Although we don't believe in timing the market or panicking over market movements, we do like to keep an eye on big changes -- just in case they're material to our investing thesis.
What: Shares of Integra LifeSciences (NASDAQ: IART ) , a manufacturer of surgical instruments and medical implants, fell as much as 13% after the company announced a voluntary recall of certain products at its Anyasco manufacturing facility in Puerto Rico.
So what: The recall encompasses its DuraGen Dural Graft Matrix products that were manufactured between December 2010 and May 2011 and between November 2012 and March 2013. Integra noted that there "may have been deviations from approved processes in their production." On the bright side, there have no adverse events reported, and it appears to have remedied the manufacturing problem. However, the damage of the recall is done and will reduce its upcoming quarterly revenue by $8 million to $11 million to a range of $194 million to $197 million. Earnings will also be affected, with the company slated to now only earn an adjusted $0.30-$0.40 in the first quarter. Further, its second-quarter forecast was adjusted slightly lower to $205 million to $211 million because it may not be able to meet all necessary DuraGen Dural Graft Matrix product demand. As icing on the cake, Northland Capital downgraded Integra to "market perform" from "outperform."
Hot Medical Stocks To Own For 2015: Cell Therapeutics Inc (CTIC)
Cell Therapeutics, Inc. (CTI), incorporated in 1991, develops, acquires and commercializes treatments for cancer. The Company�� research, development, acquisition and in-licensing activities concentrate on identifying and developing new ways to treat cancer. As of December 31, 2011, CTI focused its efforts on Pixuvri (pixantrone dimaleate) (Pixuvri), OPAXIO (paclitaxel poliglumex) (OPAXIO), tosedostat, brostallicin and bisplatinates. As of December 31, 2011, it developed Pixuvri, an anthracycline derivative for the treatment of hematologic malignancies and solid tumors. Another late-stage drug candidate of the Company, OPAXIO, is being studied as a potential maintenance therapy for women with advanced stage ovarian cancer, who achieve a complete remission following first-line therapy with paclitaxel and carboplatin. As of December 31, 2011, it also developed tosedostat in collaboration with Chroma Therapeutics, Ltd. (Chroma). On May 31, 2012, CTI completed its acquisition gaining worldwide rights to S*BIO Pte Ltd.'s (S*BIO) pacritinib.
Pixuvri
As of December 31, 2011, the Company developed Pixuvri, an aza-anthracenedione derivative, for the treatment of non-Hodgkin�� lymphoma (NHL), and various other hematologic malignancies, and solid tumors. Pixuvri was studied in the Company�� EXTEND, or PIX301, clinical trial, which was a phase III single-agent trial of Pixuvri for patients with relapsed, refractory aggressive NHL who received two or more prior therapies and who were sensitive to treatment with anthracyclines. On September 28, 2011, CTI announced that a second independent radiology assessment of response and progression endpoint data from its PIX301 clinical trial of Pixuvri was achieved with statistical significance. The results of the EXTEND trial met its primary endpoint and showed that patients randomized to treatment with Pixuvri achieved a significantly higher rate of confirmed and unconfirmed complete response compared to patients treated with standard chem! otherapy had a significantly increased overall response rate and experienced a statistically significant improvement in median progression free survival. Pixuvri had predictable and manageable toxicities when administered at the proposed dose and schedule in the EXTEND clinical trial in heavily pre-treated patients. In March 2011, the Company initiated the PIX-R trial to study Pixuvri in combination with rituximab in patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL). Pixuvri has also been studied in patients with HER2-negative metastatic breast cancer who have tumor progression after at least two, but not more than three, prior chemotherapy regimens. In the second quarter of 2010, the NCCTG opened this phase II study for enrollment. The study is closed to accrual and results are expected to be reported by the NCCTG later in 2012.
OPAXIO
OPAXIO is the Company�� biologically-enhanced chemotherapeutic agent that links paclitaxel to a biodegradable polyglutamate polymer, resulting in a new chemical entity. As of December 31, 2011, the Company focused its development of OPAXIO on ovarian, brain, esophageal, head and neck cancer. OPAXIO was designed to improve the delivery of paclitaxel to tumor tissue while protecting normal tissue from toxic side effects. In November 2010, results were presented by the Brown University Oncology Group from a phase II trial of OPAXIO combined with temozolomide (TMZ), and radiotherapy in patients with newly-diagnosed, high-grade gliomas, a type of brain cancer. The trial demonstrated a high rate of complete and partial responses and a high rate of six month progression free survival (PFS). Based on these results, the Brown University Oncology Group has initiated a randomized, multicenter, phase II study of OPAXIO and standard radiotherapy versus TMZ and radiotherapy for newly diagnosed patients with glioblastoma with an active gene termed MGMT that reduces responsiveness to TMZ. A phase I/II study of OPAXIO combined with radi! otherapy ! and cisplatin was initiated by SUNY Upstate Medical University, in patients with locally advanced head and neck cancer.
Tosedostat
In March 2011, the Company entered into a co-development and license agreement with Chroma Therapeutics, Ltd. (Chroma), providing the Company with marketing and co-development rights to Chroma�� drug candidate, tosedostat, in North, Central and South America. Tosedostat is an oral, aminopeptidase inhibitor that has demonstrated anti-tumor responses in blood related cancers and solid tumors in phase I-II clinical trials. Interim results from the phase II OPAL study of tosedostat in elderly patients with relapsed or refractory acute myeloid leukemia (AML) showed that once-daily, oral doses of tosedostat had predictable and manageable toxicities and results demonstrated response rates, including a high-response rate among patients who received prior hypomethylating agents, which are used to treat myelodysplastic syndrome (MDS), a precursor of AML.
Brostallicin
As of December 31, 2011, the Company developed brostallicin through its wholly owned subsidiary, Systems Medicine LLC, which holds rights to use, develop, import and export brostallicin. Brostallicin is a synthetic deoxyribonucleic acid (DNA) minor groove binding agent that has demonstrated anti-tumor activity and a favorable safety profile in clinical trials, in which more than 230 patients have been treated as of December 31, 2011. The Company uses a genomic-based platform to guide the development of brostallicin. A phase II study of brostallicin in relapsed, refractory soft tissue sarcoma met its predefined activity and safety hurdles and resulted in a first-line phase II clinical trial study that was conducted by the European Organization for Research and Treatment of Cancer (EORTC).
The Company competes with Bristol-Myers Squibb Company, Sanofi-Aventis, Pfizer, Roche Group, Genentech, Inc., Astellas Pharma, Eli Lilly and Company, Celgene, Telik, I! nc., TEVA! Pharmaceuticals Industries Ltd. and PharmaMar.
Advisors' Opinion:- [By MONEYMORNING]
Cell Therapeutics Inc. (Nasdaq: CTIC), based in Seattle, Wash., acquires, develops, and commercializes treatments for cancers, including non-Hodgkin's leukemia and ovarian, neck, and brain cancers. The company just announced it has completed patient enrollment in clinical trials for an investigational agent to be used as a maintenance therapy in ovarian cancer patients. The trial is being conducted by the Gynecologic Oncology Group, one of the National Cancer Institute's funded research groups. Roth Capital recently reiterated a "Buy" rating on the stock and raised its price target from $6 to $7. Roth believes the company's treatment for leukemia, Pacritinib, is effectively evolving. Additionally, the investment firm sees potential in CTIC's Tosedostat, which deprives tumor cells of the amino acid building blocks needed to make proteins necessary for tumor cell survival. Shares rose 2% Tuesday to $3.52 on volume of 6 million shares.
Hot Medical Stocks To Own For 2015: Opt-Sciences Corp (OPST)
Opt-Sciences Corporation, incorporated on November 1956, conducts its business through its wholly owned subsidiary, O and S Research, Inc. The Company deposits anti-glare and/or transparent conductive optical coatings on glass used primarily to cover instrument panels in aircraft cockpits. It also provides full glass cutting, grinding and painting operations, which augment its optical coating capabilities. Its products are designed to enable pilots to read aircraft instruments in direct sunlight or at night or in covert situations using appropriate night vision filters or to protect the instruments from electromagnetic interference. The Company�� business is dependent on a robust commercial, business, and regional aircraft market and to a lesser degree the military aircraft market. It generally has a four to twelve week delivery cycle depending on product complexity, available plant capacity and required lead time for specialty raw materials, such as polarizers or filter glass.
The Company�� offers incorporate an optical coating of some type. Its primary coatings are for aircraft cockpit display applications and consist of its anti-reflection coating used for glare reduction and its transparent conductive coating used for electromagnetic interference shielding. In addition, it also offers a full range of other specialty instrument glass, including night vision filter glass, circular polarizers, touchpads, glass sandwiches for liquid crystal displays (LCDs) as well as other custom designed specialty glass components and assemblies. It uses its technology to apply a micro thin optical non-glare and/or conductive coating to the glass. Both processes utilize the deposit of a thin film of metal or metal oxide on the surface of the glass. The process takes place in a heated vacuum chamber. It heats the deposited material to over 1800 degrees Centigrade causing it to evaporate.
The Company competes with JDSU, Mod A Can, Dontech, Schott Glass and Hoya Optics
Advisors' Opinion:- [By Geoff Gannon] ng>Micropac
Micropac is 76% owned by Heinz-Werner Hempel. He�� a German businessman. You can see the German company he founded here. He�� had control of Micropac for a long-time. I don�� have an exact number in front of me. But I would guess it�� been something like 25 years.
ADDvantage
ADDvantage Technologies is controlled by the Chymiak brothers. See the company�� April 4 press release explaining their decision to turn over the CEO position to an outsider. Regardless, the Chymiaks still control 47% of the company. Ken Chymiak is now chairman. And David Chymiak is still a director and now the company�� chief technology officer. Clearly, it�� still their company.
By the way, the name ADDvantage Technologies has nothing to do with the Chymiaks. Today�� AEY really traces its roots to a private company called Tulsat. The Chymiak brothers acquired that company about 27 years ago. So, effectively, when you buy shares of AEY you are buying into a 27-year-old family-controlled company.
That�� pretty typical in the world of net-nets.
Solitron
Solitron Devices is 29% owned by Shevach Saraf. He has been the CEO for 20 years. The post-bankruptcy Solitron has never known another CEO. Before the bankruptcy, Solitron was a much bigger, much different company. So even though we are not talking about the founder here ��and even though 70% of the company�� shares are not held by the CEO ��we��e still talking about a company where one person has a lot of control. Solitron only has three directors. Saraf is the chairman, CEO, president, CFO and treasurer. Neither of the other two directors joined the board within the last 15 years. So, we aren�� talking about a lot of tumult at the top.
In fact, profitable net-nets seem to be especially common candidates for abandoning the responsibilities of a public company without actually getting taken private.
OPT-Sciences
This company is controlled by Arthu
Best Clean Energy Stocks To Invest In 2015: Tekmira Pharmaceuticals Corp (TKMR)
Tekmira Pharmaceuticals Corporation is a biopharmaceutical company focused on advancing ribonucleic acid (RNA) interference (RNAi) therapeutics and providing its lipid nanoparticle (LNP) delivery technology to pharmaceutical partners. On March 1, 2012, it announced that the Company had secured a license from Alnylam to develop TKMALDH2, an RNAi therapeutic that utilizes Tekmira's LNP for the treatment of Alcohol Dependence (AD). Its lead oncology product candidate, TKM-PLK1, targets PLK1, a protein involved in tumor cell proliferation and a validated oncology target. On February 8, 2012, it announced that Phase I clinical trial for TKM-Ebola had been initiated. The Phase 1 TKM-Ebola clinical trial is a placebo-controlled, single-blind, single-ascending dose study with additional multiple-ascending dose cohorts in healthy human volunteers. In the field of RNAi therapeutics, the Company has licensed its LNP delivery technology to Alnylam Pharmaceuticals, Inc. and Merck & Co., Inc. Advisors' Opinion:- [By Ben Rooney]
Canadian biotech firm Tekmira Pharmaceuticals (TKMR)' stock surged in September after the FDA authorized the company's drug for patients with Ebola in the United States. Shares have since pulled back. The company has started limited production of its drug, TKM-Ebola, which will be available in early December.
- [By Ben Levisohn]
Tekmira (TKMR) has gained 27% this week alone, and no wonder. Its Ebola treatment is thought to be on the fast-track to approval thanks to the massive outbreak in Africa that has now reached US shores.
Getty ImagesThere’s more to Tekmira than Ebola, notes Maxim’s Jason Kolbert, even if it’s the company’s treatment that caused him to raise his target on the stock to $31 from $23:
Tekmira announced the achievement of a development milestone, supporting a $1.5 million payment from Monsanto (MON), following completion of specified program objectives. This work is part of the research program under the Option Agreement Tekmira signed with the agriculture company, which was announced on January 13, 2014. The Option Agreement relates to Tekmira’s proprietary delivery technology and intellectual property for use in agricultural applications. The potential value of the transaction could reach up to $86.2 million, following the successful completion of all program milestones.
This news follows the recent news of a reported case of Ebola in Texas. Tekmira continues to make progress in the development of TKM-EBOLA. On September 22, 2014 the company announced that TKM-EBOLA was cleared for emergency use on the ground in West Africa. The company announced it will join an international consortium that will establish clinical development centers in Ebola hot zones. We have accelerated our Ebola assumptions and as a result it drives additional upside, our new price target is $31.00.
Shares of Tekmira have gained 8.3% to $27.58 at 12:02 p.m., while Monsanto has dipped 0.1% to $110.09.
- [By Markus Aarnio]
Companies working on chemically synthesized siRNAs include Merck (MRK), through its subsidiary Sirna Therapeutics, Inc., Novartis (NVS), Takeda (TKPHF.PK), Kyowa Hakko Kirin, Marina Biotech, Inc., Arrowhead and its subsidiary, Calando, Quark, Silence Therapeutics plc, Tekmira (TKMR), Sylentis and Dicerna Pharmaceuticals, Inc.
- [By Ben Levisohn]
Biotech companies that are most likely to benefit because they are “Ahead in clinical development and/or have established relationships with [the Biomedical Advanced Research and Development Authority, or] BARDA which may facilitate getting a contract” include GlaxoSmithKline (GSK), NewLink Genetics (NLNK), Johnson & Johnson (JNJ) and Chimerix (CMRX). Kantor includes Tekmira�(TKMR) and Sarepta (SRPT) among “companies with viable programs” that are “moving forward and likely to attract additional funding.”
Hot Medical Stocks To Own For 2015: Portola Pharmaceuticals Inc (PTLA)
Portola Pharmaceuticals, Inc. (Portola), incorporated on September 2, 2003, is a biopharmaceutical company developing product candidates that have the potential to represent advances in the fields of thrombosis and hematology. The Company is advancing its three wholly owned programs using biomarker and genetic approaches.
Betrixaban
Portola's compound, betrixaban, is an oral, once-daily Factor Xa inhibitor being evaluated in the only biomarker-based Phase-III study for hospital to home prophylaxis of venous thromboembolism (VTE) in acute medically ill patients. Betrixaban's properties particularly suited to potentially demonstrate efficacy without increasing bleeding in this patient population.
Andexanet Alfa
Portola's second development candidate, andexanet alfa (PRT4445), has the potential to be a reversal agent to directly reverse the effects of Factor Xa inhibitors in patients who suffer a bleeding episode or who require emergency surgery. Portola has entered into clinical collaboration agreements with all of the manufacturers of direct Factor Xa inhibitors, including Bristol-Myers Squibb and Pfizer (Eliquis [apixaban]), Bayer HealthCare and Janssen Pharmaceuticals (XARELTO [rivaroxaban]), and Daiichi Sankyo (Savaysa [edoxaban]), while retaining all decision-making and commercial rights to the program.
Cerdulatinib (PRT2070) and PRT2607
Portola's third wholly owned product candidate, cerdulatinib (PRT2070), is an orally available kinase inhibitor that uniquely inhibits two validated tumor proliferation pathways - spleen tyrosine kinase (Syk) and janus kinase (JAK). It is being studied in patients with leukemias or lymphomas with a focus on genetically-defined subtypes, as well as in patients who have failed therapy due to relapse or acquired mutations. Portola's fourth program is partnered with Biogen Idec and is focused on the development of PRT2607, a selective Syk inhibitor.
Advisors' Opinion:- [By Todd Campbell]
That leads me to Medivation (NASDAQ: MDVN ) , Ophthotech (NASDAQ: OPHT ) , and Portola (NASDAQ: PTLA ) , three companies with important therapies that may very well be destined to become top sellers.
Hot Medical Stocks To Own For 2015: Sonova Holding AG (SOON)
Sonova Holding AG is a Switzerland-based company operating in the healthcare sector. The Company, along with its subsidiaries, specializes in the design, development, manufacture, worldwide distribution and service of technologically advanced hearing systems for adults and children with hearing impairment. The Company is active in two operating segments: the Hearing instruments segment includes the companies that are active in the design, development, manufacture, distribution and service of hearing instruments and related products, and the Cochlear implants segment includes the companies that are active in the design, development, manufacture, distribution and service of hearing implants and related products. The Company operates worldwide and distributes its products in over 90 countries through its own distribution network and through independent distributors. Sonova Holding AG is the holding company of the Sonova Group. Advisors' Opinion:- [By Corinne Gretler]
Sonova (SOON) advanced 6.9 percent to 126.50 Swiss francs after predicting that annual earnings before interest, taxes and amortization would grow as much as 14 percent, compared with a previous forecast of 9 percent to 13 percent. Sales will increase 8 percent to 10 percent, up from an earlier projection of 6 percent to 8 percent.
Hot Medical Stocks To Own For 2015: Cerner Corp (CERN)
Cerner Corporation (Cerner) is a supplier of healthcare information technology (HCIT) solutions, services, devices and hardware. Cerner solutions optimize processes for healthcare organizations. These solutions are licensed by approximately 9,300 facilities globally, including more than 2,650 hospitals; 3,750 physician practices 40,000 physicians; 500 ambulatory facilities, such as laboratories, ambulatory centers, cardiac facilities, radiology clinics and surgery centers; 800 home health facilities; 40 employer sites and 1,600 retail pharmacies. The Company operates in two segments: domestic and global. The domestic segment includes revenue contributions and expenditures associated with business activity in the United States. The global segment includes revenue contributions and expenditures linked to business activity in Argentina, Aruba, Australia, Austria, Canada, Cayman Islands, Chile, China (Hong Kong), Egypt, England, France, Germany, Guam, India, Ireland, Italy, Japan, Malaysia, Morocco, Puerto Rico, Qatar, Saudi Arabia, Singapore, Spain, Sweden, Switzerland and the United Arab Emirates. On May 23, 2011, the Company acquired Resource Systems, Inc. On October 17, 2011, the Company acquired Clairvia, Inc. Effective March 18, 2013, it acquired Labotix Automation Inc.
The Company designs and develops software solutions on the unified Cerner Millennium architecture, a person-centric computing framework, which combines clinical, financial and management information systems. This architecture allows providers to access an individual�� electronic health record (EHR) at the point of care, and it organizes and proactively delivers information to meet the specific needs of physicians, nurses, laboratory technicians, pharmacists, front- and back-office professionals and consumers. It also offers a range of services, including implementation and training, remote hosting, operational management services, revenue cycle services, support and maintenance, healthcare data analysis, clinical proc! ess optimization, transaction processing, employer health centers, employee wellness programs and third party administrator (TPA) services for employer-based health plans.
The Company offers a longitudinal, person-centric EHR, which gives clinicians electronic access to the right information at the right time and place to achieve optimal health outcomes. Medical information and care regimens accessible from home enables consumers to manage their conditions and adhere to treatment plans, creating a medium between physicians and individuals. Its Cerner ITWorks is a suite of services, which creates an alignment between Cerner and its clients. Its Cerner RevWorks includes solutions and services to help healthcare organizations improve their revenue cycle functions. It offers clinic, pharmacy and wellness services directly to employers.
The Company's Healthe Intent Chart Search includes clinical meanings of words located within the electronic medical record (EMR), as well as the context in which those words occur to create algorithms that identify and rank information contextually. The Healthe Intent platform also provides the ability to apply algorithms against contextual clinical activity to recommend clinical action.
The Company competes with Allscripts Healthcare Solutions, Inc., Computer Programs and Systems, Inc. (CPSI), Epic Systems Corporation, GE Healthcare Technologies, Healthcare Management Systems, Inc. (HMS), Healthland, Inc., Computer Sciences Corporation (iSoft), Keane, Inc., McKesson Corporation, Medical Information Technology, Inc. (Meditech), Siemens Medical Solutions Health Services Corporation, Quadramed Corporation, Accenture plc, Affiliated Computer Services (ACS), Cap Gemini S. A., Computer Task Group, Inc. (CTGHS), Dell, Inc., Deloitte Consulting LLP, Hewlett-Packard Company, IBM Corporation, maxIT Healthcare LLC, AmazingCharts.com, Inc., Athenahealth, Inc., eClinicalWorks LLC, e-MDs, Inc., Greenway Medical Technologies, MED3000, Inc., Quality Sy! stems, In! c., Conceptual MindWorks, Inc., Vitera Healthcare Solutions, API Healthcare, CapsuleTech, Inc., CareFusion Corporation, GE Healthcare Technologies, iSirona, LLC, McKesson Corporation, Omnicell, Inc., Accretive Health, Inc., Capario, Inc., Emdeon Corporation, McKesson Corporation, MedAssets, Inc., Optum, Inc., SSI Group, Inc. and 3M Company.
Advisors' Opinion:- [By Dan Caplinger]
Quality Systems certainly has plenty of growth potential. Late last month, competitor Cerner (NASDAQ: CERN ) announced record bookings for its first quarter, and with a strong backlog and favorable guidance for the full 2013 year, Cerner is finding promising ways forward to grow its business. Cerner's results point to strength not just within the company but for the broader industry as well, and Quality Systems is poised to tap into the generally positive environment.
- [By Sue Chang and Saumya Vaishampayan]
Cerner Corp. (CERN) �shares dropped 4.8% after the hospital information-technology company reported a sharp drop in fourth-quarter earnings and issued a weak outlook.
Hot Medical Stocks To Own For 2015: Bellicum Pharmaceuticals Inc (BLCM)
Bellicum Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company. The Company is focused on discovering and developing cellular immunotherapies for various forms of cancer, including hematological cancers and solid tumors, as well as orphan inherited blood disorders. The Company�� product pipeline includes clinical product candidates, such as BPX-501, which is an adjunct T-cell therapy administered after allogeneic hematopoietic stem cell transplantation; BPX-201, which is a dendritic cell cancer vaccine; and Preclinical product candidates, including BPX-701, which is a T cell receptor (TCR) product candidate for solid tumors; BPX-401, which is a CAR-T product candidate for hematological cancers that express the CD19 antigen, and BPX-601, which is a TCR product candidate for solid tumors expressing the preferentially-expressed antigen in melanoma (PRAME). The Company�� Chemical Induction of Dimerization (CID) technology platform engineers and controls components of the immune system in real time.
CaspaCIDe
CaspaCIDe is the Company�� Chemical Induction of Dimerization (CID) safety switch technology. The CaspaCIDe eliminates cells in the event of toxicity. The CaspaCIDe switch consists of the CID-binding domain coupled to the signaling domain of caspase-9 (iCasp9), an enzyme that is part of the apoptotic pathway. The infusion of rimiducid triggers activation of this domain of caspase-9, which in turn leads to selective apoptosis of the CaspaCIDe-containing cells. The CaspaCIDe technology is applied to its lead clinical product candidate, BPX-501 and to its TCR product candidate, BPX-701.
The CaspaCIDe technology has demonstrated clinical efficacy in human patients beginning as soon as 30 minutes after administration of the activating drug, rimiducid. In the preclinical studies, rimiducid reduced or eliminated CaspaCIDe-containing cells in a dosage dependent manner. The National Cancer Institute is conducting a Phase I/II clinical trial for sarcoma! and other solid tumors with a chimeric antigen receptor (CAR) construct targeting a solid tumor antigen combined with CaspaCIDe.
CIDeCAR
CIDeCAR Technology consists of a CAR T cell that incorporates its co-stimulatory domain, MC, for improved T-cell activation and proliferation, and the CaspaCIDe safety switch. CAR interaction with cancer cell antigens leads to MC signaling, which then leads to activation of T cells. In the event of serious toxicity, rimiducid activation of caspase-9 eliminates the CIDeCAR T cells.
The Company has conducted proof-of-principle preclinical studies for CIDeCAR technology, CIDeCAR candidate BPX-401 and CIDeCAR solid tumor CAR targeting Her2, in which, both were evaluated in vitro. These preclinical studies demonstrated that CIDeCAR technology results in enhanced activation, proliferation and tumor cell killing; and the elimination of these CIDeCAR T cells after exposure to rimiducid.
GoCAR-T
The Company�� GoCAR-T technology incorporates a switch that activates CAR T cells when triggered by both rimiducid and the targeted antigen expressed on the surface of the cancer cells. The GoCAR-T technology separates the CIDeCAR dual co-stimulatory domain, MC, from the antigen recognition domain and moves it onto a separate molecular switch that can be controlled by rimiducid. GoCAR-T cells can only be fully activated when exposed to both the cancer cells and rimiducid. This separation controls the degree of activation of the CAR T cells through adjustments to the amount of rimiducid administered, but still in a tumor-dependent manner.
The Company conducted a proof-of-principle in vitro study for GoCAR-T technology, in which it demonstrated that the GoCAR-T cells targeting the PSCA antigen can only be fully activated, as evidenced by production of IL-2 (left panel) and T-cell proliferation (right panel) when the GoCAR-T cells are exposed to both their target PSCA-expressing human pancreatic cancer cells ! and rimid! ucid. In further in vivo studies of GoCAR-T technology, target antigen PSCA-expressing Capan-1 human pancreatic tumors were established in immune-deficient, or NSG, mice. After seven days, five mice received control T cells modified only with firefly luciferase, an imaging protein, and 10 mice received T cells modified with MC in the form of a molecular switch or iMC, plus a PSCA. CAR (together, BPX-601) and firefly luciferase. Five mice in this second group also received 5 mg/kg rimiducid weekly. T-cell imaging clearly demonstrated that GoCAR-T cells can be stimulated to proliferate in vivo when exposed to target antigen-expressing cancer cells by rimiducid administration.
DeCIDe
The DeCIDe technology is used to control the activation of dendritic cells. The DeCIDe technology couples the signaling domains of CD40 and MyD88 to its CID binding domain, to create inducible MC switch, which is then insert into dendritic cells along with the PSMA antigen to take control of the activation of the dendritic cells and the resulting immune response to cancer. Upon exposure to rimiducid, DeCIDe-containing dendritic cells become highly activated. The DeCIDe technology activates dendritic cells with rimiducid after the patient has been vaccinated and the dendritic cells have migrated to the draining lymph nodes.
The cultured BPX-201 cells transduced with DeCIDe switch technology produce supra-normal levels of IL-12 in response to rimiducid. These data demonstrates that, in addition to the temporal control of dendritic cell activation that DeCIDe technology affords, once exposed to rimiducid, DeCIDe-containing dendritic cells become highly activated, which may lead to more potent anti-cancer activity in patients.
BPX-501
The Company�� CaspaCIDe product candidate BPX-501, is under development for the treatment of hematological diseases. BPX-501 is an adjunct T-cell therapy administered after allogeneic hematopoietic stem cell transplantation (HSCT), us! ing donor! stem cells. The BPX-501 eliminates donor T cells through the triggering of the CaspaCIDe safety switch upon emergence of Graft-versus-host disease (GvHD). The BPX-501 improves stem cell engraftment and accelerates immune system recovery, while providing for resolution of GvHD. The BPX-501 has a range of applications: an add-back of donor T cells administered to accelerate immune system recovery after allogeneic haplo-HSCT in which the T cells in the transplanted stem cells were depleted, and a donor T-cell infusion administered to prevent or treat relapse of underlying disease after allogeneic HSCT independent of donor match.
The product has undergone a 10-patient Phase I clinical trial with CaspaCIDe modified T cells. Four patients developed GvHD after donor T-cell infusion. A single dosage of rimiducid eliminated around 90% of the modified T cells and resolved GvHD in all four patients without recurrence of GvHD. In the second clinical trial of CaspaCIDe-modified T cells, these demonstrations have been replicated in preliminary data from three patients. BPX-501 is being evaluated in multiple Phase I/II clinical trials in the United States, which includes BP-001, a clinical trial in adults and and BP-003, a clinical trial in children. During the BP-001 clinical trial, BPX-501 is administered after initial allogeneic HSCT for hematological cancers. The BP-003 clinical trial in children with orphan inherited blood disorders includes the administration of BPX-501 after initial allogeneic HSCT. The Company also initiated an additional Phase I/II clinical trial, BPX-004 in children with hematological cancers or orphan inherited blood disorders.
BPX-201
The Company�� product candidate under development, BPX-201 is a dendritic cell cancer vaccine intended to treat metastatic castrate-resistant prostate cancer (mCRPC). BPX-201 is an autologous therapy, in which the patient�� own white blood cells are extracted and modified ex vivo. The cells are matured and then gen! etically ! engineered to express the DeCIDe switch domains and the prostate-specific membrane antigen (PSMA) antigen. The modified cells are then washed, apportioned into individual dosages, and frozen for later administration to the patient. The incorporation of the DeCIDe switch in the presence of rimiducid activates the therapy.
The Company is evaluating BPX-201 in an 18-patient Phase I clinical trial for mCRPC. It is evaluating opportunities for BPX-201 in combination with other cancer immunotherapies, such as checkpoint inhibitors.
BPX-701
The Company�� CaspaCIDe T cell receptor (TCR) Product Candidate, BPX-701 is under development for the treatment of Solid Tumors. BPX-701 is a TCR-based therapy for the treatment of PRAME-expressing melanoma, sarcomas and neuroblastomas. BPX-701 is designed to target preferentially-expressed antigen in melanoma (PRAMEa gene) that is predominantly expressed in human melanomas but not in normal tissues.
The BPX-701 has demonstrated complete elimination in response to rimiducid. The Clinical Cancer Research 2011 has demonstrated that PRAME-specific clones showed high reactivity against a panel of PRAME positive tumor cell lines, metastatic melanoma, sarcomas and neuroblastoma tissues, and no reactivity against normal cell types, with the exception of low reactivity against kidney epithelial cells and intermediate reactivity against mature dendritic cells. The vitro studies demonstrated BPX-701�� affinity to panels of cancer cells presenting PRAME peptides and low affinity to non-tumor cells. In other in vitro studies, rimiducid administration has proved the ability to eliminate BPX-701 cells.
BPX-401
The Company�� CIDeCAR Product Candidate under development, BPX-401, is developed for the treatment of Hematological Cancers, such as acute lymphotcytic leukemia (ALL), chronic lymphocytic leukemia (CLL), and certain types of non-Hodgkin�� lymphoma. The CIDeCAR consists of CAR T cells modified to! include ! its CaspaCIDe safety switch and in which the CAR incorporates the signaling domains of two proteins, MyD88 and CD40. These proteins form the Company�� dual co-stimulatory domain, MC, which is designed to activate T cells in the presence of cancer cells. The Company has generated preclinical proof-of-principle data in vitro signifying that BPX-401 has CAR T cell activation and proliferation potential, and may be effective in killing cancer cells.
BPX-601
The Company�� GoCAR-T Product Candidate, BPX-601, is proposed for the treatment of Solid Tumors. The BPX-601 is undergoing preclinical studies for the treatment of solid tumors overexpressing the prostate stem cell antigen (PSCA), such as some prostate, pancreatic, bladder, esophageal and gastric cancers. The Company�� GoCAR-T technology consists of CAR and T cells. GoCAR-T controls activation and proliferation of the CAR T cells through the scheduled administration of a course of rimiducid infusions.
BPX-601 is undergoing preclinical studies for the treatment of solid tumors overexpressing the PSCA antigen. The Company has demonstrated positive proof-of-principle data in an animal pancreatic tumor model.
The Company competes with Adaptimmune Limited, bluebird bio, Inc., Celgene Corporation, Cellectis SA, GlaxoSmithKline plc, Intrexon Corporation, Juno Therapeutics, Inc., Kite Pharma, Inc., Novartis AG and Pfizer Inc.
Advisors' Opinion:- [By John Udovich]
Small cap cancer drug stock Kite Pharma Inc (NASDAQ: KITE) has surged after announcing a�strategic research collaboration and license agreement with Amgen, Inc (NASDAQ: AMGN)�involving Chimeric Antigen Receptors (CAR) ��meaning its worth taking a closer look at the stock, which had an IPO last June,�along with potential peers�Bellicum Pharmaceuticals Inc (NASDAQ: BLCM) and Juno Therapeutics (NASDAQ: JUNO) which are players in the CAR therapies space and had more recent IPOs.
Hot Medical Stocks To Own For 2015: Elite Pharmaceuticals Inc (ELTP)
Elite Pharmaceuticals, Inc. (Elite), incorporated on October 1, 1997, is a specialty pharmaceutical company principally engaged in the development and manufactures of oral, controlled-release products, using technology and the development and manufacture of generic pharmaceuticals. Elite has four products: Phentermine 37.5 milligram tablets, Methadone 10 milligram tablets, Lodrane D Immediate Release capsules and Hydromorphone Hydrochloride 8 milligram tablets. During the fiscal years ended March 31, 2012 (Fiscal 2011), the Company manufactured and sold Lodrane 24 and Lodrane 24D (the Lodrane Extended Release Products).
The Company has a pipeline of additional generic drug candidates under active development, including, without limitation, ELI-154, a once-a-day oxycodone product and ELI-216, an abuse resistant oxycodone product which utilizes the Company�� propriety formulation for abuse resistant products utilizing the pharmacological approach (Elite�� Abuse Resistant Technology). ECR Pharmaceuticals (ECR), a wholly owned subsidiary of Hi-Tech Pharmacal, Inc. and the owner and marketer of the Lodrane Extended Release Products. Elite also purchased from Mikah Pharma LLC, an approved Abbreviated New Drug Application (ANDA) for Naltrexone 50 milligram tablets.
For ELI-154, Elite has developed a once-daily oxycodone formulation using its technology. An investigational new drug application (IND) has been filed and Elite has completed two pharmacokinetic studies in healthy subjects that compared blood levels of oxycodone from dosing ELI-154 and the twice-a-day product that is on the market, OxyContin marketed in the United States by Purdue Pharma LP. ELI-216 utilizes the Company's abuse-deterrent technology that is based on a pharmacological approach. ELI-216 is a combination of a narcotic agonist, oxycodone hydrochloride, in a sustained-release formulation intended for use in patients with moderate to severe chronic pain, and an antagonist, naltrexone hydrochloride, formulat! ed to deter abuse of the drug. Products utilizing the pharmacological approach to deter abuse such as Suboxone, a product marketed in the United States by Reckitt Benckiser Pharmaceuticals, Inc., and Embeda, a product marketed in the United States by Pfizer, have been approved by the United States Food & Drug Administration (FDA). ELI-216 demonstrates a euphoria-blocking effect when the product is crushed. Elite has developed ELI-154 and ELI-216 and retains the rights to these products.
The Company competes with Collegium Pharmaceuticals, Inc., Purdue Pharma LP, Acura Pharmaceuticals, Inc., Durect Corporation, Mylan Laboratories, Inc., Par Pharmaceuticals, Inc., Alkermes, Inc., Teva Pharmaceuticals Industries Ltd., Aptalis Pharma, Impax Laboratories, Inc., and Watson Pharmaceuticals.
Advisors' Opinion:- [By James E. Brumley]
Judging from the company it's keeping Green Automotive Co. (OTCMKTS:GACR) may have just made its way into the upper echelon of small cap stock opportunities. The electric car company joins Elite Pharmaceuticals Inc. (OTCBB:ELTP), Amarantus Bioscience Holdings, Inc. (OTCBB:AMBS), and only three other companies as Wall-Street.com's "Best 6 Stocks" for January of 2014. As one of the top information resources for investors - particularly in terms of information regarding small and micro cap stocks - being named among the site's top pick is an accolade for AMBS, ELTP, and GACR. Even more impressive is that Green Automotive Co. was the only consumer-goods name among those six. Amarantus Bioscience Holdings and Elite Pharmaceuticals are biotechnology names... an industry that can and often does attract a lot of attention just by the nature of the business. The other three names making the "Best 6" list were an energy explorer, a power-management technology manufacturer, and prescription/medical food producer. For an electric car manufacturer to make the list speaks quite highly of GACR.
- [By CRWE]
Today, ELTP has shed (-8.01%) down -0.009 at $.101 with 4,629,899 shares in play thus far (ref. google finance Delayed: 1:00PM EDT September 16, 2013).
Elite Pharmaceuticals, Inc. previously reported the first quarter of fiscal year 2014 ended June 30, 2013. Manufacturing and profit split revenues comprised almost all of Elite’s quarterly revenues and totaled $717k for the quarter, an increase of 41% from the prior year. This growth is attributed to the launch of two new products during the quarter, Phentermine 15mg and 30mg capsules, combined with strong year-on-year growth of the Elite’s Hydromorphone 8mg tablets and contract manufactured Methadone 10mg product lines.
- [By James E. Brumley]
Exactly one month ago today I penned some bullish thoughts on Elite Pharmaceuticals Inc. (OTCBB:ELTP). If you're familiar with the company - or a regular reader of this site - then you may know why that sounds a little "off." See, at the time, ELTP shares were falling rather quickly, giving up all the gains they had made just a few days before. Almost needless to say, my premise was not a well received one. Let's just say I received some "colorful disagreements" by being optimistic about the biopharma company.
Hot Medical Stocks To Own For 2015: Epizyme Inc (EPZM)
Epizyme, Inc., incorporated on November 1, 2007, is a clinical stage biopharmaceutical company that discovers, develops and plans to commercialize personalized therapeutics for patients with genetically defined cancers. The Company systematically identify the genetic alterations that create cancer causing genes, called oncogenes, select patients in whom the identified genetic alteration is found and then design small molecule therapeutics to inhibit the oncogene. The clinical development plan for each of its product candidates is directed towards patients with a particular genetically defined cancer.The Company is conducting a Phase I clinical trial of its advanced product candidate, EPZ-5676, an inhibitor targeting the DOT1L HMT, for the treatment of mixed lineage leukemia (MLL-r). The Company has identified its two lead product candidates using its product platform.
EPZ-5676-DOT1L Inhibitor
EPZ-5676 is an intravenously administered small molecule inhibitor of DOT1L. The Company is developing EPZ-5676 for the treatment of MLL-r, an aggressive subtype of the two most common forms of acute leukemia, ALL and AML. Patients with MLL-r are routinely diagnosed with existing technologies that are commonly used in clinical setting. The Company�� Phase 1 clinical trial of EPZ-5676 is an open label, multicenter trial that has two phases.
EPZ-6438-EZH2 Inhibitor
The Company is developing EPZ-6438 as an orally available small molecule inhibitor of EZH2 for the treatment of non-Hodgkin lymphoma patients who have an oncogenic point mutation in EZH2. EZH2 is an HMT that can become oncogenic and cause non-Hodgkin lymphoma and a range of other solid tumors. Two types of non-Hodgkin lymphoma, diffuse large B-cell lymphoma of germinal-center origin, or DLBCL, and follicular lymphoma, or FL, are particularly associated with an EZH2 point mutation. There are no therapies approved specifically for the treatment of cancer associated with an EZH2 point mutation.
Advisors' Opinion:- [By Lisa Levin]
Epizyme (NASDAQ: EPZM) shares rose 66.84% to $34.20. The volume of Epizyme shares traded was 1683% higher than normal. Epizyme reported two major milestone achievements. It announced the achievement of a proof of concept milestone in the EPZ-5676 DOT1L inhibitor clinical program.
- [By John Udovich]
On Tuesday, small cap biopharmaceutical company Epizyme Inc (NASDAQ: EPZM) surged 75.56% after the company announced that its�EPZ-5676, a DOT1L inhibitor for acute leukemias, had reached its proof-of-concept milestone, meaning its worth taking a closer look at the stock as well as look at the share performance of cancer stocks like large cap Celgene Corporation (NASDAQ: CELG) and small caps�Dendreon Corporation (NASDAQ: DNDN) and Geron Corporation (NASDAQ: GERN).
- [By Ben Levisohn]
3. We see 23+ partnered pipeline assets and are most positive on Phase I/II MOR202 anti-CD38 for myeloma with data in 2015, and others such as Acceleron Pharma (XLRN), Agios Pharmaceuticals (AGIO), Epizyme (EPZM), Concert Pharmaceuticals (CNCE) (just started Phase I for next-gen Revlimid).
No comments:
Post a Comment