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DRUG APPROVALS BY DR ANTHONY MELVIN CRASTO
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Curis phase 1 Cancer Trial for CUDC-427 Begins
CUDC-427, GDC-0917; RG-7459
Genentech Inc (Roche Holding AG)
Curis licenses GDC-0917 from Genentech
Curis Cancer Trial Begins
Curis Inc. has initiated patient dosing in a second Phase 1 dose-escalation study of CUDC-427 that is being conducted using a continuous, twice-daily oral dosing regimen in patients with advanced and refractory solid tumors or lymphoma.
FULL STORY
About CUDC-427 (GDC-0917)
CUDC-427 is an orally bioavailable small molecule that is designed to promote cancer cell death by antagonizing IAP proteins. IAP proteins are a family of functionally and structurally related proteins that promote cancer cell survival by inhibiting programmed cell death, also known as apoptosis, which is a normal process inherent in every cell. Using IAP proteins and other anti-apoptotic factors, cancer cells evade apoptosis in response to a variety of signals, including those provided by anti-cancer agents such as chemotherapy, or naturally occurring inflammatory and immune signals transmitted through members of the tumor necrosis factor, or TNF, family of factors. Evasion from apoptosis is a fundamental mechanism whereby human cancers develop resistance to standard anti-cancer treatments. IAP inhibitors such as CUDC-427 are designed to counteract the effects of IAP proteins, thus shifting the balance away from cancer cell survival and allowing apoptosis to proceed.
CUDC-427 was designed to mimic the endogenous IAP antagonist mitochondrial protein second mitochondria-derived activator of caspases/direct IAP-binding protein (Smac/DIABLO) that is released into the cytoplasm in response to pro-apoptotic stimuli. CUDC-427 has demonstrated single-agent and combination anti-tumor activity in mouse xenograft tumor models when administered orally on a daily schedule, and IND-enabling safety studies have shown it to be well tolerated when dosed daily by oral administration, potentially enabling sustained target inhibition.
In October 2010, an open-labeled, uncontrolled, dose-escalation, Phase I clinical trial of CUDC-427 (NCT01226277; IAM4914g) began in patients with refractory solid tumors or lymphoma. Genentech recently completed this Phase I clinical trial in which 42 people received daily oral doses of CUDC-427 for two weeks, followed by a one week rest period. This 21-day cycle is repeated until disease progression or study discontinuation for any other reason. The primary endpoints of the study include evaluating the safety and tolerability and the pharmacokinetics of CUDC-427 in people with solid tumors or lymphoma and determining the maximum-tolerated-dose and a potential recommended dose for further clinical studies. Secondary endpoints include a preliminary assessment of anti-tumor activity of CUDC-427 and evaluating pharmacodynamic markers. Genentech plans to present full study results at a medical conference in mid-2013. Please refer to http://www.clinicaltrials.gov for additional study details.
About Inhibitor of Apoptosis Proteins
Impairment of programmed cell death or apoptosis often contributes to the formation and progression of cancer, and evasion of apoptosis is one of the primary strategies by which cancer cells develop resistance to anticancer therapies. Inhibitor of apoptosis (IAP) proteins are a family of functionally and structurally related proteins which include X-linked IAP (XIAP), cellular IAPs (cIAP1 and cIAP2), and melanoma IAP (ML-IAP). They confer protection from death-inducing stimuli by exerting a range of biological activities that promote cancer cell survival and proliferation. Some even directly inhibit caspases, critical players in the execution of apoptosis.
Mutations, amplifications and chromosomal translocations of IAP genes are associated with various solid and hematologic cancer types, and increased IAP expression has been associated with an unfavorable prognosis and poor outcome for patients. As a consequence, IAP proteins are considered promising molecular targets for anticancer therapy.
Breast Cancer Drugs in Late-Stage Development/Recently Approved
The article is 2012-2013 based and reader discretion is sought to ascertian the stage of approval
Afinitor® (everolimus)
https://newdrugapprovals.wordpress.com/2013/04/27/drug-spotlight-afinitor-everolimus-novartis/
Sponsor: Novartis
Method of Action: Mammalian target of rapamycin (mTOR) inhibitor
Indications/Phase of Trial: Hepatocellular carcinoma; human epidermal growth factor receptor 2-positive (HER2+) breast cancer first-line and second-line; lymphoma; nonfunctional carcinoid tumor (Phase III; all new indications)
Approved in July in U.S., EU for advanced hormone-receptor-positive (HR+) and human epidermal growth factor Receptor 2-negative (HER2-) metastatic breast cancer with exemestane in postmenopausal women who have already received certain other medicines for their cancer
Approved earlier for adults with pancreatic neuroendocrine tumors (PNET) that cannot be treated with surgery; adults with advanced renal cell carcinoma (RCC) when certain other medicines have not worked; adults with angiomyolipoma, seen with tuberous sclerosis complex (TSC), when surgery is not required immediately; and adults and children with TSC who have a brain tumor called subependymal giant cell astrocytoma (SEGA) that cannot be removed completely by surgery
Avastin (Bevacizumab; RG435)
Sponsor: Roche/Genentech
Method of Action: Monoclonal antibody; Vascular endothelial growth factor (VEGF) inhibitor
Indications/Phase of Trial: U.S.: Relapsed ovarian cancer, platinum-sensitive (Registration); first-line metastatic breast cancer and first-line metastatic ovarian cancer (both Phase III).
EU: Relapsed platinum-resistance ovarian cancer (Phase III)
Metastatic colorectal cancer, treatment beyond progression (Registration); adjuvant breast cancer, HER2- and HER2+; adjuvant NSCLC; first-line glioblastoma (GBM) multiforme; high-risk carcinoid (all Phase III)
Approved for metastatic colorectal cancer (mCRC) when started with the first or second intravenous 5-FU–based chemotherapy for metastatic cancer; advanced nonsquamous non-small-cell lung cancer (NSCLC) with carboplatin and paclitaxel in people who have not received chemotherapy for their advanced disease; metastatic RCC (mRCC) with interferon alfa; and GBM in adult patients whose cancer has progressed after prior treatment. Effectiveness based on tumor response, as no data have shown whether Avastin improves disease-related symptoms or survival in people previously treated for GBM
Approval conditionally granted in 2008 and withdrawn November 2011 for HER2- metastatic breast cancer (mBC) with Paclitaxel
Buparlisib (BKM120)
Sponsor: Novartis
Method of Action: Pan-PI3K inhibitor
Indications/Phase of Trial: mBC (Phase III and confirmatory Phase I/II); with Fulvestrant, in postmenopausal women with hormone receptor-positive HER2- locally advanced or mBC which progressed on or after aromatase inhibitor (AI) treatment (Phase III; BELLE-2 study recruiting as of November 2012); with Fulvestrant, in postmenopausal women with hormone receptor-positive HER2- AI-treated, locally-advanced or mBC who progressed on or after mTOR inhibitor-based treatment (Phase III; BELLE-3 study, recruiting as of October 2012); with Paclitaxel in patients with HER2- inoperable locally advanced or mBC, with or without PI3K pathway activation (Phase III; BELLE-4 study, recruiting as of November); metastatic castration-resistant prostate cancer (CRPC; Phase II; recruiting as of October); recurrent glioblastoma (Phase II; recruiting as of November); recurrent/metastatic head and neck squamous cell carcinoma (Phase II; recruiting as of October); endometrial cancer (Phase I/II); NSCLC (Phase I/II); prostate cancer (Phase I/II); GBM multiforme (Phase I/II); with Fulvestrant in postmenopausal women with estrogen receptor-positive metastatic breast cancer (Phase I); previously treated advanced colorectal cancer (Phase I)
Faslodex (Fulvestrant Injection)
Sponsor: AstraZeneca
Method of Action: Estrogen receptor antagonist
Indications/Phase of Trial: First line HR+ mBC (Phase III; FALCON study commenced Oct. 29)
Approved for HR+ mBC in women who have experienced menopause and whose breast cancer has worsened after they were treated with antiestrogen medications
Herceptin (Trastuzumab; RG597)
Sponsor: Roche, in partnership with Halozyme
Method of Action: Humanized monoclonal antibody designed to target and block the function of HER2+
Indications/Phase of Trial: EU: Early HER2+ breast cancer, subcutaneous formulation (Registration)
Approved for early-stage HER2+ breast cancer that has spread into the lymph nodes, and HER2+ breast cancer that has not spread into the lymph nodes and is estrogen receptor/progesterone receptor-negative (ER-/PR-) or have one high-risk feature. High-risk is defined as estrogen receptor/progesterone receptor-positive (ER+/PR+) with one of the following features: tumor size >2 cm, age <35 years, or tumor grade 2 or 3. Can be used with Adriamycin® (doxorubicin), Cytoxan® (cyclophosphamide), and either Taxol® (paclitaxel) or Taxotere® (docetaxel); or with Taxotere and Paraplatin® (carboplatin); or alone after treatment with multiple other therapies, including an anthracycline (Adriamycin)-based chemotherapy
Also approved alone for the treatment of HER2+ breast cancer in patients who have received one or more chemotherapy courses for metastatic disease; and with paclitaxel for first-line treatment of HER2+ mBC
Iniparib (Tivolza; BSI-201; SAR240550)
Sponsor: Sanofi, through acquisition of original developer BiPar Sciences
Method of Action: Poly (ADP-ribose) polymerase 1 (PARP1) inhibitor
Indications/Phase of Trial: Stage IV squamous NSCLC (Phase III; NME); solid tumors such as sarcoma and breast, uterine, lung, and ovarian cancers (Phase I/II)
Phase III trial in breast cancer failed January 2011 by failing to improve survival and progression-free survival (PFS) in breast cancer patients
Nexavar® (Sorafenib)
https://newdrugapprovals.wordpress.com/2013/07/16/nexavar-sorafenib/
Sponsor: Onyx Pharmaceuticals
Method of Action: Dual-action inhibitor that targets RAF/MEK/ERK pathway in tumor cells and tyrosine kinases
Indications/Phase of Trial: Liver cancer adjuvant (Phase III; STORM study); kidney cancer adjuvant (Phase III; SORCE/ASSURE study); thyroid cancer monotherapy (Phase III; DECISION study); breast cancer with capecitabine (Phase III; RESILIENCE study)
Approved for hepatocellular carcinoma (HCC) and RCC
Perjeta (Pertuzumab; RG1273)
Sponsor: Roche/Genentech
Method of Action: HER2/neu receptor antagonist
Indications/Phase of Trial: EU: With Herceptin and docetaxel chemotherapy for previously-untreated HER2+ mBC or locally recurrent, inoperable breast cancer in patients who have not received previous treatment or whose disease has returned after treatment in the early-stage setting (Registration)
U.S.: Approved June 2012 for HER2+ mBC with Herceptin (trastuzumab) and docetaxel, in patients who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease
Switzerland: Approved August 2012 for HER2+ breast cancer with Herceptin (trastuzumab) and docetaxel in patients with advanced or locally recurring breast cancer that has not previously been treated with chemotherapy
Ridaforolimus (MK-8669; AP23573; formerly Deforolimus)
Sponsor: Merck, under exclusive worldwide license agreement with Ariad Pharmaceuticals
Method of Action: Oral inhibitor of mammalian target of rapamycin inhibitor (mTOR)
Indications/Phase of Trial: Maintenance therapy for metastatic soft-tissue sarcoma and bone sarcomas after at least four chemotherapy cycles (under review after receiving Complete Response letter from FDA in June; NME); breast cancer with exemestane, compared to breast cancer with dalotuzumab and exemestane (Phase II; recruiting as of November); advanced head and neck cancer, NSCLC and colon cancer, with cetuximab (Phase II); pediatric patients with advanced solid tumors (Phase I; recruiting as of September); with dalotuzumab in pediatric patients with advanced solid tumors (Phase I; recruiting as of August); advanced RCC, with vorinostat (Phase I; recruiting as of October 2012); breast cancer, with dalotuzumab (Phase I: recruiting as of September); endometrial and ovarian cancers, with paclitaxel and carboplatin (Phase I; recruiting as of September 2012); advanced cancer, with MK-2206 and MK-0752 (Phase I: recruiting as of September 2012); advanced cancer, with dalotuzumab, MK-2206 and MK-0752 (Phase I: recruiting as of August 2012)
Tivozanib (ASP4130; AV-951)
Sponsor: Aveo Oncology and Astellas
Method of Action: Tyrosine kinase inhibitor; inhibits VEGF receptor 1, 2, and 3
Indications/Phase of Trial: U.S.: Advanced RCC (Registration; NDA filed September 2012); tivozanib biomarkers in solid tumors (Phase II; BATON study); stage IV metastatic colorectal cancer (mCRC), with mFOLFOX6, and compared with bevacizumab and mFOLFOX6 (Phase II; recruiting as of November); additional data as first-line therapy for advanced RCC, followed by sunitinib (Phase II; TAURUS study, enrollment initiated in October 2012); advanced solid tumors, with capecitabine (Xeloda®; Phase I; recruiting as of October)
EU: Advanced RCC (Phase III)
Trastuzumab-DM1 (T-DM1; Trastuzumab emtansine; RG3502)
Sponsor: Roche, with linker technology developed by ImmunoGen
Method of Action: Antibody-drug conjugate, consisting of the antibody trastuzumab and the chemotherapy DM1 attached via a stable linker
Indications/Phase of Trial: U.S.: HER2+, unresectable locally-advanced or mBC who have received prior treatment with Herceptin (trastuzumab) and a taxane chemotherapy (Registration; Priority review approved Nov. 7; action date Feb. 26, 2013)
EU: Marketing Authorization Application for HER2+ mBC accepted for review by European Medicines Agency
Tyverb/Tykerb (lapatinib)
Sponsor: GlaxoSmithKline
Method of Action: Human epidermal growth factor receptor-2 (Her2) and epidermal growth factor receptor (EGFR) dual kinase inhibitor
Indications/Phase of Trial: mBC with trastuzumab (Registration); breast cancer, adjuvant therapy (Phase III); Gastric cancer (Phase III); head & neck squamous cell carcinoma, resectable disease (Phase III)
Xgeva (denosumab)
Sponsor: Amgen, with commercialization by GlaxoSmithKline in countries where Amgen has no presence
Method of Action: Fully human monoclonal antibody that specifically targets a ligand known as RANKL that binds to a receptor known as RANK
Indications/Phase of Trial: Delay or prevention of bone metastases in breast cancer (Phase III); delay or prevention of bone metastases in prostate cancer (Phase III)
Approved for prevention of fractures in men with advanced prostate cancer
Rejected in April for supplemental Biologics License Application to treat men with CRPC at high risk of developing bone metastases
Yondelis® (trabectedin)
Sponsor: Johnson & Johnson; developed in collaboration with PharmaMar
Method of Action: Binds to minor groove of DNA, interfering with the cell division and gene transcription processes, as well as DNA’s repair machinery
Indications/Phase of Trial: U.S.: Locally advanced or metastatic soft tissue sarcoma excluding leiomyosarcoma and liposarcoma who have relapsed or are refractory to standard-of-care treatment (Phase III; recruiting as of November); soft tissue sarcoma, excluding liposarcoma and leiomyosarcoma (L-type sarcoma), in previously-treated patients who cannot be expected to benefit from currently available therapeutic options (Phase III; recruiting as of November); locally advanced or metastatic L-sarcoma (liposarcoma or leiomyosarcoma) who were previously treated with at least an anthracycline and ifosfamide-containing regimen, or an anthracycline-containing regimen and one additional cytotoxic chemotherapy regimen, compared with dacarbazine group (Phase III; recruiting as of November); breast cancer and pediatric tumors (Phase II); Advanced malignancies and liver dysfunction (Phase I; recruiting as of November)
EU: Approved for advanced or metastatic soft tissue sarcoma, and for relapsed platinum-sensitive ovarian cancer, with DOXIL®/Caelyx®
Xtandi® Capsules (Enzalutamide; formerly MDV3100)
Sponsor: Medivation in collaboration with Astellas
Method of Action: Androgen receptor inhibitor
Indications/Phase of Trial: Prechemotherapy CRPC in patients who have failed luteinizing hormone-releasing hormone (LHRH) analog treatment only, as well as patients who have failed both LHRH analog and anti-androgen treatment. (Phase III; PREVAIL study); prostate cancer neoadjuvant therapy (Phase II); prechemo metastatic prostate cancer in Europe (Phase II; TERRAIN); prechemo metastatic and nonmetastatic prostate cancer patients in U.S. (Phase II; STRIVE); prostate cancer Hormone-naïve (Phase II; ASPIRE); prostate cancer with docetaxel (Phase I); breast cancer (Phase I)
EU: Marketing Authorization Application submitted June 2012 to European Medicines Agency, for patients with metastatic CRPC who have received docetaxel-based chemotherapy
Japan: Metastatic CRPC who have received docetaxel-based chemotherapy (Phase II)
Approved Aug. 31 for patients with metastatic CRPC who have previously received docetaxel. As a post-marketing requirement, Medivation and Astellas agreed to conduct an open-label safety study of Xtandi (160 mg/day) in patients at high risk for seizure, with data to be submitted to FDA in 2019
Cancer is just as deadly as it was 50 years ago. Here’s why that’s about to change.
Why haven’t we cured cancer yet? It seems like almost every day, we hear about another miraculous advance in cancer treatment. Drugs that cause tumors to shrink, gene therapies, and even a possible vaccine. And yet, our loved ones keep dying of cancer.
We spoke to cancer experts to find out why the death rate from cancer hasn’t changed in the past 50 years — and we learned how genetic therapies could transform cancer treatments tomorrow.
Top image: Juan Gaertner/Shutterstock.com
Cannabis-Linked Cell Receptor Might Help Prevent Colon Cancer
The study was published in the Aug. 1 issue of the journal Cancer Research.
A cannabinoid receptor lying on the surface of cells may help suppress colorectal cancer, say U.S. researchers. When the receptor is turned off, tumor growth is switched on. Cannabinoids are compounds related to the tetrahydrocannabinol (THC) found in the cannabis plant.
It’s already known that the receptor, CB1, plays a role in relieving pain and nausea, elevating mood and stimulating appetite by serving as a docking station for the cannabinoid group of signaling molecules. This study suggests that CB1 may offer a new path for cancer prevention or treatment.
In the study of human colorectal tumor specimens, the researchers also found that the drug decitabine can restore CB1 expression.In addition, mice those are prone to developing intestinal tumors and also have functioning CB1 receptors developed fewer and smaller tumors when treated with a drug that mimics a cannabinoid receptor ligand, the researchers found. Ligands are molecules that function by binding to specific receptors.
This therapy may help the cancer research team to found out the caner in early stage.
1. www.washingtonpost.com/wp-dyn/content/article/2008/08/01/AR2008080100937.html
2. www.medicinenet.com/script/main/art.asp?articlekey=91511
3. hightimes.com/news/dan/4542
copy paste link
4. neurotalk.psychcentral.com/thread51199.html
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| (−)-(6aR,10aR)-6,6,9-trimethyl- 3-pentyl-6a,7,8,10a-tetrahydro- 6H-benzo[c]chromen-1-ol |
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Tetrahydrocannabinol (THC), or more precisely its main isomer (−)-trans-Δ9-tetrahydrocannabinol ((6aR,10aR)-delta-9-tetrahydrocannabinol), is the principal psychoactive constituent (or cannabinoid) of the cannabis plant. First isolated in 1964, in its pure form, by Israeli scientists Raphael Mechoulam, Yechiel Gaoni and colleagues at the Hebrew University of Jerusalem, it is a glassy solid when cold, and becomes viscous and sticky if warmed. A pharmaceutical formulation of (−)-trans-Δ9-tetrahydrocannabinol, known by its INN dronabinol, is available by prescription in the U.S. and Canada under the brand name Marinol. An aromatic terpenoid, THC has a very low solubility in water, but good solubility in most organic solvents, specifically lipids and alcohols.
Like most pharmacologically-active secondary metabolites of plants, THC in cannabis is assumed to be involved in self-defense, perhaps against herbivores. THC also possesses high UV-B (280–315 nm) absorption properties, which, it has been speculated, could protect the plant from harmful UV radiation exposure.
Tetrahydrocannabinol with double bond isomers and their stereoisomers is one of only three cannabinoids scheduled by Convention on Psychotropic Substances (the other two are dimethylheptylpyran and parahexyl). Note that cannabis as a plant is scheduled by Single Convention on Narcotic Drugs (Schedule I and IV).
Promising Antiviral Compounds Discovered
Scientists sifted through thousands of potentially efficacy compounds and managed to identify two promising candidates for the development of drugs against human adenovirus, a cause of ailments ranging from colds to gastrointestinal disorders to pink eye
Scientists at the U.S. Department of Energy’s Brookhaven National Laboratory have identified two promising candidates for the development of drugs against human adenovirus, a cause of ailments ranging from colds to gastrointestinal disorders to pink eye. A paper published in FEBS Letters, a journal of the Federation of European Biochemical Societies, describes how the researchers sifted through thousands of compounds to determine which might block the effects of a key viral enzyme they had previously studied in atomic-level detail.
GRAVIOLA TREE “10000 TIMES STRONGER KILLER OF CANCER THAN CHEMO” – FACTS ANALYSIS
“10000 times stronger killer of Cancer than Chemo”.. do share it.. can save many lives, fill up hopes and build confidence in the patients…
The Sour Sop or the fruit from the graviola tree is a miraculous natural cancer cell killer 10,000 times stronger than Chemo. Why are we not aware of this?
read all at
http://www.hoaxorfact.com/Health/graviola-tree-10000-times-stronger-killer-of-cancer-than-chemo.html
Tesaro and the European Network of Gynecological Oncological Trial Groups Forge Partnership to Develop Niraparib for Ovarian Cancer
Niraparib; MK 4827
MOLECULAR FORMULA C19H20N4O
MOLECULAR WEIGHT 320.4
SPONSOR Merck Sharp & Dohme Corp.
CAS REGISTRY NUMBER 1038915-60-4
THERAPEUTIC CLAIM Antineoplastic
CHEMICAL NAMES
1. 2H-Indazole-7-carboxamide, 2-[4-(3S)-3-piperidinylphenyl]-
2. 2-{4-[(3S)-piperidin-3-yl]phenyl}-2H-indazole-7-carboxamide
TESARO and the European Network of Gynecological Oncological Trial Groups (ENGOT) Forge Partnership to Develop Niraparib for Ovarian Cancer
June 3, 2013 — TESARO, Inc. an oncology-focused biopharmaceutical company, and the European Network of Gynecological Oncological Trial Groups (ENGOT), a network of national and regional clinical trial organizations, today announced a partnership for the Phase 3 clinical development of niraparib, an orally active, potent poly (ADP-ribose) polymerase (PARP) inhibitor. READ ALL AT http://www.pharmalive.com/tesaro-and-the-european-network-of-gynecological-oncological-trial-groups-forge-partnership-to
http://www.ama-assn.org/resources/doc/usan/niraparib.pdf
http://clinicaltrials.gov/show/NCT01847274
MK-4827:
MK-4827 is a potent, Selective, PARP 1/2 inhibitor with IC50 of 3.8 and 2.1 nM for PARP1 and 2, respectively. MK-4827 possesses potential Antineoplastic Activity. In a Whole Cell assay, MK -4827 prevented PARP activity with an EC50 of 4 nM, enhancing the accumulation of DNA strand breaks and promoting genomic instability and apoptosis. MK-4827 induces selective synthetic lethality in homologous recombination (HR) repair deficient tumors with BRCA1 / 2 loss and tumor cell lines with non-BRCA-related HR defects, supporting clinical utility in sporadic tumors. MK-4827 reveals good pharmacokinetic properties and is currently in phase I clin. trials. The phase I clinical trials for MK-4827 is ongoing in the treatment of solid tumors.
BY WORLD DRUG TRACKER
GSK’s Votrient meets primary objective in Phase III ovarian cancer trial
pazopanib
GlaxoSmithKline’s (GSK) Votrient (pazopanib) has met the primary objective of a statistically significant improvement in the time to disease progression or death that is the progression-free survival (PFS) against placebo in Phase III ovarian cancer..
Pazopanib (trade name Votrient) is a potent and selective multi-targeted receptortyrosine kinase inhibitor of VEGFR-1, VEGFR-2, VEGFR-3, PDGFR-a/β, and c-kit that blocks tumor growth and inhibits angiogenesis. It has been approved for renal cell carcinoma and soft tissue sarcoma by the U.S. Food and Drug Administration.Pazopanib may also be active in ovarian cancer Pazopanib also appears effective in the treatment of non-small cell lung carcinoma.
Top 10 experimental cancer drugs – 2013
Top 10 experimental cancer drugs – 2013
http://www.fiercebiotech.com/special-reports/top-10-experimental-cancer-drugs-2013?utm_medium=nl&utm_source=internal
New Drug Approvals 