Are we PrEPared to eradicate HIV?

Are we PrEPared to eradicate HIV?.

I can’t let my patients see

I can’t let my patients see.

DREAM DRUGS: Drugs at the Clinical Stage — In the Pipeline

The Biotech-100 Index includes 100 small cap biotechnology stocks whose product drug pipeline contain at least one drug in either phase II and/or Phase III clinical development. There is a 90% chance of rejection in early-stage phase I clinical trials; a 50% chance in phase II; 20% in phase III; and 10% post-phase III. Companies that are in phase II and III tend to show great promise but still have a high degree of volatiliy.

Pipeline Drugs	Company	Symbol	Application
ABX-EGF (panitumumab)	Abgenix	ABGX	targets the epidermal growth factor receptor (EGFr), which is over-expressed in a variety of cancers including lung cancer, breast cancer, bladder, pancreatic, colorectal cancer, kidney and head and neck cancer.
ABX-MA1	Abgenix	ABGX	ABX-MA1 targets a protein called MUC18, a cell-surface adhesion molecule that is highly expressed on metastatic melanoma cells but not on normal skin cells
ACP-103	Acadia	ACAD	Parkinson’s Disease, adjunctive therapy forschizophrenia (Hallucinations, Psychoses)
Onconase (ranpirnase)	AlfaCell	ACEL	Ribonuclease anti-cancer drug,
Entereg (alvimopan)	Adolor	ADLR	pain management of POI and OBD
lidocaine patch	Adolor	ADLR	postoperative incisional pain
perifosine	Æterna Zentaris Inc	AEZS	Multiple myeloma and advanced metastatic colorectal cancer — multiple cancers
SolorelTM (AEZS-130)	Æterna Zentaris Inc	AEZS	Growth hormone secretagogue– potential applications for the treatment of cachexia
AEZS-108	Æterna Zentaris Inc	AEZS	Ovarian cancer, endometrial cancer
AG-858	Antigenics Inc.	AGEN	Chronic myelogenous leukemia (CML)
Oncophage	Antigenics Inc.	AGEN	Metastatic melanoma, Kidney cancer (renal cell carcinoma)
AG-702	Antigenics Inc.	AGEN	Genital herpes
V -Protectants® (AGI-1067)	Atherogenics	AGIX	chronic inflammatory diseases, such as atherosclerosis, rheumatoid arthritis andasthma
Vivitrex	Alkermes	ALKS	Alchol Dependence
Medisorb	Alkermes	ALKS	Diabetes
AIR Insulin	Alkermes	ALKS	Diabetes
AIR hGH	Alkermes	ALKS	GHD
AIR Epinephrine	Alkermes	ALKS	Anaphylaxis
Pexelizumab	Alexion	ALXN	Cardiopulmonary Bypass, Acute Myocardial Infarction
Eculizumab	Alexion	ALXN	Nephritis, Dermatomyositis , Paroxysmal Nocturnal Hemoglinuria
Efaproxiral	Allos Therapeutics	ALTH	Brain metastases from breast cancer, non-small cell lung cancer, cervical cancer
PDX (pralatrexate)	Allos Therapeutics	ALTH	non-small cell lung cancer, Mesothelioma, non-Hodgkin’s Lymphoma
SYMLIN® (pramlintide acetate)	Amylin	AMLN	synthetic version of human amylin -glucose control with type 1 diabetes
exenatide (synthetic exendin-4)	Amylin	AMLN	type 2 diabetes
Isatoribine (ANA245)	Anadys	ANDS	Hepatitis C
ANA 380	Anadys	ANDS	Hepatitis B
Oral Prodrug ANA971	Anadys	ANDS	reduce the risk of HCV relapse
AMD3100	AnorMED	AOM.TO	stem cell mobilizer
AMD070	AnorMED	AOM.TO	chemokine inhibitor for HIV
Insegia(G17DT immunogen)	Aphton Corp	APHT	cancer and gastrointestinal disease
AP23573	Ariad	ARIA	solid tumor and blood malignancies
TP10	Avant	AVAN	Cardiac Surgery
CETi-I	Avant	AVAN	Cholesterol Management
CholeraGarde	Avant	AVAN	Cholera
Ty800	Avant	AVAN	Typhoid Fever
Injectable Anthrax	Avant	AVAN	Anthrax
Therapore	Avant	AVAN	HIV
Resten-NG	Avi Biopharma	AVII	cardiovascular restenosis
Avicine	Avi Biopharma	AVII	vaccine — anti-hCG immune response targeting hCG-producing cancer cells
NeuGene compounds	Avi Biopharma	AVII	anti-sense drugs for cancer, polycystic kidney disease, and viral diseases
Neurodex	Avanir	AVN	pseudobulbar affect, neuropathic pain
Avanir	Avanir	AVN	Asthma
AV201	Avigin	AVGN	severe Parkinson’s disease
Phenserine	Axonyx	AXYX	Alzheimer’s disease
Theratope Vaccine	Biomira	BIOM	colorectal, metastatic breast cancer
BLP25 Liposome Vaccine	Biomira	BIOM	Prostate, non-small cell lung cancer
Modrenal	Bioenvision	BIVN	Prostate Cancer
Clofarabine (CLOLAR)	Bioenvision	BIVN	pediatric acute lymphoblastic leukemia, solid Tumors
Velostan	Bioenvision	BIVN	post-menopausal advanced breast cancer,bladder cancer
virostat	Bioenvision	BIVN	hepatitis C
GVAX (vaccine)	Cell Genesys	CEGE	Prostate, lung, pancreatic, leukemia, myeloma
CG7870 Oncolytic Virus Therapy	Cell Genesys	CEGE	Prostate cancer
Daptomycin (cubicin)	Cubist	CBST	soft tissue infection, infective endocarditis
HepeX-B	Cubist	CBST	prevention of infection by hepatitis B in liver transplant
Oracea	Collagenex Pharmaceuticals Inc	CGPI	rosacea
E2F Decoy	Corgentech	CGTK	Coronary Bypass Graft, Arterio-Venous Graft
mifepristone ( Corlux)	Corcept	CORT	Psychotic major depression, Alzheimers
Ventavis	CoTherix Inc	CTRX	pulmonary arterial hypertension
Ranexa	CV Therapeutics Inc	CVTX	Chronic Angina
Regadenoson	CV Therapeutics Inc	CVTX	Myocardial Perfusion Imaging
Tecadenoson	CV Therapeutics Inc	CVTX	(PSVT Atrial Fibrillation)
Adentri	CV Therapeutics Inc	CVTX	congestive heart failure (CHF)
Milnacipran	Cypress Biosciences	CYPB	fibromyalgia syndrome (FMS) and related chronic pain conditions
SB-715992	Cytokinetics	CYTK	multiple forms of cancer, including combination therapy
provenge	Dendreon	DNDN	prostate cancer vaccine
APC8024(Neuvenge)	Dendreon	DNDN	HER-2/neu positive cancers, including breast,ovarian and colorectal cancers
indiplon	DOV Pharmaceuticals	DOVP	insomnia
bicifadine	DOV Pharmaceuticals	DOVP	pain
ocinaplon	DOV Pharmaceuticals	DOVP	generalized anxiety disorder
DOV 216,303	DOV Pharmaceuticals	DOVP	depression, anxiety and substance abuse
DOV Diltiazen	DOV Pharmaceuticals	DOVP	Angina and Hypertension
DX-88	Dyax	DYAX	hereditary angioedema (HAE)
DX-890	Dyax	DYAX	cystic fibrosis (CF),chronic obstructive airways diseases
Thelin (sitaxsentan)	Encysive Pharmaceuticals	ENCY	pulmonary arterial hypertension (PAH)
BIMOSIAMOSE	Encysive Pharmaceuticals	ENCY	inhaled therapy for asthma, psoriasis and atopic dermatitis
TBC3711	Encysive Pharmaceuticals	ENCY	endothelin A antagonis
Panzem (2-methoxyestradiol)	EntreMed	ENMD	cancer
XL119	Exelixis	EXEL	bile duct tumors
Macugen(pegaptanib sodium injection)	Eyetech Pharmaceuticals	EYET	wet form of age-related macular degeneration (AMD)
FM-VP4	Forbes Medi-Tech	FMTI	cholesterol-lowering and anti-atherosclerotic
Genasense® (oblimersen sodium	Genta	GNTA	melanoma, lung and prostate cancers
Ganite® (gallium nitrate injection).	Genta	GNTA	cancer related hypercalcemia
TNFerade	GenVec	GNVC	Tumor necrosis factor alpha gene
TVAX Telomerase Cancer Vaccine (TVAX)	Geron	GERN	prostate cancer
Aquavan Injection	Guilford Pharmaceuticals	GLFD	mild to moderate sedation for non-invasive procedures
GPI 1485	Guilford Pharmaceuticals	GLFD	Impotence, Prostate Cancer
GPI 5693	Guilford Pharmaceuticals	GLFD	neuropathic pain
MyVax	Genitope Corp	GTOP	idotypic vaccine for cancer follicular non-Hodgkin’s lymphoma (f-NHL).
ACAPODEME	GTX Inc.	GTXI	Prevention of prostate cancer in men with high grade PIN
Andarine	GTX Inc.	GTXI	Cachexia from various types of cancer
Ostarine	GTX Inc.	GTXI	andropause
HE2100 NEUMUNE	Hollis-Eden Pharmaceuticals	HEPH	protecting the body’s bone marrow from acute radiation syndrom
PHOSPHONOL	Hollis-Eden Pharmaceuticals	HEPH	protect against DNA mutations (mutagenesis)– from radiation
(HE2000) IMMUNITIN	Hollis-Eden Pharmaceuticals	HEPH	Malaria and HIV and preclinical benefit in a number of tuberculosis model
LymphoStat-B	Human Genome Sciences	HGSI	drugs discovered through genomics-based research
Albuferon	Human Genome Sciences	HGSI	hepatitis C, b?? and a broad range of cancers
HGS-ETRI	Human Genome Sciences	HGSI	apoptosis, in cancer cells.
HGS-TR2J	Human Genome Sciences	HGSI	apoptosis, in cancer cells.
480848	Human Genome Sciences	HGSI	inhibits atherosclerotic plaques
IC485	ICOS	ICOS	Chronic Obstructive Pulmonary Disease
Tadalafil	ICOS	ICOS	Benign Prostatic Hyperplasia
FluINsure	ID Biomedical Corp	IDBE	vaccine prevention of influenza (flu)
StreptAvax	ID Biomedical Corp	IDBE	vaccine for prevention of diseases caused by group A streptococcus in children
PPV	ID Biomedical Corp	IDBE	vaccine for the prevention of disease caused by Streptococcus pneumoniae (pneumococcus)
Pagocione	Indevus Pharmaceuticals	IDEV	Stuttering
PRO2000	Indevus Pharmaceuticals	IDEV	HIV and STD Prevention
IP 751	Indevus Pharmaceuticals	IDEV	Pain and Inflammation
Aminocandin	Indevus Pharmaceuticals	IDEV	Serious Fungal Infections
HuN901-DM1	Immunogen	IMGN	cancers that express the CanAg antigen
MLN2704	Immunogen	IMGN	-targets the prostate-specific membrane antigen (PSMA)
Cantuzumab mertansine	Immunogen	IMGN	cancers that express the CanAg antigen
Reverset	Incyte Corp	INCY	HIV
CCR2 Antagonists	Incyte Corp	INCY	Rheumatoid Arthritis, MS, Neuropathic Pain, Atherosclerosis
Sheddase Inhibitors	Incyte Corp	INCY	Cancer
ADVEXIN	Introgen Therapeutics	INGN	Cancer ?? Advexin (adenoviral p53) —bladder cancer--gene therapy -PI
INGN 241	Introgen Therapeutics	INGN	tumor suppressor product candidate
INGN 225	Introgen Therapeutics	INGN	tumor vaccine
Visicol	InKline Pharamceuticals	INKP	Constipation
INKP-102	InKline Pharamceuticals	INKP	Colon cleansing prior to colonoscopy
IB-Stat	InKline Pharamceuticals	INKP	Symptoms associated with Irritable Bowel Syndrome (IBS)
CEA-Scan	Immunomedics	IMMU	targets tumors that have carcinoembryonic antigen (CEA) on their cell membrane
antisense drugs	ISIS Pharmaceuticals	ISIS	ulcerative colitis, diabetes, MS, cardiovascular disease, cancer, psoriasis
diquafosol tetrasodium (INS365 Ophthalmic)	Inspire Pharamceuticals	ISPH	for the treatment of dry eye disease
INS37217– Respiratory (denufosol tetrasodium)	Inspire Pharamceuticals	ISPH	cystic fibrosis, retinal disease
IN50589	Inspire Pharamceuticals	ISPH	Antiplatelet for Platelet Inhibition
Sulodexide (KRX-101)	Keryx Biopharmaceuticals	KERX	diabetic nephropathy
Perifosine (KRX-0401)	Keryx Biopharmaceuticals	KERX	multiple forms of cancer
KS 01-019	Kos Pharmaceuticals	KOSP	dyslipidemia
KS 01-018	Kos Pharmaceuticals	KOSP	Periperhal Arterial Disease
Azmacort	Kos Pharmaceuticals	KOSP	treatment of asthma as prophylactic therapy
Targretin	Ligand Pharmaceuticals	LGND	non-small cell lung cancer
ONTAK	Ligand Pharmaceuticals	LGND	B- and T-cell non-Hodgkin’s lymphomas and chronic lymphocytic leukemia,
Targretin gel	Ligand Pharmaceuticals	LGND	hand dermatitis
LJP 394	La Jolla Pharmaceuticals	LJPC	Lupus Erythematosus, Systemic Lupus Nephritis
Riquent® (abetimus sodium	La Jolla Pharmaceuticals	LJPC	systemic lupus erythematosus (SLE)
Ceplene	Maxim Pharmaceuticals	MAXM	Advanced Melanoma, Acute Myeloid Leukemia, Renal Cell Carcinoma, Hepatitis C
Medarex Antibodies	Medarex	MEDX	cancer, inflammation, autoimmune and infectious diseases
Anidulafungin	Vicuron Pharmaceuticals	MICU	anti-fungal
Dalbavancin	Vicuron Pharmaceuticals	MICU	glycopeptide class of antibiotics (hospital infections)
Oxazolidinones	Vicuron Pharmaceuticals	MICU	most-difficult-to-treat, multi-drug-resistant bacteria
Deformylase Inhibitors	Vicuron Pharmaceuticals	MICU	antibiotic — respiratory tract infections
INTEGRILIN® (EPTIFIBATIDE)	Millenium Pharmaceuticals	MLNM	cardiovascular
VELCADE® (bortezomib)-	Millenium Pharmaceuticals	MLNM	lung, breast, prostate cancers
MLN1202,MLN2704	Millenium Pharmaceuticals	MLNM	Rheumatoid arthritis, multiple sclerosis,inflammation
Technosphere Insulin System	MannKind Corp	MNKD	pulmonary delivery system for diabetes
Enoximone	Myogen	MYOG	Advanced Chronic Heart Failure
Ambristentan	Myogen	MYOG	Pulmonary Arterial Hypertension
Darusentan	Myogen	MYOG	Uncontrolled Hypertension
Flurizan	Myriad Genetics Inc	MYGN	Alzheimer’s, cancer
StaphVAX	Nabi Biopharmaceuticals	NABI	Vaccine for staphylococcus infections
NicVax	Nabi Biopharmaceuticals	NABI	Vaccine for smoking cessation vaccine
Civacir	Nabi Biopharmaceuticals	NABI	Hepatitis C antibody-based therapies
IL13-PE38QQR	NeoPharm Inc	NEOL	Glioblastoma Multiforme brain tumor
Liposomal SN38	NeoPharm Inc	NEOL	Advanced cancers; including colorectal and lung
Liposomal c-raf Antisense Oligonucleotide	NeoPharm Inc	NEOL	Advanced cancers; including pancreatic (monotherapy and combination with radiation/chemotherapy)
Liposomal Paclitaxel-Easy-to-use	NeoPharm Inc	NEOL	Advanced cancers; including breast cancer, lung and ovarian
Indiplon	Neurocrine Biosciences	NBIX	insomnia via inhibitory neurotransmitter —GABA
CRF Receptor Antagonis	Neurocrine Biosciences	NBIX	Anxiety and depression
NBL- 5788	Neurocrine Biosciences	NBIX	Multiple Sclerosis
Urocortin 2	Neurocrine Biosciences	NBIX	Acute congestive heart failure (CHF)
GnRH antagonists	Neurocrine Biosciences	NBIX	Endometriosis
PREOS® (recombinant human parathyroid hormone)	NPS Pharmaceuticals	NPSP	treatment of osteoporosis
Teduglutide	NPS Pharmaceuticals	NPSP	gastrointestinal disorders including Short Bowel Syndrome
Preotact	NPS Pharmaceuticals	NPSP	Osteoperosis
Calcilytics	NPS Pharmaceuticals	NPSP	Osteoperosis
GlyT-1	NPS Pharmaceuticals	NPSP	Schizophrenia
Fibrillex	Neurochem Inc.	NRMX	AA Amyloidosis
Alzhemed	Neurochem Inc.	NRMX	Alzheimer’s Disease –inhibit the AmyloidCascade
Cerebril	Neurochem Inc.	NRMX	Hemorrhagic stroke due to cerebral amyloidangiopathy
Memantine (Namenda)	Neurobiological Tech	NTII	progressive neurological impairment due to neuronal injur
XERECEPT — natural human peptide CRF	Neurobiological Tech	NTII	inhibitor of swelling, or edema
VIPRINEX™ (ancrod)	Neurobiological Tech	NTII	stroke patients — anticoagulation
BiDil	NitroMed	NTMD	Heart failure, or end-stage cardiovascular disease
Alfimeprase	Nuvelo	NUVO	thrombolytic agent or blood clot dissolver
rNAPc2	Nuvelo	NUVO	Factor VIIa / Tissue Factor Inhibitor
ARC183	Nuvelo	NUVO	DNA-based direct thrombin inhibitor–anticoagulant / anti-thrombotic
BAY 43-9006	Onyx Pharmaceuticals	ONXX	advanced renal (kidney) cancer
Ramoplanin	Oscient Pharmaceuticals	OSCI	Clostridium difficile-associated diarrhea
FACTIVE	Oscient Pharmaceuticals	OSCI	Intravenous– Bacterial Infections
CA4P (combretastatin)–	Oxigene	OXGN	Vascular targeting agent ??CK PHASE
Motexafin gadolinium	Pharmacyclics Inc.	PCYC	anti-cancer product
Motexafin lutetium	Pharmacyclics Inc	PCYC	reduce or eliminate “vulnerable plaque ”
Apan	Praecis Pharmaceuticals	PRCS	Alzheimer’s Disease
PPI-2458	Praecis Pharmaceuticals	PRCS	Non-Hodgkin’s Lymphoma/RA
MNTX	Progenics Pharmaceuticals	PGNX	Advanced medical ilness, post-operative ileus, chronic pain
GMX	Progenics Pharmaceuticals	PGNX	Melanoma Cancer
PSMA	Progenics Pharmaceuticals	PGNX	prostate cancer
PRO542	Progenics Pharmaceuticals	PGNX	HIV
PRO 140	Progenics Pharmaceuticals	PGNX	HIV
Trexima	POZEN Inc.	POZN	migraine pain
OXYTREX	Pain Therapeutics Inc.	PTIE	severe chronic pain, such as low back, osteoarthritic pain or cancer pain
REMOXY	Pain Therapeutics Inc.	PTIE	proprietary abuse-resistant version of time-release oxycodone
PTI-901	Pain Therapeutics Inc.	PTIE	chronic Irritable Bowel Syndrome (IBS).
AXOKINE IL-1	Regeneron Pharmaceuticals	REGN	potential treatment of obesity
VEGF Trap	Regeneron Pharmaceuticals	REGN	inihibits tumor blood vessel growth
L-4/13 Trap	Regeneron Pharmaceuticals	REGN	treatment in allergy and asthma
IL-1 Trap	Regeneron Pharmaceuticals	REGN	decreases inflammation and blocks cartilage erosion in the joint — Rhematoid Arthritis
ZADAXIN	Sciclone Pharmaceuticals	SCLN	viral infections– hepatitis C, and cancer
SCV-07	Sciclone Pharmaceuticals	SCLN	fight infection
SGN-30	Seattle Genetics	SGEN	Hodgkin’s disease and some types of non-Hodgkin’s lymphoma
SGN-15	Seattle Genetics	SGEN	non-small cell lung cancer
SGN-40	Seattle Genetics	SGEN	multiple myeloma and non-Hodgkin’slymphoma
XIFAXAN™ (rifaximin)	Salix Pharmaceuticals	SLXP	gastrointestinal- selective, oral antibiotic
ZEGERID	Santarus Inc	SNTS	Heartburn/GERD, Erosive esophagitis, Duodenal ulcers
Orathecin	Supergen Inc.	SUPG	pancreatic cancer
Avicine™	Supergen Inc.	SUPG	colorectal cancer
Satraplatin	Spectrum Pharmaceuticals	SPPI	Prostate Cancer
SPI-153	Spectrum Pharmaceuticals	SPPI	Hormone Depenmdent Prostate Cancer
EOquin	Spectrum Pharmaceuticals	SPPI	Bladder Cancer, Radiation Sensitizer
Elsamitrucin	Spectrum Pharmaceuticals	SPPI	Non-Hodgkin’s Lymphoma
prosaptide	Savient	SVNT	peripheral neuropathic pain
puricase	Savient	SVNT	symptomatic gout
fibrimage	Savient	SVNT	diagnostic agent for the detection of deep veinthrombosis
I2S	Transkaryotic Therapies	TKTX	Hunter syndrome
GA-GCB	Transkaryotic Therapies	TKTX	Gaucher disease
TELCYTA (TLK286)	Telik Inc.	TELK	advanced ovarian cancer and non-small cell lung cancer (a selective apoptotic agent)
TELINTRA	Telik Inc.	TELK	myelodysplastic syndrome –Bone marrow stimulant
TNX -355	Tanox Inc.	TNOX	HIV
T-1249	Trimeris Inc.	TRMS	HIV
Pivanex	Titan Pharmaceuticals	TTP	Refractory Chronic Lymphocytic Leukemia
DITPA	Titan Pharmaceuticals		Congestive Heart Failure
Probuphine	Titan Pharmaceuticals		Opiate addition
Spheramine	Titan Pharmaceuticals		Advanced Parkinson’s
Iloperidone	Titan Pharmaceuticals		Schizophrenia
Gallium Maltolate	Titan Pharmaceuticals		Bone Disease
OvaRex	United Therapeutics Corp	UTHR	Ovarian Cancer
Remodulin	United Therapeutics Corp	UTHR	Critical limb ischemia (CLI)
UT-231B	United Therapeutics Corp	UTHR	Hepatitis C
Celacade	Vasogen Inc.	VSGN	Chronic Heart Failure, Periperheral Arterial Disease
VP025	Vasogen Inc.	VSGN	Alzheimer’s disease, Parkinson’s disease, and amyotrophic lateral sclerosis
VX-385	Vertex Pharmaceuticals	VRTX	HIV infection
Merimepodib	Vertex Pharmaceuticals	VRTX	hepatitis C
VX-950	Vertex Pharmaceuticals	VRTX	hepatitis C
VX-765	Vertex Pharmaceuticals	VRTX	cytokine inhibitor of interleukin-1 beta converting enzyme (ICE)
VX-702	Vertex Pharmaceuticals	VRTX	acute coronary syndromes
Pralnacasan	Vertex Pharmaceuticals	VRTX	inflammatory diseases
VX944, VX630	Vertex Pharmaceuticals	VRTX	Cancer
DNA Vaccines	Vical Inc	VICL	malaria, cytomegalovirus, eboa, west nile virus, hiv, hepatitis
Avanafil	Vivus Inc.	VVUS	erectile dysfunction
ALISTA	Vivus Inc.	VVUS	female sexual arousal disorder
Testosterone MDTS	Vivus Inc.	VVUS	low sexual desire
Evamist	Vivus Inc.	VVUS	symptoms associated with menopause
Neuprex	XOMA LTD	XOMA	immunologic and inflammatory disorders, cancer and infectious diseases
XMP.629	XOMA LTD	XOMA	Acne
MLN2222	XOMA LTD	XOMA	coronary artery bypass graft (CABG) surgery patients.
TransMID	Xenova Group	XNVA	Glioblastoma multiforme (GBM)
XR303	Xenova Group	XNVA	Pancreatic Cancer
XR5944/XR11576	Xenova Group	XNVA	Solid Tumors
TA-CD Vaccine	Xenova Group	XNVA	Cocaine addition
TA_NIC Vaccine	Xenova Group	XNVA	Nicotine Addiction
Recombinant human Thrombin	Zymogenetics Inc.	ZGEN	control of bleeding associated with various surgical procedures
-TACI-Ig	Zymogenetics Inc.	ZGEN	autoimmune diseases and for advanced B-cell malignancies
Interleukin 21 (IL-21)	Zymogenetics Inc.	ZGEN	cancer

source: http://www.pipelinedrugs.com/

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Act Now Against Cipro! The FDA is Ready!

Clueless Doctors & Scientists

Cipro is only one killer of many in the fuoroquinolone class antibiotics!

As some of you may know, I have filed at the FDA a Citizen’s Petition again the antibiotic drug class fluoroquinolones, the most frequently prescribed antibiotics today. I started my attack with Cipro as guilty #1 since that is what nearly everyone gets and the number of people getting sick from Cipro is staggering. Cipro is now also understood to be the cause of the Gulf War Syndrome since soldiers were mandated to take it every day against anthrax in the field.

Many people have been permanently injured–some even have committed suicide. I am a firm believer that fibromyalgia is yet one more of the diseases we may be able to point to this class of drugs. The citizen petition docket is still open.

I just received a letter from the FDA stating that the matter is so complex that they…

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Researchers identify new target for anti-malaria drugs

A new target for drug development in the fight against the deadly disease malaria has been discovered by researchers at MIT.

In a paper published today in the journal Cell Host & Microbe, the researchers describe how they identified the drug target while studying the way in which the parasites Toxoplasma gondii, which causes toxoplasmosis, and Plasmodium, which causes malaria, access vital nutrients from their host cells.

Around one-third of the world’s deadly infectious diseases, including malaria and tuberculosis, are caused by pathogens that spend a large portion of their life inside specially built compartments within their host cells.

These compartments, known as “parasitophorous vacuoles,” separate the host cytoplasm and the parasite by a membrane, and thereby protect the parasites from the host cell’s defenses. They also provide an environment tailored to their needs, according to Dan Gold, a postdoc who led the research in the laboratory of Jeroen Saeij, the Robert A. Swanson Career Development Associate Professor of Life Sciences in MIT’s Department of Biology.

However, the membrane of these vacuoles also acts as a barrier between the parasite and the host cell. This makes it more difficult for the parasite to release proteins involved in the transformation of the host cell beyond the membrane in order to spread the disease, and for the pathogen to gain access to vital nutrients, Gold says.

“Ultimately what defines a parasite is that they require certain key nutrients from their host,” he says. “So they have had to evolve ways to get around their own barriers, to gain access to these nutrients.”

Previous research has shown that the vacuoles are selectively permeable to small molecules, allowing certain nutrients to pass through pores in the membrane. But until now, no one has been able to determine the molecular makeup of these pores, and how they are formed.

Two new proteins

When studying Toxoplasma, the researchers discovered two proteins secreted by the parasite, known as GRA17 and GRA23, which are responsible for forming these pores in the vacuole, Gold says.

The researchers discovered the proteins’ roles by accident, while investigating how the parasites are able to release their own proteins out into the host cell beyond the vacuole membrane after invasion.

Similar research into how the related Plasmodium pathogen performs this trick had identified a so-called “protein export complex” that transports encoded proteins from the parasite into its host red blood cell, which transforms these red blood cells in a way that is vital to the spread of malaria. “The clinical symptoms of malaria are dependent on this process and this remodeling of the red blood cell that occurs,” Gold says.

The researchers identified proteins secreted by Toxoplasma that appeared to be homologues, or of shared ancestry to, this protein export complex in Plasmodium. But when they stopped these proteins from functioning, they found it made no difference to the export of proteins from the parasite beyond the vacuole.

“We were left wondering what GRA17 and GRA23 actually do, if they are not involved in protein export, and so we went back to look at this longstanding phenomenon of nutrient transport,” Gold says.

When they added dyes to the host cell, and again knocked out the two proteins, the researchers found that it prevented the dyes flowing into the vacuole. “That was our first indication that these proteins actually have a role in small-molecule transfer,” he says.

More significantly though, when the researchers expressed a Plasmodium export complex gene in the modified Toxoplasma, they found that the dyes were able to flow into the vacuole once again, suggesting that this small-molecule transport function had been restored.

“All of this came together to strongly suggest that this protein that is involved in proteinexport in Plasmodium may also have an additional function in small-molecule transport,” Gold says.

Limited effects

Crucially, since these proteins are only found in the parasite phylum Apicomplexa, to which both Toxoplasma and Plasmodium belong, they could be used as a drug target against the diseases they cause, including malaria, he says.

“This very strongly suggests that you could find small-molecule drugs to target these pores, which would be very damaging to these parasites, but likely wouldn’t have any interaction with any human molecules,” he says. “So I think this is a really strong potential drug target for restricting the access of these parasites to a set of nutrients.”

In addition to malaria, the technique could also be used to target the parasite Eimeria, which affects cattle and poultry, among other animals, and therefore has a huge economic cost, Gold says.

This “very exciting” research elegantly identifies a molecular component of a pore in the vacuole that separates the growing Toxoplasma parasite from its host cell to help in the acquisition of nutrients, according to Manoj Duraisingh, a professor of immunology and infectious diseases at Harvard School of Public Health who was not involved in the research.

“Strikingly, this molecule is conserved for this function in the related and deadlymalaria parasite Plasmodium, where it was intriguingly found to be a part of a complex required for the export of proteins for the transformation of the host red blood cell and the virulence of the parasite,” Duraisingh says. “This suggests that a virulence determinant in Plasmodium parasites was co-opted from a basic function of parasitism broadly conserved in apicomplexan parasites.”

Researchers make progress engineering digestive system tissues

New proof-of-concept research at Wake Forest Institute for Regenerative Medicine suggests the potential for engineering replacement intestine tissue in the lab, a treatment that could be applied to infants born with a short bowel and adults having large pieces of gut removed due to cancer or inflammatory bowel disease.

 

Lead researcher Khalil N Bitar, Ph.D., a professor at the institute, which is part of Wake Forest Baptist Medical Center, reported the results this week at Digestive Diseases Week in Washington, D.C. He also updated attendees on a related project to engineer anal sphincters for patients with fecal incontinence.

“Results from both projects are promising and exciting,” said Bitar. “Our latest effort, to find a new solution for the urgent need for gut-lengthening procedures, shows we can meet the basic requirements for regenerating segments of the gastrointestinal tract.”

Both projects are based on using a patient’s own cells to grow replacement tissue in the lab. Elie Zakhem, a doctoral student in Bitar’s lab, is currently working on developing tissue-engineered gut replacements. The researchers use smooth muscleand nerve stem cells from human intestine to engineer innervated muscle “sheets.” The sheets are then wrapped around tubular chitosan scaffolds. Chitosan is a natural biomaterial derived from shrimp shells. The material is already approved by the U.S. Food and Drug Administration for certain applications.

The tubular structures were implanted just under the skin of rats for 14 days, a first step in assessing their performance. Researchers found that the implants developed a blood vessel supply and that the tube opening was maintained. In addition, the innervated muscle “remodeled,” which means that the cells began the process of releasing their own materials to replace the scaffold.

“It is the combination of smooth muscle and neural cells in gut tissue that moves digested food material through the gastrointestinal tract and this has been a major challenge in efforts to build replacement tissue,” said Bitar. “Our preliminary results demonstrate that these cells maintained their function and the implant became vascularized, providing proof of concept that regenerating segments of thegastrointestinal tract is achievable.”

The researchers’ next steps are to develop the lining of the intestine that is responsible for absorption and secretion. In a study involving research animals, they also plan to surgically connect the replacement segments to native intestine to assess function.

The group’s second project, to engineer anal sphincters, also reached a new milestone with the successful implantation of the structures in rabbits.

“These bioengineered sphincters, made with both muscle and nerve cells, restored fecal continence in the animals throughout the six-month follow-up period after implantation,” he said. “This provides proof of concept of the safety and efficacy of these constructs.”

Sphincters are ring-like muscles that maintain constriction of a body passage, such as controlling the release of urine and feces. There are actually two sphincters at the anus – one internal and one external. A large proportion of fecal incontinence in humans is the result of a weakened internal sphincter.

“Many individuals find themselves withdrawing from their social lives and attempting to hide the problem from their families, friends and even their doctors,” said Bitar. “Many people suffer without little help.”

To engineer the internal anal sphincters, researchers used a small biopsy from the animals’ sphincter tissue and isolated smooth muscle cells that were then multiplied in the lab. In a ring-shaped mold, these cells were layered with nerve cells isolated from small intestine to build the sphincter. The mold was placed in an incubator, allowing for tissue formation. The entire process took about four to six weeks.

The bioengineered sphincters mimicked the architecture and function of native tissue and there are no signs of inflammation or infection after implantation. The constructs demonstrated the presence of contractile smooth muscle as well as mature nerve-cell populations.

“In essence, we have built a replacement sphincter that we hope can one day benefit human patients,” said Bitar. “Because these sphincters are made with both muscle and nerve cells, they are ‘pre-wired’ to be connected with nerve pathways in the intestine.”

Bitar’s goal is to eventually conduct studies of the technology in humans. He said the technology could be applied to other diseases of the sphincter muscles, including urinary incontinence.

Age-reversal effects of ‘young blood’ molecule GDF-11 called into question

The leading theory for why the blood of younger mice rejuvenates the muscles of older mice is now in contest. The vampiric exchange of young blood and old blood has long been reported to have anti-aging effects, but it was in 2013 when Harvard University researchers first linked GDF-11, a molecule that circulates in the blood, to this effect.

Now, an analysis that set out to see how GDF-11 works in the muscles published May 19 in Cell Metabolism found just the opposite. The investigators showed first that GDF-11 was not specifically measured; the methods that were previously used were not specific for GDF-11, but also measured another molecule it closely resembles, called myostatin, which is well known to inhibit muscle growth.

The new study, led by David Glass at the Novartis Institutes for BioMedical Research, in collaboration with Massachusetts General Hospital and the University of California, San Francisco, used tests to more accurately measure GDF-11 (short for Growth Differentiation Factor 11) in the blood of animals and humans and found that it showed hints of increasing with age, and clearly did not decrease with age. They also show that regularly injecting mice with pure GDF-11 causes muscle repair to worsen, resembling effects seen in older age.

“This is a carefully conducted study that is certain to generate a vigorous discussion about what role GDF-11 plays, if any, in aging muscle,” says Se-Jin Lee, an expert on growth/differentiation factors and molecular biologist at Johns Hopkins University who did not participate in the research.

“I think that these new results definitely raise questions as to whether GDF-11 was really being exclusively detected in the prior paper,” Lee adds. “Clearly, these discrepancies will need to be resolved with additional studies, especially given the enormous effort being undertaken in the pharmaceutical community to target the myostatin pathway to treat muscle loss.”

Giving GDF-11 at doses previously used in aged animals did not improve regeneration, as previously claimed. When younger animals were treated with GDF-11, regeneration was worsened. The authors developed a test that could detect GDF-11 levels specifically and suggest that, for humans, testing for high levels of GDF-11 could potentially make them eligible for medicines that block GDF-11 activity.

“Clearly, like the mythical fountain of youth, GDF11 is not the long sought rejuvenation factor,” write Caroline Brun and Michael A. Rudnicki of the Ottawa Hospital Research Institute in a preview to the Cell Metabolism paper. They say, given these new findings, “the suggested ‘rejuvenating’ activity of GDF11 in the heart and brain should also be re-examined – since the underlying premise of those other two manuscripts, that GDF11 decreases with age, is contradicted by [the new] manuscript.”

Tuberculosis drug can improve effect of cognitive behavioral therapy

A new study from Sweden’s Karolinska Institutet shows that the effect of internet-based CBT (cognitive behavioural therapy) for people with people with obsessive-compulsive disorder (OCD) may be boosted with a drug called d-cycloserine, which has long been used to treat TB. According to the results, which are published in the journal JAMA Psychiatry, this enhancing effect is counteracted by antidepressants.

By Aidsmam.com

“These types of drugs are sometimes called cognitive enhancers, as they affect specific brain processes that can speed up and boost the effects of psychotherapy,” says Dr Christian Rück, psychiatrist and researcher, who conducted the study with his colleagues at Karolinska Institutet’s Department of Clinical Neuroscience. “You could say that it’s to CBT what spinach is to Popeye.”

The active therapeutic component of CBT is based on the concept of exposure or extinction, whereby the individual puts him/herself in feared situations that evoke feelings of discomfort or anxiety and remains there until the sensation wanes. D-cycloserine (DCS) is an old tuberculosis drug that also affects one of the brain’s most common receptors, the NMDA receptor. Previous studies have shown, for example, that DCS can amplify the effect of CBT if taken just prior to exposure to the fear-inducing stimulus.

In the present study, the researchers tried adding DCS to online CBT for people with OCD. Previous research had shown that DCS can speed up the therapeutic effect of CBT for this disorder, but no study had been large enough to demonstrate lasting effects once the therapy has finished. The study randomly assigned 128 people with an OCD diagnosis to either a DCS or a placebo group.

The initial analysis indicated that while there was no difference between DCS and placebo, the effect of online CBT was considerable. In their subsequent analysis, the team therefore took into account whether the participants were also taking antidepressants. Doing so, they found that those not on antidepressants responded much better to DCS.

“This tells us that the mechanism for DCS can be affected by antidepressants or vice versa and that it might one day be possible to use DCS and similar substances to boost the effect of CBT,” says Dr Rück. “Our study is the largest to date on DCS and OCD, but more research needs to be done to substantiate these positive effects and to fully understand and utilise the biological mechanisms behind effective CBT therapy.”

Source: Science Daily

Pactamycin analogs offer new, gentler approach to cancer treatment

Researchers at Oregon State University are pursuing a new concept in treatment of epithelial cancer, especially head and neck cancer, by using two promising “analogs” of an old compound that was once studied as a potent anti-tumor agent, but long ago abandoned because it was too toxic.

By Redorbit.com

The analogs are more highly selective than the parent compound, pactamycin, which originally was found to kill all cells, from bacteria to mammals, by inhibiting their protein synthesis.

The pactamycin analogs, which were developed with biosynthetic engineering, also offer a different approach toward cancer therapy — an effort to essentially put cancer cells to sleep, instead of killing them. If successful, this trend may herald a new future in “kinder and gentler” cancer treatments.

Findings on this promising approach to cancer were just published in PLOS One, in work supported by the National Institute of Health and other agencies.

The effects of the pactamycin analogs, called TM-025 and TM-026, were characterized in head and neck cancer cell lines, which cause the eighth most common cancer in the world. But they may have applications to a wider range of cancers, the researchers said, particularly melanoma.

“A traditional view of chemotherapy is that you try to completely kill cancer cells and destroy tumors,” said Arup Indra, an associate professor in the OSU College of Pharmacy and one of the lead authors on the study. “Sometimes this is effective, sometimes not as much. An alternative approach is to cause rapid cell aging and induce premature senescence, which we believe could become a new frontier in cancer drug development.”

A senescent cancer cell, Indra said, doesn’t usually die, but the growth of it and the larger tumor is slowed or stops, and it continues to live in a vegetative state, almost like being asleep. Such an approach can be an alternative way to control cancer without completely killing it, which may help reduce problems with resistance that can quickly develop to chemotherapeutic drugs. And it also avoids some of the most toxic and debilitating side effects of cancer chemotherapies, which are often caused by cell death.

The new findings showed that these analogs of pactamycin largely stopped cancer cell proliferation and growth, causing cells to age and lose their ability to divide and grow. These effects are partly mediated by tumor suppressor p53, which is frequently mutated in human cancers. They do not yet form the basis for a therapy, researchers said, because methods must still be perfected to get them more selectively into the cancer cells.

“With further research we hope to create a nontoxic nanocarrier that could provide targeted delivery of the TM-025 and TM-026 analogs specifically to cancer cells,” said Gitali Indra, an OSU assistant professor and also a lead and corresponding author on the study. “In some cases, such as oral cancer, it may also be possible to use topical treatments. But this approach should have significant promise if we can develop techniques to adequately target the cancer cells.”

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Story Source: Science Daily

More than half of probiotics contain traces of gluten, study finds

First author Dr. Samantha Nazareth, a gastroenterologist at Columbia University Medical Center (CUMC) in New York, NY, and colleagues recently presented their findings at the Digestive Disease Week 2015 meeting in Washington, DC.

When a person with celiac disease eats gluten – a protein found in wheat, barley and rye – their immune system attacks the villi of the small intestine. When the villi are damaged, the body has difficulty absorbing nutrients.

It is estimated that around 1% of the US population – the equivalent to around 1 in 133 Americans – have celiac disease. Around 83% of people with the condition, however, are believed to be undiagnosed or misdiagnosed with other illnesses.

Celiac disease can present more than 300 symptoms, making it tricky to diagnose. Some people may experience diarrhea and abdominal pain or bloating, while others may experience fatigue and weight loss, among other symptoms.

At present, the only treatment for celiac disease is to follow a gluten-free diet, though some people with the condition turn to dietary supplements – particularly probiotics – believing the products will help alleviate symptoms.

According to Dr. Nazareth and colleagues, previous research has found that patients with celiac disease who use dietary supplements tend to have more symptoms than those who do not use them. As such, they set out to determine whether probiotics on sale in the US may be contaminated with gluten.

Two probiotics labeled gluten-free contained gluten at levels exceeding FDA standards

Using a sensitive detection technique known as liquid chromatography-mass spectrometry, the team tested 22 popular probiotics for traces of gluten – more than half of which were labeled “gluten-free.”

The team found that 12 (55%) of the probiotics contained traces of gluten. While the majority of these probiotics contained the protein at levels less than 20 parts per million – a level considered to be gluten-free by the US Food and Drug Administration (FDA) – four (18%) of them exceeded this level.

What is more, two of the probiotics that contained gluten at levels higher than 20 parts per million – exceeding FDA standards for gluten-free products – were labeled gluten-free.

Dr. Peter Green, professor of medicine and director of the Celiac Disease Center at CUMC, believes the findings are worrisome for patients with celiac disease:

“We have been following reports in the scientific literature and news media on inaccurate labeling of nutritional supplements, and it appears that labels claiming a product is gluten-free are not to be trusted, at least when it comes to probiotics. This is a potential hazard for our patients, and we are concerned.”

Study co-author Dr. Benjamin Lebwohl, assistant professor of medicine and epidemiology at the Celiac Disease Center, stresses that it is unclear as to whether the gluten in these probiotics may pose harm for patients with celiac disease at the levels identified.

“We know that most patients with celiac disease only develop intestinal damage when consuming more than 10 milligrams of gluten daily, and it is unlikely that contaminated probiotics can lead to that amount unless patients are ingesting mega-doses,” he explains.

He adds, however, that their findings are still a cause for concern. “Why is there any gluten in these products? Why should the consumer pay any attention to gluten-free labeling on such products? And given the great consumer interest in probiotics, will regulatory bodies take action to protect the public?”

Last week, Medical News Today reported on a study published in JAMA Neurology, in which researchers found people with celiac disease may be at higher risk of nerve damage.

Written by Honor Whiteman