Company*

Product

Description

Indication

Status (Date)

(Symbol)


CANCER

AEterna Laboratories Inc. (Canada; AELA)

Neovastat

Orally bioavailable; activates apoptosis of endothelial cells; also inhibits matrix metalloproteinase and vascular endothelial growth factor

Progressive multiple myeloma

Patient recruiting for a pivotal Phase II trial continues in about 35 investigative centers in Canada, the U.S. and Europe (5/8)

AEterna Laboratories Inc. (Canada; AELA)

Neovastat

Orally bioavailable; activates apoptosis of endothelial cells; also inhibits matrix metalloproteinase and vascular endothelial growth factor

Renal cell carcinoma

At ASCO, the company said patient recruitment in its Phase III trial is more than half complete (5/15)

Allos Therapeutics Inc. (ALTH)

RSR13

Synthetic allosteric modifier of hemoglobin that noncovalently binds to hemoglobin, increasing oxygen delivery to hypoxic tissue

Non-small-cell lung cancer

Phase II data presented at ASCO showed RSR13 in combination with radiation therapy demonstrated an overall response rate of 89% within the radiation therapy portal in the chest (5/14)

AltaRex Corp. (Canada; OTC BB: ALRXF; TSE:AXO)

BrevaRex MAb

Targets antigen, MUC1, and elicits cancer-killing B- and T-cell immune responses

Cancer

Phase I results demonstrated the antibody's ability to elicit cancer-killing B- and T-cell immune responses to the target antigen (5/7)

AltaRex Corp. (Canada; OTC BB: ALRXF; TSE:AXO)

OvaRex

Modified murine monoclonal antibody that binds to CA125 cancer antigen

Ovarian cancer

Phase II results presented at ASCO indicate the treatment can provide comparable efficacy to salvage chemotherapies, but without toxicities (5/14)

Amgen Inc.
(AMGN)

Aranesp

Recombinant erythropoietic protein that stimulates production of oxygen-carrying red blood cells; an extended-release version of Epogen

Cancer-related conditions, including anemia and the need for transfusions

Phase III data presented at ASCO showed Aranesp could reduce red blood cell transfusions in patients receiving multicycle platinum-based chemotherapy regimens, treat chronic anemia of cancer in patients who are not receiving chemotherapy, and correct anemia associated with chemotherapy (5/13)

AnorMED Inc. (Canada; TSE:AOM)

ZD0473

Platinum-based anticancer agent

Ovarian and small-cell lung cancer

Phase II data presented at ASCO showed the compound produced objective responses (5/15)

Antigenics Inc.
(AGEN)

Oncophage

Cancer vaccine; uses heat shock proteins to activate cellular immune responses

Advanced melanoma and colon cancer

Phase II results presented at ASCO showed that five of 28 patients who were incurable with surgery responded favorably; another Phase II trial showed that half of the 29 patients treated generated anticolon cancer immunity (5/14)

Aphton Corp.
(APHT)

Anti-gastrin 17 immunogen

Administered with cisplatin and 5-FU

Metastatic stomach cancer

Phase II data presented at ASCO showed that two of the six evaluable patients had tumor volume shrinkage of more than 50% (5/15)

Aronex Pharmaceuticals Inc. (ARNX)

Annamycin

Liposomal anthracycline

Acute myeloid and lymphoid leukemia

Phase I results presented at ASCO showed two out of 21 patients achieved complete remission (5/15)

Aronex Pharmaceuticals Inc. (ARNX)

Atragen

Injectable liposomal formulation of all-trans retinoic acid (tretinoin)

Advanced renal cell cancer

Phase I data presented at ASCO of Atragen in combination with interferon-alpha showed two of 16 evaluable patients had partial remission in bone and lung; five patients had stable disease (5/14)

AVI BioPharma Inc. (AVII)

Oncomycin-NG

Neugene antisense cancer drug

Cancer

Company began a Phase I/II study (5/21)

Biomira Inc. (Canada; BIOM; TSE:BRA)

Theratope

Synthetic carbohydrate- based vaccine; mimic of cancer antigen si alyl-Tn plus carrier molecule KLH

Metastatic colorectal cancer

Phase II data presented at ASCO showed the median survival time was 14.2 months from the time of commencing the vaccine (5/14)

British Biotech plc (UK; BBIOY)

Marimastat

Oral matrix metalloproteinase inhibitor

Non-small-cell lung cancer

Company said it will halt a Phase III trial, which failed to meet its primary endpoint in a gastric cancer trial (5/2)

British Biotech plc (UK; BBIOY) and ImmunoGen Inc. (IMGN)

BB-10901/ huN901-DM1

Tumor-activated prodrug

Small-cell lung cancer

Companies started patient enrollment for a Phase I/II study (5/29)

Celgene Corp.
(CELG)

Revimid

Immunomodulatory drug to treat solid tumors

Multiple myeloma

Phase I/II results showed that more than 60% of the late-stage patients treated were responding or had their disease stabilized (5/8)

Celgene Corp.
(CELG)

Thalomid

Thalidomide; thought to act by modulating levels of tumor necrosis factor-alpha

Late-stage renal cell carcinoma

Company said it will pursue a major trial with time to disease progression and survival as endpoints (5/16)

Celgene Corp.
(CELG)

Thalomid

Thalidomide; thought to act by modulating levels of tumor necrosis factor-alpha

Metastatic colorectal cancer

Company will initiate a Phase II trial that will team Thalomid with Camptosar (irinotecan) and 5-fluorouracil/leucovorin regimen (5/17)

Cell Genesys Inc.
(CEGE)

GVAX

Lung cancer vaccine

Lung cancer

Phase I/II data presented at ASCO showed three of 22 patients had a complete disappearance of metastatic tumors following treatment; one patient had a greater than 50% tumor reduction (5/14)

Cell Genesys Inc.
(CEGE)

GVAX

Prostate cancer vaccine

Prostate cancer

Phase II results presented at ASCO showed that 55 patients who had failed hormone therapy showed a trend toward increased median time to progression, but another trial of 41 early stage patients showed that median time to progression had not been reached (5/15)

Cell Pathways Inc. (CLPA)

CP461

Selective apoptotic antineoplastic drug

Advanced cancer

Phase I data presented at ASCO showed CP461 was rapidly absorbed and achieved, at certain doses, the plasma concentrations required to induce apoptosis (5/14)

Cel-Sci Corp. (AMEX:CVM)

Multikine

Immunotherapy drug; natural mixture of human cytokines, including interleukin-2

Cervical cancer

Phase I trials will begin at the University of Maryland, focusing on women infected with both human papillomavirus and HIV (5/7)

Chiron Corp.
(CHIR)

Proleukin

Recombinant form of human interleukin-2

Metastatic renal cell carcinoma

Phase III results presented at ASCO showed the high-dose group had a tumor response of 25%, while the low-dose group had a response of 12%; two patients had a complete response and 10 achieved a partial response (5/14)

Cytran Inc.*

IM862

Naturally occurring peptide administered as nose drops

Ovarian cancer

A Phase II trial will begin evaluating IM862 in combination with initial chemotherapy using paclitaxel and carboplatin (5/2)

EntreMed Inc. (ENMD)

Angiostatin

Subcutaneous antiangiogenic

Cancer

Phase I results presented at ASCO showed the drug was safe, has linear and predictable pharmacokinetics, and did not alter blood-clotting mechanisms (5/14)

EntreMed Inc. (ENMD)

Endostatin

Angiogenesis inhibitor

Tumors

Phase I data presented at ASCO showed the product had no serious side effects (5/15)

Enzon Inc.
(ENZN)

PEG-paclitaxel

PEG-modified version of paclitaxel formulated for ease of administration

Advanced solid tumors and lymphomas

Company initiated a Phase I trial in up to 40 patients (5/7)

Genaera Corp.
(GENR)

Squalamine

Combination therapy with standard chemotherapy of carboplatin and paclitaxel

Non-small-cell lung cancer

Phase IIa data presented at ASCO showed, overall, that 27% of patients at all doses experienced an objective response (5/15)

Genentech Inc. (NYSE:DNA)

Rituxan

Rituximab; genetically engineered chimeric pan B monoclonal antibody that targets CD20 antigen on B-cell surface

Chronic lymphocytic leukemia

Phase II results presented at ASCO showed an overall response rate of 90% when patients were treated with Rituxan in combination with fludarabine (5/15)

Genentech Inc. (NYSE:DNA)

Rituxan

Rituximab; genetically engineered chimeric pan B monoclonal antibody that targets CD20 antigen on B-cell surface

Low-grade non-Hodgkin's lymphoma

Clinical data presented at ASCO showed a 47% objective response rate in patients receiving Rituxan alone (5/15)

Genta Inc.
(GNTA)

Genasense

Antisense compound geared toward blocking the production of Bcl-2

Prostate cancer

Clinical results presented at ASCO showed antitumor activity when Genasense and Taxotere were used in combination (5/14)

ImClone Systems
Inc.
(IMCL)

IMC-C225

Designed to target and block the epidermal growth factor receptor

Pancreatic cancer

Phase II trials presented at ASCO showed the combination of the compound with gemcitabine produced a one-year survival rate of 32.5% (5/14)

ImClone Systems
Inc.
(IMCL)

IMC-C225

Designed to target and block the epidermal growth factor receptor

Head and neck cancer

Phase II results presented at ASCO showed the combination of IMC-C225 and cisplatin can produce major responses (5/14)

Immunex Corp. (IMNX) and Abgenix Inc. (ABGX)

ABX-EGF

Fully human monoclonal antibody

Kidney cancer

Phase I data presented at ASCO showed the product was well tolerated; the companies initiated a Phase II study (5/15)

Immunex Corp. (IMNX)

Novantrone

Mitoxantrone for injection concentrate

Prostate cancer

Data in patients who have failed radiation therapy or surgery demonstrated the drug improved prostate-specific antigen test results (5/18)

ImmunoGen Inc. (IMGN)

huC242-SM1/ SB-408075

Tumor-activated prodrug

Colorectal, pancreatic and non-small-cell lung cancers

Company began enrollment for a third Phase I/II trial (5/8); Phase I data presented at ASCO showed antitumor activity (5/14)

Inspire Pharmaceuticals Inc. (ISPH)

INS316 Diagnostic

Diagnostic inhaled solution

Lung cancer diagnosis

Company initiated its Phase III program (5/10)

IntraBiotics Pharmaceuticals Inc. (IBPI)

Protegrin IB-367 Rinse

Synthetically derived analogue of naturally occurring protegrins

Prevention of oral mucositis in patients undergoing high-dose chemotherapy

Phase III final results presented at ASCO indicated the company would have to conduct a repeat Phase III trial due to a third-party vendor error that caused patients to receive incorrect bottles (5/14)

Introgen Therapeutics Inc. (INGN)

INGN 201

Adenoviral p53 gene therapy candidate

Cancer

Biosafety data indicated the vector used is genetically stable; data was presented at ASCO (5/14); Phase II lung cancer results presented at ASCO showed that 12 of 19 patients had complete or partial responses at the injected site; Phase I ovarian cancer results showed up to a 17-fold increase in the percent of tumor cells expressing p53 protein (5/15)

Isis Pharmaceuticals Inc. (ISIP)

ISIS 3521

Antisense protein kinase C-alpha inhibitor that binds to an mRNA sequence specific to PKC-alpha

Non-small-cell lung cancer

Phase I/II data presented at ASCO showed prolonged survival and time to progression of disease, and robust overall response rates (5/14)

Ligand Pharmaceuticals Inc. (LGND)

Targretin

Bexarotene capsules; synthetic retinoid analogue that selectively activates retinoid X receptors

Advanced renal cell cancer

Phase I/II results presented at ASCO showed the optimal dose was 400 mg/m2/day (5/15)

Ligand Pharmaceuticals Inc. (LGND)

Targretin

Bexarotene capsules; synthetic retinoid analogue that selectively activates retinoid X receptors

Non-small-cell lung cancer

Phase I/II results presented at ASCO suggest Targretin administered in combination with chemotherapy may prolong survival in patients (5/16)

Matrix Pharmaceutical Inc. (MATX)

IntraDose Injectable Gel

Biodegradable gel containing cisplatin and epinephrine

Squamous cell carcinoma of the head and neck

Phase III data presented at ASCO showed a response rate of 29% (5/15)

Matrix Pharmaceutical Inc. (MATX)

Tezacitabine

Nucleoside analogue that irreversibly inhibits ribonucleotide reductase and terminates DNA chain elongation

Cancer

Phase I data presented at ASCO showed a combination of tezacitabine and fluorouracil demonstrated antitumor activity at tolerable doses (5/14)

Maxim Pharmaceuticals Inc. (MAXM)

Ceplene

Histamine dihydrochloride; an adjuvant to interleukin-2

Metastatic renal cell carcinoma

Phase II results presented at ASCO showed Ceplene in combination with interferon-alpha and interleukin-2 resulted in a median survival of an intent-to-treat basis of 16.3 months (5/14)

MetaPhore Pharmaceuticals
Inc.*

M40403

Enzyme mimetic compound

Advanced skin and end-stage kidney cancers

Company initiated a Phase I study (5/31)

MGI Pharma Inc. (MOGN)

MGI-114

Irofulven; hydroxymethyl- acylfulvene

Recurrent malignant glioma

Company initiated a Phase II trial, which will include up to 27 patients (5/4)

MGI Pharma Inc. (MOGN)

MGI-114

Irofulven; hydroxymethyl- acylfulvene

Advanced, metastatic soft tissue sarcoma

Company initiated a Phase II trial of irofulven as a single-agent treatment (5/7)

MGI Pharma Inc. (MOGN)

MGI-114

Irofulven; hydroxymethyl- acylfulvene

Ovarian cancer

Phase II data presented at ASCO showed that seven of 38 patients demonstrated objective responses and 13 had stable disease (5/14)

MGI Pharma Inc. (MOGN)

Salagen

Tablets; pilocarpine
HCl

Head and neck cancer

Phase III data presented at ASCO showed use of Salagen resulted in a statistically significant improvement of salivary flow vs. placebo (5/17)

NeoRx Corp.
(NERX)

STR

Skeletal targeted radiotherapy

Multiple myeloma

Phase I/II data showed that 32 of 75 evaluable patients are in complete remission (5/7)

Northwest Biotherapeutics
Inc.*

DCVax- Prostate

Dendritic cell-based immunotherapy

Prostate cancer

Phase I/II data show that immune tolerance in elderly patients can be overcome safely with DCVax (5/8)

Onyx Pharmaceuticals Inc. (ONXX)

CI-1042 (ONYX-015)

Administered via hepatic artery infusion; tumor-selective, modified adenovirus that has been genetically engineered to replicate in and kill cancer cells that have dysfunctional p53

Colorectal cancer liver metastases

Phase I/II data presented at ASCO showed the product was well tolerated and, at the highest dose, had prolonged survival when compared to the lowest dose (5/14)

Onyx Pharmaceuticals Inc. (ONXX)

CI-1042 (ONYX-015)

Administered via hepatic artery infusion; tumor-selective, modified adenovirus that has been genetic-ally engineered to replicate in and kill cancer cells that have dysfunctional p53

Premalignant oral dysplasia

Phase II data presented at ASCO showed the product was well tolerated and may cause resolution of dysplasia in some patients (5/15)

OSI Pharmaceuticals (OSIP), Genentech Inc. (NYSE:DNA) and F. Hoffmann- La Roche Ltd. (Switzerland)

Tarceva
(OSI-774)

Inhibitor of the epidermal growth factor receptor tyrosine kinase

Non-small-cell lung cancer

Phase II data presented at ASCO showed one complete response and eight partial responses out of 57 evaluable patients; data also indicated a one-year survival rate of 48% (5/14)

Peregrine Pharmaceuticals Inc. (PPHM)

Cotara

Tumor necrosis therapy; chimeric monoclonal antibody that targets DNA-associated histone antigens, labeled with I-131

Biliary system and pancreatic cancers

Company opened a Phase I trial (5/8)

Peregrine Pharmaceuticals Inc. (PPHM)

Cotara

Tumor necrosis therapy; chimeric monoclonal antibody that targets DNA-associated histone antigens, labeled with I-131

Brain cancer

Phase II data presented at ASCO showed the overall median time to progression was 13.9 weeks (5/15)

Pharmacyclics Inc. (PCYC)

Xcytrin

Injection therapy; motexafin gadolinium

Glioblastoma multiforme

Phase I results presented at ASCO showed median survival to date was 17.3 months (5/14)

SciClone Pharmaceuticals Inc. (SCLN)

Zadaxin

Immune system enhancer; synthetic immunostimulant peptide

Hepatocellular carcinoma

Company initiated a Phase II trial of Zadaxin in combination with transarterial chemoembolization (5/14)

Telik Inc. (TELK)

TLK286

Small-molecule candidate that targets tumors that overexpress GST P1-1

Refractory cancers

Phase I data presented at ASCO indicate the compound is well tolerated over a range of doses (5/14); company initiated a Phase II trial (5/29)

Therion Biologics*
and Aventis Pasteur
SA
(France)

Vaccinia-CEA and Alvac-CEA

Vaccines

Late-stage metastatic cancers

Phase I/II data presented at ASCO showed five of nine patients treated with sequential vaccinations of the two products showed increased immune response and also remained alive two years out compared to zero long-term survivors in other treatment groups (5/15)

Titan Pharmaceuticals Inc. (AMEX:TTP)

TriGem

Anti-idiotypic monoclonal antibody-based vaccine; mimics GD2 antigen present on many types of cancer cells

Stage III melanoma

Phase II data presented at ASCO suggest TriGem provides a therapeutic benefit both as a single agent and in combination with alpha-interferon (5/14)

Vical Inc. (VICL)

Allovectin-7

DNA lipid complex containing the human gene encoding the
HLA-B7 antigen

Late-stage metastatic melanoma

Phase II data presented at ASCO showed a reduction in total tumor burden of 50% or more in 14.8% of the evaluable patients (5/14)

Vion
Pharmaceuticals
Inc. (VION)

Triapine

Inhibitor of the enzyme ribonucleotide reductase

Cancer

Company initiated a Phase I trial (5/10); Phase I data presented at ASCO showed Triapine was well tolerated and showed evidence of antitumor activity (5/15)

Vion
Pharmaceuticals
Inc. (VION)

VNP20009

First-generation Tapet vector administered by intratumoral injection

Cancer

Phase I data presented at ASCO showed the product was well tolerated (5/14)

Wilex AG
(Germany)*

WX-G250

Monoclonal antibody that recognizes an antigen predominantly expressed on renal cancer cells

Renal cell carcinoma

Phase I data presented at ASCO showed the product to be safe and well tolerated (5/15)

YM BioSciences
Inc.
(Canada)*

Tesmilifene

Combination therapy with doxorubicin

Metastatic breast cancer

Phase III data presented at ASCO showed patients receiving the combination therapy lived about 50% longer than those receiving doxorubicin alone (5/17)


CARDIOVASCULAR

Actelion Ltd. (Switzerland; SWX:ATLN) and Genentech Inc. (NYSE:DNA)

Tracleer

Bosentan; endothelin receptor antagonist

Pulmonary arterial hypertension

Phase III results indicated a statistically significant greater walking distance in treated patients (5/2)

Alliance Pharmaceutical Corp. (ALLP)

LiquiVent

Perflubron; an oxygen-carrying liquid drug; intrapulmonary agent

Acute respiratory distress syndrome

Company is abandoning studies because LiquiVent failed to meet its primary and secondary endpoints in a Phase II/III study (5/22)

Avant Immunotherapeutics Inc. (AVAN)

TP10

Complement inhibitor

Infants undergoing cardiac surgery

Company began treating patients in the second of its Phase IIb trials (5/10)

Carrington Laboratories Inc. (CARN)

Manapol

Powder at 160 mg per day

Moderate hyper- cholesterolemia

Data from an open-label study showed that LDL cholesterol levels were lowered by 9.8% after three weeks of treatment (5/18)

ConjuChem Inc. (Canada; TSE:CJC)

DAC-TI

Designed to prevent localized blood clotting

Blood clots

Company completed enrollment in a Phase I trial conducted in kidney dialysis patients (5/17)

Endovasc Ltd. Inc. (OTC BB:ENDV)

Liprostin

A vasodilator and stimulator for new
blood vessel growth; liposome-encapsulated PGE-1

Critical limb ischemia

Company said it will bypass Phase II trials and move directly into Phase III with Liprostin, if the FDA gives its approval (5/7)

ICOS Corp. (ICOS) and Texas Biotechnology Corp. (AMEX:TXB)

Sitaxsentan

Oral endothelin A receptor antagonist

Pulmonary hypertension

Companies began recruiting patients in a pivotal Phase II/III trial (5/30)


CENTRAL NERVOUS SYSTEM

Durect Corp.
(DRRX)

DUROS sufentanil

Approved opioid that uses the DUROS osmotic delivery system to deliver sufentanil

Chronic pain

Company completed a Phase II program evaluating a continuous dose of sufentanil (5/11)

Nouvel Pharma Inc. (unit of Neo-Pharma Production AB; Sweden)*

Duodopa

A liquid gel preparation of levodopa/carbidopa and administration via intra- duodenal infusion to the small intestine

Parkinson's disease

Company began a Phase III trial, which is scheduled to complete in late 2001 (5/4)

Pozen Inc.
(POZN)

MT-400

Combines an approved triptan drug with an approved long-acting, nonsteroidal anti-inflammatory agent

Migraine

Phase II results showed that MT-400 was significantly better than placebo with the primary endpoint of sustained pain relief, as well as the secondary endpoints (5/21)

Serono SA (Switzerland; NYSE:SRA)

Rebif

Recombinant interferon beta-1a

Relapsing- remitting multiple sclerosis

In a 677-patient study, Rebif was shown to give patients a 90% greater chance of remaining relapse-free compared to patients treated with Biogen Inc.'s Avonex (5/8)

Titan Pharmaceuticals Inc. (AMEX:TTP)

Spheramine

Cell therapy product that uses human retinal pigmented epithelial cells that secrete dopamine

Parkinson's disease

Phase I/II results showed improvement in motor function and quality of life in all patients treated, with no safety concerns or significant adverse events (5/10)


DIABETES

Sangstat Inc.
(SANG)

Thymoglobulin

Anti-thymocyte globulin, rabbit; organ rejection therapeutic

Diabetes caused by organ rejection

Data showed the therapeutic produced a lower incidence of diabetes, infection and hepatitis C than when it was used in combination with steroids (5/10)


INFECTION

AnorMED Inc. (Canada; TSE:AOM)

AMD-3100

Inhibits the binding action of HIV with the CXCR4 chemokine co-receptor

HIV

Company said it is discontinuing its Phase Ia/IIb trial due in part to abnormal cardiac activity observed in two patients (5/29)

Avant Therapeutics Inc. (AVAN)

Peru-15

Oral vaccine that deploys a live, attenuated mutant of V. cholerae O1 biotype El Tor

Cholera

Phase IIb results showed 100% protection against moderate to severe diarrhea associated with the disease (5/8)

BioMedicines Inc.*

¿

Omega interferon

Chronic hepatitis C

Company completed enrollment in a Phase II trial (5/16)

Enzon Inc. (ENZN)

PEG-intron

Peginterferon alfa-2b injections

Chronic hepatitis C

Studies of PEG-Intron used in combination with Rebetol showed that 35% had a virologic response after 24 weeks of treatment (5/22)

Hemispherx Biopharma Inc. (AMEX:HEB)

Antiviral

Uses HAART (highly active antiretroviral therapy)

HIV

Company began a Phase IIb trial (5/10)

ID Biomedical Corp. (Canada)*

¿

Intranasal flu vaccine

Flu

Company initiated a Phase I trial (5/22)

Immtech International Inc. (IMMT)

DB289

Oral, anti-infective

Pneumocystis carinii pneumonia and Trypano- somiasis

Company completed a Phase I trial, which showed the drug was safe at all dose levels (5/23)

Maxim Pharmaceuticals Inc. (MAXM)

Ceplene

Histamine dihydrochloride

Hepatitis C

Phase II results of Ceplene in combination with interferon-alpha showed that 5% of patients discontinued treatment due to adverse events, compared to 14% of patients treated with interferon-alpha alone (5/21)

Nabi (NABI)

StaphVAX

Injection; staphylococcus aureus conjugate vaccine

Staphylococcus aureus blood infections

Company initiated a trial to evaluate a booster dose of Nabi StaphVAX (5/17)

The Immune Response Corp. (IMNR)

Remune

HIV-1 Immunogen

HIV

Preliminary interim Phase II data show Remune to induce both alloand HIV-specific cell-mediated immune responses (5/21)

Versicor Inc.
(VERS)

V-Glycopeptide

Dalbavancin; a novel antibiotic

Skin and soft tissue infections

Company started a Phase II study (5/22)

XTL Biopharmaceuticals Ltd. (Israel; LSE:XTL)

XTL-001

Consists of two fully human monoclonal antibodies that recognize different areas of the virus and a range of viral serotypes

Chronic hepatitis B

Company began a Phase II study of XTL-001 in combination with lamivudine (5/16)


MISCELLANEOUS

Advanced Tissue Sciences Inc. (ATIS)

NouriCel

Human tissue-engineered skin

Facial wrinkles

Data indicated that nine of 14 patients had visible improvements in at least one of four areas (5/14)

Alkermes Inc. (ALKS) and Janssen Pharmaceutical Products LP

Risperdal

A long-lasting injectable form of Risperdal, using Alkermes' Medisorb technology

Schizophrenia

Results suggest the formulation provides relief without the need to take daily medication (5/2)

Alkermes Inc. (ALKS) and Serono SA (Switzerland; NYSE:SRA)

rhFSH

Long-acting formulation of recombinant human follicle stimulating hormone

Infertility

Companies completed a Phase I trial and intend to proceed with clinical development (5/16)

Apex Bioscience Inc.*

VTR-PHP

Pyridoxalated hemoglobin polyoxyethylene conjugate

Nitric oxide-induced shock

Company initiated a Phase III trial (5/24)

AtheroGenics Inc. (AGIX)

AGI-1067

Oral agent; anti-inflammatory compound with antioxidant properties

Restenosis after angioplasty

Preliminary Phase II results showed that six months after angioplasty, patients who received AGI-1067 had statistically significant greater luminal diameters of their coronary arteries than patients in the placebo group (5/21)

Biogen Inc. (BGEN) and Elan Corp. plc (Ireland)

Antegren

Humanized monoclonal antibody

Crohn's disease

Phase II data indicated a statistically significant difference in clinical response between the drug and placebo groups (5/23)

BioMarin Pharmaceutical Inc. (BMRN), Glyco Biomedical Ltd. (OTC BB:GLYK; TSE: GBL) and Genzyme General (GENZ)

Aldurazyme

Recombinant human alpha-L-iduronidase enzyme replacement therapy

Mucopoly- saccharidosis-I

Data indicated significantly decreased liver and spleen size in all patients after one year of therapy; results also showed reduced levels of urinary carbohydrates and improvements in range of motion and physical function (5/10)

Biopure Corp. (BPUR)

Hemopure

An oxygen therapeutic; hemoglobin glutamer-250 (bovine)

Orthopedic surgery

Phase III results showed Hemopure eliminated the need for red blood cell transfusion in patients undergoing elective orthopedic surgery (5/8)

Cambridge Antibody Technology Group plc (UK; CATG; LSE:CAT)

CAT-152

Human anti-TGD-beta2 monoclonal antibody

Prevention of scarring after eye surgery

Phase I/II data showed that patients treated with CAT-152 at the time of surgery had significantly lower intraocular pressure (5/8)

Centaur Pharmaceuticals
Inc.*

CPI-1189

Oral drug that
potentially inhibits neuroinflammation

Dementia

Centaur said it obtained proof of concept in its dementia trials, showing the drug protects brain cells and improves cognitive function (5/15)

Centocor Inc.
(unit of Johnson & Johnson)

Remicade

Infliximab; chimeric monoclonal antibody to tumor necrosis factor- alpha

Crohn's disease

Data from a 573-patient trial demonstrated prolonged remissions in patients with moderate to severe Crohn's disease (5/21)

Cephalon Inc.
(CEPH)

Provigil

Modafinil tablets

Depression

Two pilot studies indicated that Provigil tablets reduce fatigue and sleepiness in clinically depressed patients (5/10)

Dynavax Technologies
Corp.*

Amb a-1

Immunostimulatory oligo- deoxyribonucleotide conjugate

Ragweed allergies

Company started a Phase I/II trial (5/22)

Genzyme General (GENZ)

Fabrazyme

Agalsidase beta enzyme replacement therapy

Fabry disease

Phase III extension study data demonstrated the product's ability to clear the lipid globo- triaosylceramide from a range of cell types in organs affected by Fabry disease (5/29)

InKine Pharmaceuticals Co. Inc. (INKP)

Colirest

Oral steroid molecule; Fc receptor technology

Crohn's disease

Phase II results demonstrated a response rate after two months of therapy of 82%; the data also indicated a 64% remission rate (5/21)

Inspire Pharmaceuticals
Inc.
(ISPH)

INS365 Ophthalmic and INS37217 Ophthalmic

P2Y(2) receptor agonist; second-generation P2Y(2) agonist designed to enhance the lung's innate mucosal hydration and mucociliary clearance mechanisms

Dry eye disease and retinal detachment

Company presented positive Phase II results of INS365 and launched a Phase I/II trial of INS-37217 to treat retinal detachment (5/3)

Lilly ICOS LLC
(joint venture between ICOS Corp. and Eli Lilly and Co.)

Cialis

A PDE5 inhibitor

Erectile dysfunction

Clinical results indicated that Cialis improved men's ability to achieve erections 24 hours after taking the drug (5/1)

Neurocrine Biosciences Inc. (NBIX)

NBI-34060

Type I GABA, a receptor agonist; chemically distinct from benzodiazepines

Transient and chronic insomnia

Company completed enrollment in its Phase II trials (5/10)

NexMed Inc. (NEXM)

Femprox

Topical treatment

Female sexual arousal disorder

Company initiated a Phase II study (5/21)

Orphan Medical Inc. (ORPH)

Xyrem

Sodium oxybate; oral solution

Narcolepsy

Open-label trial indicated that Xyrem produced an overall improvement in both the quality and the integration of sleep (5/28)

Palatin Technologies Inc. (AMEX:PTN)

PT-141

Synthetic modification of PT-14, an analogue of a naturally occurring peptide hormone called alpha M.S.H.

Erectile dysfunction

Palatin completed a Phase I study in 56 volunteers; a maximum tolerated dose was not established (5/31)

TheraMed Inc. (subsidiary of
EntreMed Inc.;
ENMD)

ErythroMax

Red blood cell-enhancing therapeutic which replaces 2,3 DPG with Inositol Hexaphosphate

Infection, cardiovascular and cerebrovascular conditions

Company will begin a Phase I trial (5/17)

Transkaryotic Therapies Inc. (TKTX)

Replagal

Agalsidase alfa enzyme replacement therapy

Fabry disease

Phase II data indicated Replagal therapy reduced cardiac mass and corrected the metabolic defect of Fabry disease; the therapy also appeared safe and well tolerated (5/18)

Vivus Inc. (VVUS)

Alista

Topical formulation of alprostadil

Female sexual arousal disorder

Clinical results demonstrated the safety of a single dose applied topically (5/22)

XOMA Ltd.
(XOMA) and Genentech Inc. (NYSE:DNA)

Xanelim

Efalizumab

Psoriasis

Xanelim hit its primary endpoint of achieving a 75% or greater improvement in Psoriasis Area and Severity Index scores over placebo in two Phase III trials (5/24)


Notes:

* Denotes privately held company.

ASCO = The 37th Annual Meeting of the American Society for Clinical Oncology.

Unless otherwise noted, shares are traded on the Nasdaq market.

AMEX = American Stock Exchange; LSE = London Stock Exchange; NYSE = New York Stock Exchange; OTC BB = Over the Counter Bulletin Board; SWX = Swiss Stock Exchange; TSE = Toronto Stock Exchange

NEXT WEEK: Non-U.S. clinical trials and FDA actions in May.

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