Company* |
Product |
Description |
Indication |
Status |
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AUTOIMMUNE | ||||
La Jolla Pharmaceutical Co. (LJPC) |
Riquent |
Arrests the production of antibodies to dsDNA without suppressing healthy functions of the immune system |
Lupus |
Phase III data showed Riquent missed its primary endpoint of time to renal flare, but did show some positive results (2/18) |
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CANCER | ||||
AltaRex Corp. (TSE:AXO) |
OvaRex |
Oregovamab; immunotherapeutic; a |
Ovarian |
Phase II data demonstrated a correlation between OvaRex-induced T-cell responses and prolonged survival in platinum-sensitive patients (2/3) |
Aphton |
G17DT |
Antigastrin |
Metastatic |
Clinical data showed that 82% of patients had either tumor shrinkage or stable disease in a trial with G17DT and chemotherapy consisting of cisplatin and 5-FU (2/6) |
Cell Genesys |
GVAX |
Lung cancer vaccine made directly from |
Lung cancer |
Phase I/II data showed that 18 of 22 patients demonstrated enhanced antitumor immunity (2/17) |
Gamida-Cell |
StemEx |
Utilizes a small molecule that enables large-scale, self-renewal of stem/progenitor cells ex vivo |
Advanced stages of hematologic malignancies |
Company began enrolling patients in a Phase I trial (2/12) |
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Exelixis Inc. |
DEAE-rebeccamycin |
Anticancer compound; rebaccamycin analogue |
Bile duct tumors |
Phase II data suggest that the rebeccamycin analogue may be safely administered and may result in tumor shrinkage in patients with bile duct tumors (2/3) |
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Nymox Pharmaceutical |
NX-1207 |
Prospective drug to |
Benign prostatic hyperplasia |
Company began a Phase I trial (2/18) |
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Peregrine Pharmaceuticals |
Cotara |
A monoclonal antibody that carries the radioactive isotope iodine-131 to the necrotic core of solid tumor cancers |
Recurrent glioblastoma multiforme |
Company began to enroll the first patients in a Phase III trial (2/24) |
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Praecis Pharmaceuticals Inc. (PRCS) |
Plenaxis |
Abarelix for injectable suspension |
Prostate cancer |
Clinical data showed that the primary endpoint, avoidance of surgical castration at four and 12 weeks, was met by 100% of patients (2/6) |
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Pro-Pharma- |
Davanat-1 |
Capitalizes on the natural properties of glyco-molecules to attach selectively to binding sites on the surface of cancer cells |
Solid tumors |
Company initiated Phase I trials (2/6) |
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QLT Inc. (QLTI) |
Tariquidar |
P-glycoprotein membrane inhibitor |
Non-small-cell lung cancer |
QLT is suspending enrollment temporarily in two Phase III studies of tariquidar after a monitoring committee noticed some toxicity (2/21) |
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Transgene SA |
Ad-IL2 |
Adeno Interleukin-2 |
Metastatic melanoma or other solid tumors |
Phase I data showed it was well tolerated with only injection-site reactions and transient episodes of fever (2/10) |
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Transgene SA |
Ad-IFNg |
Adeno interferon gamma |
T-cell and B-cell lymphoma |
Phase I data showed there were clinical responses and stabilizations in most patients (2/10) |
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Vion |
VPN4010M |
A DNA-damaging alkylating agent |
Solid tumors |
Company initiated a Phase I trial (2/3) |
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CARDIOVASCULAR | ||||
Alexion Pharmaceuticals Inc. (ALXN) |
Pexelizumab |
An anti-inflammatory, C5 inhibitor monoclonal antibody fragment |
Patients under-going coronary artery bypass graft surgery with cardiopulmonary bypass |
Company completed enrollment in a Phase III trial (2/24) |
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NicOx SA (France; Nouveau Marche:NICOX) |
NCX 1000 |
Nitric oxide-donating derivative of ursodeoxycholic acid |
Portal hypertension |
Company will begin Phase I trials in the U.S. and Europe (2/5) |
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Valentis Inc. |
Del-1 |
A protein involved in the early growth and development of blood vessels |
Peripheral arterial disease |
Company completed the initial follow-up of the last patients in the final cohort of the Phase I trial (2/18) |
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CENTRAL NERVOUS SYSTEM | ||||
ExonHit |
EHT 0201 |
Pentoxifylline; compound identified with DATAS technology |
Amyotrophic lateral sclerosis |
Company completed the recruitment of patients in the Phase II trial (2/18) |
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Guilford Pharmaceuticals Inc. (GLFD) |
Aquavan |
Injection; rapid-acting sedative/hypnotic |
For sedation during colonoscopy |
Company began a Phase II trial (2/13) |
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Ligand Pharmaceuticals Inc. (LGND) |
Avinza (FDA-approved) |
Morphine sulfate extended-release capsules |
Osteoarthritis pain |
Clinical results showed Avinza improved overall quality of sleep in patients with chronic, moderate to severe osteoarthritis pain (2/21) |
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NicOx SA (France; Nouveau Marche:NICOX) and AstraZeneca plc (UK) |
AZD3582 |
First of a new class of analgesic and anti-inflammatory drugs known as COX-inhibiting nitric oxide donators |
Acute and chronic nociceptive pain |
Phase II data showed it did not meet the primary endpoint with respect to gastrointestinal ulcers (2/18) |
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DIABETES | ||||
DepoMed Inc. (AMEX:DMI) and Biovail Corp. (Canada; NYSE: BVF; TSE:BVF) |
Metformin GR |
Extended-release formulation of metformin based on DepoMed's once-daily gastric retention technology |
Type II diabetes |
Phase III data was positive (2/3) |
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Probiodrug AG* |
P93/01 |
Dipeptidyl peptidase IV-inhibitor molecule |
Type II diabetes |
Company concluded its dosing study of P93/01 (2/19) |
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INFECTION | ||||
AM-Pharma Holding BV (the Netherlands) |
AP |
Calf intestinal alkaline phosphatase |
Sepsis |
Company started Phase I trials (2/12**) |
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Bavarian Nordic A/S (Denmark; CSE:BAVA) |
MVA-BN |
Nef vaccine |
Smallpox |
Company is enrolling 165 healthy volunteers in a Phase II trial (2/26) |
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Cerus |
-- |
Cellular vaccine that generates EBV-specific immune responses |
Epstein-Barr virus |
Company began a Phase I trial (2/4) |
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Chiron |
Menjugate |
A conjugate vaccine against Neisseria meningitidis sero group C |
To prevent meningococcal C disease |
Company plans to begin a Phase III trial (2/27) |
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Gilead |
Coviracil (FTC) |
Emtricitabine; a once-daily nucleoside reverse transcriptase inhibitor |
HIV |
Phase III data in 355 patients showed that 94% of patients receiving the once-daily regimen of FTC, didanosine and efavirenz had HIV RNA levels less than 400 copies/mL, compared to 92% randomized to continue therapy in the Pl-based arm (2/11) |
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Gilead |
Hepsera (FDA-approved) |
Adefovir |
Chronic hepatitis |
Clinical results showed Hepsera significantly reduced liver damage and improved liver function compared to placebo, and provided effective and well-tolerated long-term therapy (2/26) |
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Gilead |
Viread (FDA-approved) |
Tenofovir disoproxil fumarate |
HIV |
Data demonstrated Viread-treat-ed patients experienced substantially less lipodrystrophy and lower elevations in fasting cholesterol and triglyceride levels, while achieving similar reductions in HIV viral load and increases in CD4 cell counts, compared to those who received stavudine (2/11) |
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ID Biomedical Corp. (Canada; IDBE; TSE:IDB) |
FluINsure |
Intranasal, non-live, influenza vaccine |
Influenza |
Clinical data showed positive results with respect to both safety and clinical efficacy endpoints (2/13) |
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Immtech |
DB 289 |
Orally administered, more stable molecule based on Pentamidine |
Pneumocystis carinii pneumonia |
Company completed enrollment in a Phase IIa pilot trial (2/6) |
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IntraBiotics Pharmaceuticals Inc. (IBPI) |
Iseganan |
Hydrochloride oral solution |
To prevent ventilator-associated pneumonia |
Company plans to lauch a 500-patient Phase II/III study to investigate iseganan hydrochloride (2/7) |
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Micrologix |
MBI 226 |
An antimicrobial peptide |
To prevent central venous catheter-related bloodstream infections |
Company completed enrollment in a Phase III trial (2/3) |
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Microscience Ltd. (UK) |
-- |
Oral vaccine |
Typhoid |
Clinical results showed the vaccine was safe, well tolerated and highly immunogenic (2/27) |
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Progenics |
PRO 542 |
HIV entry inhibitor |
HIV |
Phase II data was positive (2/11) |
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Tanox Inc. |
TNX-355 |
Humanized, non-immunosuppressive, anti-CD4 monoclonal antibody |
HIV |
Phase Ia data showed TNX-355 was well tolerated and showed a significant decrease in viral load in patients with treatment-refractory HIV infection (2/11) |
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Trimeris |
Fuzeon |
Enfurvitide; a fusion inhibitor |
HIV |
Clinical data showed treatment-experienced patients receiving Fuzeon plus an individualized regimen of standard anti-HIV drugs were twice as likely to achieve undetectable levels of HIV in the blood, as patients who received an individualized regimen without Fuzeon (2/10) |
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VaxGen Inc. |
AidsVax B/B |
AIDS vaccine made from a synthetic protein |
HIV |
Phase III data showed that Aids-Vax did not show a statistically significant reduction of HIV infection within the study population as a whole (2/24) |
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Vertex Pharmaceuticals Inc. (VRTX) and GlaxoSmithKline |
GW433908 |
Protease inhibitor; calcium phosphate ester prodrug of amprenavir |
HIV |
Phase III data showed none of the 32 patients in one arm experienced virologic failure or had detectable or secondary protease inhibitor mutations; PI mutations were observed in other arms of the study (2/11) |
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Virxsys Corp. |
VRX496 |
Lentviral vector |
HIV/AIDS |
Company began Phase I trials (2/17) |
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MISCELLANEOUS | ||||
Adprotech |
APT070 |
Naturally occurring complement inhibitor protein, which identifies cells as nonforeign and protects them from system attack |
To prevent graft dysfunction in kidney transplantation |
Company entered Phase IIa trials with APT070 (2/26) |
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Amarin Corp. |
LAX-101 |
Compound that inhibits certain harmful enzymes, including phospholipases and caspases |
Huntington's disease |
Companies are planning a Phase III trial to support an NDA (2/3) |
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AVI |
Neugene |
Antisense drug that targets cytochrome P450 3A4, the human liver enzyme responsible for metaboli- zing more than 50% of current FDA approved drugs |
To down-regulate a liver enzyme |
Phase I data showed the drug successfully down-regulated the liver enzyme as shown by a significant reduction in the breakdown of the test drug, Midazolam, a pre-anesthetic (2/20) |
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AVI |
Neugene |
Antisense drug that targets cytochrome P450 3A4, the human liver enzyme responsible for metaboli- zing more than 50% of current FDA approved drugs |
Polycystic kidney disease |
Phase Ib data showed the product was safe (2/26) |
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Cypress |
Milnacipran |
The first of a new class of agents known as NSRIs, or norepinephrine serotonin reuptake inhibitors |
Fibromyalgia syndrome |
Phase II data showed 70% of treated patients reported overall improvement, compared to 36% in the placebo group (2/10) |
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Dynavax |
ISS |
Immunostimulatory DNA sequences |
Asthma |
Company initiated an exploratory Phase II trial (2/11) |
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Genome |
Ramoplanin |
Naturally occurring antibiotic |
Clostridium-difficile- |
Company began a Phase II trial (2/20) |
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Ligand |
Ontak (FDA-approved) |
Denileukin diftitox |
Acute graft-vs.- host disease |
Company said the drug generated complete remission of acute graft-vs.-host disease in five of 11 steroid-resistant patients after allogeneic stem cell transplants (2/11) |
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Ligand |
Targretin (FDA-approved) |
Bexarotene gel 1% |
Hand dermatitis |
Phase I/II data showed that nearly 40% of patients with chronic severe hand dermatitis who were treated with Targretin experienced clinical improvement of 90% or more (2/21) |
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Nabi Biopharmaceuticals (NABI) |
NicVAX |
Nicotine conjugate vaccine |
Nicotine addiction |
Company began enrollment in a Phase I/II trial in smokers, ex-smokers and nonsmokers (2/19) |
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NeuroSearch A/S* (Denmark) |
NS1209 |
Water soluble, glutamate AMPA antagonist |
Epilepsy |
NeuroSearch initiated a Phase II trial (2/26**) |
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Ortec |
OrCel (FDA-approved) |
Cryopreserved version of OrCel, a collagen sponge seeded with allogeneic epidermal and dermal cells |
Venous ulcers |
Clinical results showed that at 12 weeks, 64% of OrCel-treated patients achieved 100% wound closure, compared to 39.1% for standard care (2/5) |
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Pharmos |
Dexanabinol |
Non-psychotropic, synthetic analogue of marijuana |
Traumatic brain injury |
Company is adding U.S. centers to an ongoing international Phase III study (2/18) |
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Repligen |
RG2133 |
Triacetyluridine, a prodrug of uridine |
Mitochondrial disease |
Company initiated a Phase I/II trial (2/13) |
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Rigel |
R112 |
The first of a new class of drugs that works against mast cells |
Allergic rhinitis |
Company began a Phase I trial (2/3) |
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SangStat Medical Corp. (SANG) and Abgenix Inc. (ABGX) |
ABX-CBL |
Anti-CD147 monoclonal antibody |
Steroid-resistant graft-vs.-host disease |
Companies are dropping development after ABX-CBL showed a similar survival rate of 180 days as compared to Pharmacia Corp.'s Atgam; the primary endpoint was superior survival (2/18) |
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Vivus Inc. |
Alista
|
Formulation of alprostadil, a synthetic version of prostaglandin E1, a naturally genitalia occurring vasodilating agent |
For increasing blood flow to the female |
Company completed patient treatment in an at-home study of Alista (2/17) |
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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; NYSE = New York Stock Exchange; OTC BB = Over-the-Counter Bulletin Board; TSE = Toronto Stock Exchange | ||||
