Celldex drug nearly doubles survival rates. Celsion receives positive FDA guidance Print E-mail
By BioMedReports.com Staff   
Monday, 04 October 2010 18:48
Below is a look at some of the headlines for companies that made news in the healthcare sector on October 04, 2010.
Celldex Therapeutics, Inc. (NASDAQ:CLDX) today announced that the Company presented initial clinical data on CDX-1401 at the 25th Annual Meeting of the International Society of Biological Therapy of Cancer (iSBTc) in Washington, DC. CDX-1401 is a novel antibody-based targeted cancer vaccine candidate being evaluated as a treatment for patients with melanoma and other cancers that are known to express the tumor antigen NY-ESO-1.

The data presented were from a Phase 1/2 dose-escalating clinical trial evaluating three different doses of the vaccine in combination with resiquimod , which is an activator of toll-like receptors 7 and 8 (TLR7/8) and stimulator of immune cells. The study has enrolled 20 patients with advanced cancer, of which 35% had confirmed NY-ESO-1 expression. Six patients maintained stable disease and were eligible for multiple cycles of the treatment regimen, including 4 patients who have received 3 or more cycles (6 weeks of treatment followed by a 6 week rest), with stable disease of up to 11.5+ months. The treatment was well tolerated and there were no dose-limiting toxicities. Robust anti-NY-ESO-1 immunity was induced with the majority of the patients developing anti-NY-ESO-1 antibody responses and 39% of the patients having increases in NY-ESO-1 specific T cell responses, including both CD4 and CD8 responses. Importantly, the T cell responses were directed against multiple regions of the NY-ESO-1 antigen.

"CDX-1401 represents a new generation of off-the-shelf dendritic cell targeted vaccines built upon excellent preclinical activity data," said Tom Davis, M.D., Chief Medical Officer of Celldex Therapeutics. "The initial data from this ongoing study confirm safety and immunogenicity even in patients with advanced cancer who have received multiple prior therapies. CDX-1401 has passed the initial Phase 1 hurdles and we look forward to forthcoming cohorts that will include additional TLR agonists in combination regimens."

The CDX-1401 study is continuing to enroll patients to additional cohorts that include combination with poly-ICLC (Hiltonol), a potent TLR3 agonist and stimulator of immune cells. The study is currently being conducted at multiple centers including Yale Cancer Center, Henry Ford Hospital and Medical Group, Memorial Sloan Kettering Cancer Center, and Weill Cornell Medical College.

Shares of Celldex opened the day higher but sold off and closed the day at $3.92, down 21 cents. After the bell however, shares rallied on heavy volume, spiking 73 cents or 18% to $4.58.

Celsion Corporation (Nasdaq:CLSN), a leading oncology drug development company, announced that the Company has reached agreement with the U.S. Food and Drug Administration (FDA) that the requirements for non-clinical studies have been met for the New Drug Application (NDA) of ThermoDox.

The FDA has provided written guidance that the Company is not required to conduct any additional non-clinical pharmacology, safety pharmacology and general toxicology studies assuming the results of current studies are adequate. The results of these current studies will be reviewed at the time of NDA submission. This agreement takes advantage of an NDA application known as a 505(b)2 which allows a company to reference existing data regarding doxorubicin and other liposomal drugs currently approved by the FDA.

As previously announced, the FDA has granted Fast Track Development for the Company's 600 patient pivotal Phase III clinical trial (the HEAT study) of its investigational drug, ThermoDox®, in combination with radiofrequency ablation (RFA), The Fast Track Development Program provides for expedited regulatory review including frequent interactions between the FDA. Celsion is eligible to submit its NDA on a rolling basis and review sections of the NDA with the FDA in advance of submitting the complete submission. The HEAT study is being conducted under a Special Protocol Assessment (SPA) agreement with the FDA.

"We are very pleased with the FDA's continued willingness to work closely with the Company to identify the most expeditious regulatory pathway forward for ThermoDox® in HCC, a life threatening disorder," stated Mr. Michael H. Tardugno, Celsion's President and Chief Executive Officer. "Our past consultation with the FDA regarding Chemistry Manufacturing and Controls (CMC) has permitted Celsion to implement and validate process improvements to its manufacturing methods used to produce ThermoDox at commercial scale."

Shares opened higher and rose to $3.54 before settling at $3.14, up 3 cents.

Arena Pharmaceuticals, Inc. (Nasdaq:ARNA) on heavy volume jumped 17 cents or 11.58% to $1.17 today on no apparent news.

BIOLASE Technology, Inc. (NASDAQ:BLTI), the world's leading dental laser company, announced today that Vice President of Engineering Dmitri Boutoussov, Ph.D., has been promoted to Chief Technology Officer, effective immediately. In the newly created position, Boutoussov will report directly to Federico Pignatelli, Chairman and CEO.

Boutoussov, 47, has more than 18 years in developing laser technologies for dentistry and medical applications in the U.S. and Europe. He has authored and co-authored more than 20 U.S. and international patents and patent applications, and more than 25 publications in peer reviewed magazines and conferences. He also has lectured in the U.S. and internationally on Laser Physics and Laser Medical Applications.

Shares of Biolase 23 cents, nearly 17% to $1.59.

BSD Medical Corporation (NASDAQ:BSDM) surged 79 cents or 25% to $3.94 on no apparent news. Volume of more than 3 million shares was double the daily average.

CellCyte Genetics Corporation (OTCBB:CCYG) announced today that the Company has signed a beta test collaboration agreement with the Fred Hutchinson Cancer Research Center in Seattle, Washington, to evaluate the effectiveness of CellCyte’s CCG-E45 Culture Chamber product as a supplement or replacement to their current methods of culturing specific cell lines.

Codexis, Inc. (Nasdaq:CDXS) today after the bell announced the expansion of its line of Codex® Panels with the introduction of Codex® Screening Kits. The Codex® Screening Kits are developed from, and complement, the established Codex® Panels biocatalyst screening plates. Codex® Panels are used by more than 15 pharmaceutical and fine chemical companies worldwide, including Roche and Merck, to reduce pharmaceutical manufacturing process development time and costs.

Mylan Inc. (Nasdaq:MYL) today announced that its subsidiary Bioniche Pharma received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Fludarabine Phosphate Injection USP, 25 mg/mL, packaged in 50 mg/2 mL Single-dose Vials. The product was determined to be bioequivalent and, therefore, therapeutically equivalent to Teva Parenteral's Fludarabine Phosphate Injection USP, 25 mg/mL, a chemotherapy medication for B-cell chronic lymphocytic leukemia (CLL). Fludarabine Phosphate Injection USP, 25 mg/mL had U.S. sales of approximately $15 million for the 12 months ending June 30, 2010, according to IMS Health.

Myriad Genetics, Inc. (Nasdaq:MYGN) announced today that results from a preliminary study indicate that BRCA germline mutations occur at a high frequency in women with triple negative breast cancer, sufficiently high enough to justify screening of all women with TNBC. Details of the study were presented on October 3, 2010, at the 2010 ASCO Breast Cancer Symposium in Washington DC. "This study confirms the emerging story of the importance of BRACAnalysis testing in triple negative breast cancer," said Mark Capone, President of Myriad Genetic Laboratories. "The high prevalence of BRCA mutations in women that do not currently qualify for BRACAnalysis testing, if confirmed in additional studies, could be considered for future updates to testing guidelines."

Orthovita, Inc. (NASDAQ:VITA), an orthobiologics and biosurgery company, announced that it received 510(k) clearance from the U.S. Food and Drug Administration to market VITOMATRIX Bone Graft Substitute as a bone grafting material in certain dental procedures.

VITOMATRIX is a resorbable, highly porous synthetic scaffold that utilizes the core proprietary technology from our VITOSS Bone Graft Substitute product line. VITOMATRIX is indicated for use in procedures to fill, augment or reconstruct periodontal or bony defects of the oral and maxillofacial region. An estimated 375,000 procedures are performed domestically each year where VITOMATRIX can be used.

Orthovita is evaluating potential commercial partners to distribute the product or license its underlying technology.

Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP) today announced that the FDA has extended the Prescription Drug User Fee Act (PDUFA) goal date for the Agency’s Priority Review of the efficacy supplement to NDA 21-361 for XIFAXAN 550mg Tablets for the proposed indication of the treatment of non-constipation irritable bowel syndrome (Non-C IBS) and IBS-related bloating. The FDA has notified Salix that it requires additional time for review of the application and has extended the December 7, 2010 goal date by three months. The extended user fee goal date is March 7, 2011.

"The extension of the PDUFA goal date is not unexpected, given the Agency’s historical management of Priority Reviews," stated Bill Forbes, Pharm.D., Executive Vice President and Chief Development Officer, Salix Pharmaceuticals. "We are encouraged by the productive interactions we continue to have with the Agency during the review and believe it is unlikely that there will be an advisory committee meeting for this submission. We look forward to the completion of the review by the new goal date."

Seattle Genetics, Inc. (Nasdaq:SGEN) today announced that preliminary data from a phase I study of SGN-75 in relapsed and refractory non-Hodgkin lymphoma and metastatic renal cell carcinoma will be presented during a poster session at the 35th European Society for Medical Oncology (ESMO) Congress being held October 8-12, 2010 in Milan, Italy. SGN-75 is an antibody-drug conjugate (ADC) targeting CD70 that utilizes the company’s proprietary technology.

VIVUS, Inc. (Nasdaq:VVUS) today announced that it has entered into an asset purchase agreement with Meda - an international specialty pharma company - for MUSE®, transurethral alprostadil, for the treatment of erectile dysfunction (ED). Under the agreement, Meda will acquire the MUSE assets including the United States and foreign MUSE patents, existing inventory and the manufacturing facility located in Lakewood, New Jersey. As part of the transaction, the existing VIVUS employees that are MUSE dedicated, including the field sales force, are expected to join Meda. VIVUS will retain all of the liabilities associated with the pre-closing operations of the MUSE business. The acquisition price is $23.5 million, which includes an upfront cash payment of $22 million. VIVUS is eligible to receive a one-time milestone payment of $1.5 million based on future sales of MUSE.

Also Monday:

Aoxing Pharmaceutical (NYSE Amex: AXN) ("Aoxing Pharma"), a specialty pharmaceutical company focusing on research, development, manufacturing and distribution of narcotic and pain-management products, today announced its financial and operational results for the fiscal year ended June 30, 2010.
Ceelox, Inc., (OTCBB: CELO) continues to focus on evolving their product line and company strategy to meet changes in the competitive landscape.
 
Celgene Corporation (NASDAQ: CELG) today announced its intention to offer, subject to market and other conditions, senior unsecured notes under a shelf registration statement on Form S-3 on file with the Securities and Exchange Commission.
Cleveland BioLabs, Inc. (NASDAQ:CBLI) announced today that it has received a notice of grant of patent for Protectan CBLB612 from South Africa and a notice of intent to grant patent for Protectan CBLB612 from the Eurasian Patent Organization (EAPO), which includes the Russian Federation and eight other member countries.
CryoLife, Inc. (NYSE:CRY), an implantable biological medical device and cardiovascular tissue processing company, announced today that it has appointed David P. Lang as vice president of market development for CryoLife International Inc.
Edwards Lifesciences Corporation (NYSE:EW), the global leader in the science of heart valves and hemodynamic monitoring, today announced that it has opened a new facility in Draper, Utah that will enable the company to significantly expand its manufacturing and development capabilities, and accommodate its plans for growth.
Forest Laboratories, Inc. (NYSE: FRX), an international manufacturer and marketer of pharmaceutical products, will release its Fiscal 2011 Second Quarter financial results before the U.S. stock market opens on Tuesday, October 19, 2010.
Genomic Health, Inc. (NASDAQ: GHDX) today announced the launch of an online campaign, Pass It On... Until Every Woman Knows, to educate people about personalized breast cancer treatment and the Oncotype DX® breast cancer test.
Genzyme Corp. (NASDAQ: GENZ) said today that its board of directors urged shareholders to take no action on an unsolicited tender offer from Sanofi-Aventis to acquire all outstanding common shares of Genzyme for $69 per share.
Hansen Medical, Inc. (NASDAQ: HNSN), the global leader in flexible robotics, today announced the completion of its First in Man Study, during which 20 peripheral endovascular procedures were successfully performed with the Company's new flexible catheter vascular robotic system.
Healthmed Services, Ltd. (OTCQB: HEME) (PINKSHEETS: HEME), an innovative software and application development company, confirms the Company is testing the neural communicator on a voluntary select group of individuals.
Impax Laboratories, Inc. (NASDAQ: IPXL) announced today that its third quarter 2010 financial results will be released before the market opens on Tuesday, November 2, 2010 and will be available on Impax's Web site.
Kinetic Concepts, Inc. (NYSE: KCI), through its regenerative medicine business unit LifeCell™ Corporation, will announce 12-month interim results from the ongoing study: Strattice™ Repair of Infected or Contaminated Abdominal Incisional Hernias (R.I.C.H.) on Tuesday, Oct. 5, at 9 a.m. at the American College of Surgeons (ACS) Clinical Congress at the Walter E. Washington Convention Center in Washington, D.C.
Macada Holding, Inc. (PINKSHEETS:MCDA) announced that management has completed negotiations on three Marketing and distribution agreements with Lyfetec, Inc for their Bio-Skin products.
MAP Pharmaceuticals, Inc. (Nasdaq:MAPP) announced today the completion of its previously announced underwritten offering of 3,000,000 shares of its common stock, as well as 450,000 additional shares of its common stock pursuant to the full exercise of the over-allotment option granted to the underwriters, at an offering price of $14.50 per share.
  
MedEx, Inc. (PINKSHEETS:MDXX) is pleased to announce a shareholder update in light of missing the date of the previously announced audit.
MedLink (OTCBB: MLKNA), a leading provider of Electronic Health Records and healthcare IT interoperability solutions, announced today that it has been selected as an National Health Information Network (NHIN) CONNECT partner, which is a project aimed at providing all Americans with interoperable Health Records by promoting interoperability in the U.S. healthcare system.
Neuro-Biotech Corporation (PINKSHEET: MRES) (OTCQB: MRES) introduces a Neuro-biomarker which is linked to a series of Neuro-Bio tests.
OncoGenex Pharmaceuticals, Inc. (NASDAQ:OGXI) announced today that management of OncoGenex will present at the 9th Annual BIO Investor Forum on Wednesday, October 6 at 10:30 a.m. PDT at The Palace Hotel in San Francisco, CA.
Ophthalmic Imaging Systems (OIS) (OTCBB:OISI), a leading digital imaging and informatics company, today announced that management will present a Company overview during Precision IR's Informed Investors Forum Biotech, Healthcare & Pharma Virtual Conference.
PDL BioPharma, Inc. (PDL) (Nasdaq:PDLI) today announced that it has paid the October 1, 2010 special dividend payment of $0.50 per share to all stockholders owning shares of PDL as of September 15, 2010, the record date.
Pfizer Inc. (NYSE:PFE) invites investors and the general public to view and listen to a webcast of a conference call with investment analysts at 10 a.m. EDT on Tuesday, November 2, 2010.
Unigene Laboratories, Inc. (OTCBB: UGNE), a leader in the design, delivery, manufacture and development of peptide-based therapeutics, announced today the expansion of the Company's leadership team with the appointment of Gregory T. Mayes to the newly created position of Vice President, Corporate Affairs and General Counsel, and the promotion of Roxanne Tavakkol to Vice President, Global Regulatory Affairs, effective immediately.
Versus Technology, Inc. (PINKSHEETS: VSTI) is pleased to announce that another phenomenal customer, Pacific Medical Center (PacMed), is now realizing the benefits of the Versus Advantages™ Real-time Locating System (RTLS).
WellTek, Inc. (OTCBB: WTKN), a global health, fitness and wellness company, announced today that its subsidiary WellCity, the premier online destination for those into health and wellness, formed a strategic alliance with Nutraceutics Corporation and launched Nutraceutics products on its social network.
XTend Medical Corporation (PINKSHEETS:XMDC), a company that specializes in delivering life-changing medical technology to healthcare organizations globally, has successfully acquired the BioHarp Assets from Mr. Sang M. Lee and U&I Bio-Tech, Inc., as provided in the Asset Purchase Agreement that the parties signed on December 9, 2009.
Ziegler (PINKSHEETS: ZGCO), specialty investment banking firm serving hospital and healthcare systems clients since 1928, announced the successful transaction closing for Bronson Methodist Hospital (Bronson). Bronson is a 405-licensed bed general acute care hospital located in Kalamazoo, Michigan; Bronson is a part of the Bronson Healthcare Group, Inc.



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