Company*
(Country;
Symbol)

Product

Description

Indication

Status
(Date)


AUTOIMMUNE

Amgen Inc.
(AMGN)

Enbrel (FDA-
approved)

Etanercept; tumor
necrosis factor
inhibitor

Ankylosing spondylitis

Phase III data demonstrated that Enbrel produced a significant reduction in back pain and morning stiffness, as well as improvement in spinal mobility and physical function (6/19)

Amgen Inc.
(AMGN)

Enbrel (FDA-
approved)

Etanercept; tumor
necrosis factor
inhibitor

Rheumatoid arthritis

One-year clinical results of Enbrel with methotrexate showed that 80% of patients experienced no radiographic progression, compared to 68% of patients treated with Enbrel alone and 57% of methotrexate patients (6/20)

AtheroGenics
Inc.
(AGIX)

AGI-1067

Oral anti-
inflammatory
agent

Athero-
sclerosis

Company began enrolling patients in a Phase III trial (6/30)

Biogen Inc.
(BGEN)

Amevive (FDA-
approved)

Alefacept; novel immunomodulatory
agent that selectively targets the CD45RO+ subset of T cells

Psoriasis

Clinical data showed one 12-week course of Amevive administered via intramuscular injection provided a median duration of response of seven months (6/20)

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

Humira
(FDA-
approved)

Adalimumab; human monoclonal antibody; tumor necrosis factor
alpha

Rheumatoid arthritis

Phase III data showed the product is effective in patients with both early stage rheumatoid arthritis and established rheumatoid arthritis, with a trend toward higher efficacy in early stage patients (6/19)

Centocor Inc.
(unit of Johnson
& Johnson)
and Schering- Plough
Corp.

Remicade (FDA-
approved)

Infliximab; monoclonal antibody that specifically targets and irreversibly binds to TNF-alpha

Rheumatoid arthritis

Phase III data of Remicade plus methotrexate demonstrated a superiority to standard therapy of methotrexate (6/19)

Enzo Biochem
Inc.
(NYSE:ENZ)

--

A complex of antigens administered orally

Crohn's disease

Company initiated a Phase II trial (6/9)

Ester Neurosciences Ltd.* (Israel)

EN101

Antisense drug; lead compound in Ester's disease-modifying
platform technology for
the pre-expression
control of a specific
variant of the AchE
protein

Myasthenia gravis

Company began a second Phase Ib trial; results from the first trial showed the drug was safe and effective (6/16)

Labopharm Inc.
(Canada; TSE:DDS)

--

Once-daily version of the analgesic tramadol

Osteoarthritis

Company completed enrollment in two Phase III trials (6/11)

La Jolla
Pharmaceutical
Co.
(LJPC)

Riquent

B-cell toleragen; arrests
the production of antibodies to dsDNA without suppressing
healthy functions of the immune system

Lupus

Phase III data showed that lupus patients with sustained reductions in antibodies to double- stranded DNA reported improved health-relate quality of life and had a lower risk of major SLE flares compared with patients who did not have sustained reductions (6/16)

Serono SA
(Switzerland;
NYSE:SRA)

Onercept

Recombinant,
unmodified, fully human soluble type I TNF receptor (p55), which
acts as an anti-TNF
agent

Psoriasis

Phase II data showed that patients treated with a 150-mg subcutaneous dose of onercept three times per week showed a significant improvement in their psoriasis area and severity index score (6/23)

CANCER

Active Biotech
AB
(Sweden;
SSE:ACTI)

TTS CD2

Tumor-targeted super-antigens

Cancer

Phase IIa data showed that 40% of the evaluated patients had stable disease, while one patient had a partial response to treatment (6/4**)

Allos
Therapeutics
Inc.
(ALTH)

RSR13

Efaproxiral; synthetic
small molecule

Brain
metastases

Phase II data of RSR13 plus whole-brain radiation therapy resulted in a significant improvement in survival (6/17)

Allos
Therapeutics
Inc.
(ALTH)

PDX

10-propargyl-10-
deazaaminopterin

Non-small-cell lung cancer

Clinical data showed a median survival time of 13.5 months, with one- and two-year survival rates of 56% and 36%, respectively (6/30)

AltaRex Corp.
(TSE:AXO)

OvaRex

Oregovamab; immunotherapeutic;
a fully foreign
monoclonal antibody
that targets CA125

Ovarian cancer

Phase II data in a particular population showed a median time to disease relapse for OvaRex-treated patients was 24 months vs. 10.8 months for placebo-treated patient (6/2)#

Amgen Inc.
(AMGN)

Neupogen (FDA-
approved)

Filgrastim; a white blood cell booster

Non-Hodgkin's lymphoma

Clinical data showed patients who received chemotherapy on a dose-dense or every-two-week schedule along with recommended Neupogen administration experienced fewer infections than those who received a reduced administration of Neupogen (6/2)#

Amgen Inc.
(AMGN)

Palifermin

Recombinant human keratinocyte growth
factor (rHuKGF)
molecule

Mucositis

Data showed that palifermin compared to placebo significantly reduced the duration and incidence of severe oral mucositis in patients with hematolic malignancies undergoin high-dose chemotherapy, radiotherapy and total body irradiation followed by hematopoietic stem cell support (6/2)#

AnorMED Inc.
(Canada; TSE:AOM)

AMD-3100

Designed to block the CXCR4 chemokine receptor

Multiple myeloma and non-Hodgkin's lymphoma

Phase I data showed AMD-3100 administered alone mobilizes stem cells (6/16)

Antigenics Inc.
(AGEN)

AG-858

Vaccine; a
personalized
heat-shock protein 70

Chronic myelogenous leukemia

Seven of eight patients evaluated in a pilot study demonstrated responses (6/2)#

Antigenics Inc.
(AGEN)

Oncophage

Vaccine; uses heat-
shock proteins to
activate cellular
immune responses

Non-Hodgkin's lymphom and renal cell carcinoma

Phase II data showed Oncophage was associated with clinical and immunological response in both types of cancer (6/2)#

Aton
Pharma Inc.*

SAHA

Suberoylanilide
hydroxamic acid

Solid tumors, lymphomas myeloma and leukemias

Phase I data showed SAHA can induce antitumor responses of substantial durability (6/3)#

AVI BioPharma
Inc.
(AVII)

AVI-4126

Neugene antisense
drug targeting the oncogene c-myc

Breast and prostate cancer

Phase Ib data demonstrated the effectiveness of systemic drug delivery into solid tumor tissues (6/19)

Bioenvision
Inc.

Clofarabine

A second-generation nucleoside analogue

Acute myeloid leukemia

Phase I/II data of clofarabine with (OTC BB:BIOV) cytarabine showed the combination has activity in patients with acute myeloid leukemia (6/3)#; Phase II data showed an overall response rate of 28% for clofarabine in heavily pretreated children with acute leukemia (6/13)

Biomira Inc. (BIOM)

Theratope

Vaccine; synthetic carbohydrate-based
mimi of cancer antigen sialyl-Tnplus carrier molecule KLH

Metastatic
breast cancer

A Phase III trial failed to reach its two primary endpoints of time to disease progression and overall survival (6/17)

BioNumerik
Pharma-
ceuticals Inc.*

Karenitecin BNP1350

A member of a new class of lipophilic camptothecins; a silicon-containing
agent

Non-small-cell lung cancer

Phase II data showed the rates of partial response plus stable disease and median survival were similar to other agents considered active (6/3)#

BioVex
Ltd.*
(UK)

OncoVEX GM-CSF

Oncolytic virus that
delivers the gene for GM-CSF

Tumors

Phase I data showed that OncoVEX was well tolerated, caused tumor cells to secrete GM-CSF and induced tumor necrosis and inflammation (6/4**)#

Celgene Corp.
(CELG)

Revimid

A small-molecule com- pound that modulates the immune system

Gliomas and other refractory central nervous system malignancies, advanced malignant melanoma and refractory metastatic cancers

Phase I data demonstrated tolerability and potential clinical activity in solid tumor cancers (6/3)#

Cell Genesys
Inc.
(CEGE)

GVAX

Cancer vaccine

Multiple myeloma

Phase I/II data showed that combination therapy with transplantation and GVAX resulted in two complete responses, six partial responses, two patients with stable disease and one patient with progression (6/2)#

Celltech Group
plc
(UK; NYSE:CLL) and Bristol-Myers Squibb Co.

BMS-275291

A selective matrix metalloproteinas
inhibitor

Non-small-cell lung cancer

Bristol-Myers decided against further development after Phase II results showed the drug was unlikely to meet its efficacy endpoint (6/16)

Cell
Therapeutics
Inc.
(CTIC)

CT-2106

PG-CPT
(polyglutamate
camptothecin)

Colorectal cancer and small-cell lung cancer

Company will begin Phase I and Phase II studies of CT-2106 in combination with standard chemotherapy in colorectal cancer and as a single agent in small-cell lung cancer (6/10)

Cell
Therapeutics
Inc.
(CTIC)

Xyotax

Links paclitaxel, the
active ingredient in
Taxol, to a
biodegradable
polyglutamate
polymer

Ovarian cancer, mesotheliom and malignant schwannoma

Phase I data showed partial remissions in 30% of patients treated with Xyotax in combination with standard-dose cisplatin (6/3)#

Corixa Corp.
(CRXA) and GlaxoSmithKline
Biologials
(Belgium)

--

A HER-2/neu
vaccine consisting of
a protein with a
GSK adjuvant
system containing
Corixa's MLP
adjuvant

Breast cancer

Companies started a Phase I trial (6/3)

Corixa Corp.
(CRXA)

Bexxar (FDA-
approved)

Tositumomab and
iodine I-131

Non-Hodgkin's lymphoma

Clinical data showed patients had complete responses; many patients remained in remission five or more years after treatment (6/2)#

Dendreon Corp.
(DNDN)

Provenge

Therapeutic vaccine
that appears to delay tumor progression

Prostate cancer

Phase III data confirms that the underlying mechanism of action, a T-cell immune response, is consistent with the positive clinical response seen in patients (6/2); also, preliminary results from a Phase II trial showed that combination of Provenge and Genetech Inc.'s Avastin demonstrated evidence of decreasing PSA doubling time in men with androgen-dependent prostate cancer (6/2)#

Dendreon Corp.
(DNDN)

APC8024

Vaccine designed to
induce an immune
response against tumor cells that show
increased amounts
of the protein antigen Her-2/neu

Breast, colon and ovarian cancer

Phase I data showed the product is well tolerated, stimulates T-cell immunity and is continuing to show ongoing clinical benefit in patients with HER-2-positive breast cancer (6/2)#

Endo Pharma-
ceuticals
Inc.
(ENDP)

Oxy-
morphone

Extended-release opioid

Cancer pain

Phase III data showed that oxymorphone provided pain relief for patients with moderate to severe cancer pain equivalent to oxycodone controlled release at half the milligram dose (6/3)#

EntreMed Inc.
(ENMD)

Panzem

An orally available small-molecule drug candidate

Ovarian cancer

Phase I data showed Panzem was well tolerated and produced an objective response in a patient with ovarian cancer (6/2)#

Ethypharm SA*
(France)

--

5-fluorouracil
microspheres

Glioblastoma

Phase II data showed an overall survival improvement of three months in the patient group that had undergone complete resection of a tumor and was treated with the microspheres with radiotherapy (6/30)

Exelixis Inc.
(EXEL)

XL119

DEAE-
rebeccamycin
analogue

Bile duct
tumors

Phase II data showed encouraging results relative to overall and progression-free survival (6/2)#

Exelixis Inc.
(EXEL)

XL784

Small-molecule
compound

Cancer

Company initiated a Phase I trial (6/18)

FeRx Inc.*

MagneTarg

Drug delivery system

Primary liver cancer

Company began enrollment in a Phase II/III trial (6/2)#

Genaera Corp.
(GENR)

Squalamine

Angiogenesis inhibitor
that blocks a number
of angiogenic growth factors, including vascular endothelial growth factor

Non-small-cell lung cancer

Phase IIb data showed that 23% of 43 patients receiving the drug with carboplatin and paclitaxel experienced objective response, compared with a historical benchmark rate of 17% with the two chemotherapeutics alone (6/3)

Genentech Inc.
(NYSE:DNA)

Avastin

Bevacizumab; an
antibody directed at vascular endothelial
growth factor

Metastatic colorectal
cancer

Phase III data showed the study met its primary endpoint of improving overall survival, with patients getting the drug plus chemotherapy increasing their chance of survival by 50% compared to those given chemo alone (6/2)#

Genentech Inc. (NYSE:DNA), IDEC Pharma-
ceuticals
Corp. (IDPH) and F. Hoffmann-La Roche Ltd. (Switzerland)

Rituxan (FDA-
approved)

Rituximab;
monoclonal
antibody therapy

Chronic lymphocytic leukemia and small lymphocytic lymphoma

Clinical data showed Rituxan produced high response rates in previously untreated patients with CLL and SLL (6/2)#

Genentech Inc.
(NYSE:DNA)

Herceptin (FDA-
approved)

Trastuzumab; monoclonal antibody developed against the HER-2/neu protein

Breast cancer

Phase II data evaluating Herceptin in combination with Navelbine demonstrated thatpatients with HER2-positive early stage breast cancer can respond to treatment with Herceptin and chemotherapy regardless of their estrogen receptor status (6/2)#

Genentech Inc. (NYSE:DNA),
OSI
Pharma-
ceuticals
Inc. (OSIP) and Roche Holdings Inc.

Tarceva

Epidermal growth
factor receptor

Bronchiolo- alveolar cell carcinoma

Phase I/II data showed a 26% response rate in 50 patients (6/2)#

Genentech Inc. (NYSE:DNA),
OSI Pharma-
ceuticals
Inc. (OSIP) and Roche Holdings Inc.

Tarceva

Epidermal growth
factor receptor

Glioblastoma multiforme

Phase I data showed eight partial responses, three minor responses and 11 patients with stable disease out of 49 evaluable patients; rash and occasional diarrhea were reported as side effects (6/3)#

Genta Inc.
(GNTA)

Genasense

Oblimersen sodium; designed to inhibit production of Bcl-2

Mantle-cell lymphoma prostate cancer; other various cancers

Clinical data support the activity of Genasense as a single agent and in combination with chemotherapy (6/2); Phase II data of Genasense with Taxotere in hormone-refractory prostate cancer showed that 48% of patients achieved greater than 50% reduction in blood levels of prostate-specific antigen (6/3)#; company began four clinical trials: a Phase II in advanced kidney cancer; a Phase I/II in Waldenstrom's macroglobulinemia; a Phase I trial in advanced solid tumors and a Phase I in non-Hodgkin's lymphoma (6/26)

Genta Inc.
(GNTA)

Genasense

Oblimersen sodium

Advanced
breast cancer

Company initiated a clinical
trial (6/11)

GenVec Inc.
(GNVC)

TNFerade

Delivers the human
tumor necrosis factor-
alpha gene to tumors,
using GenVec's adenovector gene
delivery technology

Pancreatic cancer and soft tissue sarcoma

Phase II data showed TNFerade was well tolerated and that local control or stabilization was seen in 11 of 17 evaluable patients; the therapy also was well tolerated with no dose-limiting toxicity in soft tissue sarcoma (6/2)#

GPC Biotech
AG
(Germany; FSE:GPC)

Satraplatin

Member of the
platinum family of compounds

Prostate cancer

Clinical results demonstrated statistical significance in time to disease progression (6/3)#

GTx Inc.*

Acapodene

Toremifene

Prostate intraepithelial neoplasia

Phase II data showed Acapodene was well tolerated and significantly reduced high-grade prostate intraepithelial neoplasia (6/24)

Helsinn
Healthcare
SA*
(Switzerland)
and MGI Pharma
Inc.
(MOGN)

Palonosetron

HCl injection; Aloxi

Cancer

Phase III data showed the complete response rate of patients receiving palonosetron was significantly greater than the complete response rate among patients receiving ondansetron and dolasetron (6/19)

IDEC
Pharma-
ceuticals
Corp.
(IDPH)

Zevalin
(FDA-
approved)

Ibritumomab tiuxetan; monoclonal antibody
linked to the radio-
isotope Yttrium-90
that targets the CD20 antigen on the surface
of mature cells and
B-cell tumors

B-cell non-Hodgkin's lymphoma

Clinical results showed Zevalin produced complete and enduring responses in a subset of patients; it also showed that Zevalin is assocated with higher response rates and longer durations of response when used before multiple courses of chemotherapy (6/3)#

Igeneon*
(Austria)

IGN101

An antibody-based product; vaccine

Epithelial
cancers

Phase II data showed that the vaccine retained an immune response despite concomitant chemotherapies (6/3)#

ILEX Oncology
Inc.
(ILXO)

Clofarabine

A second-generation nucleoside analogue

Acute
leukemia

Phase II data showed the overall response rate was 28% (6/2)#

ILEX Oncology
Inc.
(ILXO)

ILX-651

Synthetic pentapeptide analogue of dolastatin

Advanced refractory solid tumors

Phase I data showed ILX-651 appears to be biologically active at tolerable doses (6/2)#

Inex Pharma-
ceuticals Corp.
(Canada;
TSE:IEX)

Onco TCS

Liposomal version of
the widely used agent vincristine

Non-Hodgkin's lymphoma

Phase II/III data show an overall response rate of 25%, including seven patients whose tumors were completely eliminated and 23 whose tumor volume was reduced by more than 50% (6/25)

Introgen
Therapeutics
Inc.
(INGN)

Advexin

p53 gene therapy

Bronchoalveolar lung carcinoma

Phase I data showed the drug is safe and had evidence of therapeutic activity (6/3)#

Introgen
Therapeutics
Inc.
(INGN)

INGN 241

Mda-7 therapeutic; a modified adenoviral
vector that carries the cancer-killing mda-7
gene

Metastatic melanoma

Clinical data showed that a cancer patient had regression of multiple tumors including a complete regression of one lesion after treatment with INGN 241 (6/4)#

Introgen
Therapeutics
Inc.
(INGN)

INGN 241

A modified adenoviral vector that carries the cancer-killing mda-7 gene

Solid tumors

Phase I data showed the product was well tolerated and had biologically active with minimal toxicities (6/6)

Isis Pharma-
ceuticals Inc.
(ISIS)

ISIS 2503

An antisense agent targeting Ha-ras

Pancreatic cancer breast cancer

Phase II data showed six-month survival was achieved with 57.5% of patients, with a median survival of 6.6 months; the overall response rate was 10% (6/3); a trial with 26 breast cancer patients showed a response rate of 54% (6/3)#

Ligand Pharma-
ceuticals Inc.
(LGND)

Ontak (FDA-
approved)

Denileukin diftitox

Fludarabine- refractory chronic lympho-cytic leukemia

Phase II data showed Ontak might benefit patients by combating the disease in blood, lymph nodes and bone marrow (6/2)#

Maxim Pharma-
ceuticals Inc.
(MAXM)

Ceplene

Histamine
dihydrochloride

Advanced metastatic melanoma

Phase III data showed survival was achieved without adversely affecting quality of life (6/12)

Medarex Inc.
(MEDX)

MDX-010

A fully human
antibody against
human CTLA-4,
a molecule on T cells

Melanoma

Phase II data showed an objective response rate of 21%, which included two complete tumor responses (6/25)

MethylGene Inc.*
(Canada)

MG98

A second-generation antisense compound designed to inhibit the expression of DNA methyltransferase, an enzyme implicated in
tumor growth

Head and neck cancer

Phase II data showed that general demethylation was observed post-MG98 treatment including on some tumor suppressor genes or genes implicated in some cancers (6/3)#

MGI Pharma
Inc.
(MOGN)

Palonosetron

Differentiated 5-HT3 receptor antagonist

Nausea and vomiting due to chemotherapy

Phase III data showed that the complete response rate for patients in the 0.25-mg palonosetron arm was significantly greater than the complete response rate among patients who received 32 mg of ondansetron (6/2)#

Millennium Pharma-
ceuticals
Inc.
(MLNM)

Velcade (FDA-
approved)

Blocks the proteasome,
an enzyme complex involved in degrading proteins that control
cellular processes

Non-Hodgkin's lymphoma non- small-cell lung cancer, renal cancer and other cancers

Phase I and Phase II data showed early signs of antitumor activity with Velcade as a single agent and used in combination with other therapies (6/2)#

NeoRx Corp.
(NERX)

Skeletal
Targeted
Radiotherapy

Designed to deliver
high doses of radiation
to tumor sites
throughout the skeleton with minimal damage
to organs outside the bone, targeting bone
and adjacent marrow with small-molecule agent DOTMP, combined with the radionuclide holmium-166

Multiple myeloma

Phase I/II data demonstrated an overall response rate of 64%, including a complete response rate of 35% (6/2)#

Onyx Pharma-
ceuticals
Inc.
(ONXX) and Bayer Pharma-
ceuticals Corp.
(division of Bayer AG; Germany)

BAY 43-9006

A RAF kinase
inhibitor

Tumors

Phase I data showed safety and antitumor activity (6/2)#

Pharmacyclics
Inc.
(PCYC)

Xcytrin

Motexafin gadolinium injection

Glioblastoma multiforme

Phase I data of Xcytrin plus radiation therapy suggested a survival benefit in favor of Xcytrin (6/3)#

PharmaMar*
(Spain)

ES-285

Derived from the edible Arctic clam, Mactromeris polynyma

Solid tumors

Company entered Phase I trials (6/19)

Protein Design
Labs Inc.
(PDLI)

--

Anti-a5B1 integrin antibody

Solid tumors

Company initiated a Phase I trial (6/2)

Seattle Genentics
Inc. (SGEN)

SGN-30

Monoclonal antibody

Hematologic malignancies

Phase I data showed SGN-30 was safe with a favorable pharmacokinetic profile (6/2)#

Seattle Genetics
Inc.
(SGEN)

SGN-15

cBR96-doxorubicin immunoconjugate; antibod drug conjugate product candidate

Non-small-cell lung cancer

Phase II data of SGN-15 in combination with Taxotere showed improved disease control rates and progression-free survival compared to Taxotere alone (6/2)#

Spectrum
Pharma-
ceuticals

Inc.
(SPPI)

Eoquin

Bioreductive prodrug, activated by reducing enzymes to form the active alkylating agent

Bladder cancer

Each of the first five patients experienced a complete response in a clinical trial (6/11)

SuperGen Inc.
(SUPG)

Dacogen

Decitabine for injection

Dacogen

Company began a Phase II trial of Dacogen in combination with Gleevec (6/13)

SuperGen Inc.
(SUPG)

Nipent

Pentostatin for injection

Chronic lymphocytic leukemia

Phase II data of Nipent in combination with cyclophosphamid and rituximab showed it was active and well tolerated (6/3)#

SuperGen Inc.
(SUPG)

Orathecin

Rubitecan capsules;
oral topoisomerase I-inhibiting chemotherapeutic compound

Pancreatic cancer

Phase III data showed the primary endpoint of overall survival was not met, while both secondary endpoints of tumor response and time to disease progression were achieved (6/2)#

Telik Inc.
(TELK)

Telcyta (TLK286)

A small-molecule anti- tumor drug that is activated by GST-P1-1

Metastatic breast cancer, non-small-cell lung cancer and ovarian cancer

Phase II data were positive (6/2)#

Titan Pharma-
ceuticals Inc.
(AMEX:TTP)

Pivanex

Acts by inhibiting enzymes called histone deacetylases

Non-small-cell lung cancer

Company initiated a Phase IIb trial (6/30)

Transgene
SA
(France;
TRGNY)

Ad-IFN
gamma

Uses an improved version of Transgene's adenovirus vector carrying the interferon gamma gene

Primary cutaneous lymphoma

Phase I/II data showed the product was well tolerated and that there were clinical responses both locally and at distant sites, for an overall response rate of 60% (6/11)

Vion Pharma-
ceuticals
Inc.
(VION)

VNP-
20009

Tapet vector used to deliver anticancer agents directly to tumors

Advanced solid tumors or lymphomas

Company ended the Phase I trial to focus its financial resources elsewhere (6/13)

Vion Pharma-
ceuticals

Inc. (VION)

VNP-
40101M

DNA alkylating agent

Leukemia

Phase I data showed a complete response in a patient with myelo-dysplasia and significant reduction or elimination of marrow blasts at the end of the first cycle in five patients (6/3)#

YM BioSciences Inc. (Canada; TSE:YM_pb; LSE: YM_pb)

Norelin

Therapeutic cancer vaccine targeting the gonadotropin-releasing hormone

Prostate cancer

Clinical data showed the vaccine was well tolerated, with no major adverse events reported (6/13)

YM BioSciences Inc. (Canada; TSE:YM_pb; LSE: YM_pb)

TheraCIM
h-R3

A humanized monoclonal antibody

Head and neck cancer

Phase I/II data demonstrated a complete tumor response in nine of 12 patients who received 200 mg, and eight of 12 patients who received 100 mg, given once weekly for six weeks with standard radiation therapy (6/10)

CARDIOVASCULAR

Agenix Ltd.
(Australia; ASX:AGX)

Thrombo-
View

Blood clot-detection technology

Blood clots

Company completed a Phase Ia trial that showed it was well tolerated with no serious side effects (6/17)

Discovery Laboratories Inc. (DSCO)

Surfaxin

Humanized,
synthesized peptide containing surfactant

Respiratory distress
syndrome

Clinical data showed Surfaxin was statistically equivalent to Curosurf regarding the endpoint of the number of living patients with no bronchopulmonary dysplasia at 28 days of age, and it demonstrated a roughly 14% relative difference in favor of Surfaxin (6/5)

Endovasc Inc.
(OTC BB:ENDV)

Liprostin

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

Peripheral artery occlusive disease

Phase II data showed the first angioplasty case using Liprostin was successfully performed (6/16)

Esperion
Therapeutics
Inc. (ESPR)

ETC-216

ApoA-1 Milano
product

Acute coronary syndromes

Phase II data showed the study met its primary efficacy objective of demonstrating statistically significant regression of atherosclerosis (6/26)

Esperion
Therapeutics
Inc. (ESPR)

ETC-642

RLT peptide

Cardiovascular disease

Company began a Phase I trial (6/30)

Hemosol Inc.
(HMSL)

Hemolink

Hemoglobin raffimer; blood substitute

Patients undergoing cardiac bypass grafting surgery

Hemosol completed an internal review of the halted trial, confirming the conclusions of a data and safety monitoring board concerning adverse events (6/13)

Nuvelo Inc.
(NUVO)

Alfimeprase

A modified fibrolase that directly degrades fibrin when delivered through a catheter at the site of a blood clot

Catheter
occlusion

Company initiated dosing in a Phase II trial (6/5)

Sunol Molecular Corp.*

Sunol-cH36

A chimeric recombinant antibody

Coronary
artery disease

Company began a Phase I trial (6/18)

Valentis Inc.
(VLTS)

Del-1

Angiogenesis product

Peripheral
arterial disease

Phase I data showed there were no observed severe adverse events from the drug and Del-1 was well tolerated (6/9)

XOMA Ltd.
(XOMA)

MLN2201

A humanized monoclonal antibody

Conditions related to inflammation of the heart and blood vessels

Company initiated a Phase I trial (6/19)

CENTRAL NERVOUS SYSTEM

Altea
Therapeutics
Corp.*

ATI022

A hydromorphone skin patch designed to deliver an opiate

Severe pain

Company began a Phase I trial (6/3)

Axonyx Inc.
(AXYX)

Phenserine

Acetylcholinesterase and beta-APP inhibitor

Alzheimer's disease

Company initiated the first trial in its planned Phase IIb/Phase III program (6/2)

Boston Life
Sciences Inc.
(BLSI)

Altropane

Radioimaging agent

Parkinson's disease

Company plans to conduct an additional Phase III trial (6/17)

Durect Corp.
(DRRX)

--

Post-operative pain-relief depot product, a sustained- release injectable using the Saber delivery system and a local anesthetic

Pain

Company began clinical testing (6/10)

Forest Laboratories Inc. (NYSE:FRX) and Neurobiologic l Technologies Inc. (NTII)

Memantine

Moderate-affinity N-methyl D-aspartate recepto antagonist

Alzheimer's disease

Clinical data of Memantine administered to patients receiving acetylcholinesterase inhibitor therapy failed to demonstrate statistically significant differences on cognitive or global outcomes vs. placebo/actylcholin-esterase treatment (6/19)

Metaphore Pharma-
ceuticals Inc.*

M40403

Small molecule that mimics the activity of superoxide dismutase

Dental pain

Phase IIa data showed that statistically significant pain relief was achieved compared to placebo (6/13)

Myriad Genetics Inc. (MYGN)

MPC-7869

R-flurbiprofen

Alzheimer's disease

Company began enrollment in a Phase II trial (6/25)

Neurochem Inc. (Canada; TSE:NRM)

Alzhemed

A small sulfonated molecule that has been specifically designed to interfere with the association of glycosaminoglycans with the amyloid beta amyloidogenic protein

Alzheimer's disease

Phase II data showed promising results relative to primary and secondary objectives (6/23)

NeuroSearch A/S (Denmark;
CSE:NEUR) and
Abbott Laboratories

ABT-202

Ion channel
modulator

Pain

Company initiated a Phase I trial (6/10)

NeuroSearch A/S (Denmark; CSE:NEUR) an Boehringer Ingelheim GmbH (Germany)

NS2330

Inhibits re-uptake of
the three neurotransmitters: serotonin,
noradrenaline and dopamine

Parkinson's disease

Companies initiated a Phase II trial (6/16)

NicOx SA
(France; Nouveau Marche:NICOX)

NCX 701

Nitric oxide-releasing derivativ of paracetamol (acetaminophen)

Dental pain

Phase II data showed NCX 701 reached all primary endpoints with respect to analgesic efficacy and safety (6/18)

Orphan Medical
Inc.
(ORPH)

Xyrem (FDA-
approved)

Sodium oxybate oral solution

Excessive daytime sleepiness associated with narcolepsy

Patient enrollment began for a second Phase IIIb trial (6/3)

Pain Therapeutics
Inc.
(PTIE)

Oxytrex

A combination of immediate-release oxycodone and low-dose naltrexone

Chronic pain

Company began a pivotal Phase III trial (6/30)

Pozen Inc.
(POZN)

MT 300

An injectable dihydroergotamine mesylate compound

Migraine pain

Phase III demonstrated that MT 300 is effective in providing sustained pain relief (6/23)

SkyePharma plc
(UK; LSE:SKP; SKYE)

Depo-
Morphine

Sustained-release morphin formulation using SkyePharma's DepoFoam injection technology

Pain

Phase III data showed sustained dose-related analgesia and superiority over study comparators in terms of total demand for opioid analgesics after surgery, meeting its primary endpoint; it also achieved statistical significance on several secondary endpoints (6/11)

DIABETES

Amylin Pharma-
ceuticals
Inc.
(AMLN)

Exenatide

Synthetic exendin-4

Type II
diabetes

Phase III data showed that 63 patients completing five months of treatment with exenatide had a 1.4% reduction in HbA1c, accompanied by a 2.4-kilogram reduction in body weight (6/2)

Auxilium
Pharma-
ceuticals Inc.*

Testim

Testosterone gel

Hypogonadism
in men with diabetes

Clinical data showed men had significant improvements in sexual performance and lean body mass, as well as a decline in glucose levels (6/23)

Avanir Pharma-
ceuticals
Inc. (AMEX:AVN)

Neurodex

An orally administered combination of dextromethorphan and quinidine sulfate

Diabetic neuropathy

Clinical results of 36 patients showed that Neurodex was well tolerated and patients reported decreased pain intensity that was significantly different from baseline (6/13)

ConjuChem Inc. (Canada; TSE:CJC)

DAC:GLP-1

An insulinotropic hormone that is a naturally occurring 30-amino-acid peptide; uses DAC technology

Type II
diabetes

Phase I/II data showed the compound was well tolerated with no serious adverse events and no injection-site irritation (6/11)

Emisphere Technologies Inc. (EMIS)

--

Orally delivered eligen technology

Type II
diabetes

Clinical data showed the technology induced clinically relevant activity in Type II diabetes (6/16)

Generex Biotechnology Corp. (Canada; GNBT)

Oralin

Oral insulin spray

Type I and
Type II
diabetes

Company will begin Phase IIb studies (6/2)

Nektar
Therapeutics

(NKTR)

Exubera

Inhaled insulin

Type II diabetes

Phase III data suggested Exubera might provide acceptable glycemic control to significantly more subjects than rosiglitazone in Type II diabetes patients not optimally controlled on diet and exercise (6/16)

Thera-
technologies
Inc.
(Canada;
TSE:TH)

P2-354

ThGRF; growth hormone-releasing factor analogue-using Macroflux transdermal patch technology

Type II diabetes

Clinical results showed ThGRF can be administered for 12 weeks with a very good safety profile (6/20)

INFECTION

Cubist Pharma-
ceuticals
Inc.
(CBST)

CAB-175

Parenteral cephalosporin
antibiotic

Gram-positive and Gram-negative bacterial infections

Company began a Phase I trial (6/24)

DepoMed Inc. (AMEX:DMI)

Ciprofloxacin
GR

Newer formulation of Cipro using
DepoMed's Gastric Retention System technology;
an antimicrobial

Urinary tract infection

Company started a Phase III trial (6/3)

Hollis-Eden Pharmaceuticals Inc. (HEPH)

Immunitin

Immune-regulating hormone

HIV

Phase II data showed that AIDS patients experienced a statistically significant reduction in the total number of all opportunistic infections compared to placebo (6/23)

ID Biomedical Corp. (Canada; IDBE; TSE:IDB)

FluINsure

An intranasal, non-live influenza vaccine

Influenza

Phase II data showed the drug has strong immunogenicity (6/16)

InterMune Inc. (ITMN)

Oritavancin

Second-generation glycopeptide antibiotic

Skin/skin- structure infections

Phase III data showed the drug achieved its primary efficacy endpoint, demonstrating that oritavancin was as effective as the comparator regimen of vancomycin followed by cephalexin (6/13)

Medarex Inc. (MEDX)

MDX-010

A fully human anti-CTLA-4 antibody

HIV

Company began a Phase I trial (6/11)

NeuTec Pharma
plc
(UK; LSE:NTP)

Aurograb

A recombinant antibody based on natural antibodies isolated from patients who recovered from MRSA

Staphylococcus aureus

Phase IIb data showed the drug was well tolerated and demonstrated a profile that suggested activity against methicillin-resistant Staphylococcus aureus (6/18)**

Pharmasset Inc.*

Reverset

A nucleoside analogue that retains activity against 3TC- and AZT-resistant HIV-1
in vitro

HIV

Phase I data showed that HIV-1 viral load was reduced by a mean of about 40% for all dose levels (6/11)

Stressgen Biotechnologies Corp. (Canada; TSE:SSB)

HspE7

Immunotherapeutic to treat diseases caused by the human papillomavirus

Recurrent respiratory papillomatosis

Phase II data showed a statistical- ly significant 78.6% difference re- ated to the primary endpoint, a reduction in the number of surgeries (6/10)

MISCELLANEOUS

Adolor Corp. (ADLR)

Alvimopan

Small-molecule opioid receptor antagonist

Postoperative ileus

Company completed enrollment in a Phase III trial (6/5)

Alkermes Inc. (ALKS)

Vivitrex

Once-monthly injection; a formulation of naltrexone based on Alkermes' Medisorb injectable

Alcohol dependence

Phase II data showed that patients treated with Vivitrex in combination with psychosocial therapy experienced a 50% reduction in heavy drinking days compared to patients receiving placebo injections in combination with psychosocial therapy (6/23)

AnorMED Inc. (Canada; TSE:AOM)

Fosrenol

Lanthanum carbonate; phosphate binder

End-stage renal disease

Clinical data showed Fosrenol sustained efficacy and a good safety profile during three years of treatment (6/10)

Arriva Pharma-
ceuticals
Inc.*

rAAT

Recombinant alpha 1- antitrypsin

Middle ear disease

Clinical data showed the high level of neutrophil elastase in the exudates could be neutralized using Arriva's rAAT (6/5)

Atrix Laboratories Inc. (ATRX)

Atrisone

5% dapsone topical
gel

Acne

Company completed enrollment in a Phase III trial (6/2)

Cellegy Pharmaceuticals Inc. (CLGY)

Tostrelle

Testosterone gel

Sexual dysfunction

Phase II data on women showed a 71% response rate vs. a 13% placebo response rate (6/19)

Chiron Corp.
(CHIR)

TOBI

Tobramycin solution for inhalation

Cystic fibrosis

Clinical data showed that patients undergoing TOBI treatment in conjunction with routine care were less likely to be hospitalized for respiratory symptoms or to be treated with oral antibiotics than those getting routine care alone (6/4)

CollaGenex
Pharma-
ceuticals
Inc. (CGPI)

Periostat (FDA-
approved)

Doxycycline hyclate tablets

Rosacea

Phase II data showed the combination of Periostat and Metro- Lotion resulted in significantly fewer inflammatory lesions among rosacea patients than those on placebo (6/24)

Connetics Corp. (CNCT)

Actiza

Formulation of 1% clindamycin delivered in Connetics' foam delivery system

Acne

Company completed enrollment in a Phase III trial (6/5)

Copernicus Therapeutics Inc.*

--

Compacted DNA formulation

Cystic fibrosis

Phase I/II data showed that the formulation partially restored chloride channel function in the nasal epithelial cells of human subjects (6/13)

Enhance Biotech Inc. (OTC BB:EBOI)

LIF-301

Compound affects dis- turbed or maladaptive 5-HT2C receptor properties in specific brain areas

Premature ejaculation

Company completed enrollment in a Phase IIa trial (6/6)

Insmed Inc.
(INSM)

rhIGF-
1/rhI-
GFBP-3

Hormone replacement therapy

Growth hormone insensitivity syndrome

Clinical results showed the drug safely normalized serum levels of insulin-like growth factor-1 in children; there were no adverse events (6/20); company began a Phase III trial (6/23)

Isotechnika Inc. (Canada; TSE:ISA)

ISA247

Immunosuppressive drug

Kidney
transplant

Phase IIa data showed the drug was well tolerated and efficacious as the study met all of its primary and secondary endpoints (6/4)

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

Cialis

Tadalafil oral treatment

Erectile dysfunction

Clinical data showed a majority of men who took Cialis reported a successful intercourse attempt at 24 or 36 hours later (6/5)

MacroChem
Corp.
(MCHM)

Topiglan

Topical drug; 1% alprostadil and 5% Sepatopical formulation

Erectile dysfunction

Company will begin enrolling pat- ients this month in an efficacy trial (6/2)

Nastech
Pharma-
ceutical Co.
Inc.
(NSTK)

--

Intranasal apomorphine hydrochloride

Erectile dysfunction

Company began a Phase II trial (6/4)

NexMed Inc. (NEXM)

Alprox-TD

Cream; incorporates alprostadil with the company's NexACT transdermal delivery technology

Erectile dysfunction

Phase III data showed the three dose levels were effective over placebo (6/13)

Procyon Biopharma Inc. (Canada; TSE:PBP)

Fibrostat

Topical cream

Excessive scarring

Company began a Phase IIb trial (6/13)

Serono SA (Switzerland; NYSE:SRA)

Emfilermin

r-hLIF; a protein growth factor naturally produced

Recurrent implantation failure

Clinical data showed improved embryo implantation (6/30)

Targeted
Genetics
Corp.
(TGEN)

tgAAVCF

Gene therapy product that uses an adeno-associated virus vector delivery system

Cystic fibrosis

Phase II data showed tgAAVCF met its primary endpoint demonstrating safety and tolerability in the repeat-dosing study (6/5)

Titan Pharma-
ceuticals
Inc. (AMEX:TTP)

Probuphine

Delivers buprenorphine

Opiate
addiction

Company initiated clinical testing (6/19)

Transgene SA (France; TRGNY)

--

Gene transfer involving the administration of a plasmid containing the human dystrophin gene

Duchenne/ Becker's muscular dystrophy

Phase I data demonstrated that it is possible to obtain local expression of dystrophin following the administration of a plasmid containing the human dystrophin gene, without any detectable immune reaction (6/6)

Xenova Group plc (UK; XNVA)

TA-CD

Anti-cocaine addiction vaccine

Cocaine dependence

Phase IIa data showed the vaccine to be safe and well tolerated (6/17)


Notes:

* Privately held

** Denotes the date the item ran in BioWorld International.

# Clinical news reported at the American Society of Clinical Oncology meeting in Chicago.

Unless otherwise noted, the stock symbols listed for public companies are on the Nasdaq market.

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