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DRUG APPROVALS BY DR ANTHONY MELVIN CRASTO
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New Drug Application for Belinostat in Relapsed or Refractory PTCL Submitted to the FDA
Belinostat (PXD101)
Belinostat (PXD101) is a novel HDAC inhibitor with IC50 of 27 nM, with activity demonstrated in cisplatin-resistant tumors.
Belinostat inhibits the growth of tumor cells (A2780, HCT116, HT29, WIL, CALU-3, MCF7, PC3 and HS852) with IC50 from 0.2-0.66 μM. PD101 shows low activity in A2780/cp70 and 2780AD cells. Belinostat inhibits bladder cancer cell growth, especially in 5637 cells, which shows accumulation of G0-G1 phase, decrease in S phase, and increase in G2-M phase. Belinostat also shows enhanced tubulin acetylation in ovarian cancer cell lines. A recent study shows that Belinostat activates protein kinase A in a TGF-β signaling-dependent mechanism and decreases survivin mRNA.
| MW 318.07 | |
| Molecular Formula: | C15H14N2O4S |
414864-00-9 cas no
(2E)-N-hydroxy-3-[3-(phenylsulfamoyl)phenyl]acrylamide
A novel HDAC inhibitor
…………………………
SPECTRUM
Tiny Biotech With Three Cancer Drugs Is More Alluring Takeover Bet Now
Forbes
The drug is one of Spectrum’s two drugs undergoing phase 3 clinical trials. Allergan paid Spectrum $41.5 million and will make additional payments of up to $304 million based on achieving certain milestones. So far, Raj Shrotriya, Spectrum’s chairman, …
Belinostat (PXD101) is experimental drug candidate under development byTopoTarget for the treatment of hematological malignancies and solid tumors. It is a histone deacetylase inhibitor.[1]
In 2007 preliminary results were released from the Phase II clinical trial of intravenous belinostat in combination with carboplatin and paclitaxel for relapsedovarian cancer.[2] Final results in late 2009 of a phase II trial for T cell lymphomawere encouraging.[3] Belinostat has been granted orphan drug and fast trackdesignation by the FDA.[4]
- Plumb, Jane A.; Finn, Paul W.; Williams, Robert J.; Bandara, Morwenna J.; Romero, M. Rosario; Watkins, Claire J.; La Thangue, Nicholas B.; Brown, Robert (2003). “Pharmacodynamic Response and Inhibition of Growth of Human Tumor Xenografts by the Novel Histone Deacetylase Inhibitor PXD101″. Molecular Cancer Therapeutics 2 (8): 721–728. PMID 12939461.
- “CuraGen Corporation (CRGN) and TopoTarget A/S Announce Presentation of Belinostat Clinical Trial Results at AACR-NCI-EORTC International Conference”. October 2007.
- Final Results of a Phase II Trial of Belinostat (PXD101) in Patients with Recurrent or Refractory Peripheral or Cutaneous T-Cell Lymphoma, December 2009
- “Spectrum adds to cancer pipeline with $350M deal.”. February 2010.
PXD101/Belinostat®
(E)-N-hydroxy-3-(3-phenylsulfamoyl-phenyl)-acrylamide, also known as PXD101 and Belinostat®, shown below, is a well known histone deacetylate (HDAC) inhibitor. It is being developed for treatment of a range of disorders mediated by HDAC, including proliferative conditions (such as cancer and psoriasis), malaria, etc.
PXD101 was first described in WO 02/30879 A2. That document describes a multi-step method of synthesis which may conveniently be illustrated by the following scheme.
…………
US20100286279
SEE COMPILATION ON SIMILAR COMPOUNDS AT …………..http://drugsynthesisint.blogspot.in/p/nostat-series.html
VBL Therapeutics announced FDA has granted Fast Track designation to its lead oncology drug VB-111
VB-111
VBL Therapeutics announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to its lead oncology drug VB-111, for prolongation of survival in patients with recurrent glioblastoma multiforme (rGBM).
VB-111 – highly targeted anti-angiogenic agent for the specific inhibition of tumor vascular growth
VB-111 is the first highly targeted anti-angiogenic agent for the specific inhibition of tumor vascular growth to use VTS™™, our proprietary platform technology, for cancer therapy. VB-111 is an IV-administered anti angiogenic agent that works in a manner akin to a “biological knife” to destroy tumor vasculature, thus cutting off blood vessels feeding the tumor.
Preclinical Insights
VB-111 has shown significant promise as a targeted cancer treatment with the potential to work synergistically in combination with conventional chemotherapy treatments to provide an effective treatment regimen for cancer patients. Pharmacological and toxicology studies of VB-111 have showed tissue specificity for the tumor tissue, no significant damage to normal non-cancerous tissues or to the normal vasculatures in the body and more than 90 percent tumor burden reduction in a metastatic lung cancer model with only one injection. Similar efficacy was shown in other tumor models.
Completed Clinical Trials
Phase 1 Clinical Trial – in a Phase 1 “all comers” dose escalation study in 33 patients with advanced metastatic cancer, therapeutic doses of VB-111 demonstrated antitumor activity and was found to be safe and well tolerated with no effect on liver function or major changes in complete blood count. Findings have been presented at the American Association of Cancer Research (AACR) and the American Society of Clinical Oncology (ASCO) annual meetings.
Copanlisib (BAY 80-6946), Bayer’s novel, oral phosphatidylinositol-3 kinases (PI3K) inhibitor
Copanlisib (BAY 80-6946)
1032568-63-0, cas no
MW: 480.5262
In oncology, Copanlisib (BAY 80-6946), a novel, oral phosphatidylinositol-3 kinases (PI3K) inhibitor, was selected for accelerated development. Copanlisib demonstrated a broad anti-tumor spectrum in preclinical tumor models and promising early clinical signals in a Phase I study in patients with follicular lymphoma. A Phase II study in patients with Non-Hodgkin’s lymphoma is currently ongoing.
PI3K inhibitor BAY 80-6946
A phosphoinositide 3-kinase (PI3K) inhibitor with potential antineoplastic activity. PI3K inhibitor BAY 80-6946 inhibits the activation of the PI3K signaling pathway, which may result in inhibition of tumor cell growth and survival in susceptible tumor cell populations. Activation of the PI3K signaling pathway is frequently associated with tumorigenesis and dysregulated PI3K signaling may contribute to tumor resistance to a variety of antineoplastic agents.
Novartis Muscle Drug Bimagrumab Gets Breakthrough Status
immunoglobulin G1-lambda2, anti-[Homo sapiens ACVR2B (activin
A receptor type IIB, ActR-IIB)], Homo sapiens monoclonal antibody;
gamma1 heavy chain (1-445) [Homo sapiens VH (IGHV1-2*02
(91.80%) -(IGHD)-IGHJ5*01 [8.8.8] (1-115) -IGHG1*03 (CH1 (116-
213), hinge (214-228), CH2 L1.3>A (232), L1.2>A (233) (229-338),
CH3 (339-443), CHS (444-445)) (116-445)], (218-216′)-disulfide with
lambda light chain (1′-217′) [Homo sapiens V-LAMBDA (IGLV2-
23*02 (90.90%) -IGLJ2*01) [9.3.11] (1′-111′) -IGLC2*01 (112′-217′)];
dimer (224-224”:227-227”)-bisdisulfide
myostatin inhibitor
bimagrumab immunoglobuline G1-lambda2, anti-[Homo sapiens ACVR2B
(récepteur type IIB de l’activine A, ActR-IIB)], Homo sapiens
anticorps monoclonal;
chaîne lourde gamma1 (1-445) [Homo sapiens VH (IGHV1-2*02
(91.80%) -(IGHD)-IGHJ5*01 [8.8.8] (1-115) -IGHG1*03 (CH1 (116-
213), charnière (214-228), CH2 L1.3>A (232), L1.2>A (233) (229-
338), CH3 (339-443), CHS (444-445)) (116-445)], (218-216′)-
disulfure avec la chaîne légère lambda (1′-217′) [Homo sapiens
V-LAMBDA (IGLV2-23*02 (90.90%) -IGLJ2*01) [9.3.11] (1′-111′) –
IGLC2*01 (112′-217′)]; dimère (224-224”:227-227”)-bisdisulfure
inhibiteur de la myostatine
inmunoglobulina G1-lambda2, anti-[Homo sapiens ACVR2B
(receptor tipo IIB de la activina A, ActR-IIB)], anticuerpo monoclonal
de Homo sapiens;
cadena pesada gamma1 (1-445) [Homo sapiens VH (IGHV1-2*02
(91.80%) -(IGHD)-IGHJ5*01 [8.8.8] (1-115) -IGHG1*03 (CH1 (116-
213), bisagra (214-228), CH2 L1.3>A (232), L1.2>A (233) (229-338),
CH3 (339-443), CHS (444-445)) (116-445)], (218-216′)-disulfuro con
la cadena ligera lambda (1′-217′) [Homo sapiens V-LAMBDA
(IGLV2-23*02 (90.90%) -IGLJ2*01) [9.3.11] (1′-111′) -IGLC2*01
(112′-217′)]; dímero (224-224”:227-227”)-bisdisulfuro
inhibidor de la miostatina
1356922-05-8
Heavy chain / Chaîne lourde / Cadena pesada
QVQLVQSGAE VKKPGASVKV SCKASGYTFT SSYINWVRQA PGQGLEWMGT 50
INPVSGSTSY AQKFQGRVTM TRDTSISTAY MELSRLRSDD TAVYYCARGG 100
WFDYWGQGTL VTVSSASTKG PSVFPLAPSS KSTSGGTAAL GCLVKDYFPE 150
PVTVSWNSGA LTSGVHTFPA VLQSSGLYSL SSVVTVPSSS LGTQTYICNV 200
NHKPSNTKVD KRVEPKSCDK THTCPPCPAP EAAGGPSVFL FPPKPKDTLM 250
ISRTPEVTCV VVDVSHEDPE VKFNWYVDGV EVHNAKTKPR EEQYNSTYRV 300
VSVLTVLHQD WLNGKEYKCK VSNKALPAPI EKTISKAKGQ PREPQVYTLP 350
PSREEMTKNQ VSLTCLVKGF YPSDIAVEWE SNGQPENNYK TTPPVLDSDG 400
SFFLYSKLTV DKSRWQQGNV FSCSVMHEAL HNHYTQKSLS LSPGK 445
Light chain / Chaîne légère / Cadena ligera
QSALTQPASV SGSPGQSITI SCTGTSSDVG SYNYVNWYQQ HPGKAPKLMI 50
YGVSKRPSGV SNRFSGSKSG NTASLTISGL QAEDEADYYC GTFAGGSYYG 100
VFGGGTKLTV LGQPKAAPSV TLFPPSSEEL QANKATLVCL ISDFYPGAVT 150
VAWKADSSPV KAGVETTTPS KQSNNKYAAS SYLSLTPEQW KSHRSYSCQV 200
THEGSTVEKT VAPTECS 217
Disulfide bridges location / Position des ponts disulfure / Posiciones de los puentes disulfuro
Intra-H 22-96 142-198 259-319 365-423
22”-96” 142”-198” 259”-319” 365”-423”
Intra-L 22′-90′ 139′-198′
22”’-90”’ 139”’-198”’
Inter-H-L 218-216′ 218”-216”’
Inter-H-H 224-224” 227-227”
N-glycosylation sites / Sites de N-glycosylation / Posiciones de N-glicosilación
H CH2 N84.4
Bimagrumab
http://www.who.int/medicines/publications/druginformation/innlists/PL108_Final.pdf
Novartis announced that the US Food and Drug Administration (FDA) has granted breakthrough therapy designation to BYM338 for sporadic inclusion body myositis (sIBM). This designation is based on the results of a phase 2 proof-of-concept study that showed BYM338 substantially benefited patients with sIBM compared to placebo.
read all at
Novartis receives FDA breakthrough therapy designation for BYM338 (bimagrumab) for sporadic inclusion body myositis (sIBM)
• Designation highlights potential of BYM338 to address an unmet medical need in a serious disease
• If approved, BYM338 has the potential to be the first treatment for sIBM patients
• BYM338 is the third Novartis investigational treatment this year to receive a breakthrough therapy designation by the FDA, highlighting Novartis’ leadership in the industry in breakthrough therapy designations
Bimagrumab (BYM338) is a human monoclonal antibody developed by Novartis to treat pathological muscle loss and weakness. On August 20, 2013 it was announced that bimagrumab was granted breakthrough therapy designation for sporadic inclusion body myositis(sIBM) by US Food and Drug Administration.[1]
- “Novartis receives FDA breakthrough therapy designation for BYM338 (bimagrumab) for sporadic inclusion body myositis (sIBM)”. Retrieved 20 August 2013.
World Health Organization (2012). “International Nonproprietary Names for Pharmaceutical Substances (INN). Proposed INN: List 108” (PDF). WHO Drug Information 26(4)
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Amgen In Focus
Amgen In Focus
Seeking Alpha
According to Amgen, they have 45 drugs in development from Phase 1 to Phase 3. Conversely, Gilead has 32 drugs in development and Pfizer has 64. Meanwhile, Gilead only has 8 drugs in Phase 3, Pfizer has 25, and Amgen has 14. 7 of those Phase 3 …
http://seekingalpha.com/article/1510002-amgen-in-focus?source=google_news
Amgen has the second deepest pipeline of drugs of the three large cap biotechs. According to Amgen, they have 45 drugs in development from Phase 1 to Phase 3. Conversely, Gilead has 32 drugs in development and Pfizer has 64. Meanwhile, Gilead only has 8 drugs in Phase 3, Pfizer has 25, and Amgen has 14. 7 of those Phase 3 drugs are focused on cancer treatments for Amgen, more than either Pfizer or Gilead. Keep in mind that 12.4 million people learn they have cancer each year, while 7.6 million people lose that battle each year. The CDC predicts that the global number of cancer related deaths will increase by 80% by 2030. It doesn’t take a rocket scientist to know that cancer treating drugs presents the largest opportunity for any drug maker considering those statistics. Amgen has the inside track versus Gilead and Pfizer as far as quantity of drugs in late stage development.
Modality
ASLAN’s Pan-HER Inhibitor Shows Positive Data In Gastric Cancer PhII Study
AsianScientist (Jun. 3, 2013) – ASLAN Pharmaceuticals Pte Ltd announced this week results of a Phase II clinical trial with ASLAN001, a small-molecule pan-HER inhibitor, in gastric cancer, a major public-health problem in Asia.
ASLAN001 was invented by Array BioPharma Inc and licensed to ASLAN in 2011. ASLAN001 (ARRY-543) is a novel, selective and oral HER2/EGFR inhibitor, and has previously shown clinical activity in both HER2 positive and EGFR positive tumors in US studies. READ ALL AT
TheraVida Presents Positive Phase 2 Data for Tolenix (THVD-201) in Patients with Overactive Bladder
mar18, 2013
TheraVida, Inc., a clinical-stage biopharmaceutical company developing novel combination drug products, presented positive results from a Phase 2 clinical trial of its lead product candidate, Tolenix ™ (THVD-201), for the treatment of overactive bladder (OAB) and urge urinary incontinence (UUI) at the 28 th Annual Congress of the European Urological Association (EAU) in Milan, Italy.
Tolenix ™ is a twice-daily (BID) proprietary combination of tolterodine, to treat OAB and UUI, and pilocarpine, to reduce the significant dry mouth (xerostomia) caused by muscarinic antagonist medications such as tolterodine.
tolterodine
pilocarpine
The objectives of the randomized, double-blinded, multiple-crossover Phase 2 trial were to assess the safety and efficacy of Tolenix ™ in reducing the frequency of micturition (urination) and incontinence episodes per day, as compared to both placebo control and active control Detrol ® (tolterodine). In addition, common side effects of muscarinic antagonist therapies, such as dry mouth, were carefully assessed in the 138 patients enrolled in the trial. This international Phase 2 clinical trial was conducted in South Korea, Australia, and New Zealand.
Patients receiving Tolenix ™ (2mg tolterodine plus 9mg pilocarpine, administered BID) experienced statistically significant improvements in their OAB and UUI symptoms over placebo, with a reduction in daily micturitions of 0.88 (p<0.0001) and a reduction in daily incontinence episodes of 0.47 (p<0.0001). This efficacy was similar in magnitude to the maximum dose of active control Detrol ® (2mg tolterodine, administered BID).
Phase 2 ORM-12741, Orion’s Experimental Alzheimer’s Drug Shows Promise, Study Finds
 ORM-12741 in WO 2003082866 |
The purpose of this study is to determine whether ORM-12741 is safe and effective in the treatment of Alzheimer’s disease.,
March 11, 2013
A small Finnish study is raising hopes for a new drug designed to help stave off memory loss among patients struggling with moderate Alzheimer’s disease.
Still in the preliminary stages of investigation, the drug — called ORM-12741 — showed promise during a three-month trial involving 100 such patients, half of whom were given the medication on top of their current drug treatment.
By the end of the study, memory scores plummeted by 33 percent among the 50 patients who were given a dummy pill (placebo) rather than the new drug, while patients who took the new drug showed a 4 percent improvement on the tests.
“The bottom line is that this was the first study investigating [effectiveness] of a drug with a novel mechanism of action in patients with Alzheimer’s disease,” said study lead author Dr. Juha Rouru, who heads the central nervous system therapy area at Orion Pharma in Turku, Finland.
“The results were clearly positive,” he said, adding they were seen particularly on important episodic memory, which involves remembering events and personal experiences. Orion, the maker of ORM-12741, funded the research.
Rouru and his colleagues are scheduled to present their work in San Diego at a meeting of the American Academy of Neurology, which starts Saturday.
By 2050, as the elderly population increases, an estimated 13.8 million Americans will have Alzheimer’s, a progressive brain disease that robs people of their memory and the ability to perform even simple everyday tasks. There is no cure for the disease, and drugs aimed at controlling the debilitating symptoms are only moderately effective, Rouru said.
With that in mind, the team set out to assess the potential of ORM-12741, the first drug to target a specific receptor in the brain, called alpha-2C. This receptor is thought to play a role in the brain’s “fight or flight” response to stress, and the authors noted that the new drug’s impact on alpha-2C had shown promise in prior animal studies.
All the patients in the study were already taking a cholinesterase drug. Some were also using memantine, another type of Alzheimer’s medication.
Fifty patients were then given a placebo on top of their current regimen, while 50 were given either a low-dose (30 to 60 milligrams) twice daily supply of ORM-12741 or a high-dose (100 to 200 milligrams) version.
Computerized memory tests highlighted an apparent memory benefit (without prompting severe side effects) among the ORM-12741 patients, and Rouru suggested that the new drug should be seen as just one more potentially effective tool in an ongoing battle to reign in “a devastating disease.”
“I am afraid that wonder drugs hardly exist,” he noted. “In the present study, our drug was used on top of existing Alzheimer’s medications. In that setting it showed clear effect, which suggests that it is giving additional clinically significant benefit for patients that are already using Alzheimer’s medications.”
Catherine Roe, an assistant professor of neurology at Washington University School of Medicine in St. Louis, described Rouru’s research as “impressive.”
“This is really a new approach, in terms of the biology that they’re targeting,” she noted. “And they showed significant results after only three months of treatment, which is exciting particularly because this drug combination was tested on people who had moderate Alzheimer’s disease.”
Many experts have thought moderate Alzheimer’s disease would be untreatable, she said. “By the time it’s that advanced, the nerves have already died and it would be too late to do anything about memory by this stage,” she explained.
Still, much more testing will need to be done, Roe cautioned. “And these results will have to be replicated with other groups of people,” she said. “But if they can do that, this would be awesome.”
The data and conclusions of research presented at medical meetings are typically considered preliminary until published in a peer-reviewed journal.
More information
For more on Alzheimer’s disease, visit the U.S. National Institutes of Health.
Phase 2- Cylene Pharmaceuticals and TetraGene Enter Agreement for Quarfloxin and Anticancer Quadruplex Technologies
Quarfloxin, CX-3543
Molecular Formula: C35H33FN6O3
cas no 865311-47-3
Molecular Formula: 604.67
SAN DIEGO, March 6, 2013
Cylene Pharmaceuticals, Inc. announced today that it has entered into an exclusive, worldwide Option and License Agreement that will allow TetraGene LLC to advance the development of Quarfloxin and Cylene’s associated anticancer quadruplex-targeting technologies. Cylene will receive an upfront fee, as well as potential milestone payments and royalties on product sales for the exclusive license.
TetraGene is developing small molecule drugs aimed at highly validated cancer-causing genes, by directly targeting G-quadruplex structures in genomic DNA. TetraGene has the option to acquire worldwide rights to the technologies licensed from Cylene, which include the Phase II compound Quarfloxin and several registered patents. Quarfloxin has been demonstrated to be safe and well-tolerated in Phase I clinical trials.
“This agreement is a clear win for both organizations,” stated William G. Rice, PhD, President and CEO of Cylene Pharmaceuticals. “TetraGene is well placed to advance Quarfloxin through the clinic and to capture exclusive worldwide rights to the quadruplex-targeting technologies. Cylene will receive standard industry payments as the quadruplex program progresses and we will continue to focus our in-house development efforts on CX-5461, Cylene’s clinical stage Pol I inhibitor that activates the p53 tumor suppressor selectively in cancer cells and not normal cells.”
“The agreement between TetraGene and Cylene immediately provides us with access to a clinical stage drug,” commented Laurence H. Hurley, PhD, CSO of TetraGene and a pioneer of G-quadruplex targeted therapeutics. “The validity of drug targeting G-quadruplex DNA and modulating expression of cancer genes has dramatically increased in the last few years and our team is uniquely positioned to take advantage of these new insights.”
About Cylene Pharmaceuticals
Cylene Pharmaceuticals is a clinical-stage private company developing small molecule drugs against newly validated targets in essential cancer pathways. The Company’s Pol I program provides a non-genotoxic mechanism for activating p53 to kill cancer cells. Cylene’s leadership in exploiting CK2 pathways enables rational drug combinations for improved treatment outcomes against many cancer indications. Cylene’s unique approaches deliver innovative cancer agents that can enable pharmaceutical companies to expand their portfolios and extend the efficacy, lifecycle and reach of current cancer therapeutics. For more information on Cylene and its programs, please visit www.cylenepharma.com.
About TetraGene
TetraGene leverages a novel platform technology to develop cancer drugs that target well-validated cancer-causing oncogenes previously considered as undruggable by the pharmaceutical industry. This technology exploits a gene regulatory mechanism where the expression of a gene is controlled by folded DNA structures (called G-quadruplex DNA). By targeting gene transcription, TetraGene has carved out a niche where its technology platform can be directly applied to inhibit these undruggable cancer targets. For more information about TetraGene please visit www.tetragene.com.
…………………………………….
DR ANTHONY MELVIN CRASTO Ph.D , Born in Mumbai in 1964 and graduated from Mumbai University, Completed his PhD from ICT ,1991, Mumbai, India in Organic chemistry, The thesis topic was Synthesis of Novel Pyrethroid Analogues,
Currently he is working with GLENMARK- GENERICS LTD, Research centre as Principal Scientist, Process Research (bulk actives) at Mahape, Navi Mumbai, India.
Prior to joining Glenmark, he worked with major multinationals like Hoechst Marion Roussel, now Sanofi Aventis, & Searle India ltd, now Rpg lifesciences, etc. He has worked in Basic research, Neutraceuticals, Natural products, Flavors, Fragrances, Pheromones, Vet Drugs, Drugs, formulation, GMP etc. He has total 25 yrs exp in this field, he is now helping millions, has million hits on google on all organic chemistry websites.
His New Drug Approvals , Green Chemistry International, Eurekamoments in Organic Chemistry , Organic Chemistry by Dr Anthony, WIX BLOG , are some most read chemistry blogs
He has hands on experience in initiation and developing novel routes for drug molecules and implementation them on commercial scale over a 25 year tenure, good knowledge of IPM, GMP, Regulatory aspects, he has several international drug patents published worldwide .
He has good proficiency in Technology Transfer, Spectroscopy , Stereochemistry , Synthesis, Reactions in Org Chem , Polymorphism, Pharmaceuticals , Medicinal chemistry , Organic chemistry literature , Patent related site , Green chemistry , Reagents , R & D , Molecules , Heterocyclic chem , Sourcing etc
He suffered a paralytic stroke in dec 2006 and is bound to a wheelchair, this seems to have injected feul in him to help chemists around the world, he is more active than before and is pushing boundaries, he has one lakh connections on all networking sites, He makes himself available to all, contact him on +91 9323115463, amcrasto@gmail.com
New Drug Approvals 