Biotech Trial Dates to Watch in '08

Myriad Genetics will release top-line results from a pivotal phase III study of its drug Flurizan; while Elan/Wyeth will present phase II data on its drug bapineuzumab.

No calendar of big 2008 clinical trials would be complete without a mention of Dendreon(DNDN) and its prostate cancer vaccine Provenge. All-important interim results from the ongoing phase III study are expected in the back half of 2008. Is everyone ready for another dose of Dendreon mania?

Also on the immunotherapy front: Cell Genesys(CEGE) and its phase III study of the GVAX prostate cancer vaccine.

Two more cancer trials of note: Shares of ImClone Systems(IMCL) will move when European partner Merck KGaA presents results from the Erbitux "FLEX" trial in non-small cell lung cancer at the American Society of Clinical Oncology meeting.

Onyx Pharmaceuticals(ONXX) had a great 2007 because of Nexavar's success in liver cancer. Next year, the company will release data from a phase III non-small cell lung cancer study.

Among small and mid-cap biotechs, look for important clinical trials results from GTX(GTXI), Osiris Therapeutics(OSIR), Altus Pharmaceuticals(ALTU) and Keryx Biopharmaceuticals(KERX).

See the table below for other important trial dates.

Key Biotech Clinical Trial Dates for 2008
Expected Date	Company	Drug	Indication
First quarter 2008	Amgen	Denosumab	Osteoporosis
	EpiCept	NP-1	Peripheral Neuropathy
	Accentia Biopharmaceuticals	SinuNase	Anti-bacterial, Mycobacterial, or Fungal
	Keryx Biopharmaceuticals	Sulonex	Diabetic Nephropathy
	GTx	Acapodene	Prostate Cancer
	GTx	Acapodene	Prostatic Intraepithelial Neoplasia
	Neurogesx	NGX-4010	Neuropathic Pain
	Genitope	MyVax	Non-Hodgkin's Lymphoma
	Genentech/Biogen IDEC	Rituxan	Chronic Lymphocytic Leukemia
First half 2008	Somaxon Pharmaceuticals	Silenor	Insomnia
	Cadence Pharmaceuticals	Acetavance	Pain Indications
	Genentech/Biogen IDEC	Rituxan	Multiple Sclerosis
	Genentech/Biogen IDEC	Rituxan	Systemic Lupus Erythematosus
	Gentium	Defibrotide	Veno-Occlusive Disease
	Dynavax Technologies	Tolamba	Allergic Rhinitis
	Nuvelo	Alfimeprase	Anticoagulation
	Cell Genesys	GVAX Prostate Cancer Vaccine	Prostate Cancer
	Amgen	Denosumab	Metastatic Bone Complications
	ImClone Systems	Erbitux	Non-Small Cell Lung Cancer
	Dyax Corporation	DX-88	Hereditary angioedema
	Medivation	Dimebon	Huntington's Disease
Mid 2008	Altus Pharmaceuticals	Trizytek	Exocrine Pancreatic Insufficiency
	Elan/Wyeth	Bapineuzumab	Alzheimer's Disease
	AtheroGenics	AGI-1067	Diabetes Mellitus, Type II
	MannKind Corp.	Technosphere	Diabetes Mellitus, Type II
	Acorda Therapeutics	Fampridine-SR	Multiple Sclerosis
	Myriad Genetics	Flurizan	Alzheimer's Disease
	Auxilium Pharmaceuticals	Xiaflex	Dupuytren's Contracture
	Osiris Therapeutics	Prochymal	Crohn's Disease
	Favrille	FavId	Non-Hodgkin's Lymphoma
Second half 2008	AstraZeneca	Zactima	Non-Small Cell Lung Cancer
	Salix Pharmaceuticals	Xifaxan	Clostridium difficile associated Diarrhea
	Salix Pharmaceuticals	Xifaxan	Hepatic Encephalopathy
	Immtech Pharmaceuticals	Pafuramidine	Anti-parasitic or other infectious disease
	MannKind Corp.	Technosphere	Diabetes Mellitus, Type I
	Isis Pharmaceuticals	Mipomersen	Dyslipidemia/Hypercholesterolemia
	Inspire Pharmaceuticals	Denufosol	Cystic Fibrosis
	Titan Pharmaceuticals	Probuphine	Drug Addiction
	Neurobiological Technologies	Viprinex	Ischemic Stroke
	GTC Biotherapeutics	ATryn	Anticoagulation
	Pharmion	Amrubicin	Small Cell Lung Cancer
	Onyx Pharmaceuticals	Nexavar	Non-Small Cell Lung Cancer
	Medarex	MDX-010	Melanoma
	Actelion Pharmaceuticals	Tracleer	Idiopathic Pulmonary Fibrosis
	Jazz Pharmaceuticals	Xyrem	Fibromyalgia
	Cypress Bioscience	Milnacipran	Fibromyalgia
	Vivus	Qnexa	Obesity
	SciClone Pharmaceuticals	Zadaxin	Hepatitis C
	Osiris Therapeutics	Prochymal	Graft vs. Host Disease
	Keryx Biopharmaceuticals	Sulonex	Diabetic Nephropathy
	ViroPharma	Camvia	Cytomegalovirus Infection
Fourth quarter 2008	The Medicines Co.	Cangrelor	Acute Coronary Syndrome
	Dendreon	Provenge	Prostate Cancer
	United Therapeutics	UT-15C	Pulmonary Arterial Hypertension
	Human Genome Sciences	Albuferon	Hepatitis C
	Poniard Pharmaceuticals	Picoplatin	Small Cell Lung Cancer
	Vanda Pharmaceuticals	VEC-162	Insomnia
	Synta Pharmaceuticals	Elesclomol	Melanoma
2008	Amgen	AMG 706	Non-Small Cell Lung Cancer
	Onyx Pharmaceuticals	Nexavar	Melanoma
	Amgen	Denosumab	Hypercalcemia of Malignancy/Metastatic Bone Complications
	ImClone Systems	Erbitux	Non-Small Cell Lung Cancer
	Pfizer	Ticilimumab	Melanoma
Source: BioMedtracker, company and analyst reports

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