Company* |
Product | Description |
Indication | Status (Date) |
| ||||
AUTOIMMUNE | ||||
Active Biotech |
57-57 |
Product derived from the company's linomide chemistry platform |
Lupus |
Began a Phase I trial in Sweden to test increasing doses in healthy volunteers (11/2) |
Antisense |
ATL1101 |
Antisense drug designed to block the synthesis of the IGF-1 receptor |
Psoriasis |
Began a trial in Australia to test the product against a placebo cream and against reference cream products (11/18) |
Cytochroma |
CTA018 |
Vitamin D signal amplifier |
Psoriasis |
Began a Phase Ia trial in Canada to test various doses of the topical formulation in patients (11/23) |
Isotechnika |
Trans-ISA247 |
Immunosuppressive agent; calcineurin inhibitor |
Psoriasis |
Ascending-dose study in healthy volunteers in Canada achieved all safety endpoints (11/3) |
CANCER | ||||
AnorMED Inc. |
AMD3100 |
Agent designed to block receptor that triggers movement of stem cells out of bone marrow |
Stem cell transplantation in cancer patients |
Began a Phase II trial in Canada and Europe with G-CSF in up to 50 non-Hodgkin's lymphoma and multiple myeloma patients (11/4) |
BioAlliance |
Doxorubicin Transdrug |
Nanoparticle formulation of the cancer drug |
Hepatocellular carcinoma |
The European Commission granted orphan designation to the product, which is in Phase I/II trials (11/16) |
Chroma |
CHR-2797 |
Metalloenzyme designed to inhibit intracellular aminopeptidases |
Cancer |
Began Phase I trial in the UK to evaluate safety, tolerability, dosing and preliminary activity in up to 40 patients with advanced disease (11/16) |
Dragon |
-- |
Recombinant erythropoietin product |
Anemia |
The product was approved in the Dominican Republic and Trinidad and Tobago; a license application was accepted in Kosovo (11/15) |
Igeneon AG* |
IGN101 |
Vaccine designed to trigger an immune response to epithelial cell-adhesion molecule |
Cancers |
A Phase II trial in 239 patients did not demonstrate statistical significance on surival overall, but did in the subgroup of 53 patients with metastatic rectal cancer (11/8) |
ImClone |
IMC-11F8 |
Fully human monoclonal antibody targeting the epidermal growth factor receptor |
Solid tumors |
Began Phase I trial in the Netherlands to evaluate safety and pharmacology in up to 40 patients (11/30) |
ImClone |
Erbitux |
Cetuximab; antibody that blocks the epidermal growth factor receptor |
Colorectal cancer |
Merck KGaA presented data showing the drug might be safe and effective in combination with standard chemotherapies (11/1) |
Inex |
Marqibo (formerly Onco TCS) |
Vincristine encapsulated in Inex's TCS (liposomal) drug delivery technology |
Non-Hodgkin's lymphoma |
They filed in Canada for approval as a single-agent treatment for relapsed, aggressive NHL previously treated with at least two combination chemotherapy regimens (11/5) |
Lorus |
GTI-2040 |
Antisense oligonucleotide complementary to the R2 component of ribonucleotide reductase |
Hormone- refractory prostate cancer |
Began a National Cancer Institute- sponsored Phase trial in Canada to test the agent in combination with docetaxel and prednisone (11/18) |
Marshall |
Phenoxodiol |
Apoptotic agent designed to block sphingosine-1- phosphate |
Prostate cancer |
Study in Australia in 19 patients with hormone-refractory disease showed a dose-response effect in terms of disease progression and PSA levels (11/22) |
PharmaMar |
Aplidin |
Antitumor agent derived from the marine tunicate Aplidium albicans |
Hematological malignancies |
Began various Phase II trials in multiple myeloma, non-Hodgkin's lymphoma and adult acute lymphoblastic leukemia (11/25) |
PharmaMar |
Aplidin |
Antitumor agent derived from the marine tunicate Aplidium albicans |
Multiple myeloma |
The product was granted orphan drug status by the European Commission (11/19) |
Pharmexa |
HER-2 Protein AutoVac |
Vaccine designed to generate an antibody response against the HER-2 protein |
Breast cancer |
Began a Phase II trial that will include up to 50 patients in Hungary and Poland (11/11) |
Transgene SA |
MVA-HPV-IL2 |
Product using the MVA virus to carry and express two HPV antigens found in HPV 16 |
Precancerous lesions of the cervix |
Began Phase II trial in France to test the product in 16 women (11/30) |
Viragen Inc. |
Multiferon |
Multisubtype, natural human alpha interferon |
Various diseases |
Partner Arriani Pharmaceuticals SA gained approval in Bulgaria for use as a second-line treatment in recombinant interferon failures (11/22) |
YM BioSciences |
Theraloc (TheraCIM hR3) |
Humanized anti-epidermal growth factor receptor monoclonal antibody |
Metastatic pancreatic cancer |
Began a Phase I/II trial in Germany in 30 patients; depending on response rates, another 30 patients could be enrolled (11/18) |
CARDIOVASCULAR | ||||
Acelion Ltd. |
Veletri |
Tezosentan; intravenous dual endothelin receptor antagonist |
Acute heart failure |
Stopped Phase III VERITAS study after an interim analysis indicated that it would not attain primary efficacy endpoints (11/7) |
DIABETES | ||||
Generex |
Orallyn (Oralin) |
Oral insulin spray formulation |
Type II diabetes |
Study in Ecuador showed the product can be used in place of mealtime insulin injections to regulate postprandial glucose levels (11/30) |
INFECTION | ||||
Gilead Sciences |
Truvada (FDA-approved) |
Fixed-dose combination of the company's Viread and Emtriva drugs |
HIV |
The scientific comittee of the EMEA recommended approval of the product for use with other antiretroviral agents (11/18) |
Helix |
Interferon alpha |
Cream formulation of interferon-alpha 2b |
Human pappiloma-virus |
Began a Phase II trial in Germany to evaluate the product in women with low-grade squamous intraepithelial lesions that are positive for HPV infection (11/1) |
Hemispherx |
Alferon LDO |
Low-dose, oral alpha- interferon cocktail |
Severe acute respiratoy syndrome |
Hong Kong officials approved a trial in normal volunteers and/or asymtomatic subjects possibly exposed to SARS (11/22) |
Immtech |
DB289 |
Oral, dicationic antiviral agent |
African sleeping sickness |
All 30 patients in extended-dose regimen of Phase IIb trial in the Congo cleared the parasite within treatment period;no significant adverse results were seen (11/9) |
Microscience |
spi-VECTM |
Vaccine consisting of a Salmonella bacterium modified to carry the hepatitis B core antigen |
Hepatitis B |
Phase I trial in 30 healthy volunteers demonstrated safety and immunogenicity (11/3) |
PowderMed |
-- |
Powdered DNA vaccine |
Influenza |
Phase I trial in 36 volunteers supported continued development (11/18) |
SciClone |
Zadaxin |
Synthetic preparation of thymosin alpha-1 |
Hepatitis C |
Triple therapy with pegylated interferon and ribavirin in a pilot trial in Mexico sustained virologic response in 19% of previous non-responders (11/1) |
The Immune |
Remune |
Immune-based therapy comprised of a whole-killed virus and an adjuvant |
HIV |
Phase II data on 37 patients from a trial in Italy showed positive trends in disease markers over the 28-day treatment period (11/17) |
Viral Genetics |
VGV-1 |
Thymus nuclear protein extracted from bovine thymus gland |
HIV |
Five of 10 patients in a trial in Mexico who had failed other therapies had undetectable viral loads within three months of treatment (11/29) |
MISCELLANEOUS | ||||
Angiotech |
Adhibit |
Adhesion prevention gel |
Reduction of post-surgical adhesions |
Eight-week follow-up data on 20 patients from pivotal European trial in patients undergoing myoectomy suggested the product prevented adhesions (11/12) |
BioPartners |
Valtropin |
Somatropin; recombinant human growth hormone |
Growth hormone deficiency |
Filed with the EMEA seeking approval in Europe for treating adult and pediatric GHD and other growth disorders (11/29) |
BioXell SpA* |
BXL628 |
Inhibitor of growth factor phosphorylation and bcl-2 |
Overactive bladder |
Began Phase IIa trial in Italy in 120 patients to evaluate urination levels and related endpoints (11/29) |
Cambridge |
Trabio (CAT-152) |
Lerdelimumab; fully human monoclonal antibody that neutralizes transforming growth factor beta-2 |
Glaucoma |
Phase III trial in 344 patients in Europe failed to meet the primary endpoint of improving the outcome of surgery for glaucoma compared to placebo (11/9) |
LifeCycle |
-- |
Tablet formulation of the marketed immunosuppressant drug tacrolimus (Prograf) |
For use in organ transplantations and other indications |
Began clinical trials to test multiple tablet formulations (11/10) |
Nabi Biopharmaceuticals |
PhosLo (FDA-approved) |
Calcium acetate |
Control of blood phosphorus in end-stage renal disease |
The company filed for approval in Europe (11/4) |
SR Pharma |
SRP299 |
Immunomodulator |
Atopic dermatitis |
Company stopped development in that indication following Phase II trial that failed to demonstrate efficacy (11/19) |
Zonagen Inc. |
Progenta |
Agent designed to block progesterone without blocking adrenal hormones |
Uterine fibroids |
One-month data from trial in Poland showed a statistically significant reduction of fibroid size in the highest dose, but not in the other doses or in the positive control (11/8) |
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Notes: | ||||
* Privately held. | ||||
EMEA = European Medicines Agency; MAA = Marketing authorization application. | ||||
Unless otherwise noted, the stock symbols listed for public companies are on the Nasdaq market. | ||||
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