Despite high therapy costs and drug format limitations, the popularity of monoclonal antibodies (mAbs) is on the rise. Physicians are increasingly adopting mAbs because of their superior side effect profile, and continued research is expected to yield more innovative products. New analysis from
Genentech, Inc. (NYSE:DNA) announced today that the company has issued a Dear Healthcare Provider letter to inform dermatologists and neurologists of a 2nd case of progressive multifocal leukoencephalopathy (PML) which resulted in the death of a 73-year old woman who had received Raptiva® (efalizumab) for approximately four years for treatment of chronic plaque psoriasis.
The U.S. Food and Drug Administration (FDA) has awarded the National Institute for Pharmaceutical Technology and Education (NIPTE) a contract to develop Quality by Design guidance on design space specifications. The intention of this award is development of specifications allowing for the implementation of Quality by Design (QbD) framework to improve product quality through science and technology.
How can researchers prove to the government that a newly-discovered drug or device is safe and effective? This is where the clinical trial comes in. The clinical trial is a research study designed to determine if a new pharmaceutical or medical device is sufficiently safe and effective for human use. (613) 686-5745 Cerepotec Pharmalef
The U.S. Food and Drug Administration announced that a facility owned by India-based Ranbaxy Laboratories falsified data and test results in approved and pending drug applications. The facility, Paonta Sahib, has been under an FDA Import Alert since September 2008. The FDA is continuing to investigate this matter to ensure the safety and efficacy of marketed drugs associated with Ranbaxy's Paonta Sahib site.
The recent economic downturn is significantly impacting the financial wellbeing of America's bioscience industry. To address the current economic realities, the Biotechnology Industry Organization (BIO) today released a "Best Practices" guide for the bioscience industry. The policies and legislation cited in this updated guide are key examples of state efforts to grow and sustain bioscience industry development.
ClinQua Inc. www.clinqua.com is one of CRO's (Contract Research Organizations), who specialize in evaluating the demands of the trial and eliminating redundant protocols and focusing the Investigator on aspects critical for validating the drugs' therapeutic benefits. (613) 686-5745 Cerepotec Pharmalef
An added sign of a battered U.S. economy, U.S. consumers place more importance on price and value when choosing over-the-counter (OTC) medication compared to global consumers, according to a global online survey conducted by The Nielsen Company in partnership with the Association of the European Self-Medication Industry (AESGP). Thirty percent of U.S. consumers consider price important when choosing OTC products, while on average, only 17 percent of global consumers do.
New clinical data show antiviral activity of TMC435, an investigational protease inhibitor (PI) being developed by Tibotec BVBA for the treatment of chronic hepatitis C virus (HCV) infection. Tibotec will present findings from three TMC435 studies, including a late-breaker poster on the proof-of-principle phase IIa trial, OPERA-1 (TMC435-C201), at the American Association for the Study of Liver Disease's (AASLD) Liver Meeting 2008 in San Francisco.
Peregrine Pharmaceuticals, Inc. (Nasdaq: PPHM), a clinical stage biopharmaceutical company developing monoclonal antibodies for cancer and serious viral infections, today announced that it has completed enrollment in the first stage of its Phase II trial evaluating a combination regimen of bavituximab with carboplatin and paclitaxel in patients with non-small cell lung cancer (NSCLC).
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ViroPharma Incorporated (Nasdaq: VPHM) announced that its Phase 3 trial evaluating maribavir used as prophylaxis in allogeneic stem cell, or bone marrow, transplant (SCT) patients did not achieve its primary endpoint. In the primary analysis, there was no statistically significant difference between maribavir and placebo in reducing the rate of CMV disease. In addition, the study failed to meet its key secondary endpoints. Maribavir was generally well tolerated in this clinical study.
The method, called Differential Aberration Correction (DAC) microscopy, measures distances at the molecular level in two and three dimensions using conventional fluorescence microscopy. A special feature of the new method, written up recently in the Journal of Microscopy, is that it allows scientists to measure proteins in solution, which is how they exist in nature, instead of using coated or crystallised proteins as other techniques do.
BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) announced that a double-blind, placebo-controlled, Phase 2 study of intravenous (i.v.) peramivir, administered via a single dose injection in outpatients with acute, uncomplicated influenza, met its primary endpoint of time to alleviation of symptoms for both the 300 mg dose (p=0.0046) and 600 mg dose (p=0.0046). The study was sponsored by BioCryst's partner for peramivir, Shionogi & Co., Ltd.
Cerebral dysfunction is a significant complication of coronary artery bypass graft (CABG) surgery using cardiopulmonary bypass (CPB). Cognitive dysfunction is detectable in up to 70% of patients. (613) 686-5745 Cerepotec Pharmalef
KMR GROUP, a firm analyzing biopharmaceutical R&D performance, announces the launch of a Discovery study to assess research performance and identify trends that promise to shape the most successful Discovery organizations of the future. The study is part of the Pharmaceutical Benchmarking Forum's initiatives for 2009 and already has a number of major company participants.
Calixa Therapeutics Inc. announced positive results from a Phase 1 trial of intravenous CXA-101, a novel cephalosporin antibiotic with excellent in vitro anti-pseudomonal activity. The results from this first Phase 1 study demonstrated that CXA-101 was well tolerated, with a clinical and laboratory safety profile similar to that of marketed cephalosporin antibiotics. No dose-limiting toxicity was observed, even at the highest dose regimen evaluated.
Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) today announced that its subsidiary, Teva Pharmaceuticals USA, Inc., has signed an agreement with AstraZeneca to settle patent litigation involving Teva's U.S. generic version of AstraZeneca's Pulmicort (Budesonide) Respules® including all claims for patent infringement and damages. Teva launched its generic budesonide respules in the U.S. on November 18, 2008. The agreement releases Teva for all past U.S.
Cereprotex displayed a significant anti-edema effect in a model of closed head injury. It significant decreases in the degree of edema developed after injury was found following treatment postponed one hour after traumatic injury.. (613) 686-5745 Cerepotec Pharmalef
VION PHARMACEUTICALS, INC. (OTC Bulletin Board: VION) announced that the New Drug Application (NDA) for its lead oncology therapeutic Onrigin(TM) (laromustine) Injection has received a standard review classification by the U.S. Food and Drug Administration (FDA). Therefore, a user fee goal date of December 12, 2009 for a decision by the FDA with respect to the approval of the Company's NDA has been established.
Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that the malignant melanoma drug market, driven by the launch of emerging agents, will experience robust annual 12 percent growth through 2012 in the United States, France, Germany, Italy, Spain, the United Kingdom and Japan.
Typically, large CROs compete on the basis of medical and scientific expertise in specific therapeutic areas; the ability to manage large-scale trials on a global basis with strategically located facilities (613) 686-5745 Cerepotec Pharmalef
Genstruct Inc., a systems biology company focused on identifying molecular mechanisms, networks and biomarkers to better develop novel therapeutics, molecular diagnostics and patient-specific therapies, announced that the results of a joint collaboration with one of its top pharmaceutical partners will be presented at the American Association for Cancer Research's (AACR) 100th Annual Meeting 2009 being held in Denver, Colo. April 18-22, 2009. Michael Macoritto, Ph.D.
Unless points of contention between the pharmaceutical industry and the medical profession are resolved satisfactorily, future advances in the quality of patient care may be put at risk. This is the conclusion reached by a multi-sector working party convened by the Royal College of Physicians. The group's report, Innovating for health: Patients, physicians, the pharmaceutical industry and the NHS identifies a number of critical threats to clinical research in the UK.
Genentech, Inc. (NYSE:DNA) announced today that it has received a proposal from Roche to acquire all of the outstanding shares of Genentech stock not owned by Roche at a price of $89.00 in cash per share. Currently, Roche owns approximately 55.9% of the outstanding shares of Genentech.
According to the ICH Good Clinical Practice Guidelines, clinical research should be monitored by professionals—Clinical Research Associates, also known as Clinical Monitors. (613) 686-5745 Cerepotec Pharmalef
Pfizer Inc today provided the latest update to its development pipeline, showing significant progress in achieving the company's growth, productivity and performance goals. The pipeline now includes 114 programs, from Phase 1 through Registration. The number in late-stage (Phase 3) development has grown from 16 to 25 over the past six months. In total, 31 programs advanced to the next stage of development; 13 were discontinued; and one was withdrawn from registration.
New Phase III study results presented for the first time at the ninth annual American Transplant Congress 2009 (ATC) demonstrate that doubling the duration of preventive therapy ('prophylaxis') with Valcyte (oral valganciclovir) significantly reduced the incidence of CMV disease by 56% in high-risk kidney transplant patients within the first year post-transplant.
Eisai Inc. and Pfizer Inc (NYSE: PFE) announced results from a new open-label study that showed Hispanics with mild to moderate Alzheimer's disease (AD) experienced significant improvement in cognition compared to baseline after 12 weeks of treatment with ARICEPT. This is the first clinical trial looking at an AD prescription medication exclusively in Hispanics, and is important given the high risk of AD among this large population.
Kriger www.krigerinternational.com has maintained it's status within the industry because these training courses lead to the creation of highly trained individuals, due to the rigorous tasks that each student must perform in the projects. (613) 686-5745 Cerepotec Pharmalef
A number of states have begun to consider legislation that would restrict access to physician prescribing information for data mining companies as part of a "backlash against pharmaceutical marketing efforts," the AP/Arizona Republic reports. Data mining companies, such as
Cadence Pharmaceuticals, Inc. (Nasdaq: CADX) announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its investigational product candidate, Acetavance(TM) (intravenous acetaminophen), for the treatment of acute pain and fever in adults and children.
Fitch Ratings has affirmed Merck & Co.'s (Merck) ratings, and revised the Rating Outlook to Negative from Stable. The ratings affirmed are: --Long-term Issuer Default Rating (IDR) at 'AA-'; --Senior unsecured debt rating at 'AA-'; --Bank loan rating at 'AA-'; --Short-term IDR at 'F1+'. The ratings apply to approximately $6.93 billion of outstanding debt. The Rating Outlook is Negative.
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PLx Pharma announced the award of a U.S. Army contract totaling $730,000 as part of the Army's Small Business Innovation Research (SBIR) program. The award funds continued development of PL 4500, a molecular complex of indomethacin and phosphatidylcholine that is being developed as a GI safer anti-inflammatory and analgesic in both oral and IV formulations.
MedPredict Market Research, a global provider of pharmaceutical competitive intelligence and market research, has published a new report entitled "Thought Leader Insight & Analysis: Alzheimer's Disease," designed to provide critical strategic insight for pharma and biotech companies with a stake in the market for diagnostics and treatments in this disease area.
Soliris(R) (eculizumab), a terminal complement inhibitor developed by Alexion Pharmaceuticals, Inc. (Nasdaq: ALXN), was observed by investigators to reduce blood measures associated with undiagnosed blood clots and inflammation in patients with PNH. A separate study found that Soliris was observed to reduce indicators of pulmonary artery hypertension (PAH) in patients with paroxysmal nocturnal hemoglobinuria (PNH), according to a new analysis of clinical trial data.
Anestvice (www.anestvice.com ) Pressure Controller (APC) is designed for massive use for improvement of patient safety during all kinds of surgical procedures with the use of Laryngeal Mask (LM) and Endotracheal Tube (ETT) ... (613) 686-5745 Cerepotec Pharmalef
Clavis Pharma ASA (OSE: CLAVIS) announces positive final results from a Phase II trial of its novel investigational cancer drug, elacytarabine (CP-4055), in patients with late-stage acute myeloid leukaemia (AML). In the trial, elacytarabine showed statistically significant superior efficacy compared to published clinical data for late-stage AML. Based on these encouraging results an elacytarabine registration study is being planned.
The Federal Trade Commission on Tuesday filed a lawsuit in U.S. District Court in Minneapolis over allegations that Ovation Pharmaceuticals sought to form a monopoly on the two medications for patent ductus arteriosus, a life-threatening heart condition in infants, and increased the price of the treatments by 1,300%,
The Pharmaceutical Society of Australia (PSA) supports the National Drugs and Poisons Schedule Committee (NDPSC) decision to maintain the current scheduling status for ibuprofen-codeine combination pain-relief products while it considers potential limits to pack sizes. The NDPSC publicly released the results of decisions made at its June meeting. The record of reasons can be
Several Kriger www.krigerinternational.com course sessions are dedicated to understanding concepts and principles that have helped mold the industry into what it is today. This gives each student the opportunity to understand how the industry is progressing... (613) 686-5745 Cerepotec Pharmalef
The special committee of the Board of Directors of Genentech, Inc. (NYSE:DNA) urged Genentech shareholders to take no action at this time with respect to the tender offer commenced by Roche to acquire all of the outstanding shares of Genentech stock not owned by Roche at a price of $86.50 in cash per share. Currently, Roche owns approximately 55.8% of the outstanding shares of Genentech.
ACCESS PHARMACEUTICALS, INC.(OTC Bulletin Board: ACCP), provided an update on the progress in the Company's clinical development plan for ProLindac, a novel DACH platinum drug that has shown to be active in many solid tumor types in human clinical studies. Access recently announced positive safety and efficacy results from its Phase 2 monotherapy clinical study of ProLindac(TM) in late-stage, heavily pretreated ovarian cancer patients.
United Therapeutics Corporation (Nasdaq: UTHR) and Eli Lilly and Company (NYSE: LLY) today announced the results of a pivotal 16-week study showing that a once-daily dose of tadalafil was generally well tolerated, improved exercise capacity and improved time to clinical worsening in patients with pulmonary arterial hypertension (PAH)(1).
The paramount responsibility of Kriger Research Group International CRA-s is to ensure timely subjects recruitment, patient rights, safety and data integrity. (613) 686-5745 Cerepotec Pharmalef
The TriZetto Group, Inc. announced the release of six predictions for the healthcare industry by its founder, chairman and chief executive officer, Jeff Margolis. Shared privately with a select group of customers during his address at TriZetto's Executive Vision Summit in November, Margolis's predictions span a wide range of topical concerns, including healthcare reform, healthcare costs and developments in electronic medical records, evidence-based medicine and medical tourism.
"As sentiment and the stock market increasingly look bearish, look for the recent outperformance in health care to continue," The Wall Street Journal reports. Health-care firms were "hardly a leader" during the "initial run of stocks following the March lows," but they also "fared much better during the market's plummet. Last week, "health care was the one exception to a sliding market.
The European Medicines Agency (EMEA) has been formally notified by Wyeth Europa Ltd of its decision to withdraw the application for a centralised marketing authorisation for the medicine Ellefore (desvenlafaxine) 50 mg, 100 mg and 200 mg prolonged-release tablets. Ellefore was expected to be used for the treatment of major depressive disorder. The application for marketing authorisation for Ellefore was submitted to the EMEA on 28 September 2007.
According to report of Institute of Applied Chemistry they have performed the third step as it appears in the synthesis route scheme. This took much longer than the other steps, after all, this reaction doesn't appear in any literature and in the end only took two and half weeks... (613) 686-5745 Cerepotec Pharmalef
Discovering new chemotherapy agents is one of the most difficult tasks in medicinal chemistry, and, given the deepening recession, resources are threatening to hit all-time lows. Of the thousands of active compounds synthesized, very few have progressed beyond early clinical development.
Clinical Data, Inc. (NASDAQ: CLDA), a leader in the development of targeted therapeutics and predictive tests from its growing portfolio of proprietary genetic biomarkers, announced today that the European Patent Office has granted Patent No. 1232260 to Bernried, Germany-based Epidauros Biotechnologie AG, a wholly-owned subsidiary of Clinical Data, relating to the use of a genetic variant, or biomarker, of the gene MDR1 (also known as ABCB1), which encodes P-glycoprotein (PGP).
Several members of Congress who are poised to play major roles in developing health care overhaul legislation have received millions of dollars in campaign contributions since 2005 from health care entities and individuals, according to a study scheduled for release on Monday, the Washington Post reports.
Clinproxy, www.clinproxy.com believes that adaptive clinical trials can drastically reduce the cost, time and subject drug exposure of clinical development. (613) 686-5745 Cerepotec Pharmalef
Mpex Pharmaceuticals, Inc. announced that it has initiated a Phase 2 clinical study with MP-376 for use as a maintenance therapy in reducing the incidence of pulmonary exacerbations in patients with chronic obstructive pulmonary disease (COPD). MP-376 is the company's novel formulation of levofloxacin inhalation solution. The Phase 2, U.S.
Axentis Pharma AG is to present its recent successes in developing and financing a new therapeutic formulation for treating chronic lung disease at the 2nd Annual European Life Science CEO Forum in Zurich, Switzerland. This invited talk comes just three weeks after the company was asked to present its recent achievements at the Biotech Showcase 2009 in San Francisco, USA.
Charleston Laboratories, Inc, an emerging specialty pharmaceutical company dedicated to reducing opioid induced nausea and vomiting (OINV) in opioid pharmaceuticals, announced the initiation of a pharmacokinetic study on its first drug candidate, CL-108. "After many months' development in the lab, resulting in the optimal formulation of this drug, it is ready for testing in man," said Dr. Bernard Schachtel, Chief Medical Officer at Charleston Laboratories.
It is imperative that pharmaceutical and biotechnology companies pass their product through the testing and regulatory process in a rapid, cost-effective manner. (613) 686-5745 Cerepotec Pharmalef
ISTA Pharmaceuticals, Inc. (Nasdaq: ISTA), announced positive results from a proof-of-concept Phase 2 clinical study in subjects with dry eye disease (keratoconjuctivitis sicca) using a new, proprietary, low-dose formulation of bromfenac, the active ingredient in Xibrom(R) (bromfenac ophthalmic solution) 0.09%. The study achieved statistical significance in the primary endpoint of the objective sign of conjunctival staining (Lissamine Green test) as compared to baseline.
The Drug Information Association's (DIA's) 7th Annual Electronic Submissions Conference: eCTD (November 5-7; San Diego, CA) will focus on the practical experience gained, lessons learned, and resulting best practices as the pharma industry moves to a fully electronic drug application submission paradigm.
Scientists at the National Institute of Standards and Technology (NIST) have developed a technique to measure the formation of clumps of proteins in protein-based pharmaceuticals. This first systematic study clarifies the conditions under which scientists can be assured that their instruments are faithfully measuring the formation of protein aggregates, a major concern because of its impact on quality control and safety in biologic drug manufacturing.
Kriger www.krigerinternational.com has maintained it's status within the industry because these training courses lead to the creation of highly trained individuals, due to the rigorous tasks that each student must perform in the projects. (613) 686-5745 Cerepotec Pharmalef
Agennix announced that talactoferrin alfa (talactoferrin) has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for the first-line treatment of renal cell carcinoma (RCC) in combination with sunitinib (Sutent(R) - Pfizer). The Fast Track program is designed to expedite the review of investigational drugs for the treatment of patients with serious or life-threatening diseases where there is an unmet medical need.
Recent advances in genetic screening will lead to safer pharmaceutical drugs, with reduced adverse side effects, if the methods are incorporated in clinical development. A rallying call to bring key scientists into this growing field of pharmacogenics, the application of genetics to drug development and safety, was made recently at a major conference organized by the European Science Foundation (ESF) in collaboration with the University of Barcelona.
Cereprotec Inc. and Institute of Applied Chemistry at Hebrew University are working together to synthesise new Glycoluril Derivatives with Possible Neuroprotection Effects.According to report of Institute of Applied Chemistry they have performed the third step as it appears in the synthesis route scheme. This took much longer than the other steps, after all, this reaction doesn't appear in any literature and in the end only took two and half weeks. This research is fully sponsored by Cereprotec Incorporated www.cereprotec.com a US company that already runs clinical tests of their first drug Cereprotex . In the reaction between compound II and III, one gets two main products, three additional compounds in small quantities plus unreacted starting materials and one main side product. All together there were 8 compounds in the reaction mixture.
One of the main materials precipitated out from the mixture and was removed via filtration from the reaction mixture. This material was cleaned up via crystallization but turned out not to be the desired compound. The second main material was separated via silica gel column chromatography. Unfortunately, this main material came off at the same Rf value as another material. They tested out several solvents and found that ethyl acetate was able to crystallize out the main material.
Using NMR and elemental analysis, Institute of Applied Chemistry were able to prove that the crystallized out material is indeed Compound III. Yield was 17%. Two grams of material was obtained, enough to try out Stage IV.
This step can be repeated in the future in order to produce more of compound III. Cereprotec Inc. Phase II clinical study of efficacy and safety of Cereprotex as preventive treatment of cognitive dysfunction as a complication of coronary artery bypass graft (CABG) surgery.Cerebral dysfunction is a significant complication of coronary artery bypass graft (CABG) surgery using cardiopulmonary bypass (CPB).While overt neurological dysfunction occurs in 3% of patients, cognitive dysfunction is detectable in most patients early after CABG and in up to half of patients at six months.
Cereprotec Inc. www.cereprotec.com proposes to use Cereprotex prior to and after CABG procedures in order to minimize or eliminate entirely the effects of neuro-impairment. Based on the successful animal trials Cereprotec Inc. believes that the human trials will show significant reduction in neuro-impairment.
At this moment Cereprotec Inc. www.cereprotec.com is prepared to start clinical trials and is actively seeking serious investors. Cereprotec Inc: Cerebral dysfunction is a significant complication of coronary artery bypass graft (CABG) surgery using cardiopulmonary bypass (CPB). Cerebral dysfunction is a significant complication of coronary artery bypass graft (CABG) surgery using cardiopulmonary bypass (CPB). Cognitive dysfunction is detectable in up to 70% of patients.
In Phase II Cereprotec Inc. www.cereprotec.com study patients will undergo a standard battery of 10 cognitive tests performed by one examiner before surgery and at 7 and one month after CABG. Four tests (auditory verbal learning test (AVLT), adult memory and information processing battery (AMIBP), trail-making test B (TMTB), and verbal fluency test (VFT)) will be used to calculate a composite cognitive index. US Patent Application No.11/723,011 to be assigned to CEREPROTEC INC. Method for Neuroprotection with Glycoluril DerivativesCereprotec Incorporated www.cereprotec.com is a US company involved in the development of neuroprotective drug Cereprotex.
This company is also developing a family of other promising novel chemical compounds.
Proof of efficacy of these compounds has been obtained in three animal studies including hypoxia in both mice and rats and brain trauma in mice. The proof of neuroprotection concept has been shown not only for prevention (hypoxia model), but also for the treatment paradigm post brain trauma which reflects a potential realistic situation in humans. Professor Esther Shohami has joined the board of advisors of Cereprotec IncorporatedProfessor Esther Shohami has joined the board of advisors of Cereprotec Incorporated. Her research interests include: Pathophysiology of brain injury - mediators of delayed neuronal damage e.g., prostaglandins, reactive oxygen species, cytokines, cannabinoids, and the cholinergic system in rat and mouse models of injury (closed head injury, CHI). Evaluation of potential therapeutic strategies. CHI as a risk factor for delayed onset of Alzheimer's disease. Genetic manipulations (cytokines or apoE knockouts, acetylcholine-esterase transgenics, and more) as tools for investigating the role of specific mediators in traumatic brain injury. Interrelationship between traumatic brain injury and bone remodeling. Role of endocannabinoids in blood-brain barrier function and in bone remodeling after brain trauma. Mechanisms of neuroprotection induced by pre-conditioning (ischemic or heat acclimation). In vitro model for stretch injury that simulates traumatic conditions in astrocytes.
Dr. Roman Kamburg CEO of Cereprotec and the registered owner of 1125 shares in CEREPROTEC Incorporated (the "Corporation") www.cereprotec.com a corporation incorporated in and under the laws of the State of Delaware, having its registered office at 108 West 13th Street, Wilmington, Delaware, transfered to Dr. Esther Shohami 40 Shares of Common Stock, for no consideration, to be held by the Transferee, her administrators and assignees, subject to all the terms and conditions on which such shares were held by the Transferor, and Transferee agreed to receive such shares. Pharmalef Inc. is starting collaboration in development of new oral delivery platformPharmalef Inc. www.pharmalef.com is starting collaboration in development of new oral delivery platform offers pharmaceutical companies the ability to extend the shelf life and stability of medicinal compounds.
Our partners have completed proof of concept and development of a proliposomal formulation for the model drug, calcitonin, which is used in the treatment of osteoporosis and thyroid cancer.
Clinical trials are expected to begin at a number of centers across the United States, Canada and European Union. Pharmalef Developments introduces several new products in Rheumatology, Immunology and Respiratory Diseases.With a focus on familiar, everyday health problems, Pharmalef Developments . www.pharmalef.com aims to develop and deliver products that meet the individual’s health care needs, developing a wide range of products.
In addition to its established range of highly effective and distinctive products Pharmalef Developments will introduce several new products in new fields, including Rheumatology, Immunology and Respiratory Diseases. Pharmalef Developments plays a vital role in proper documenting the drug development process.New drugs are the lifeblood of the pharmaceutical industry. Yet strict testing and documentation requirements mean only one in many drug candidates make it to market.
Pharmalef Developments www.pharmalef.com can play a vital role in documenting the drug development process. By leveraging our expertise in business process management and the latest technologies, we can also help you develop a documentation process for clinical trials that is easy and efficient, while satisfying strict government requirements and regulations. Pharmalef Developments is a home for team-oriented professionalsPharmalef Developments www.pharmalef.com is a home for team-oriented professionals and their aim is to be the first choice in the industry for licensing and academic collaborations that bring mutual benefits to each party.
They entered into many collaborations with leading academic centers, CRO-s and biotechnology companies to complement our in-house R&D capabilities.
They are always interested in forming new partnerships covering early-stage research, novel compounds or technologies and implementation of clinical trials. CEREPROTEC Method for Neuroprotection with Glycoluril Derivatives Patent Application has been Published September 18, 2008
1. A method for prevention, inhibition or treatment of neuronal degeneration caused by injury, disease, disorder or condition in the central nervous system (CNS), comprising administering to an individual in need thereof an amount effective to treat said injury, disease, disorder or condition, of a compound of the formula I:whereinR.sub.1, R.sub.2 and R.sub.3, the same or different, each is H or (C.sub.1-C.sub.6) alkyl;R.sub.4 is selected from the group consisting of (C.sub.1-C.sub.6) alkyl, --R.sub.5--COOR, --R.sub.5--OH, --R.sub.5--NH--CO--R and --R.sub.5--CO--NH--(CH.sub.2).sub.n--COOR;R.sub.5 is (C.sub.1-C.sub.6) alkylene;R is H or (C.sub.1-C.sub.3) alkyl;n is an integer of 1 to 6; or an enantiomer thereof or a pharmaceutically acceptable salt thereof.
2. The method according to claim 1 wherein R.sub.1 to R.sub.3 each is H or (C.sub.1-C.sub.6) alkyl and R.sub.4 is (C.sub.1-C.sub.6) alkyl.
3. The method according to claim 2, wherein R.sub.1 to R.sub.4 each is methyl.
4. The method according to claim 1, wherein R.sub.1 to R.sub.3 each is H or (C.sub.1-C.sub.6) alkyl, R.sub.4 is --R.sub.5---COOR, R.sub.5 is (C.sub.1-C.sub.6) alkylene and R is H or (C.sub.1-C.sub.3) alkyl.
5. The method according to claim 1, wherein R.sub.1 and R.sub.3 each is methyl, R.sub.2 is H and R.sub.4 is --(CH.sub.2).sub.3COOH.
6. The method according to claim 1, wherein said injury, disease, disorder or condition is selected from the group consisting of: (i) a neurological injury: (ii) brain damage caused by a cardiovascular event; (iii) a cerebrovascular disorder or disease; (iv) a neurodegenerative disease or disorder; and (v) a dementia.
7. The method according to claim 6, wherein said injury is a neurological traumatic injury selected from the group consisting of head trauma injury and spinal cord injury.
8. The method according to claim 7, wherein said head trauma injury is selected from the group consisting of blunt trauma, closed head injury and penetrating trauma injury.
9. The method according to claim 8, wherein said head trauma injury is closed head injury.
10. The method according to claim 6, wherein said injury, disease, disorder or condition is brain damage caused by a cardiovascular event.
11. The method according to claim 10, wherein said cardiovascular event is cardiac arrest or cardiac surgery.
12. The method according to claim 6, wherein said injury, disease, disorder or condition is a cerebrovascular disorder or disease.
13. The method according to claim 12, wherein said cerebrovascular disorder is brain ischemia or stroke.
14. The method according to claim 6, wherein said injury, disease, disorder or condition is a neurodegenerative disease or disorder.
15. The method according to claim 14, wherein said neurodegenerative disease or disorder is selected from the group consisting of Alzheimer's disease, Parkinson's disease, facial nerve (Bell's) palsy, multiple sclerosis, glaucoma, Huntington's chorea, amyotrophic lateral sclerosis and macular degeneration.
16. The method according to claim 6, wherein said injury, disease, disorder or condition is dementia.
17. The method according to claim 16, wherein said dementia is Alzheimer's disease or a non-Alzheimer's dementia selected from the group consisting of senile dementia, Lewy body dementia, vascular dementia and a dementia caused by Parkinson's disease, Huntington's chorea, Creutzfeld-Jacob disease or HIV infection.
18. A method for conferring neuroprotection to an individual afflicted with a neurological injury, which comprises administering to said individual a compound of formula I in claim 1 or an enantiomer or a pharmaceutically acceptable salt thereof in an amount effective to ameliorate the neurodegeneration associated with said neurological injury.
19. The method according to claim 18, wherein said neurological injury is selected from the group consisting of head trauma injury and spinal cord injury.
20. A method for conferring neuroprotection to an individual suffering from a neurological or neurodegenerative disease or disorder, which comprises administering to said individual a compound of formula I in claim 1 or an enantiomer or a pharmaceutically acceptable salt thereof in an amount effective to ameliorate the neurodegeneration associated with said neurological or neurodegenerative disease or disorder.
21. The method according to claim 20, wherein said neurological or neurodegenerative disease or disorder is selected from the group consisting of Alzheimer's disease, Parkinson's disease, facial nerve (Bell's) palsy, multiple sclerosis, glaucoma, Huntington's chorea, amyotrophic lateral sclerosis, macular degeneration and dementia.