|Antigenics reports encouraging data from brain cancer study. After the bell Abraxis BioScience pancreatic cancer drug shows promise, ZymoGenetics reports preliminary Phase II study results.|
|By BioMedReports.com Staff|
|Thursday, 20 May 2010 17:46|
Below is a list of the companies that made news in the healthcare sector on Thursday, May 20, 2010.
Abraxis BioScience, Inc. (NASDAQ:ABII), rose after the bell after the company announced after the market close that a phase 2 clinical study evaluating nab-paclitaxel in advanced pancreatic cancer patients who have progressed on gemcitabine-based therapy, treatment resulted in 58 percent of patients achieving six-month overall survival (OS), with a median survival of 7.3 months and a median progression-free survival (PFS) of 1.6 months. Five patients remain alive at a median follow-up of 12.7 months, including one patient with stable disease on cycle 15 of therapy. Complete trial results will be presented during a poster session on June 6 at the 46th Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago.
"The success of ABRAXANE in patients with pancreatic cancer supports our belief and understanding of how the nab-driven chemotherapy leverages the tumor biology against itself to increase efficacy," said Patrick Soon-Shiong, M.D., Executive Chairman and founder of Abraxis BioScience. "We believe ABRAXANE exploits the albumin-binding protein receptor, Gp60, to penetrate the blood-stroma barrier in essence opening a portal to the tumor micro-environment, enabling the delivery of targeted cytotoxic agents leading to stromal collapse and tumor penetration."
ZymoGenetics, Inc. (NASDAQ:ZGEN) edged higher after the bell as the company announced after the market close that final progression-free survival results will be presented from a Phase 2 clinical trial in patients with Stage 4 metastatic melanoma at the American Society of Clinical Oncology annual meeting in Chicago on June 5, 2010 in an oral presentation. The open-label multi-center clinical trial evaluated 3 dose regimens of Interleukin 21 (IL-21) in 40 patients with no prior systemic therapy for metastatic melanoma.
"We’re encouraged by the progression-free survival and response rate in patients with advanced melanoma," said Eleanor L. Ramos, M.D., Senior Vice President and Chief Medical Officer of ZymoGenetics. "We selected 30µg/kg/day as the dose for further investigation and are planning a randomized Phase 2b study with the National Cancer Institute of Canada Clinical Trials Group that will seek to further validate the efficacy of IL-21 as a treatment for metastatic melanoma."
Also after the bell:
Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), announced that ASCO has published its abstract pertaining to preliminary results from an ongoing Phase I trial with ALN-VSP, a systemically delivered RNAi therapeutic for the treatment of advanced solid tumors with liver involvement. The results will be presented in a poster at the ASCO 2010 Annual Meeting being held June 4 – 8 in Chicago.
Array BioPharma Inc. (NASDAQ: ARRY) today announced that four abstracts have been selected for presentation at the American Society of Clinical Oncology (ASCO) Annual Meeting, being held from June 4-8, 2010, in Chicago, Illinois. Presentations will disclose new findings about its anti-cancer programs: AZD6244 (ARRY-886), a MEK inhibitor licensed to AstraZeneca PLC and ARRY-520, a KSP inhibitor.
GTx Inc. (Nasdaq: GTXI) announced that additional study results from clinical trials evaluating Ostarine (GTx-024) for the treatment of cancer cachexia and toremifene 80 mg for the reduction of fractures in men with prostate cancer on androgen deprivation therapy (ADT) will be presented at the 2010 American Society of Clinical Oncology (ASCO) Annual Meeting.
Labopharm Inc. (TSX: DDS; NASDAQ: DDSS)after the bell today announced that it has completed the previously announced transaction to establish a joint venture with Gruppo Angelini. The joint venture, Angelini Labopharm, will launch OLEPTRO(TM), Labopharm's novel once-daily formulation of trazodone indicated for the treatment of major depressive disorder in adults, in the U.S. in the third quarter of this year.
Onyx Pharmaceuticals, Inc. (Nasdaq:ONXX) today announced the presentation of several studies evaluating carfilzomib, a selective, next-generation proteasome inhibitor, at the 46th American Society of Clinical Oncology Annual Meeting, June 4-8, 2010 in Chicago, IL. Presentations will highlight data from the carfilzomib development program in patients with relapsed/refractory multiple myeloma and solid tumors.
Peregrine Pharmaceuticals, Inc. (NASDAQ:PPHM) announced that it will present cancer data from four clinical trials, including its first-in-class phosphatidylserine (PS)-targeting monoclonal antibody bavituximab and novel brain cancer therapy Cotara, at the 2010 ASCO Annual Meeting. Based on encouraging interim Phase II data, Peregrine plans to initiate a new randomized, placebo-controlled, double-blinded Phase II trial of bavituximab in combination with chemotherapy in refractory non-small cell lung cancer (NSCLC) patients, with an additional randomized Phase II trial in front-line NSCLC planned to begin by mid-year.
In news from earlier in the day:
Antigenics (NASDAQ: AGEN) announced that data from a multi-center Phase 1/2 clinical trial of Oncophage (vitespen) for recurrent high-grade glioma (brain cancer) was presented at the International Conference on Brain Tumor Research and Therapy. The study was conducted by the Brain Tumor Research Center at the University of California, San Francisco (UCSF).
Data from 32 evaluable patients suggest that vaccination with Oncophage may improve overall survival in patients with recurrent high-grade glioma. An overall median survival of 44 weeks after tumor resection was observed. Approximately 70% of the evaluable patients survived beyond 36 weeks, and 41% survived up to or longer than one year. This is considered a significant achievement in the treatment of recurrent high-grade glioma. In addition, Oncophage was well tolerated, with no serious adverse events attributable to the vaccine.
"The results from this trial suggest clear biological activity associated with Oncophage treatment as evidenced by stimulation of robust immune responses in the patients evaluated to date," said Andrew T. Parsa, MD, PhD, associate professor in the department of neurological surgery at UCSF, and principal investigator of the trial, who presented the update. "Furthermore, I am encouraged that recurrent glioma patients treated with Oncophage are experiencing longer than anticipated survival without treatment-related toxicities. These data could potentially justify advancement into late-stage trials."
A.P. Pharma, Inc. (Nasdaq: APPA), a specialty pharmaceutical company, today announced that, on May 18, 2010, the Company received a letter from Nasdaq indicating that the minimum closing bid price of its common stock had fallen below $1.00 for 30 consecutive trading days, and therefore, A.P. Pharma was not in compliance with Marketplace Rule 5550(a)(2). The Company has been provided 180 calendar days, or until November 15, 2010, to regain compliance with the minimum bid price requirement. This notice does not impact the Company’s listing on Nasdaq at this time.
BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) today announced that results of an evaluation of its 2A/Furin technology by Novartis Pharma AG in its industrial antibody CHO expression system were published in the Journal of Applied Microbiology & Biotechnology. The results demonstrate that the 2A/Furin technology was integrated successfully into a plasmid-based, industrial-scale, CHO antibody cell line development process, with minimal optimization required. Use of 2A/Furin could enhance further the distribution of high-expressing clones, improve the average productivity of clones, while also improving the stability of high producer cell lines generated using this animal-free CHO antibody development platform.
Genentech, Inc., a wholly owned member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), and Biogen Idec (Nasdaq: BIIB) today announced data from the Phase III PRIMA study. The data showed that continuing Rituxan for two years in patients who responded to initial treatment with Rituxan plus chemotherapy, doubled the likelihood of them living without their disease worsening compared to those who stopped treatment. The study enrolled patients with previously untreated advanced follicular lymphoma. After two-years of follow-up, 82 percent of patients who received Rituxan maintenance were in remission compared to 66 percent of patients who did not. No new safety signals were observed in this study and the safety profile was consistent with previous experience with Rituxan.
Merge Healthcare (NASDAQ: MRGE), a leading Health IT solutions provider, announced today that it was selected by Cato Research Ltd. to provide the proprietary etrials EDC solution through Merge’s technology transfer program. This new agreement expands Merge’s partnership with CATO to provide additional technology for clinical trials management, as well as extending the relationship for an additional five years.
NeoStem, Inc. (NYSE Amex: NBS) announced the conversion of Convertible Redeemable Series C Preferred Stock by RimAsia Capital Partners, LP, a principal shareholder. With the conversion of the Series C Preferred, the Company will no longer be required to pay the annual dividend and expects to recognize cash savings of $408,875 per year.
RimAsia has exercised its right to convert its 8,177,512 shares of Series C Preferred, issued in October 2009 as part of the China Biopharmaceutical Holdings acquisition, into 9,086,124 shares of the Company's common stock. RimAsia is currently subject to a lock-up agreement through the end of the summer 2010.
"We are both pleased and encouraged by the recent positive developments at NeoStem, which prompted our decision to convert all of the Series C Preferred held by us into NeoStem common shares. By doing so now, RimAsia will release the Company from a 5% per annum cumulative dividend charge on the income statement, significantly improve its balance sheet by reclassifying the principal amount (approximately $13.7 million) from its accounting treatment as temporary equity to shareholder equity, and provide NeoStem with an expanded primary equity base and a significantly higher market cap," said Eric Wei, the Managing Partner of RimAsia and a member of the Company's board of directors.
"This decision by RimAsia also reflects our encouragement from the rapid expansion, successful pursuit, and strong execution of NeoStem's business strategies on multiple fronts by management. We are also impressed with the Company's outlook and especially the recent partnership with the Pontifical Council for Culture, which we believe will leapfrog NeoStem to the forefront of the stem cell community," added Mr. Wei. "This collaboration with the Pontifical Council for Culture highlights the quality of NeoStem's technology and we are delighted to be able to provide our further support through the conversion of the Series C Preferred."
"We appreciate RimAsia's ongoing support of our endeavor to leverage our adult stem cell technologies to revolutionize the treatment paradigm for a wide range of disease. We are excited about our recent collaboration with the Pontifical Council for Culture, which validates our leadership and strategy in the stem cell field," said Robin Smith, M.D., NeoStem's CEO and Chairman of the board of directors. "The Company has transformed significantly over the past year to become a sophisticated international biopharmaceutical company with multiple commercial revenue streams. We thank RimAsia and all of our shareholders for the continued support in NeoStem to grow our adult stem cell platform in the U.S. and China, and to expand the capacity of our majority-owned Suzhou Erye subsidiary in anticipation of the significant growth in China's pharmaceutical market."
Nymox Pharmaceutical Corporation (Nasdaq:NYMX) announced that a symposium and panel discussion devoted to progress in the development of NX-1207, the Company's Phase 3 drug for benign prostatic hyperplasia (BPH), will be held at the 2010 Annual Meeting of the American Urological Association which begins May 29 in San Francisco. The symposium, entitled "Progress with NX-1207: Phase 3 Pro-Apoptotic Injectable for BPH," will be chaired by Dr. Neal Shore, a U.S. expert in prostate diseases, and will also include several other well known authorities and practitioners in the field.
Orthofix International (NASDAQ: OFIX) announced today that its sports medicine division, Breg, has introduced three new products, including a soft knee brace with an integrated hinge for added stability, a hip pad to be used with its cold therapy devices for post surgery pain management, and a wrist immobilization accessory for its T-Scope Elbow brace. The Company also introduced the OrthoFind app, one of the first iPhone applications for the orthopedics market, designed to assist health care providers in choosing products for their patients directly from their mobile phones.
Pharmasset, Inc. (Nasdaq:VRUS) announced today the underwriters of its recent stock offering have exercised their option to purchase an additional 480,000 shares of common stock. The net proceeds to Pharmasset, Inc., after deducting the underwriting discount, from the sale of these additional shares are expected to be approximately $13.2 million. This brings the total expected proceeds of the offering, after deducting the underwriting discount and estimated offering expenses, to $101.1 million.
Pfizer Oncology (NYSE:PFE) will present new data highlighting the company's focused approach to cancer drug development through the identification and validation of molecular targets at the 46th Annual American Society of Clinical Oncology (ASCO) meeting in Chicago from June 4-8.
"Pfizer Oncology is committed to applying discoveries from cancer biology and genetics to the development of new drugs in a focused and rational way. This approach is being used to study crizotinib, an ALK inhibitor, in lung cancer patients carrying the ALK fusion gene, and bosutinib, a dual Src and Bcr-Abl kinase inhibitor, in patients with chronic myelogenous leukemia who have progressed despite standard-dose imatinib," said Dr. Mace Rothenberg, senior vice president of clinical development and medical affairs for Pfizer's Oncology Business Unit. "We're also working to apply this personalized approach to better understand how already approved agents, such as Sutent, may work better in certain patient populations within approved indications."
Pluristem Therapeutics Inc. (NasdaqCM: PSTI) (DAX: PJT) today announced that its off-the-shelf placenta-derived cell therapies will be the focus of presentations at upcoming investor and medical conferences. "We recently reported interim top-line results from our Phase I clinical trials demonstrating that PLX-PAD is safe, well tolerated and had improved the quality of life of CLI patients in the studies," said Zami Aberman, Pluristem’s chairman and CEO. "With PLX-PAD, we have the unique opportunity to utilize a single source of cells, the placenta, to treat an unlimited number of CLI patients. Our presentations at the ISCT Annual Meeting and other conferences will highlight the potential of PLX-PAD as well as our core technology that enables the cost-effective development of cell therapies derived from the human placenta."
Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP) today announced that the United States Patent and Trademark Office has issued a patent that provides protection until August 2019 for rifaximin, which Salix markets in the United States under the trade names XIFAXAN (200mg) and XIFAXAN550 (550mg).
STAAR Surgical Company (Nasdaq:STAA) today announced CE Mark approval for a range of product improvements to the Company's Visian Implantable Collamer Lens (ICL) that more than doubles the current Visian addressable market in Europe. Included in the approval, STAAR Surgical received CE Mark approval for a Hyperopic Toric ICL which is designed for patients with both hyperopia, as well as astigmatism. Patients with hyperopia often referred to as farsightedness; have difficulty focusing on objects that are close up. Astigmatism is usually caused by an irregularly shaped cornea that causes blurred vision. Such patients are beyond the effective reach of existing surgical technologies and the Visian is the only option which will allow for the treatment of both conditions with one procedure.
St. Jude Medical, Inc. (NYSE:STJ), yesterday (Wednesday) after the bell announced a definitive agreement to acquire LightLab Imaging Inc., a subsidiary of Goodman Co., Ltd. (JASDAQ: 7535) for approximately $90 million in cash.
LightLab is the pioneer and leader in the development of Optical Coherence Tomography (OCT), a high resolution diagnostic coronary imaging technology which aids physicians in the treatment of cardiovascular disease. Earlier this month LightLab received Food and Drug Administration clearance of the first OCT products to be available in the United States. OCT diagnostic imaging technology has been shown to provide image resolution 10 times greater than intravascular ultrasound imaging systems (IVUS) and 20 times faster image capture.
VIA Pharmaceuticals, Inc. (Pinksheets:VIAP), a biotechnology company focused on the development of compounds for the treatment of cardiovascular and metabolic diseases, and The Montreal Heart Institute today announced the publication of clinical trial data from a study of VIA-2291, a 5-Lipoxygenase inhibitor (5-LO). Said Dr. Jean-Claude Tardif, Director of the Montreal Heart Institute Research Centre, professor of medicine at the University of Montreal, principal investigator of the VIA-2291 ACS trial and the lead author of the publication, "VIA-2291 is designed to target the underlying inflammatory disease process active in atherosclerosis, including the reduction of leukotrienes, an approach not addressed by currently available treatment. These newly published data strongly support the evaluation of VIA-2291 in larger outcome trials."
Vivakor, Inc. (OTCBB:VIVK) announced today that the Company has engaged IME Capital to structure joint venture relationships for its VIVASLICES MRI technology. Vivakor Inc. has also engaged its board member John Gryga, former GE Healthcare Executive, to act as lead on all transactions for VIVASLICES. VIVASLICES is a software technology aimed at increasing image resolution of previous generations of MRI units, thereby saving hospitals and clinics with older equipment millions of dollars in costs related to purchasing new MRI units with enhanced image resolution capacity.
Watson Pharmaceuticals, Inc. (NYSE:WPI) today announced that its subsidiary Cobalt Pharmaceuticals has received a Notice of Compliance from Health Canada to market Atorvastatin Calcium Tablets in the 10, 20, 40 and 80 mg strengths. Watson has initiated shipments of this product. Atorvastatin Calcium is the generic equivalent to Pfizer's LIPITOR tablets and is indicated to reduce the risk of heart attack, stroke,certain kinds of heart surgeries, and chest pain in patients with heart disease or several common risk factors for heart disease.
Allos Therapeutics, Inc. (NASDAQ: ALTH), a biopharmaceutical company committed to the development and commercialization of innovative anti-cancer therapeutics today announced that members of the Company's senior management will present on Thursday, May 27, 2010 at 8:30 a.m. ET at the 2010 Citi Investment Research Global Health Care Conference taking place at the Hilton New York.
Array BioPharma Inc. (NASDAQ:ARRY) announced four abstracts have been selected for presentation at the American Society of Clinical Oncology (ASCO) Annual Meeting, being held from June 4-8, 2010, in Chicago, Illinois.
Arcadia Resources, Inc. (NYSE Amex: KAD), a leading provider of innovative consumer health care services under the Arcadia HealthCare(SM) brand, today announced plans to expand its national headquarters and pharmacy operations.
BioReference Laboratories, Inc. (NASDAQ: BRLI) announced today it plans to issue earnings results for the second quarter of fiscal 2010 before the open of market trading on Thursday, May 27, 2010.
Boston Scientific Corporation (NYSE:BSX) today announced the schedule of the Company's major events at the annual EuroPCR Scientific Program, May 25 – 28 in Paris.
ChromoCure, Inc. (PINKSHEETS:KKUR) announced today its planned US Research Grant Centres.
Cord Blood America, Inc. (OTC Bulletin Board: CBAI), the umbilical cord blood stem cell preservation company focused on bringing the life saving potential of stem cells, a biological insurance policy, to families nationwide and internationally, announced today that it has filed its Form 10-Q for the first quarter ended March 31, 2010 with the U.S. Securities and Exchange Commission.
GeoVax Labs, Inc. (OTC Bulletin Board: GOVXD), a biotechnology company that creates, develops and tests innovative HIV/AIDS vaccines, is spotlighted on an interactive map posted on the website of Inc. magazine.
HemaCare Corporation (OTCBB: HEMA) today announced an agreement with Dendreon Corporation (NASDAQ: DNDN) to provide cellular collection services in Los Angeles and Maine for their new autologous cellular immunotherapy, PROVENGE® (sipuleucel-T).
David B. Snow Jr., chairman and chief executive officer, Medco Health Solutions, Inc. (NYSE:MHS), is scheduled to address the 2010 Citi Investment Research Global Health Care Conference in New York on Wednesday, May 26, 2010.
Medidata Solutions (NASDAQ: MDSO), a leading global provider of SaaS-based clinical development solutions, today announced that Tarek Sherif, chairman and chief executive officer, and Bruce Dalziel, chief financial officer, will present at the Citi Global Health Care Conference at 11:00 a.m. ET on May 27, 2010 in New York City.
MedVentive announced today that Universal American Corp. (NYSE:UAM), a leading provider of Medicare Advantage and Medicare Part D prescription drug plans, recently selected MedVentive's technology to enable increased collaboration among members, physicians, pharmacists and other healthcare professionals as a way to improve member health and confidence and reduce member cost.
Power3 Medical Products, Inc. (OTCBB: PWRM) announced today that, in collaboration with Lourdes R. Bosquez, MD, it has unexpectedly discovered new and unprecedented findings regarding clinically important differences in the response of the NuroPro® protein biomarkers in the blood of untreated Alzheimer’s disease patients compared to patients treated with the widely used anti-dementia drugs Aricept® (Donepezil HCl, Pfizer – NYSE: PFE), Exelon® (Rivastigmine, Novartis – NYSE: NVS), and Namenda® (Memantine HCl, Forest Laboratories – NYSE: FRX).
Regeneron Pharmaceuticals, Inc. (Nasdaq: REGN) will webcast its presentation at the 2010 Citi Investment Research Global Healthcare Conference on Wednesday, May 26, 2010.
Renhuang Pharmaceuticals, Inc. (Pink Sheets: RHGP), a developer, manufacturer and distributor of botanical products, bio-pharmaceuticals and traditional Chinese medicines, today announced that the Company successfully exhibited its unique portfolio of natural products at the 107th China Import and Export Fair held in Guangzhou, China from May 1 to May 5, 2010.
Rosetta Genomics, Ltd. (NASDAQ: ROSG), a leading developer and provider of microRNA-based molecular diagnostic tests, today announced that the Company will release financial results for the first quarter ended March 31, 2010, after the market closes on Wednesday, May 26, 2010.
Vitro Diagnostics, Inc. (OTCBB: VODG), dba Vitro Biopharma, announced that its CEO, Dr. James Musick was interviewed regarding the Company's current results and future prospects.
Volcano Corporation (Nasdaq: VOLC) announced today the successful completion of Optical Coherence Tomography (OCT) cases with Volcano's second generation OCT catheter and system. Pending IDE approval, Volcano plans to use this OCT system in the US and South America as part of VOILA, a U.S. regulatory trial during 2010.
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