its regularly scheduled Board meeting, authorizing the repurchase of up to $217 million of its common stock.

Lipocine Inc. (OTCQB:LPCN) (OTCBB:LPCN)
, a specialty pharmaceutical company, today announced that Dr. William I. Higuchi will receive an honorary Doctor of Science degree from the University of Michigan at the winter commencement ceremony, Sunday December 15, 2013.

MAKO Surgical Corp. (Nasdaq:MAKO)
announced that MAKO stockholders voted at a special meeting of stockholders held today to approve the adoption of the Agreement and Plan of Merger  providing for the merger of MAKO with and into a wholly owned subsidiary of Stryker Corporation (NYSE:SYK).

Onconova Therapeutics, Inc. (Nasdaq:ONTX)
a clinical-stage biopharmaceutical company focused on discovering and developing novel products to treat cancer, will be hosting an investor and analyst event on Thursday, December 19, 2013, from 8:00 am to 12:00 pm ET in New York, NY.

Response Genetics, Inc. (Nasdaq:RGDX)
, a company focused on the development and sale of molecular diagnostic tests that help determine a patient's response to cancer therapy, announced today it priced its previously announced underwritten public offering of 4,464,443 registered shares of its common stock, par value $0.01 per share, at a price of $1.20 per share.

Synthetic Biologics, Inc. (NYSE MKT: SYN)
, a developer of product candidates focused on the prevention and treatment of serious infectious and other diseases, today announced the exercise of the over-allotment option granted to the underwriters to purchase an additional 1,725,000 shares of its common stock, at a price to the public of $1.00 per share, in connection with the Company's recently announced underwritten public offering of 11,500,000 shares of common stock, bringing total gross proceeds from the offering to $13,225,000, before underwriting discounts and commissions and other offering expenses payable by the Company.

Tekmira Pharmaceuticals Corporation (Nasdaq:TKMR) (TSX:TKM)
, a leading developer of RNA interference (RNAi) therapeutics, today announced it has received clearance to proceed with the use of a more potent formulation in its TKM-Ebola Phase I clinical trial, which is expected to begin enrolling patients early next year.

XOMA Corporation (Nasdaq:XOMA)
announced today the pricing of 9,500,000 shares of its common stock at a price to the public of $5.25 per share.



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