Even with overall markets experiencing some jitters this week, several health-care stocks had spectacular results. Here are three of the most humongous health-care performers over the past five days.
Vertical
How does a 60% gain in one day sound? The stock chart for Vertex Pharmaceuticals (NASDAQ: VRTX ) shows a nearly vertical line this week, as that one-day increase had shares jumping 53% for the week.
All of this exuberance stemmed from very positive results from Vertex's phase 2 study of experimental drug VX-661 and currently marketed drug Kalydeco. The company reported on Thursday that the combination of the two drugs produced significant improvement in lung capacity for adult patients, with the most common gene mutation related to cystic fibrosis.
The solid results bode well for Vertex, as it hopes to move into late-stage studies for VX-661. The biotech received FDA approval for Kalydeco in treating another cystic fibrosis mutation last year. Vertex also has another drug targeting the disease, VX-809, in a phase 3 study.
Best Value Stocks To Invest In Right Now: Clovis Oncology Inc (CLVS)
Clovis Oncology, Inc. (Clovis) incorporated on April 20, 2009, is a Development-stage Company. The Company is a Biopharmaceutical Company. The Company focuses on acquiring, developing and commercializing anti-cancer agents in the United States, Europe and additional international markets. The Company also focuses on the treatment of specific subsets of cancer populations. During the year ended December 31, 2010, the Company was in the process of developing three product candidates for which it holds global marketing rights: CO-101, a lipid-conjugated form of the anti-cancer drug gemcitabine; CO-1686, an oral epidermal growth factor receptor (EGFR) mutant-selective inhibitor and CO-338, a poly ADP (Adenosine Diphosphate)-ribose polymerase (PARP) inhibitor. Effective November 19, 2013, Clovis Oncology Inc acquired the entire share capital of Ethical Oncology Science SpA.
CO-101 - a Lipid-Conjugated Form of the Anti-Cancer Drug Gemcitabine
CO-101 is designed to treat patients with pancreatic cancer whose tumors express low amounts of a membrane transporter protein on the surface of the cancer cell known as hENT1 and are thus expected to be resistant to standard gemcitabine-based therapy. Based on the published results of multiple studies assessing the correlation of hENT1 expression to survival outcomes in pancreatic cancer patients treated with gemcitabine, the Company estimates that approximately 40% to 50% of pancreatic patients express low levels of hENT1, and thus derive little or no benefit from gemcitabine therapy. CO-101 is in an international, randomized and controlled 360-patient study for the first-line treatment of metastatic pancreatic cancer. This open-label study compares CO-101 to gemcitabine as a first-line therapy in patients with metastatic pancreatic cancer. Clovis is partnered with Ventana Medical Systems for the development and commercialization of a companion diagnostic for the assessment of hENT1 levels.
CO-1686-an Oral EGFR Mutant-Selective ! Inhibitor
CO-1686 is an orally available, small molecule covalent inhibitor of the cancer-causing mutant forms of EGFR for the treatment of non-small cell lung cancer (NSCLC). CO-1686 targets both the initial activating EGFR mutations as well as the primary resistance mutation, T790M, it treats both first- and second-line NSCLC patients with EGFR mutations. Such initiating activating mutations occur in approximately 10% to 15% of NSCLC cases in Caucasian patients and approximately 30% to 35% of NSCLC cases in East Asian patients. Following treatment with approved NSCLC therapies, Tarceva (erlotinib) or Iressa (gefitinib), both known as tyrosine kinase inhibitors (TKIs), approximately half of these patients develop the T790M mutation.
The Company focuses on the development of CO-1686 as both a second-line therapy for EGFR-mutated NSCLC patients who become resistant to TKIs due to the emergence of the T790M secondary mutation and as a first-line treatment for EGFR-mutated NSCLC. Clovis is partnered with Roche Molecular Systems for the development and commercialization of a companion diagnostic for identification of EGFR mutations.
CO-338-a PARP Inhibitor
CO-338 is a small molecule PARP inhibitor that the Company focuses to develop as both monotherapy and in combination with chemotherapeutic agents for the treatment of selected cancer patients. CO-338 is in a Phase I clinical trial to determine the maximum tolerated dose of oral CO-338 that can be combined with intravenous, or IV, platinum chemotherapy in the treatment of solid tumors. This program is supplemented by two ongoing investigator-initiated trials, using the IV formulation of CO-338: a Phase I/II study in germ-line BRCA mutant breast and ovarian cancer and a Phase II study in the adjuvant treatment of germ-line BRCA mutant and triple-negative breast cancer. The Company also focuses on initiating a Phase I monotherapy study of the oral formulation, to determine an appropriate dose and schedule.!
The Company competes with Eli Lilly, Teva Pharmaceutical Industries, APP Pharmaceuticals, AB Science SA, Amgen Inc., Astellas Pharma, BioSante Pharmaceuticals, Inc., Celgene Corporation, Immunomedics, Inc., Lorus Therapeutics, Threshold Pharmaceuticals, Inc., Boehringer Ingelheim, Pfizer, Sanofi-Aventis, Astra Zeneca, Abbott, Merck, Eisai, Cephalon and Biomarin.
Advisors' Opinion:- [By James E. Brumley]
Cancer drug investors who have been disappointed in recent results from shares of Clovis Oncology Inc. (NASDAQ:CLVS) or Nuvilex Inc. (OTCMKTS:NVLX) lately may want to take a look at ZIOPHARM Oncology Inc. (NASDAQ:ZIOP) as a replacement for either of those first two stocks. CLVS is down about 16% for the week on a less-than-flattering write-up in a Bloomberg publication, and NVLX has moved under a pair of key moving averages this week because, well, for no specific reason, but broadly because the recent wave of compelling news is already losing its potency, with most of that upside already being priced into shares (and then some) before it became official.
- [By Anders Bylund]
No. 1 with a bullet
Nobody, but nobody, is beating Clovis Oncology (NASDAQ: CLVS ) right now. The cancer-focused biotech company got the party started with a fine earnings report in February, which helped push the stock 15% higher overnight. But that's nothing next to the 136% one-day pop Clovis experienced after releasing positive data from early-stage studies on two types of cancer-busting drugs. - [By John Udovich]
Bubble talk, biotech IPO setbacks plus news�about small cap biotechs like Intrexon Corp (NYSE: XON) and TNI BioTech (OTCMKTS: TNIB) have dominated biotech news this week or in recent weeks. Just consider the following news:
Why There is No Biotech Bubble & Where to Look for Value in Biotech. Marshall Gordon, the Director and senior health-care analyst of ClearBridge Investments, was recently interviewed by Barron�� where he stated his belief that there is no biotech bubble because biotech stocks have delivered new drugs and have shown an ability to innovate. With that said, he added that the sector got ahead of itself while some biotechs suffered setbacks plus hedge funds decided to trim risk from their portfolios. Nevertheless, Marshall likes or is watching mid cap biotechs BioMarin Pharmaceutical Inc (NASDAQ: BMRN) and Pharmacyclics, Inc (NASDAQ: PCYC) along with small cap biotechs�Pacira Pharmaceuticals Inc (NASDAQ: PCRX) and Clovis Oncology Inc (NASDAQ: CLVS). He also added that recent biotech IPOs have been lesser quality names than earlier offerings. A Trio of Biotech�IPO Setbacks. FierceBiotech has�summarized how a trio of biotech IPO have suffered setbacks. Specifically, Relypsa (NASDAQ: RLYP), a late-stage biotech developing a treatment for hyperkalemia,�slashed its asking price on 6.9 million shares to $12 a share to raise $82 million�from a range of $16 to $19 a share while�Xencor (NASDAQ: XNCR), a biotech developing antibodies for severe autoimmune/allergic diseases and cancer,�has dropped its IPO price to $7 a share to raise $75 million from a range of $14 to $16. Meanwhile, Celladon, which is developing a first-in-class gene therapy for patients with systolic heart failure, has postponed its IPO citing poor market conditions. Coming�Biotech IPOs. Nevertheless, FierceBiotech has noted that GeNO Healthcare (NASDAQ: GNO) is looking to raise $50 million for its�new, patient-friendly approach for delivering inhaled nitric oxide on the - [By Jake L'Ecuyer]
Clovis Oncology (NASDAQ: CLVS) was also up, gaining 7.26 percent to $79.35 after the company announced 2014 objectives and financial outlook. The company projected to initiate three global registration studies for CO-1686.
10 Best Biotech Stocks For 2014: Bio-Path Holdings Inc (BPTH)
Bio-Path Holdings Inc is a development stage company. The Company, through its wholly owned subsidiary, Bio-Path, Inc. is engaged in the business of developing cancer therapeutics. As of December 31, 2011, the Company had licenses from The University of Texas M. D. Anderson Cancer Center (MD Anderson) for three lead products and nucleic acid delivery technology, including tumor targeting technology. The licenses provide drug delivery platform technology with composition of matter intellectual property for antisense that enables systemic delivery of antisense, formulation intellectual property for systemic delivery of small interfering Ribonucleic acid (RNA) (siRNA) and small molecules for treatment of cancer. The Company issued a press release announcing that the United States Food and Drug Administration (FDA) had allowed an IND (investigational new drug) for its lead cancer drug candidate liposomal BP-100-1.01 (or Liposomal Grb-2 or L-Grb-2) to proceed into clinical trials.
In February, 2012, the Company completed requirements for treating patients in the second cohort. The dose being used for treatment in the third cohort is double the dose that was used to treat patients in the second cohort. At the end of February, 2012, enrollment continued in the third cohort of the clinical trial and patients are being treated.
BP-100-1.01
BP-100-1.01 is the Company's lead lipid delivery antisense drug candidate, which is being clinically tested in patients having acute myeloid leukemia (AML), chronic myelogenous leukemia (CML), myelodysplastic syndrome (MDS) and acute lymphoblastic leukemia (ALL). Receipt of an IND allowed the Company to commence its Phase I clinical trial to study L-Grb-2 in human patients. Phase I clinical trial is a dose-escalating study to determine the safety and tolerance of escalating doses of L-Grb-2. The clinical trial is being conducted at The University of Texas MD Anderson Cancer Center. As of December 31, 2011, the trial is in the middle of ! testing the third dose in patients.
BP-100-2.01
BP-100-1.02 is Liposomal Bcl-2 (also L-Bcl-2), another liposomal antisense drug candidate that was licensed from MD Anderson. This drug has pre-clinical testing data package. The target protein for this drug candidate, Bcl-2, is involved in regulating programmed cell death. In cancer, the Bcl-2 protein can over-express, which can lead to a situation, in which the Bcl-2 protein blocks the cell�� normal death signals, making the cancer cell resistant to chemotherapy. Types of cancer potentially treatable with L-Bcl-2 include lymphoma, prostate cancer, small cell lung cancer, breast cancer, melanoma, chronic lymphoid leukemia (CLL) and several others.
Advisors' Opinion:- [By Lisa Levin]
Bio-Path Holdings (NASDAQ: BPTH) shares declined 5.66% to touch a new 52-week low of $2.50. Bio-Path shares have jumped 349.15% over the past 52 weeks, while the S&P 500 index has gained 19.24% in the same period.
10 Best Biotech Stocks For 2014: Cellular Dynamics International Inc (ICEL)
Cellular Dynamics International, Inc., incorporated on November 16, 2007, develops and manufactures fully functioning human cells in industrial quantities to precise specifications. The Company�� iCell Operating System (iCell O/S) includes true human cells in multiple cell types (iCell products), human induced pluripotent stem cells (iPSCs) and custom iPSCs and iCell products (MyCell products). Customers use its iCell O/S products, among other purposes, for drug discovery and screening; to test the safety and efficacy of their small molecule and biologic drug candidates; for stem cell banking; and in researching cellular therapeutics. The Company�� iCell product line includes four different cell types: cardiomyocytes, neurons, hepatocytes and endothelial cells. The Company is actively developing an additional seven different cell types. iCell products are a consumable designed to be used once and then reordered.
The Company manufactures its iCell products from its iPSCs. An iPSC is a cell that has the ability both to replicate indefinitely and to be transformed into any cell type in the human body. The Company�� iCell O/S consists of six products, which include iCell Cardiomyocytes, iCell Neurons, iCell Endothelial Cells, iCell Hepatocytes and MyCell.
Advisors' Opinion:- [By John Udovich]
Stem cells may not be in the news much�as the sector has moved beyond the use of embryotic�ones, but small cap stem cell stocks Cellular Dynamics International Inc (NASDAQ: ICEL), International Stem Cell Corp (OTCMKTS: ISCO) and BioRestorative Therapies (OTCBB: BRTX) have been fairly active over the past several trading days as ICEL went public, ISCO raised additional funding and BRTX grabbed more attention:
10 Best Biotech Stocks For 2014: Stemline Therapeutics Inc (STML)
Stemline Therapeutics, Inc. (Stemline), incorporated on August 8, 2003, is a clinical-stage biopharmaceutical company focused on discovering, acquiring, developing and commercializing therapeutics that target both cancer stem cells (CSCs) and tumor bulk. The Company is developing two clinical-stage product candidates, SL-401 and SL-701, for which it holds global marketing rights. The indication for SL-401, a biologic-drug conjugate, is acute myeloid leukemia (AML). The indications for SL-701, a synthetic peptide vaccine, are pediatric and adult brain cancer. It has a platform, StemScreen, for the discovery of CSC-targeted compounds, from which it has discovered or validated several of its clinical and preclinical product candidates. Stemline�� StemScreen consists of StemScreen-1 and StemScreen-2 for the identification of CSC-directed compounds.
SL-301 is a small molecule gamma-secretase inhibitor that inhibits Notch, a pathway expressed by CSCs and tumor bulk of multiple cancer types. SL-101 is a monoclonal antibody-based (mAb -based) compound that targets CD123 and has shown in vitro activity against certain hematologic cancers. SL-201 is a small molecule active against certain hematologic and solid tumor types. SL-601 is a mAb-based compound that targets a cell surface marker on bladder CSCs, which is also expressed on a variety of other solid tumor types. It has also in-licensed certain intellectual property directed to mAb-based therapeutics to validated oncology targets, including Glypican-3, Tie-1, CD133, Frizzled, Smoothened and Patched.
SL-401 - An IL-3R-Directed Compound Targeting Cancer Stem Cells and Tumor Bulk
SL-401 is a clinically active biologic-drug conjugate consisting of human interleukin-3 (IL-3) genetically linked to a truncated version of diphtheria toxin. SL-401 targets the IL-3 receptor (IL-3R), which is overexpressed on both the CSCs and tumor bulk of multiple hematologic cancers, including AML. SL-401 has demonstrated preclinical in vit! ro and in vivo activity against both leukemia blasts (which includes tumor bulk) and CSCs of a range of human leukemia cell lines and primary leukemia cells from patients.
SL-701
SL-701 is a clinically active synthetic peptide vaccine that targets several epitopes on CSCs and tumor bulk of brain cancer. In two completed Phase 1/2 clinical trials, SL-701 demonstrated single agent anti-tumor activity in pediatric patients with newly diagnosed brainstem glioma (BSG) and other high-grade gliomas (HGGs) and in adult patients with refractory or recurrent GBM, and other HGGs.
StemScreen-1
StemScreen-1 is a drug discovery platform designed to identify CSC-targeted compounds based on the isolation of CSCs and evaluation of CSC gene expression profiles. CSCs are isolated from primary tumor tissue or cell lines, and then subjected to gene expression analysis using a variety of technologies, including microarray. A control tissue, such as normal bone marrow is analyzed as a comparator against the gene expression profile of the isolated CSCs. These data are then interfaced with an information base of compounds and their mechanisms of action (that is which gene products and pathways they impact). It has utilized StemScreen-1 to discover a number of its preclinical drug candidates. These include SL-201, SL-301, and SL-601. In addition, SL-401 demonstrated activity against CSCs as determined by both an in vitro colony formation and in vivo animal implantation assay, thereby validating certain StemScreen-1 anti-CSC assays.
StemScreen-2
StemScreen-2 is a high throughput drug discovery platform it is developing to discover anti-CSC compounds. StemScreen-2 utilizes a cell-based assay that can track and follow CSCs in their natural state during high throughput screening. In particular, StemScreen-2 utilizes a CSC-specific promoter linked to a reporter as a method for identifying and following CSCs in their native environment of surrounding tumor b! ulk. In t! his way, StemScreen-2 enables the identification of compound hits, in a high throughput manner, with anti-CSC activity.
The Company competes with Boston Biomedical, Inc., Eclipse Therapeutics, Inc., OncoMed Pharmaceuticals, Inc., Verastem, Inc., Astellas Pharma US, Inc., Boehringer Ingelheim GmbH, Dainippon Sumitomo Pharma Co. Ltd., Geron Corp., GlaxoSmithKline plc, ImmunoCellular Therapeutics, Ltd, Macrogenics Inc., Amgen, Inc., Pfizer Inc., Roche Holding AG, Sanofi U.S. LLC., Cyclacel Pharmaceuticals, Inc., Sunesis Pharmaceuticals Inc., Clavis Pharma ASA, Ambit Biosciences Corporation, Celgene Corporation, Eisai Co. Ltd., Celator Pharmaceuticals, Inc., Merck & Co., Inc., Eisai Co., Inc., Roche Holding AG, Novartis AG and Celldex Therapeutics, Inc.
Advisors' Opinion:- [By Jay Silverman]
Some of the biggest leaders in that field, and there have been dozens in fields, if not more this year, such as Bluebird (BLUE) and Stemline Therapeutics (STML) and have all pulled back to significantly lower levels; even below, in Bluebird's case, the price that had actually opened up as an IPO, even though it's above its IPO price.
- [By David Zeiler]
3. Stemline Therapeutics Inc. (Nasdaq: STML): This biotech develops drugs that target cancer stem cells and tumors. Stemline went public January 29 at $10 a share and rose just 11.78% on its first day. But STML has climbed steadily since, and currently trades at $37.46, up 274.6% from its IPO price.
- [By Keith Speights]
Best-performing biotech IPO
Stemline Therapeutics� (NASDAQ: STML ) has only traded publicly this year, but what a year it's been. The stock's performance ranks Stemline as the best-performing biotech IPO so far in 2013. This week has been pretty good also, with shares moving up by 28%.
10 Best Biotech Stocks For 2014: Prosensa Holding NV (RNA)
Prosensa Holding N.V., formerly Prosensa Holding B.V., is a biotechnology company engaged in the discovery and development of ribonucleic acid-modulating (RNA)-modulating, therapeutics for the treatment of genetic disorders. The Company�� primary focus is on rare neuromuscular and neurodegenerative disorders with a large unmet medical need, including Duchenne muscular dystrophy, myotonic dystrophy and Huntington�� disease. The Company�� clinical portfolio of RNA-based product candidates is focused on the treatment of Duchenne muscular dystrophy (DMD). The Company�� platform technology allows the development of RNA-modulating therapeutics that either interferes with splicing (exon skipping, exon inclusion, or splice mutation correction), remove mutant RNA, or block RNA expression, for different indications.
DMD is a rare, severe muscle wasting disease that occurs in up to 1 in 3,500 male births. It is commonly diagnosed between the ages of three to five, when boys begin to show signs of impaired motor development. PRO044, the Company�� product candidate, addresses a separate sub-population of DMD patients. The Company developed PRO044 using its exon-skipping technology to generate a product candidate with the same mechanism of action that is used by drisapersen.
Advisors' Opinion:- [By John Udovich]
It should also be mentioned that earlier in the week, GlaxoSmithKline plc (NYSE: GSK) returned full rights of Duchenne muscular dystrophy drug drisapersen to their partner�Prosensa Holding NV (NASDAQ: RNA) and that news sent shares down 12.48% on�Monday. Moreover,�Prosensa Holding also sank some 70% last fall when Drisapersen failed a phase 3 trial by missing a primary endpoint measuring for how far patients could walk over the course of six minutes (the improvement�wasn't significantly better than the placebo).�However, Prosensa Holding also rose 24.37% yesterday after announcing�initial findings from further analyses from the aggregate data for drisapersen, with the CEO saying:
- [By Garrett Cook]
Prosensa Holding N.V. (NASDAQ: RNA) shares were also up, gaining 8.20 percent to $13.00 on the FDA requirement of additional data from Sarepta on Eteplirsen. Prosensa Holding is also looking to provide a drug to treat Duchenne muscular dystrophy.
- [By Leo Sun]
However, these three biotech stocks -- Amarin (NASDAQ: AMRN ) , Dendreon (NASDAQ: DNDN ) , Prosensa (NASDAQ: RNA ) -- don't fit that category at all. Read on to understand why these dogs of the sector should never be mistaken as underdogs.
10 Best Biotech Stocks For 2014: Senesco Technologies Inc (SNTI)
Senesco Technologies, Inc., incorporated on September 30. 1999, is engaged in utilize its eukaryotic translation initiation Factor 5A, or Factor 5A, and deoxyhypusine synthase (DHS), and related technologies for human therapeutic applications to develop approaches to treat cancer and inflammatory diseases. In agricultural applications, the Company has licensed applications of the Factor 5A, DHS and Lipase platforms to develop the productivity of fruits, flowers, vegetables, agronomic and biofuel feedstock crops through the control of cell death and growth in plants.
Human Therapeutic Applications
The Company has developed a therapeutic candidate, SNS01-T, an improved formulation of SNS01, for the potential treatment of multiple myeloma and non-Hodgkin B-cell lymplomas. SNS01-T utilizes the Company's Factor 5A technology and consists of two components, which include a DNA plasmid (pDNA), expressing human eIF5A containing a lysine to arginine substitution at amino acid position 50, (eIF5AK50R), and a small inhibitory RNA (siRNA). These two components are combined in a fixed ratio with a polymer, polyethyleneimine (PEI), which enables self-assembly of the DNA and RNA into nanoparticles with demonstrated enhanced delivery to tissues and protection from degradation in the blood stream. The Company has also demonstrated that the combination of lenalidomide and SNS 01-T performs better than either treatment alone in mouses xenograft models of human mantle cell lymphoma. The Company's human therapeutic research program, which consists of pre-clinical in-vitro and in-vivo experiments designed to assess the role and mode of action of Factor 5A in human diseases and a phase 1a/2b clinical trial.
The Company competes with Celgene, Inc., Takeda/Millennium, ONYX Pharmaceuticals, Inc., Amgen Inc., Janssen Biotech, Inc., Novartis AG, and Pharmacyclics, Inc.
Agricultural Applications
The Company's agricultural research focuses on the discovery and develo! pment of certain gene technologies, which are designed to confer positive traits on fruits, flowers, vegetables, forestry species and agronomic crops. The Company's research and development initiatives for agriculture include develop and implement the DHS and Factor 5A gene technology in banana, canola, cotton, turfgrass, rice, alfalfa, corn, soybean and trees; and test the resultant crops for new beneficial traits such as increased yield, increased tolerance to environmental stress, disease resistance and more efficient use of fertilizer.
The Company competes with Mendel Biotechnology, Renessen LLC, Exelixis Plant Sciences, Inc., and Syngenta International AG.
Advisors' Opinion:- [By Peter Graham]
At the end of last week, small cap stocks Senesco Technologies, Inc (OTCBB: SNTI), VolitionRX Ltd (OTCMKTS: VNRX) and Micromem Technologies Inc (OTCBB: MMTIF) were all trending upwards ��ending up 13.65%, 8.73% and 7.61%, respectively, on Friday. However, it�� a new trading week with the last two trading days for the year. So what direction will these three small caps head in for the end of this year and into next year? Here is a quick look to help you decide on a trading or investment strategy:
- [By CRWE]
Today, SNTI has shed (-2.44%) down -0.0010 at $.0400 with�723,673 shares in play thus far (ref. google finance Delayed: 2:58PM EDT October 7, 2013).
Senesco Technologies, Inc. previously reported it has entered into a securities purchase agreement with certain investors to raise $1.725 million in gross proceeds through the sale of 69,000,000 shares of its common stock. The common stock was priced at $0.025 per share.
The offering is expected to close on or about October 2, 2013, subject to customary closing conditions. The net proceeds of the financing will be used primarily for working capital, research and development and general corporate purposes.
10 Best Biotech Stocks For 2014: Galena Biopharma Inc (GALE)
Galena Biopharma, Inc. (Galena), formerly RXi Pharmaceuticals Corporation, incorporated on April 3, 2006, is a biotechnology company focused on discovering, developing and commercializing therapies addressing unmet medical needs using targeted biotherapeutics. The Company is pursuing the development of cancer therapeutics using peptide-based immunotherapy products, including its main product candidate, NeuVaxTM (E75), for the treatment of breast cancer and other tumors. NeuVax is a peptide-based immunotherapy intended to reduce the recurrence of breast cancer in low-to-intermediate HER2-positive breast cancer patients not eligible for trastuzumab (Herceptin; Genentech/Roche). On January 19, 2012, the Company initiated enrollment in its Phase 3 PRESENT clinical trial for NeuVax (E75 peptide plus GM-CSF) vaccine in low-to-intermediate HER2 1+ and 2+ breast cancer patients in the adjuvant setting to prevent recurrence (Clinicaltrials.gov identifier NCT01479244). The Prevention of Recurrence in Early-Stage, Node-Positive Breast Cancer with Low to Intermediate HER2 Expression with NeuVax Treatment study is a randomized, multicenter, multinational clinical trial that will enroll approximately 700 breast cancer patients. The Company�� Phase 2 trial of NeuVax achieved its primary endpoint of disease-free survival (DFS). On April 13, 2011, the Company completed its acquisition of Apthera, Inc.,(Apthera).
The Company focuses to start a Phase 2 trial comparing NeuVax in combination with trastuzumab (Herceptin) versus trastuzumab, alone, in a 300-patient, randomized study in the adjuvant breast cancer setting. The Company's second product candidate, Folate Binding Protein-E39 (FBP), is a vaccine, consisting of the peptides E39 and J65, aimed at preventing the recurrence of ovarian, endometrial, and breast cancers. On February 14, 2012, the Company announced the initiation of a Phase 1/2 clinical trial in two gynecological cancers: ovarian and endometrial adenocarcinomas. Folate binding protein has ! very limited tissue distribution and expression in non-malignant tissue and is over-expressed in more than 90% of ovarian and endometrial cancers, as well as in 20% to 50% of breast, lung, colorectal and renal cell carcinomas.
In April 2011, the Company acquired Apthera Inc and its NeuVax product candidate. The Company focuses on developing a pipeline of immunotherapy product candidates for the treatment of various cancers based on the E75 peptide, the advanced of which is NeuVax, which is targeted at preventing the recurrence of breast cancer. NeuVax has had positive Phase 1/2 clinical trial results for the prevention of breast cancer recurrence in patients who have had breast cancer and received the standard of care treatment (surgery, chemotherapy, radiotherapy and hormonal therapy as indicated). The Company had also initiated its Phase 3 PRESENT clinical trial of NeuVax for the prevention of breast cancer recurrence in early-stage low-to-intermediate HER2 breast cancer patients. NeuVax directs killer T-cells to target and destroy cancer cells that express HER2/neu, a protein associated with epithelial tumors in breast, ovarian, pancreatic, colon, bladder and prostate cancers. NeuVax is comprised of a HER2/neu-derived peptide called E75. E75 is a nine-amino acid sequence that is immunogenic (produces an immune response) and GM-CSF is a commercially available protein that acts to stimulate and activate components of the immune system such as macrophages and dendritic cells.
The Company also develops novel applications for NeuVax based on preclinical studies and phases 2 clinical trials which suggest that combining NeuVax and trastuzumab (Herceptin; Genentech/Roche) can increase antigen presentation by tumor cells by promoting receptor internalization and subsequent proteosomal degradation of the HER2 protein. The Company also is pursuing additional therapeutic indications for NeuVax that are in Phase 1/2 clinical trials. RXI-109, is a dermal anti-scarring therapy that targets! connecti! ve tissue growth factor (CTGF) and that may inhibit connective tissue formation in human fibrotic disease.
The Company competes with Roche Laboratories, Inc., Pfizer Inc., Bayer HealthCare AG, Sanofi-Aventis, US, LLC, Amgen, Inc., GlaxoSmithKline plc, Renovo Group plc, CoDa Therapeutics, Inc., Sirnaomics, Inc., FirstString Research, Inc., Merz Pharmaceuticals, LLC, Capstone Therapeutics, Halscion, Inc., Garnet Bio Therapeutics, Inc., AkPharma Inc., Promedior, Inc., Kissei Pharmaceutical Co., Ltd., Eyegene, Derma Sciences, Inc., Healthpoint Biotherapeutics, Pharmaxon, Excaliard Pharmaceuticals, Inc., Alnylam Pharmaceuticals, Inc., Marina Biotech, Inc., Tacere Therapeutics, Inc., Benitec Limited, OPKO Health, Inc., Silence Therapeutics plc, Quark Pharmaceuticals, Inc., Rosetta Genomics Ltd., Lorus Therapeutics, Inc., Tekmira Pharmaceuticals Corporation, Arrowhead Research Corporation, Regulus Therapeutics Inc. and Santaris.
Advisors' Opinion:- [By James E. Brumley]
It may look like little more than a choppy mess with just a quick glance at Galena Biopharma Inc. (NASDAQ:GALE). But, the more you study the chart - and the company - the more you realize there's enough long-term potential from the company's pipeline to keep spurring GALE in a generally-upward direction. In fact, the bulls look like they're on the verge of taking Galena Biopharma out of second gear and putting it into third. As such, it may not be a bad bet at this point.
No comments:
Post a Comment