Company*
(Country; Symbol)

Product

Description

Indication

Status (Date)


AUTOIMMUNE

Abgenix Inc.
(ABGX)

ABX-IL8

Monoclonal antibody that blocks interleukin-8

Psoriasis

ABX-IL8 failed in a Phase IIb trial to meet its primary endpoint of improvement in PASI scores (5/14)

Celltech plc
(UK; NYSE:CLL)

CDP 870

Antibody drug administered by monthly injection

Crohn's disease

A pilot study with 92 patients showed that 47% of patients treated with a single infusion achieved remission, compared with 20% in the placebo group (5/29**)

Centocor Inc. (subsidiary of Johnson & Johnson)

Remicade (FDA-approved)

Infliximab; a monoclonal antibody that specifically targets and irreversibly binds to TNF-alpha on the cell membrane in the blood

Crohn's disease

A study showed sustained use of infliximab could benefit sufferers of Crohn's disease (5/2)

Cyanotech Corp.
(CYAN)

BioAstin

Formulation of the micro- algae Haematococcus pluvialis, which contains high levels of astaxanthin

Rheumatoid arthritis

A clinical trial showed BioAstin significantly reduced joint pain and improved physical performance in rheumatoid arthritis patients (5/22)

Genmab A/S (Denmark; CSE:GEN)

HuMax-IL15

Fully human antibody

Rheumatoid arthritis

Company completed enrollment in a Phase I/II study (5/30)

Immunex Corp.
(IMNX)

Enbrel (FDA-approved)

Etanercept; tumor necrosis factor inhibitor

Ankylosing spondylitis

A study showed the drug can help ease the symptoms of ankylosing spondylitis (5/2)

Protein Design Labs Inc. (PDLI)

Smart Anti- Gamma Interferon

Antibody

Crohn's disease

Company began a Phase II trial (5/8); Phase I/II results showed 50% of patients taking the lowest dose responded and none had a remission, 67% taking the 1.0 mg/ kg dose responded and 25% had a remission, and 71% taking the highest dose responded and 50% had a remission (5/22)

Serono SA (Switzerland; NYSE:SRA)

Rebif (FDA-approved)

Interferon-beta-1a

Rheumatoid arthritis

A Phase II study was discontinued after it demonstrated that IFN-beta-1a did not provide additional benefit over methotrexate (5/28)

CANCER

Abgenix Inc.
(ABGX)

ABX-EGF

A fully human monoclonal antibody against the epidermal growth factor receptor

Solid tumors

Phase I data showed it was generally well tolerated at doses up to 3.5 mg/kg (5/20); Phase II results suggest it has antitumor activity as a single-agent treatment for patients with advanced kidney cancer (5/22)

AEterna Laboratories Inc. (Canada; AELA; TSE:AEL)

Neovastat

Activated apoptosis of endothelial cells; also inhibits matrix metalloproteinase and vascular endothelial growth factor

Renal cell carcinoma

A Data Safety Monitoring Board said a planned safety analysis of two Phase III trials was completed and that the trials could continue with no adjustments (5/21)

Allos Therapeutics Inc. (ALTH)

RSR13

Efaproxiral; a synthetic small molecule that increases the release of oxygen from hemoglobin

Brain metastases

A Data Safety Monitoring Board recommended that the pivotal Phase III trial for the treatment of patients with brain metastases receiving radiation therapy continue; interim analysis for efficacy encompassed the first 344 randomized patients; Allos intends to complete patient accrual in 2H:02, conduct a six-month follow-up and file a new drug application in 2H:03 (5/31)

Allos Therapeutics Inc. (ALTH)

RSR13

Efaproxiral; a synthetic small molecule that increases the release of oxygen from hemoglobin

Non-small-cell lung cancer

Phase II results showed a median survival of 20.6 months, a one-year survival rate of 67% and an estimated two-year survival rate of 35% (5/20)

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

OvaRex

Oregovomab; a fully foreign monoclonal antibody that targets CA125

Ovarian cancer

Final results of a 345-patient study in Stage III/IV ovarian cancer showed patients with optimal surgical debulking and sensitivity to platinum chemotherapy are most likely to achieve clinical benefit from OvaRex treatment in the adjuvant setting following front-line treatment (5/21)

American Pharmaceutical Partners Inc.*

ABI-007

A protein-engineered nanoparticle form of paclitaxel

Metastatic breast cancer

Phase II results showed an 88% first-line response rate in meta- static breast cancer, and a 61% overall response rate (5/20)

Anosys Inc.*

Dexosome

Acellular anticancer dexosomes

Non-small-cell lung cancer

Clinical results showed three of seven immunized patients achieved prolonged disease stabilization (5/20)

Antigenics Inc. (AGEN)

Oncophage

Vaccine; uses heat shock proteins to activate cellular immune responses

Metastatic melanoma, gastric and colorectal cancers

Company enrolled the first patient in a pivotal Phase III trial (5/2); Phase I and II trials showed patients treated with Oncophage experienced clinical and immunological responses (5/21)

Aphton Corp. (APHT)

G17DT

Antigastrin immunogen

Stomach cancer

Phase II results of 36 patients treated with G17DT and chemotherapy showed one patient had a complete response and 18 had a partial response, with 11 others having stable disease (5/20)

AVI BioPharma
Inc. (AVII)

Avicine

A therapeutic vaccine that blocks human chorionic gonadotropin

Pancreatic cancer

Company plans to initiate a Phase III trial (5/2); Phase II results showed patients treated with Avicine and gemcitabine had a significantly improved one-year survival rate of 30% (5/21)

Bioniche Life Sciences Inc. (Canada; TSE:BNC)

Urocidin

A formulation containing mycobacterial cell wall-DNA complex prepared from Mycobacterium phlei

Refractory bladder cancer

Phase II results showed 36% of 23 evaluable patients remained disease-free after one year and 12% achieved a partial response (5/28)

BioNumerik Pharmaceuticals Inc.* and Grelan Pharmaceutical Co. Ltd. (Japan)

BNP7787

Small-molecule chemoprotectant

Advanced non-small-cell lung cancer

Phase I results showed no severe nerve damage, and nine of the 21 patients experienced a partial tumor remission after two cycles of treatment with BNP7787 and paclitaxel and cisplatin (5/21)

Bio-Technology General Corp. (BTGC)

Oxandrolone

Oral synthetic derivative of testosterone

Cancer-related weight loss

Clinical results showed 81% of patients gained or maintained weight during the first two months (5/21)

Celgene Corp. (CELG) and Pharmacia Corp.

Thalomid

Thalidomide; modulates levels of tumor necrosis factor alpha

Metastatic colorectal cancer

Phase II results showed that of 20 evaluable patients, two experienced a complete response, four experienced a partial response and five had stable disease; companies initiated a Phase II/III study (5/20)

Celgene Corp. (CELG)

Thalomid

Thalidomide; modulates levels of tumor necrosis factor alpha

Prostate cancer

Clinical data showed 37% of patients treated with docetaxel and 51% in a combination arm of Thalomid and docetaxel achieved a prostate-specific antigen decline of more than 50% (5/22)

Cell Genesys Inc. (CEGE)

GVAX

Cancer vaccine; immunotherapeutic comprising irradiated and genetically modified tumor cells that secrete granulocyte macrophage-colony stimulating factor

Prostate cancer

Phase II results showed seven of 10 patients receiving the higher dose level of the vaccine were alive 2.5 years after treatment, and nine of 22 patients receiving the lower dose were alive 2.5 years after treatment (5/20)

Cell Genesys
Inc.
(CEGE)

GVAX

Cancer vaccine; immunotherapeutic comprising irradiated and genetically modified tumor cells that secrete granulocyte macrophage-colony stimulating factor

Pancreatic cancer

Company initiated a Phase II trial in patients with inoperable or metastatic pancreatic cancer (5/29)

Cell Pathways
Inc.
(CLPA)

Aptosyn

Exisulind; first-generation selective apoptotic antineoplastic drug

Prostate cancer and precancerous adenomatous colon polyps

Phase I data showed the safety of Aptosyn in combination with carboplatin and docetaxel, carboplatin and paclitaxel, and with gemcitabine; other results showed Aptosyn treatment continued to increase prostate-specific antigen doubling time during a 24-month time period with manageable toxicity (5/20); daily treatment with Aptosyn significantly reduced the size of precancerous adenomatous polyps and prevented further polyp growth (5/22); Phase II/III results demonstrated benefits for men at high risk of prostate cancer recurrence, with median prostate-specific antigen doubling times increasing from 5.6 months to 12.6 months at 24 months (5/28)

Cell Therapeutics
Inc.
(CTIC)

Trisenox (FDA-approved)

Arsenic trioxide injection

Refractory acute promyelocytic leukemia

Company said preliminary findings indicate that Trisenox was well tolerated in children at doses that induce complete remission (5/23)

Cell Therapeutics
Inc.
(CTIC)

Xyotax

Polyglutamate paclitaxel; a new-generation taxane

Chemotherapy- refractory metastatic colorectal cancer

Phase II results showed encouraging disease control rates (5/8)

Cell Therapeutics
Inc.
(CTIC)

Xyotax

Polyglutamate paclitaxel; a new-generation taxane

Non-small-cell lung cancer

Company is continuing a Phase II trial based on a review of interim results of the study (5/14)

Cell Therapeutics
Inc.
(CTIC)

Xyotax

Polyglutamate paclitaxel; a new-generation taxane

Recurrent ovarian cancer

Phase I/II results of 88 patients showed Xyotax may offer clinical benefit compared to standard chemotherapies, as antitumor responses were observed (5/20)

DUSA Pharmaceuticals Inc. (DUSA)

Levulan

Photodynamic therapy

Barrett's esophagus

Phase I/II results showed eight of 17 patients were clear of high-grade dysplasia or early cancer at an eight-month follow-up (5/24)

EntreMed Inc. (ENMD)

Angiostatin

Subcutaneous antiangiogenic

Cancer

Angiostatin, when combined with radiation therapy, was safe with no dose-limiting toxicity in patients with cancers that require radiation therapy (5/20)

EntreMed Inc. (ENMD)

Endostatin

Naturally occurring angiogenesis inhibitor

Metastatic melanoma

Company began a Phase II trial in which patients will receive Endostatin alone or in combination with interferon-alfa-2b (5/28)

EntreMed Inc. (ENMD)

Panzem

An orally available small-molecule drug candidate

Prostate cancer

Phase II results showed Panzem demonstrated anticancer activity with disease stablization and declining prostate-specific antigen levels in some patients; it was safe and well tolerated (5/20)

EntreMed Inc. (ENMD)

Panzem

An orally available small-molecule drug candidate

Metastatic breast cancer

Phase I data showed treatment with Taxotere was well tolerated with mild side effects, and also displayed tumor responses and stable disease (5/21)

Genaera Corp. (GENR)

Squalamine

Anti-angiogenic agent with a multifaceted mechanism of action that blocks the action of a number of angiogenic growth factors, including vascular endothelial growth factor

Ovarian cancer

Phase II results showed 35% of evaluable patients had an objective response, including five complete responses and four partial responses (5/20)

Genaera Corp. (GENR)

Squalamine

Anti-angiogenic agent with a multifaceted mechanism of action that blocks the action of a number of angiogenic growth factors, including vascular endothelial growth factor

Non-small-cell lung cancer

Phase II results were positive, with 27% of patients experiencing an objective response (5/20)

Genentech Inc. (NYSE:DNA)

Avastin

Bevacizumab; monoclonal antibody

Kidney cancer

Phase II results showed patients had a statistically significant increase in the primary endpoint, time to disease progression, compared to placebo patients (5/20)

Genentech Inc. (NYSE:DNA)

Herceptin (FDA-approved)

Monoclonal antibody developed against the HER-2/neu protein

Breast cancer

Clinical results showed Herceptin, in combination with chemo- therapy drugs Taxotere and cisplatin, shrank breast tumors in one woman (5/20); other results showed the addition of weekly Taxol and Paraplatin to Herceptin produced improved responses as compared to Herceptin alone (5/21)

Genentech Inc. (NYSE:DNA)
and IDEC Pharmaceuticals Inc. (IDPH)

Rituxan (FDA-approved)

Rituximab; monoclonal antibody therapy

Non-Hodgkin's lymphoma

In a study with 86 patients, 80 patients responded to treatment, with 47 achieving a complete response (5/22)

Genitope Corp.*

GTOP-99

Personalized immunotherapy that can induce tumor-specific antibody and T-cell immune responses

Advanced-stage follicular non- Hodgkin's lymphoma

Phase II results showed that a personalized immunotherapy, when used as the initial treatment for patients with f-NHL, can induce tumor-specific antibody and T-cell immune responses (5/20)

GenVec Inc. (GNVC)

TNFerade

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

Cancer

TNFerade showed substantial activity against all types of tumors tested, with 15 of 21 patients showing objective tumor shrinkage and five of 21 showing stable disease (5/20)

GlycoDesign Inc. (Canada; TSE:GD)

GD0039

A small-molecule, orally administered inhibitor of the Golgi enzyme amannosidase II

Renal cancer

GlycoDesign decided to shelve the product following Phase II results that showed toxicities (5/24)

Human Genome Sciences Inc. (HGSI)

LymphoRad

A radio-iodinated form of B-lymphocyte stimulator

Multiple myeloma

Company will begin a Phase I trial (5/14)

ImClone Systems Inc. (IMCL)

Erbitux

Cetuximab; designed to target and block the epidermal growth factor receptor

Refractory squamous-cell head and neck cancer

Phase II results showed nine of 78 patients achieved a partial response and 13 patients achieved stable disease (5/20)

ImClone Systems Inc. (IMCL)

Erbitux

Cetuximab; designed to target and block the epidermal growth factor receptor

Advanced non-small-cell lung cancer

Clinical data of 30 evaluable patients showed eight achieved a partial response and eight achieved a stable response (5/20)

ImClone Systems Inc. (IMCL)

Erbitux

Cetuximab; designed to target and block the epidermal growth factor receptor

Refractory colon cancer

Phase II results of 57 patients showed six achieved a partial response and 21 achieved stabilization of disease (5/20)

Immuno-Designed Molecules SA* (France)

IDM-1

Antibody-based cell drug Osidem

Ovarian cancer

Company will begin a Phase III trial of IDM-1 in the U.S. (5/14)

ImmunoGen Inc. (IMGN) and
British Biotech
plc (UK; LSE:BBG)

huN901- DM1/BB- 10901

Tumor-activated prodrug product; conjugate of the cytotoxic maytansinoid drug, DM1, with the humanized monoclonal antibody huN901

Advanced small-cell lung cancer and other solid tumors

Phase I results showed the drug has been well tolerated with no dose-limiting toxicity found (5/20)

ImmunoGen Inc. (IMGN)

Cantuzumab mertansine

Tumor-activated prodrug created by conjugating the cytotoxic agent DM1 with the humanized monoclonal antibody C242

Cancer

Phase I studies showed the product was well tolerated (5/21)

Immunomedics
Inc.
(IMMU)

A bispecific antibody having one arm composed of Immunomedics' humanized anti-CEA antibody; radioimmunotherapy

Metastatic tumors

Phase I/II results showed the average tumor-absorbed doses of the I-131 radiation was more than double with the bispecific antibody method than the directly labeled antibody (5/21)

Inex Pharmaceuticals Corp. (Canada; TSE:IEX)

Onco TCS

In combination therapy

Non-Hodgkin's lymphoma

Phase II results of 26 patients showed all patients responded to treatment, with 25 of them having their tumors eliminated (5/21)

IntraBiotics Pharmaceuticals Inc. (IBPI)

Iseganan

Hydrochloride oral solution

Radiotherapy- induced mucositis

Phase III data showed the product fared poorly against placebo in primary and secondary endpoints (5/6)

Introgen Therapeutics Inc. (INGN)

INGN 241

Mda-7 gene drug

Advanced cancer

Phase I data demonstrated the drug's ability to kill cancer cells after a single dose (5/22)

Isis Pharmaceuticals Inc. (ISIS) and Eli Lilly & Co.

Affinitac

Antisense agent that targets protein kinase c-alpha

Non-small-cell lung cancer

Affinitac demonstrated high rates of tumor response and stable disease in Phase II trials (5/20)

Kosan Biosciences Inc. (KOSN)

KOS-862

Epothilone D, a polyketide that inhibits tumor cells by the same mechanism as paclitaxel, but is effective against paclitaxel-resistant cell lines

Advanced solid tumors

Company began a second Phase I dosing regimen (5/1); Phase I results showed it is well tolerated without dose-limiting toxicities or myelosuppression (5/21)

Ligand Pharmaceuticals Inc. (LGND)

Targretin (FDA-approved)

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

Lung cancer

A preliminary analysis of Phase I/II data showed that adding Targretin capsules to standard chemotherapy may enhance the activity of lung cancer treatment and reduce the growth rate of lung cancer without causing un- expected side effects (5/21)

Maxim Pharmaceuticals Inc. (MAXM)

Ceplene

Histamine dihydrochloride

Advanced metastatic melanoma

Phase III results indicated the combination of Ceplene and interleukin-2 provided a statistically significant survival benefit for the most critically ill patients (5/20)

Maxim Pharmaceuticals Inc. (MAXM)

Ceplene

Histamine dihydrochloride

Metastatic renal-cell carcinoma

Phase II results of Ceplene in combination with interleukin-2 showed 42% of those treated with the Ceplene/IL-2 combination achieved a partial response or disease stabilization, compared with 26% of those treated with IL-2 alone (5/22)

Medarex Inc. (MEDX)

MDX-010

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

Metastatic melanoma and prostate cancer

Clinical results of 17 metastatic melanoma patients showed two achieved a partial response, a third patient achieved a minor response, and two others experienced stable disease; of 14 patients with hormone-refractory prostate cancer, two of seven patients who were chemotherapy naive experienced a greater than 50% reduction in serum prostate antigen measurement (5/22)

MediGene AG (Germany; Neuer Markt:MDG)

NV1020

Oncolytic herpes simplex virus product

Liver metastases derived from colorectal cancer

Phase I results showed that NV1020 can be administered via the bloodstream, tumors were radiographically stable and all subjects experienced a decrease in the tumor marker CEA (5/21)

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

Palonosetron

A 5-HT3-receptor antagonist with an extended half-life and a receptor-binding affinity

Chemotherapy- induced nausea and vomiting

Phase II results demonstrated that palonosetron was effective in the prevention of nausea and vomiting during the initial 24- hour period and for several days beyond (5/20)

Millennium Pharmaceuticals Inc. (MLNM) and ILEX Oncology Inc. (ILXO)

Campath (FDA-approved)

Alemtuzumab; humanized monoclonal antibody

B-cell chronic lymphocytic leukemia

Campath was shown to double life expectancy for heavily pre- treated B-cell chronic lymphocytic leukemia patients, from eight to 16 months, in follow-up data from a Phase II study (5/14)

Millennium Pharmaceuticals Inc. (MLNM)

MLN341 (formerly LDP-341 and PS-341)

Anticancer agent designed to specifically block the proteasome

Multiple myeloma; pancreatic, lung and colorectal cancers

Phase II results showed that MLN-341 stabilized or reduced myeloma protein in the majority of study participants (5/20); Phase I trials showed MLN341 was well tolerated and showed signs of antitumor activity when combined with Gemzar and Camptosar for certain pancreatic, lung and colorectal cancers (5/21)

Millennium Pharmaceuticals Inc. (MLNM)

MLN518

A small molecule specific- ally designed to inhibit the FLT-3 receptor tyrosine kinase

Acute myeloid leukemia

Company initiated a Phase I trial (5/29)

NeoRx Corp. (NERX)

Pretarget Lymphoma

Targeted therapeutic that delivers intense doses of anticancer agents to tumor cells while sparing healthy tissue

Non-Hodgkin's lymphoma

Phase I data indicated that Pre-target Lymphoma was usually well tolerated, and may provide a means to deliver higher doses of radiotherapeutic to tumor cells (5/20)

Neurocrine Biosciences Inc. (NBIX)

GnRH

Orally active, small- molecule gonadotropin-releasing hormone receptor antagonist

Women's health disorders and prostate cancer

Company completed the first Phase I trial (5/7)

Onyx Pharmaceuticals Inc. (ONXX) and Bayer Corp.

BAY 43-9006

A small-molecule Raf kinase inhibitor

Cancer

Phase I data showed two of 163 patients had confirmed partial responses, and five others had evidence of tumor shrinkage; also, 45% treated at higher doses experienced disease stabilization (5/22)

OSI Pharmaceuticals Inc. (OSIP)

Tarceva

Erlotinib HCl, OSI-774

Pancreatic cancer

Company completed the initial stage of the ongoing Phase III trial (5/2)

Prima Biomed Ltd.* (Australia)

Immune system stimulant that is keyed to Mucin 1, a glycoprotein expressed by tumors; treatment involves extracting a patient's immune-stimulating cells, which then are cultured and treated with hormones and growth factors to produce dendritic cells that are treated with Mannan and recombinant MUC1

Tumors

Company is planning a Phase I/II trial after Phase I results showed increased levels of T cells being generated in response to the tumor molecule MUC1 (5/15**)

Protein Design Labs Inc. (PDLI)

Remitogen

Apolizumab; SMART 1D10; humanized antibody

Solid tumors

Company initiated a Phase I trial (5/15)

Protein Design Labs Inc. (PDLI)

Zamyl

Humanized antibody that binds to the CD33 antigen on myeloid leukemia cells

Acute myeloid leukemia

Company decided against further development on news that a Phase III trial failed to show statistical significance (5/20)

QLT Inc.
(Canada; QLTI)

Tariquidar

Inhibitor of P-gp, a membrane protein that pumps chemotherapy out of cells

Breast cancer and non-small-cell lung cancer

Company found it to be an effective inhibitor of P-gp; it is in Phase II in breast cancer; company plans to initiate a Phase III non-small-cell lung cancer program (5/21)

Seattle Genetics Inc. (SGEN)

SGN-15

Monoclonal antibody drug conjugate

Breast and colon cancer

Company completed its first study in colon cancer and accrued more than half of the targeted patients in the breast cancer study (5/21)

Sonus Pharmaceuticals Inc. (SNUS)

Tocosol Paclitaxel

Paclitaxel cancer product that uses the company's vitamin E-based Tocosol delivery technology

Tumors

Phase I results demonstrated tumor responses in 14 of 34 evaluable patients (5/21)

SuperGen Inc. (SUPG)

Orathecin

Oral anticancer compound

Advanced gastric adenocarcinoma

Phase II results showed a 12% response rate, and 33% of patients with disease stabilization (5/20); Phase II results suggest Orathecin is effective against chordoma, a type of bone tumor (5/21)

Targeted Genetics Corp. (TGEN)

tgDCC-E1A

Systemically deliverable form of E1A, a tumor-inhibitory gene

Ovarian cancer

Phase I data showed CA-125 levels were reduced in six of seven patients who entered the study with levels above 20 U/mL (5/22)

Telik Inc.
(TELK)

TLK286

Small-molecule antitumor drug that is activated by GST P1-1

Non-small-cell lung cancer and ovarian cancer

Phase II results showed TLK286 had single-agent antitumor activity in patients with highly resistant disease of non-small- cell lung cancer; it also showed significant antitumor activity in a Phase II trial of ovarian cancer (5/20)

Therion Biologics Corp.*

Prostvac

Vaccines, vaccinia and fowlpox

Prostate cancer

Clinical results showed 53% of patients treated remained stable for six months or more; 78% remained free of metastatic prostate cancer (5/20)

Titan Pharmaceuticals Inc. (AMEX:TTP)

Pivanex

Acts by inhibiting enzymes called histone deacetylases

Non-small-cell lung cancer

Pivanex demonstrated clinical benefit in a Phase II study, and was not associated with any significant side effects (5/20)

Tragen Pharmaceuticals Inc.*

ISF 154

Immunotherapy designed to activate dormant leukemia B cells and rally T cells to selectively attack blood- and tissue-based leukemia cells

Chronic lymphocytic leukemia

Company launched a Phase II trial (5/23)

Tularik Inc. (TLRK)

T67

Binds to B-tubulin, which is essential to cell division

Unresectable hepatocellular carcinoma

Phase II results showed three of 34 patients had partial responses and 38% had stable disease; also, five of 27 evaluable patients had a more than 50% reduction in alpha-fetoprotein (5/20)

Vical Inc. (VICL)

Allovectin-7

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

Cancer

Phase II data show an estimated median survival for all 78 patients treated of 14.3 months (5/20)

Vion Pharmaceuticals Inc. (VION)

TAPET-CD

Armed vector; a weakened Salmonella typhimurium bacteria engineered to produce the enzyme cytosine deaminase

Advanced or metastatic solid tumors

Phase I data showed the technology is safe, but the company is stopping all TAPET studies except for the base vector VNP20009 in order to focus on other projects (5/30)

Wilex AG* (Germany)

Docetaxel

A taxane

Breast cancer

Company initiated a Phase III trial with 540 patients to deter- mine whether chemotherapy regimens may serve as potential combination therapies for its uPA inhibitor WX-UK1 (5/28)

XOMA Ltd. (XOMA)

heMAB

Human engineered ING-1 monoclonal antibody

Solid tumors

Phase I data showed positive safety and tolerability results (5/20)

YM BioSciences Inc.* (Canada)

TheraCIM

Humanized monoclonal antibody to EGFr (h-R3)

Advanced head and neck cancer

Phase I/II results showed that h-R3 could be safely administered and that toxicities were in- frequent; 18 of 22 head and neck cancer patients showed objective antitumor response, while 11 of 16 showed complete antitumor response (5/23)

CARDIOVASCULAR

Amgen Inc. (AMGN)

Aranesp (FDA-approved)

Darbepoetin alfa

Anemia

Company started enrollment in a large, global Phase III trial (5/21)

ConjuChem Inc. (Canada; TSE:CJC)

DAC:TI

Thrombin inhibitor

To prevent blood clots

Company completed patient enrollment in a Phase I trial (5/13)

Emisphere Technologies Inc. (EMIS)

Heparin

An oral heparin solution formulation; sodium-N- [8-(2-hydroxybenzoyl) amino] caprylate delivery agent

Deep-vein thrombosis

Phase III results showed oral heparin failed to show superiority to Aventis SA's injected Lovenox in preventing deep-vein thrombosis in patients undergoing total hip replacement surgery (5/14)

GenVec Inc. (GNVC)

BioBypass

Angiogenic gene therapy that delivers vascular endothelial growth factor 121

Coronary artery disease

Company completed patient accrual in a Phase II trial (5/1)

Hollis-Eden Pharmaceuticals Inc. (HEPH)

HE2500

Fluasterone

Lipid disorders or hypertriglyc- eridemia

Clinical data showed HE2500 significantly lowered triglycerides in patients (5/6)

Hollis-Eden Pharmaceuticals Inc. (HEPH)

HE2200

Immune-regulating hormone

High cholesterol

Phase I data showed it significantly reduced total cholesterol and improved the total cholesterol/HDL ratio compared to placebo (5/6)

InterMune Inc. (ITMN)

Actimmune (FDA-approved)

Interferon gamma-1b

Idiopathic pulmonary fibrosis

Phase II data demonstrated a mortality benefit in Actimmunetreated patients (5/22)

Neose Technologies Inc. (NTEC) and Wyeth

rPSGL-lg

P-selectin glycoprotein ligand

Myocardial infarction

Wyeth is stopping development of the compound because of disappointing Phase II data (5/10)

CENTRAL NERVOUS SYSTEM

CeNeS Pharmaceuticals plc (UK; LSE:CEN)

CNS 5161

Administered intravenously

Neuropathic pain

Phase II results showed CNS 5161 gave statistically significant relief (5/15)

Cephalon Inc. (CEPH)

Modafinil

Oral formulation of synthetic compound

Fatigue and sleepiness in patients with major depressive disorder

Modafinil rapidly improved fatigue and daytime wakefulness, and it was well tolerated in combination with a variety of antidepressants, in a clinical trial (5/20)

ConjuChem Inc. (Canada; TSE:CJC)

DAC:Opioid

Peripherally acting opioid agonist

Pain

Preliminary Phase I results showed no adverse clinical response related to immunogenicity, as well as no antibody immune response or neutralizing antibody response (5/13)

Ligand Pharmaceuticals Inc. (LGND)

Avinza (FDA-approved)

Morphine sulfate extended-release capsules

Osteoarthritis pain

Data showed Avinza reduced pain and improved overall quality of sleep in patients with chronic, moderate to severe osteoarthritis pain (5/2)

NeoTherapeutics Inc. (NEOT)

Neotrofin

Small-molecule compound designed to cross blood-brain barrier and enhance nerve cell function by increasing levels of neurotrophic factors

Parkinson's disease

Interim results from a pilot study of 20 early stage Parkinson's patients treated with Neotrofin and six patients treated with placebo suggest acute efficacy in the first several weeks, when patients were receiving Neotrofin 250 mg twice daily; the data analyzed are from the first four weeks of the 12-week study (5/30)

Pain Therapeutics Inc. (PTIE)

MorViva

Painkiller; morphine solution

Pain following major surgery

Company completed patient enrollment in a Phase II study of 160 patients (5/1)

Theratechnologies Inc. (Canada; TSE:TH)

TH 9507

ThGRF peptide

Insomnia

Phase II results showed improved sleep parameters and daytime vigilance (5/29)

DIABETES

Inhale Therapeutic Systems Inc. (INHL), Pfizer Inc. and Aventis Pharma AG (Germany)

Exubera

Inhaled insulin product using Inhale's inhaleable technology

Type I diabetes

Data indicated that Exubera might provide a treatment option for patients with Type I diabetes (5/2)

Medinox Inc.*

NOX-700

Orally active nitric oxide blocking agent

Diabetes mellitus

Company started a Phase I trial (5/30)

INFECTION

Achillion Pharmaceuticals Inc.*

ACH-126,443

Beta-L-Fd4C

Chronic hepatitis B

Company completed a Phase Ib/II trial demonstrating antiviral activity of its lead candidate (5/22)

Antigenics Inc. (AGEN)

Quilimmune-P

A combination of a commercially available vaccine plus Antigenics' QS-21 adjuvant

Pneumococcal infections

Phase I results showed Quilimmune-P stimulated significantly higher levels of immune response among elderly adults (5/8)

Avant Immuno- therapeutics Inc. (AVAN)

Vaccine

Cholera

Company started a Phase II study (5/16)

Cyclacel Ltd.* (Scotland)

CYC202

R-roscovitine; a small- molecule inhibitor of CD2

Glomerulon- ephritis

Company plans to continue its clinical program after Phase I results showed the drug is safe and well tolerated (5/15)

Gilead Sciences Inc. (GILD)

Viread (FDA-approved)

Tenofovir disoproxil fumarate

HIV

Phase III data showed the Viread-containing regimen and the stavudine-containing regimen were both highly effective with comparable efficacy (5/8)

Gilead Sciences
Inc.
(GILD)

Tenofovir

The active ingredient in the antiretroviral drug Viread; topical gel

HIV

Company began a Phase I trial of the gel as a potential prevention method for vaginal transmission of HIV (5/22)

Idun Pharmaceuticals Inc.*

IDN-6556

Caspase inhibitor

Mild liver impairment and hepatitis C infection

Phase I results showed it was safe and well tolerated, and demonstrated improvements in liver enzymes (5/20)

Inspire Pharmaceuticals Inc. (ISPH)

INS37217

Intranasal solution in a nasal spray formulation

Chronic rhinitis and upper respiratory infection

Company began two Phase IIa studies (5/8)

Nabi Biopharma-
ceuticals (NABI)

StaphVAX

Staphylococcus aureus conjugate polysaccharide vaccine

Staphylococcus aureus infection

Clinical results showed that a booster dose of the vaccine given to previously vaccinated hemodialysis patients increases the concentration of vaccine-specific serum antibodies against S. aureus (5/15)

Pharmasset
Inc.*

Reverset

A nucleoside reverse transcriptase inhibitor

HIV

Company initiated a Phase I trial (5/22)

Questcor Pharmaceuticals Inc. (AMEX:QSC)

VSL#3

Preparation of live freeze-dried lactic acid bacteria

Pouchitis

Results demonstrated VSL#3 provides clinical benefit, with 90% of patients remaining in remission, compared to 94% on placebo who relapsed (5/22)

SciClone Pharmaceuticals Inc. (SCLN)

Zadaxin

Thymalfasin, thymosin alpha 1

Hepatitis C

Zadaxin appears to upregulate the expression of multiple immune system-related genes in hepatitis C patients; the addition of peyglated interferon to Zadaxin did not significantly alter the pattern of upregulation (5/22)

Serono SA (Switzerland; NYSE:SRA)

Serostim (FDA-approved)

Somatropin, rDNA origin for injection; a recombinant human growth hormone

HIV-associated adipose redistri- bution syndrome

A study of 228 patients showed positive results (5/28)

Trimeris Inc. (TRMS)

T-20

Injected subcutaneously; inhibits fusion of HIV with host cells before the virus enters the cell and starts the replication process

HIV

Phase III results were positive and the company plans to apply for conditional approval from the FDA, while continuing another Phase III study (5/16)

Versicor Inc. (VERS)

Dalbavancin

A glycopeptide agent belonging to the same class as vancomycin

Skin and soft- tissue infections

Company completed enrollment in a Phase II trial (5/21)

Vertex Pharmaceuticals Inc. (VRTX)

GW433908

Protease inhibitor

HIV

Results from a second pivotal Phase III trial showed the drug met its endpoints; an NDA filing is expected by the end of the year (5/17)

ZymoGenetics
Inc.
(ZGEN)

PDGF

A protein that stimulates osteoblasts in the formation of new bone; tested with beta tricalcium phosphate, a synthetic bone substitute that provides scaffolding for bone regeneration

Bone defects resulting from periodontal disease

Company started a pivotal study at 11 centers in the U.S. and one in Europe; it's expected to complete enrollment at the end of the year (5/29)

MISCELLANEOUS

AVI BioPharma Inc. (AVII)

Neugene

Antisense technology that targets cytochrome P450 3A4

To regulate drug metabolism

Data from a 96-patient study indicated Neugene technology can be used to regulate drug metabolism (5/7)

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

CAT-152

Lerdelimumab; human anti-TGF-beta2 monoclonal antibody

Patients under- going surgery for glaucoma and cataracts

The drug was found to be safe and well tolerated with no serious drug-related adverse events (5/8)

Dynavax Technologies Corp.*

ISS

Inhaled immunostimulatory DNA sequence

Asthma

Company initiated a Phase I trial (5/20)

Genaera Corp. (GENR)

Lomucin

Mucoregulator compound intended to block the hCLCA1-dependent mucus overproduction

Asthma

Interim results on the first 20 patients showed Lomucin oral tablets were safe and well tolerated (5/23)

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

Cialis

Tadalafil, an oral PDE5 inhibitor

Erectile dysfunction

Clinical results showed the drug gives men the ability to achieve an erection some 24 to 36 hours after taking it; patients taking nitrate, however, cannot also take Cialis (5/28)

Molichem Medicines Inc. (OTC BB:MLCM)

Moli1901

A muco-active polypeptide that may normalize the mucus composition in the lung by activating an alternative chloride and water channel

Cystic fibrosis

Company initiated a Phase II trial (5/30)

Oxford GlycoSciences plc (UK; OGSI; LSE:OGS)

Vevesca

Oral capsule formulation of a glucosyltransferase inhibitor

Gaucher's disease

Clinical results showed a statistically significant reduction from baseline to six months of liver volume, as compared to Cerezyme (5/2)

Palatin Technologies Inc. (AMEX:PTN)

PT-141

Peptide analog of (alpha)-MSH ([alpha]-melanocyte-
stimulating hormone)

Erectile dysfunction

PT-141 was shown to be highly significant for its primary end- point in a Phase IIa trial (5/30)

Tanox Inc.
(TNOX)

TNX-901

An anti-IgE antibody

Peanut allergy

Phase II results showed the primary endpoint, based on an increase in symptom threshold to peanuts by oral food challenge, was met with statistical significance (5/1)

Targeted Genetics Corp. (TGEN)

tgAAVCF

Gene therapy product that uses an adenoassociated virus vector delivery system

Cystic fibrosis

Company completed enrollment in a 36-patient Phase II cystic fibrosis trial (5/16)

Vernalis Group
plc
(UK; LSE:VER)

VR 1065

5-HT (2C) receptor agonist that targets the satiety mechanism

Obesity

Company began Phase I trials (5/22)

Vernalis Group
plc
(UK; LSE:VER)

VML 670

Designed to reduce a common side effect of SSRI treatments for depression

Sexual dysfunction

Company began Phase II trials (5/22)


Notes:

* Privately held

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

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

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

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