DRUG APPROVALS BY DR ANTHONY MELVIN CRASTO
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Phase 3-Trius Therapeutics will soon be reporting data from its second phase III trial of Tedizolid
Tedizolid
(5R)-3-{3-fluoro-4-[6-(2-methyl-2H-tetrazol-5-yl)pyridin-3-yl]phenyl}-5-(hydroxymethyl)-1,3-oxazolidin-2-one
- Molecular Formula: C17H15FN6O3
- Average mass: 370.337799
856866-72-3 cas no
Torezolid (also known as TR-701 and now tedizolid[1]) is an oxazolidinone drug being developed by Trius Therapeutics (originator Dong-A Pharmaceuticals) for complicated skin and skin-structure infections (cSSSI), including those caused by Methicillin-resistantStaphylococcus aureus (MRSA).[2]
As of July 2012, tedizolid had completed one phase III trial, with another one under way. [3]Both trials compare a six-day regimen of tedizolid 200mg once-daily against a ten-day regimen of Zyvox (linezolid) 600mg twice-daily.
The prodrug of tedizolid is called “TR-701”, while the active ingredient is called “TR-700”.[4][5]
March 5 2013
Trius Therapeutics will soon be reporting data from its second phase III trial (ESTABLILSH-2) and the recently announced publication of the data from its first phase III trial (ESTABLISH-1) in the Journal of the American Medical Association (JAMA)
- “Trius grows as lead antibiotic moves forward”. 31 Oct 2011.
- “Trius Completes Enrollment In Phase 2 Clinical Trial Evaluating Torezolid (TR-701) In Patients With Complicated Skin And Skin Structure Infections”. Jan 2009.
- http://clinicaltrials.gov/ct2/results?flds=Xf&flds=a&flds=b&term=tedizolid&phase=2&fund=2&show_flds=Y
- PMID 19528279 In vitro activity of TR-700, the active ingredient of the antibacterial prodrug TR-701, a novel oxazolidinone antibacterial agent.
- PMID 19218276 TR-700 in vitro activity against and resistance mutation frequencies among Gram-positive pathogens.
Phase 1-Sangamo Presents New Clinical Data at CROI 2013 Demonstrating Persistent Immune System Improvements After Treatment With ZFN Therapeutic(R) SB-728-T
The gene therapy diminished the levels of virus and eradicated in patients having naturally occurring mutation of gene, found a preliminary trail of HIV treatment. The first phase of very small trail tested the SB-728-T gene treatment that is intended to interrupt theCCR5 gene used by HIV to contaminate immune system cells.
The first clinical trial using zinc-finger nucleases to provide long-term resistance to HIV-1 infection has been given the go-ahead by the US Food and Drug Administration. Sangamo BioSciences of Richmond, California, and its clinical partner, the University of Pennsylvania, have begun enrolling the first 12 people in a phase 1 clinical trial to evaluate SB-728-T, a novel zinc-finger DNA-binding nuclease that permanently disrupts the CCR5 gene on CD4+ T cells (Nat. Biotechnol. 26, 808–816, 2008
Data Demonstrate that SB-728-T Possesses Necessary Immunologic Properties to Support a ‘Functional Cure’ for HIV/AIDS
RICHMOND, Calif., March 6, 2013
Sangamo BioSciences, Inc. announced new data from its program to develop a ‘functional cure’ for HIV/AIDS in two presentations at the 20th Conference on Retroviruses and Opportunistic Infections (CROI), held in Atlanta from March 3 to 6, 2013.
The first presentation described data from the SB-728-T Phase 1 study (SB-728-902, Cohorts 1-3) demonstrating that SB-728-T treatment of HIV-infected subjects leads to durable reconstitution of the immune system driven by increases in total CD4+ central memory T-cells (TCM) and CCR5-protected TCM. TCM are long-lived, self-renewing cells that have the ability to remember and react against foreign antigens including HIV. The data also showed that certain cell surface marker and gene expression profiles may predict which patients will likely respond best to SB-728-T treatment.
About Sangamo
Sangamo BioSciences, Inc. is focused on research and development of novel DNA-binding proteins for therapeutic gene regulation and genome editing. The Company has ongoing Phase 2 clinical trials to evaluate the safety and efficacy of a novel ZFP Therapeutic® for the treatment of HIV/AIDS. Sangamo’s other therapeutic programs are focused on monogenic diseases, including hemophilia, Huntington’s disease and hemoglobinopathies such as beta-thalassemia and sickle cell anemia. Sangamo’s core competencies enable the engineering of a class of DNA-binding proteins known as zinc finger DNA-binding proteins (ZFPs). Engineering of ZFPs that recognize a specific DNA sequence enables the creation of sequence-specific ZFP Nucleases (ZFNs) for gene modification and ZFP transcription factors (ZFP TFs) that can control gene expression and, consequently, cell function. Sangamo has entered into a strategic collaboration with Shire AG to develop therapeutics for hemophilia, Huntington’s disease and other monogenic diseases and has established strategic partnerships with companies in non-therapeutic applications of its technology including Dow AgroSciences and Sigma-Aldrich Corporation. For more information about Sangamo, visit the company’s website atwww.sangamo.com.
Phase III Study of Oral Laquinimod for Relapsing-Remitting Multiple Sclerosis
Laquinimod
5-chloro-N-ethyl-4-hydroxy-1-methyl-2-oxo-
N-phenyl-1,2-dihydroquinoline-3-carboxamide
Laquinimod is an experimental immunomodulator developed by Active Biotech and Teva. It is currently being investigated as an oral treatment for multiple sclerosis (MS).
Laquinimod is the successor of Active Biotech’s failed experimental immunomodulator linomide.[1]
The compound has been investigated in two Phase II trials using successive magnetic resonance scans (MRI). Laquinimod seems to be able to reduce the MS disease activity on MRI.[2][3] However, the response to a given dose was discrepant between both studies.[4]
Phase III studies for MS started in December 2007.[5] In 2011, Teva announced its clinical trials involving laquinimod had failed, being unable to significantly reduce relapses into MS among patients beyond a placebo.[6] However, the final results of above mentioned phase III trial proved oral laquinimod administered once daily slowed the progression of disability and reduced the rate of relapse in patients with relapsing–remitting multiple sclerosis [7]
Mar 6, 2013 –
CONCERTO Study Enrolling Patients Globally to Evaluate Impact of Laquinimod on Disability Progression
Teva Pharmaceutical Industries Ltd. and Active Biotech announced today enrollment of the first patient in the CONCERTO study – the third Phase III placebo-controlled study designed to evaluate the efficacy, safety and tolerability of once-daily oral laquinimod in patients with relapsing-remitting multiple sclerosis (RRMS). The primary outcome measure of CONCERTO will be confirmed disability progression as measured by the Expanded Disability Status Scale (EDSS).
“Previous Phase III studies in more than 2,400 people with RRMS suggest a unique profile of laquinimod, directly affecting the neurodegenerative processes that lead to disability progression, the main concern in the treatment of RRMS,” said CONCERTO principal investigator, Dr. Timothy Vollmer, Professor of Neurology, University of Colorado Denver, Medical Director of the Rocky Mountain Multiple Sclerosis Center, and Co-Director of the RMMSC at Anschutz. “We are currently enrolling patients in this third pivotal study to further examine the clinical benefits of laquinimod on disability progression, the primary endpoint of the CONCERTO trial, and brain atrophy, at both the previously studied 0.6 mg dose, and now a higher 1.2 mg dose.”
The multinational, randomized, double blind placebo-controlled study will aim to enroll approximately 1,800 patients at more than 300 sites globally (http://clinicaltrials.gov/show/NCT01707992). Along with the primary endpoint of time to confirmed disability progression, the study will also examine the impact of laquinimod on endpoints such as percent change in brain volume and other clinical and MRI markers of disease activity.
“For nearly 30 years, Teva has been focused on improving the lives of people with multiple sclerosis by delivering innovative treatment options that address this complex disease,” said Dr. Michael Hayden, President of Global R&D and Chief Scientific Officer at Teva Pharmaceutical Industries Ltd. “The CONCERTO study demonstrates our commitment to collaborating with MS communities worldwide to further develop laquinimod and address unmet patient needs.”
ABOUT LAQUINIMOD
Laquinimod is an oral, once-daily CNS-active immunomodulator with a novel mechanism of action being developed for the treatment of MS. In animal models laquinimod crosses the blood brain barrier to potentially have a direct effect on resident CNS inflammation and neurodegeneration. The global Phase III clinical development program evaluating oral laquinimod in MS includes two pivotal studies, ALLEGRO and BRAVO.
In addition to the MS clinical studies, laquinimod is currently in clinical development for Crohn’s disease and Lupus.
ABOUT CONCERTO
CONCERTO is a multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study followed by an active treatment phase, to evaluate the efficacy, safety and tolerability of two doses of oral administration of laquinimod 0.6 mg/day or 1.2 mg/day in subjects with RRMS. This third Phase III laquinimod study will evaluate laquinimod in approximately 1,800 patients for up to 24 months, after which patients will continue to an active treatment period with laquinimod for an additional 24 months. The primary outcome measure will be time to confirmed disability progression as measured by the Expanded Disability Status Scale (EDSS). The study will also examine the impact of laquinimod on endpoints such as percent change in brain volume, as well as other clinical and MRI markers of disease activity.
ABOUT MULTIPLE SCLEROSIS
MS is the leading cause of neurological disability in young adults. It is estimated that more than 400,000 people in the United States are affected by the disease and that two million people may be affected worldwide. Multiple sclerosis is a degenerative disease of the central nervous system in which inflammation and axonal damage and loss result in the development of progressive disability.
ABOUT TEVA
Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) is a leading global pharmaceutical company, committed to increasing access to high-quality healthcare by developing, producing and marketing affordable generic drugs as well as innovative and specialty pharmaceuticals and active pharmaceutical ingredients. Headquartered in Israel, Teva is the world’s leading generic drug maker, with a global product portfolio of more than 1,000 molecules and a direct presence in about 60 countries. Teva’s branded businesses focus on CNS, oncology, pain, respiratory and women’s health therapeutic areas as well as biologics. Teva currently employs approximately 46,000 people around the world and reached $20.3 billion in net revenues in 2012.
ABOUT ACTIVE BIOTECH
Active Biotech AB is a biotechnology company with focus on autoimmune/inflammatory diseases and cancer. Projects in or entering pivotal phase are laquinimod, an orally administered small molecule with unique immunomodulatory properties for the treatment of multiple sclerosis, TASQ for prostate cancer as well as ANYARA for use in cancer targeted therapy, primarily of renal cell cancer. In addition, laquinimod is in Phase II development for Crohn’s and Lupus. Further projects in clinical development comprise the two orally administered compounds, 57-57 for SLE & Systemic Sclerosis and RhuDex(TM) for RA. Please visit http://www.activebiotech.com for more information.
- Tan IL, Lycklama à Nijeholt GJ, Polman CH et al. (April 2000). “Linomide in the treatment of multiple sclerosis: MRI results from prematurely terminated phase-III trials”. Mult Scler 6 (2): 99–104. PMID 10773855.
- Comi G, Pulizzi A, Rovaris M et al. (June 2008). “Effect of laquinimod on MRI-monitored disease activity in patients with relapsing-remitting multiple sclerosis: a multicentre, randomised, double-blind, placebo-controlled phase IIb study”. Lancet 371 (9630): 2085–2092. doi:10.1016/S0140-6736(08)60918-6. PMID 18572078.
- Polman C, Barkhof F, Sandberg-Wollheim M et al. (March 2005). “Treatment with laquinimod reduces development of active MRI lesions in relapsing MS”. Neurology 64 (6): 987–91. doi:10.1212/01.WNL.0000154520.48391.69. PMID 15781813.
- Keegan BM, Weinshenker BG (June 2008). “Laquinimod, a new oral drug for multiple sclerosis”. Lancet 371 (9630): 2059–2060. doi:10.1016/S0140-6736(08)60894-6. PMID 18572062.
- ClinicalTrials.gov NCT00509145 Safety and Efficacy of Orally Administered Laquinimod Versus Placebo for Treatment of Relapsing Remitting Multiple Sclerosis (RRMS) (ALLEGRO)
- Kresege, Naomi (1 August 2011). “Teva’s Copaxone Successor Fails in Latest Clinical Trial”. Bloomberg. http://www.bloomberg.com/news/2011-08-01/teva-s-oral-multiple-sclerosis-drug-fails-to-meet-goal-of-clinical-trial.html. Retrieved 2 August 2011. “Teva Pharmaceutical Industries Ltd. (TEVA)’s experimental multiple sclerosis pill failed to reduce relapses more than placebo in a clinical trial, dealing a blow to the company’s effort to find a successor to an older drug.”
- (Comi et al. N Engl J Med 2012;366:1000).
EP 1073639; JP 2002513006; US 6077851; WO 9955678
5-Chloroisatoic anhydride (I) is alkylated with iodomethane and NaH to afford (II). Subsequent condensation of anhydride (II) with the malonic monoamide (III) in the presence of NaH in hot DMA furnishes the target quinoline carboxamide.
…
Reaction of 2-amino-6-chlorobenzoic acid (I) with phosgene and NaHCO3 in dioxane gives 5-chloroisatoic anhydride (II), which is methylated by means of iodomethane and NaH in DMF to yield 5-chloro-1-methylisatoic anhydride (III). Finally, anhydride (III) is condensed with the malonic monoamide (IV) by means of NaH in hot dimethylacetamide. Alternatively, condensation of anhydride (III) with ethoxy malonyl chloride (V) by means of NaOMe and triethylamine in dichloromethane affords 5-chloro-4-hydroxy-1-methyl-2-oxo-1,2-dihydroquinoline-3- carboxylic acid ethyl ester (VI), which is finally condensed with N-ethylaniline (VII) in refluxing toluene. Alternatively, ester (VI) is hydrolyzed by means of concentrated HCl in hot Ac2O to give the carboxylic acid (VIII), which is finally condensed with N-ethylaniline (VII) by means of SOCl2 and TEA in dichloromethane
Phase 1-Lorus Therapeutics Announces Allowance of Chinese Patent for Anticancer Drug LOR-253
has a fluoro gp
WO-2004016086, feb2004
2,4,5-Trisubstituted imidazoles and their use as anti-microbial agents
WO-2006126177, nov 2006
WO-2010102393, sept 2010
Description of LOR-253, LT253: LOR-253 HCl is the hydrochloride salt of a small molecule inhibitor of human metal-regulatory transcription factor 1 (MTF-1) with potential antitumor activity. MTF-1 inhibitor LOR-253 inhibits MTF-1 activity and thereby induces the expression of MTF-1 dependent tumor suppressor factor Kruppel like factor 4 (KLF4). This subsequently leads to the downregulation of cyclin D1, blocking cell cycle progression and proliferation. This agent also causes decreased expression of genes involved in tumor hypoxia and angiogenesis.
http://clinicaltrials.gov/ct2/show/NCT01281592
ClinicalTrials.gov Identifier: NCT01281592
Lorus Therapeutics
This is an open-label, phase 1 study to determine the maximum tolerated dose (MTD) or appropriate target dose if MTD not reached to identify the recommended phase 2 dose of LOR-253 HCl in patients with advanced or metastatic solid tumours.
March 5, 2013) – Lorus Therapeutics Inc. (“Lorus”), a biopharmaceutical company specializing in the discovery, research and development of pharmaceutical products and technologies for the management of cancer, today announced that Lorus’ patent for its lead small molecule anticancer drug LOR-253 has been allowed in China. The patent provides Lorus with exclusive rights to LOR-253 in China until 2026.
The Chinese patent provides composition of matter protection for LOR-253 and for use in the manufacture of therapies for the treatment of cancer. The patent covers a wide range of cancers, including leukemia, melanoma, as well as non-small cell lung, colon, prostate, and breast tumors. This patent extends the Company’s international patent portfolio which includes similar protection for LOR-253 in the United States, Canada, and Australia. Applications are pending in Europe and Japan.
“This increased patent protection for our anticancer therapies supports our business discussions with potential partners,” said Dr. Aiping Young, Lorus’ President and CEO. “This Chinese patent is an important addition to our global IP portfolio for LOR-253, and demonstrates our commitment to the development of innovative cancer therapies intended for significant markets.”
LOR-253 is currently in a clinical study at Memorial Sloan Kettering Cancer Center and MD Anderson Cancer Center evaluating tumor biomarkers in biopsy-suitable patients with advanced or metastatic solid tumors.
About LOR-253
LOR-253 represents a new class of anticancer agent, which we believe may offer a competitive advantage over conventional drugs. This drug candidate has shown selective and potent antitumor activity in preclinical investigations with a variety of human cancers, including colon cancer and non-small cell lung cancer, and has demonstrated an excellent therapeutic window due to its low toxicity. LOR-253 is a first-in-class small molecule that has been optimized to induce the novel tumor suppressor Krüppel-like factor 4 (KLF4), leading to cancer cell cycle arrest and apoptosis as well as inhibition of metastasis.
About Lorus
Lorus is a biopharmaceutical company focused on the discovery, research and development of novel therapeutics in cancer. Lorus’ goal is to capitalize on its research, preclinical, clinical and regulatory expertise by developing new drug candidates that can be used, either alone, or in combination with other drugs, to successfully manage cancer. The Company also has expertise in antimicrobial drug discovery. Lorus Therapeutics Inc. is listed on the Toronto Stock Exchange under the symbol LOR.
PHASE1,Progenics Pharmaceuticals’ Novel Small Molecule Drugs Targeting PSMA Successfully Visualize Prostate Cancer, 123-I-MIP-1095
Name: 123-I-MIP-1095
Synonym: 123-I-MIP-1095; [123I]-MIP-1095; iodine I 123 IMP-1095; 2-(3-{l-carboxy-5-[3-(4-iodo-phenyl)-ureido]-pentyl}-ureido)-pentanedioic acid.; [123I]-(S)-2-(3-((S)-1-carboxy-5-(3-(4-iodophenyl)ureido)pentyl)ureido)pentanedioic acid
IUPAC/Chemical name:
2-(3-(1-carboxy-5-(3-(4-iodophenyl)ureido)pentyl)ureido)pentanedioic acid
Chemical Formula: C19H25123IN4O8
Exact Mass: 560.07284
Molecular Weight: 560.33
123-I-MIP-1095
An iodine 123-radiolabled small molecule that exhibits high affinity for prostate-specific membrane antigen (PSMA) with potential use in molecular imaging. 123-I-MIP-1095, a radiolabeled glutamate-urea-lysine analogue, selectively binds PSMA, which allows imaging of PSMA-expressing prostate cancer cells with gamma scintigraph. PSMA is a transmembrane glycoprotein highly expressed by malignant prostate epithelial cells and vascular endothelial cells of various solid tumors.
| Synonym: | |
iodine I 123 IMP-1095 | |
|
|||
| Chemical structure: | |
2-(3-{l-carboxy-5-[3-(4-iodo-phenyl)-ureido]-pentyl}-ureido)-pentanedioic acid | |
March 5, 2013
Progenics Pharmaceuticals, Inc. (Nasdaq:PGNX) reported positive clinical data from a study of two novel radiolabeled small molecules targeting prostate-specific membrane antigen (PSMA). The imaging agents — 123I-MIP-1072 and 123I-MIP-1095 — had a high sensitivity of lesion detection in bone, tissue and the prostate gland with minimal retention in non-target tissue. The research was published as the cover article in the March issue of The Journal of Nuclear Medicine.
“Existing imaging techniques are limited in their ability to diagnose and stage prostate cancer,” said John J. Babich, Ph.D., senior author of the article “First-in-Man Evaluation of Two High-Affinity PSMA-Avid Small Molecules for Imaging Prostate Cancer.” “The approach described in this paper has the potential to assess disease status more accurately. It could help clinicians select optimal treatments and lead to better patient outcomes.”
Separate phase 1 studies were conducted under an exploratory investigational new drug (IND) application to measure the potential effectiveness of the small molecules in diagnosing and staging prostate cancer. In the first study, seven patients with documented prostate cancer were administered doses of 123I-MIP-1072 and 123I-MIP-1095, two weeks apart. In the second study, six healthy volunteers received 123I-MIP-1072 only. Whole body planar imaging and single photon emission computed tomography (SPECT)/computed tomography (CT) were performed for each group, and pharmacokinetics, tissue distribution, excretion, safety and organ radiation dose were analyzed.
Based on the data reported, Progenics is conductinga global, multi-center phase 2 trial investigating a next generation radiolabeled small molecule targeting PSMA, MIP-1404.
Mark R. Baker, chief executive officer of Progenics, said, “We recently acquired all of the rights to the compounds described in this Journal of Nuclear Medicine paper, as well as to the phase 2 stage imaging agent MIP-1404, through Progenics’ acquisition of Molecular Insight Pharmaceuticals. It is gratifying to see this expansion of our oncology pipeline demonstrating progress so soon.”
Robert J. Israel, M.D., Progenics’ senior vice president of medical affairs and clinical research, said, “We believe that MIP-1404 has excellent potential as a diagnostic radiopharmaceutical. Results to date from the study compounds and MIP-1404 show PSMA as a robust target for prostate cancer molecular imaging, and that a radiolabeled small molecule, which binds PSMA with high affinity, has the potential to detect prostate cancer throughout the body. Cancer treatment guidelines call for imaging prostate cancer with conventional bone scans or MRI. A more accurate method of imaging prostate cancer could be of great value.”
Mr. Baker further added, “Thought leaders in prostate cancer care are focused on avoiding unnecessary surgery and other invasive procedures due to the complications associated with them. Clinicians generally prefer “watchful waiting” when the cancer appears to be indolent. At the same time, some therapeutics to treat aggressive prostate cancer have recently been approved or are under development, such as Progenics’ own PSMA ADC, which currently is in phase 2 testing. Patients and their physicians would benefit from feedback on how therapeutic agents are impacting the course of cancer, and guidance on how and when to use therapeutic agents. It is clear that an improved way to visualize prostate cancer, with a high degree of specificity and sensitivity, would better inform both “watchful waiting” and the treatment of aggressive disease. We believe that data from the ongoing phase 2 trial of MIP-1404 will demonstrate its capabilities to assist prostate cancer patients and their physicians in making these critical decisions.”
About Prostate Cancer
Prostate cancer is the most common form of cancer affecting men in the United States and is the second leading cause of cancer deaths among men each year. The American Cancer Society estimates that in 2013, 238,590 new cases of prostate cancer will be diagnosed and approximately 29,720 American men will die from the disease. Accurate diagnosis and staging of prostate cancer is critical to determining appropriate patient management.
About Progenics
Progenics Pharmaceuticals, Inc. is discovering and developing innovative medicines for oncology, with a pipeline that includes product candidates in preclinical through late-stage development. Progenics’ first commercial product, Relistor® (methylnaltrexone bromide) for opioid-induced constipation, is marketed and in further development by Salix Pharmaceuticals, Ltd. for markets worldwide other than Japan, where Ono Pharmaceutical Co., Ltd. holds an exclusive license for the subcutaneous formulation. For additional information, please visit http://www.progenics.com.
Generic – Dr. Reddy’s Announces the Launch of Zoledronic Acid Injection equivalent of Navartis AG Zometa®
Zoledronic acid
Mar 5, 2013 –
Dr. Reddy’s Laboratories announced today that it has launched Zoledronic Acid Injection (4 mg/5 mL), a bioequivalent generic version of Zometa® (zoledronic acid) 4 mg/5 mL Injection in the US market on March 4, 2013, following the approval by the United States Food & Drug Administration (USFDA) of Dr. Reddy’s ANDA for Zoledronic Acid Injection (4 mg/5 mL).
Dr. Reddy’s Zoledronic Acid Injection 4 mg/5mL is available in a single use vial of concentrate.
Zoledronic acid (INN) or zoledronate (marketed by Novartis under the trade names Zometa, Zomera, Aclasta and Reclast) is a bisphosphonate. Zometa is used to prevent skeletal fractures in patients with cancers such as multiple myeloma and prostate cancer, as well as for treating osteoporosis.It can also be used to treat hypercalcemia of malignancy and can be helpful for treating pain from bone metastases.
An annual dose of zoledronic acid may also prevent recurring fractures in patients with a previous hip fracture.
Reclast is a single 5 mg infusion for the treatment of Paget’s disease of bone. In 2007, the U.S. Food and Drug Administration (FDA) also approved Reclast for the treatment of postmenopausal osteoporosis.
About Dr. Reddy’s Laboratories Ltd.
Dr. Reddy’s Laboratories Ltd. (NYSE: RDY) is an integrated global pharmaceutical company, committed to providing affordable and innovative medicines for healthier lives. Through its three businesses – Pharmaceutical Services and Active Ingredients, Global Generics and Proprietary Products – Dr. Reddy’s offers a portfolio of products and services including APIs, custom pharmaceutical services, generics, biosimilars, differentiated formulations and NCEs. Therapeutic focus is on gastro-intestinal, cardiovascular, diabetology, oncology, pain management, anti-infective and pediatrics. Major markets include India, USA, Russia and CIS, Germany, UK, Venezuela, S. Africa, Romania, and New Zealand. For more information, log on to: http://www.drreddys.com
Zometa® is a registered trademark of Novartis AG
Dalbavancin (Durata Therapeutics) success in Phase III DISCOVER 2 trial for ABSSSI
Durata Therapeutics, Inc. has announced preliminary, top-line results for its DISCOVER 2 (“Dalbavancin for Infections of the Skin COmpared to Vancomycin at an Early Response”) Phase III study of dalbavancin, which is under investigation for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible gram-positive bacteria, including methicillin resistant Staphylococcus aureus (MRSA). DISCOVER 2 results follow the recent release of data from DISCOVER 1, which also met its primary and secondary endpoints.
Preliminary top-line data show that dalbavancin achieved its primary endpoint of non-inferiority (10% non-inferiority margin) at 48-72 hours after initiation of therapy, as determined by the cessation of spread of the lesion, as well as the resolution of fever. Researchers were comparing two intravenous (IV) doses of dalbavancin given one week apart with twice-daily vancomycin doses for 14 days. Patients…
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Vital 5 Receives Clearance from the FDA for a First-To-Market, Dual Function Catheter System that Provides Simultaneous Anesthetic Infusion and Wound Drainage, ReLeaf™
Mar 6, 2013 ,
Vital 5, LLC, a VentureMD portfolio company, announces that it has received clearance from the U. S. Food and Drug Administration (FDA) for ReLeaf™, a first-to-market, dual function catheter system that provides simultaneous anesthetic infusion and wound drainage.
Continuous anesthetic infusion to the surgical site in the immediate post-operative period has been clinically proven to provide significant improvements to pain management, but this therapy is currently not compatible with the millions of surgical cases where a wound drain is prescribed. By offering an integrated system that provides effective continuous local anesthetic infusion while also providing an effective wound drain function, the Vital 5 ReLeaf will greatly expand the number of patients who can benefit from local anesthetic infusion therapy.
The clinical applications for the Vital 5 ReLeaf include any invasive surgical procedure, including spine, orthopedic, cardiothoracic, plastic, general, obstetrics and gynecological procedures.
About Vital 5, LLC
Vital 5 is an early stage medical device company focused on developing advanced catheter technologies to meet the increasing demand for improved post-operative pain management.
About VentureMD
VentureMD (venturemd.com) is an angel capital firm and medical device incubator focused on musculoskeletal products. The company provides financial, human and intellectual capital to start-up medical device companies. Focused on the orthopedic, spine, endoscopy and dental markets, the company partners with entrepreneurs, inventors, technology transfer offices and seed stage start-ups to launch and manage new medical device companies.
Ziopharm Oncology will be releasing its Phase III results for its drug Palifofsamide towards the end of March 2013
(Zymafos; ZIO-201) is a cytotoxic, active metabolite of the alkylating agent ifosfamide, which causes irreparable DNA interstrand cross-linking in cancer cells. This prevents DNA replication and cell division, leading to cell death.
In contrast to ifosfamide, palifosfamide is not metabolised to the toxins acrolein and chloracetaldehyde, which are associated with haemorrhagic cystitis, and neuro- and nephro-toxicities respectively. Also, palifosfamide is not a substrate for aldehyde dehydrogenase (ALDH), an important mediator of drug resistance
Cyclophosphamide and ifosfamide are nitrogen mustard alkylating agents that act by crosslinking DNA strands at the guanine N-7 position, resulting in cell death. Both of these are prodrugs that are metabolised in the liver to phosphoramide mustard active metabolites, but their use is limited by toxic side-effects. They are also prone to tumour resistance, which results from numerous mechanisms, including DNA repair.
In an attempt to overcome some of these problems, Ziopharm Oncology has developed palifosfamide tromethamine, which is a salt formulation of isophosphoramide mustard, the active metabolite of isofosfamide.1
isofosamide
In a Phase I trial, it was given in combination with doxorubicin to 13 patients with advanced refractory tumours – eight with soft tissue sarcoma and the remainder with small cell lung cancer – for whom there was no available standard therapy.2 It was given on the first three days of a three-week cycle, with a starting dose of 150mg/m2, and doxorubicin given on the first day at a starting dose of 60mg/m2. The doses were escalated to a maximum tolerated dose of 150mg/m2 for palifosfamide and 75mg/m2 for doxorubicin. It was well tolerated, and three of the 12 assessable patients had a partial response, two of whom were from the sarcoma group, and the median progression free survival was 20 weeks.
references
1. S. Jung and B. Kasper, IDrugs 2010, 13, 38
2. L.J. Camacho et al. J. Clin. Oncol. 2009, 27 (Suppl.), Abst. 10577
3. C.F. Verschraegen et al. J. Clin. Oncol. 2010, 28 (Suppl.), A
Palifosfamide, A Novel Molecule for the Treatment of Soft Tissue Sarcoma
Palifosfamide (Zymafos™ or ZIO-201) references a novel composition (tris formulation) that is the functional active metabolite of ifosfamide (IFOS), a bi-functional DNA alkylator being investigated as a potential therapy for the treatment of soft tissue sarcoma (STS). Palifosfamide is formulated by combining the tris (hydroxymethyl) amino methane (tris) salt of palifosfamide and a number of excipients to create the final drug product. Preclinical development of palifosfamide has included in vitro and in vivo studies demonstrating activity against various sarcomas, breast cancers, other solid tumors and leukemias, including several that are resistant to IFOS. Several clinical studies have been initiated in a variety of cancer types. A Phase I study in advanced cancers, using the original lysine formulation, has been completed. A two-stage Phase I/II Study in advanced sarcomas, introducing the tris salt formulation, has completed enrollment and data retrieval is ongoing. A Phase I study in combination with doxorubicin evaluating patients with advanced, refractory solid tumors for whom treatment with doxorubicin is considered medically acceptable, has completed enrollment and data retrieval is ongoing. Based on the result of the Phase I combination study, an international randomized Phase II study comparing palifosfamide in combination with doxorubicin versus doxorubicin alone in 1st and 2nd line patients with advanced STS has been completed. phase 3 on now also
What is Soft Tissue Sarcoma, and what are the currently available treatments?
Soft-tissue sarcomas (STS) represent a rare and diverse group of tumors that are not very well understood. Although soft-tissue sarcomas account for <1% of all cancers, they represent a high percentage of cancer-related deaths worldwide (Ref. 3, Ref. 4, Ref. 5). STS tumors can occur anywhere within the body, originating in various soft tissues including fat, smooth or striated muscle, nerve/nerve sheath, vascular tissue, and other connective tissues; the extremities are the most common site of origin, accounting for approximately 50% of cases
Pfizer receives FDA approval for the use of Prevnar 13® , Pneumococcal 13-valent Conjugate Vaccine
Prevnar 13
Publication date: 25 January 2013
Author: Pfizer
Pfizer Inc. announced today that the U.S. Food and Drug Administration (FDA) has granted approval for the expansion of the company’s pneumococcal conjugate vaccine, Prevnar 13®* (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]), for use in older children and adolescents aged 6 years through 17 years for active immunization for the prevention of invasive disease caused by the 13 Streptococcus pneumoniae serotypes contained in the vaccine. For this age group, Prevnar 13 is administered as a one-time dose to patients who have never received Prevnar 13.1
“As a global leader in pneumococcal disease prevention, extending the impact of Prevnar 13 to older children and adolescents aged 6 through 17 years is a reflection of our dedication to improving public health worldwide,”said Susan Silbermann, president, vaccines, Pfizer. “We continue to work tirelessly to make this vaccine available to people at risk for invasive pneumococcal disease.”
The FDA approval followed submission and review of a Phase 3, open-label trial of Prevnar 13 in 592 older children and adolescents, including those with asthma.2 The study met all endpoints, demonstrating immunogenicity and establishing a safety profile in children aged 6 years through 17 years consistent with the safety profile established in previous trials in infants and young children.2
About Prevnar 13
Prevnar 13 was first introduced for use in infants and young children in December 2009 in Europe and in February 2010 in the U.S., and it is now approved for such use in nearly 120 countries worldwide. It is the most widely used pneumococcal conjugate vaccine in the world, and more than 500 million doses of Prevnar/Prevnar 13 have been distributed worldwide. Currently, Prevnar 13 is included as part of a national or regional immunization program in more than 60 countries, offering coverage against invasive pneumococcal disease to nearly 30 million children per year.3
Prevnar 13 is also approved for use in adults 50 years of age and older in more than 80 countries and it is the first and only pneumococcal vaccine to be granted World Health Organization prequalification in the adult population.3
About Pneumococcal Disease
Pneumococcal disease (PD) is a group of illnesses caused by the bacterium Streptococcus pneumoniae (S. pneumoniae), also known as pneumococcus.4 PD is associated with significant morbidity and mortality.4 Invasive manifestations of the disease include bacteremia (bacteria in the blood) and meningitis (infection of the tissues surrounding the brain and spinal cord).4 Invasive pneumococcal disease can affect people of all ages, although older adults and young children are at heightened risk.4,5,6
us fda data
STN#: 125324
Proper Name: Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein)
Tradename: Prevnar 13
Manufacturer: Wyeth Pharmaceuticals, Inc, License #0003
Indications:
- Active immunization for the prevention of pneumonia and invasive disease caused by S. pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F in persons 50 years of age or older.
- Active immunization for the prevention of invasive disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F, for use in children 6 weeks through 17 years of age.
- Active immunization for the prevention of otitis media caused by Streptococcus pneumoniae serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F for use in children 6 weeks through 5 years of age.
Pfizer presents Phase 3 safety and immunogenicity data on Prevnar 13® in adults with HIV
Publication date: 4 March 2013
Author: Pfizer
Pfizer Inc. (NYSE:PFE) presented today the results from a Phase 3 study demonstrating the immunogenicity, tolerability and safety of Prevnar 13®(Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein])in adults infected with human immunodeficiency virus (HIV). The results were presented at the 20th Conference on Retroviruses and Opportunistic Infections (CROI) in Atlanta, Ga.
These data support planned regulatory submissions seeking to include data on HIV-infected immunocompromised adults in the Prevnar 13 label in the United States, the European Union, and other countries around the world.
New Drug Approvals 