Aeterna Zentaris posts encouraging data. ISTA shares up on marketing exclusivity. SurModics in proxy fight. After the bell: Dendreon surges on CMS panel Print E-mail
By BioMedReports.com Staff   
Wednesday, 17 November 2010 19:38

 

Below is a look at some of the headlines for companies that made news in the healthcare sector on November 17, 2010.


On heavy volume shares of Aeterna Zentaris Inc. (NASDAQ:AEZS) gained today after the company presented posters on encouraging preclinical results for AEZS-129 and AEZS-132, two novel orally active compounds with anti-tumor effects. Data shows that AEZS-129 and AEZS-132 block important signalling pathways which contribute to the proliferation and survival of cancer cells. Targeting these multiple signalling pathways could result in improved treatment efficacy for such cancers as lung, colon, prostate, breast, endometrial cancer and melanoma. Both posters were presented by Irene Seipelt, Associate Director, Discovery and Preclinical Development at Aeterna Zentaris, during the 22nd EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics currently being held in Berlin, Germany.

Juergen Engel, Ph.D., President and CEO of Aeterna Zentaris stated, "Data from the studies on AEZS-129 and AEZS-132 presented today, demonstrate that these two novel orally active anti-cancer compounds can inhibit the growth of tumor cells without critical safety issues. They are also prime examples of our innovative drug development programs in oncology, using molecules that work by using a targeted approach in order to tailor the treatment to a patient's specific condition and tumor characteristics. Although still in preclinical development, we believe AEZS-129 and especially the first-in-class dual PI3K/Erk inhibitor, AEZS-132, could be part of the next generation of cancer treatments."

ISTA Pharmaceuticals, Inc. (Nasdaq:ISTA) shares got a boost today after the company announced that the FDA has granted the Company three years of marketing exclusivity for BROMDAY as provided under the Drug Price Competition and Patent Term Restoration Act, commonly known as the Hatch-Waxman Act. BROMDAY (formerly referred to as XiDay), the first and only once-daily prescription eye drop for the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract extraction, was approved by the FDA in October of 2010. Under the Hatch-Waxman Act, the FDA may not approve an Abbreviated New Drug Application for a generic version of BROMDAY until October of 2013.

Shares of ISTA surged 12% or 47 cents to $4.39.

Inovio Pharmaceuticals, Inc. (NYSE Amex: INO), a leader in the development of therapeutic and preventive vaccines against cancers and infectious diseases, announced today that it has achieved high vaccine-induced response rates and strong magnitude of immune responses in its Phase I clinical study of PENNVAX-B, a DNA vaccine for the prevention of HIV infection. Similar to recently reported results from a Phase I clinical study of Inovio’s therapeutic DNA vaccine for cervical cancer, the response rates and magnitude of responses achieved in this study are significantly higher than those seen previously with other DNA vaccine trials.

Dr. J. Joseph Kim, Inovio’s President and CEO, said: "After recently announcing best-in-class immunogenicity data from our clinical trial for our cervical cancer DNA vaccine using the same technology platform, we are pleased to again see very strong T-cell immune responses from this vaccine platform for a different disease, and particularly a disease with unmet needs like HIV. They are amongst the highest immune responses seen in other HIV vaccine trials either with DNA or other vaccine platforms including proteins and viral vectors. However, unlike viral vectors, DNA vaccines do not induce unwanted immune responses against the carrier. Taken together these results further support the prospect that Inovio’s DNA vaccine and delivery platform could play an important role in developing new vaccines and therapies for major diseases like cancer and HIV."

SurModics, Inc. (Nasdaq:SRDX) shot up Wednesday after hedge fund Ramius Value and Opportunity Advisors LLC, a subsidiary of Ramius LLC revealed that it has taken a 12% ownership stake in the company. Jeffrey Smith, a managing director at Ramius, said in a letter to SurModics’ board that the company’s stock has "materially underperformed the market." The stock has dropped more than 36% since reporting Q4 results that were below expectations.

In heavy trading Wednesday, shares rose nearly 11% or 90 cents tpo $9.23.


After the bell shares of  Dendreon Corporation (Nasdaq:DNDN) moved higher after an advisory panel concluded that the company's prostate cancer therapy, Provenge, showed sufficient evidence that the treatment is helpful for patients. The advice was intended to help the Medicare and Medicaid (CMS) to decide whether or not to cover Provenge. A final decision is not expected until next year although analysts pointed out that todays panel made it clear that the drug would be covered by CMS and could also encourage more private insurers to jump on board as well. "PROVENGE is an important new treatment for patients with asymptomatic or minimally symptomatic metastatic castrate-resistant prostate cancer," said Mitchell H. Gold, M.D., president and chief executive officer. "We look forward to working closely with CMS throughout the NCA process to ensure patients with advanced prostate cancer have access to PROVENGE." The stock was halted all day.

After the bell shares jumped as high as $40.05 before falling back to close at $38.96, up $3.09 or 8.61%.

Enzon Pharmaceuticals, Inc. (Nasdaq:ENZN) today presented data from preclinical studies of three investigational messenger RNA (mRNA) antagonists. These antagonists are based on the locked nucleic acid (LNA) technology platform targets licensed from Santaris Pharma A/S. The data were presented in poster sessions at EORTC-NCI-AACR International Symposium on Molecular Targets and Cancer Therapeutics, which is being held November 16-19 in Berlin, Germany.

"The robust anti-tumor activity in these preclinical studies underscores the therapeutic potential of our third-generation mRNA antagonists to inhibit key tumor targets that are generally inaccessible to antibodies and small molecules," said Ivan Horak, MD, Enzon’s President of Research and Development and Chief Scientific Officer. "The Locked Nucleic Acid technology on which these novel compounds are based provides significant advantages over earlier RNA-targeting agents, including greater stability, affinity, and potency. We look forward to further investigating the safety and efficacy of these compounds in the clinical setting."

Neuralstem, Inc. (NYSE Amex: CUR) announced that it has filed an Investigational New Drug (IND) application with the United States Food and Drug Administration (FDA) to begin two Phase I safety trials to test NSI-189, its first small molecule compound, for the treatment of major depression. NSI-189 is a proprietary new chemical entity discovered by Neuralstem that stimulates new neuron growth in the hippocampus, an area of the brain that is believed to be involved in depression.

Also Wednesday: 

AtheroNova Inc. (OTCBB: AHRO) ("AtheroNova"), a novel compounds biotech company focused on research and development to regress atherosclerotic plaque, announced that Paul DiPerna, CTO and Founder of Tandem Diabetes Care, has been named to the Board of Directors of AtheroNova Inc.

China Cord Blood Corporation (NYSE:CO) ("CCBC" or "the Company") today announced its plan to release financial results for the second quarter of fiscal year 2011 on Wednesday, November 24, 2010, before the market opens in the US.

CytoSorbents Corporation (OTCBB:CTSO), a critical care-focused company using blood purification to treat life-threatening illnesses, announced its financial results for the third quarter of fiscal 2010.

D. Medical Industries Ltd. (NASDAQ:DMED)(TASE:DMDC) ("D. Medical"), a medical device company engaged through its subsidiaries in the research, development, manufacture and sale of innovative products for diabetes treatment and drug delivery, expects to announce its fiscal 2010 third quarter financial results prior to The NASDAQ Capital Market opening on Wednesday, November 24, 2010.

Depomed, Inc. (NASDAQ: DEPO) today announced that it ranked number 93 on Technology Fast 500™, Deloitte's ranking of 500 of the fastest growing technology, media, telecommunications, life sciences and clean technology companies in North America.

Hansen Medical, Inc. (NASDAQ: HNSN), a global leader in flexible robotics and the developer of robotic technology for accurate 3D control of catheter movement, today announced that engineering executive Jean Chang has been named Vice President, Engineering, effective immediately. Chang will report directly to President and CEO Bruce Barclay.

K-V Pharmaceutical Company (NYSE: KVa/KVb) (the "Company") today announced that it issued a warrant to U.S. Healthcare I, L.L.C. and U.S. Healthcare II, L.L.C. (together the "Lenders") that grant Lenders the right to purchase up to 9,900,000 shares of the Company's Class A Common Stock, par value $.01 per share (the "Initial Warrant"), and that it intends to issue a second warrant to Lenders that grants Lenders the right to purchase up to 2,687,511 shares of the Company's Class A Common Stock, par value $.01 per share (the "Second Warrant," and together with the Initial Warrant, the "Warrants"), in each case at an exercise price of $1.62 per share.

Luminex Corporation (Nasdaq:LMNX) today announced that the company's Board of Directors has authorized the purchase of up to 1,000,000 shares, but not more than $21 million in aggregate purchase price, of the company's common stock through November 2011.

Lpath, Inc. (OTCBB: LPTN), the industry leader in lipidomics-based therapeutics, has closed a private placement sale of 6,978,128 shares of Class A common stock at $0.70 per share for gross proceeds of $4.9 million.

Luminex Corporation (Nasdaq:LMNX), today announced that it has commercially launched its first pharmacogenetic test, the xTAG® CYP2D6 Kit, which recently received 510(k) clearance from the U.S. Food and Drug Administration (FDA).

MMRGlobal, Inc. (OTCBB:MMRF) will hold a Third Quarter Earnings Conference Call on Friday, November 19, 2010, at 1:30 p.m. Pacific Time / 4:30 p.m. Eastern Time.

PAREXEL International Corporation (Nasdaq:PRXL), a leading global biopharmaceutical services provider, today announced that it reached a milestone of completing 200 early phase studies in patient populations during the past three years.

Sangamo BioSciences, Inc. (Nasdaq:SGMO) announced today the presentation of Phase 2 clinical data from its ZFP Therapeutic program to develop SB-509, a zinc finger protein transcriptional activator (ZFP-TF) of the vascular endothelial growth factor (VEGF)-A gene as a treatment for ALS.



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