Company* |
Product |
Description |
Indication |
Status |
| ||||
AUTOIMMUNE | ||||
Amgen Inc. |
Enbrel (FDA- |
Etanercept; tumor |
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. |
Enbrel (FDA- |
Etanercept; tumor |
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 |
AGI-1067 |
Oral anti- |
Athero- |
Company began enrolling patients in a Phase III trial (6/30) |
|
||||
Biogen Inc. |
Amevive (FDA- |
Alefacept; novel immunomodulatory |
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 |
Humira |
Adalimumab; human monoclonal antibody; tumor necrosis factor |
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. |
Remicade (FDA- |
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 |
-- |
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 |
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. |
-- |
Once-daily version of the analgesic tramadol |
Osteoarthritis |
Company completed enrollment in two Phase III trials (6/11) |
|
||||
La Jolla |
Riquent |
B-cell toleragen; arrests |
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 |
Onercept |
Recombinant, |
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 |
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 |
RSR13 |
Efaproxiral; synthetic |
Brain |
Phase II data of RSR13 plus whole-brain radiation therapy resulted in a significant improvement in survival (6/17) |
|
||||
Allos |
PDX |
10-propargyl-10- |
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. |
OvaRex |
Oregovamab; immunotherapeutic; |
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. |
Neupogen (FDA- |
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. |
Palifermin |
Recombinant human keratinocyte growth |
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. |
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. |
AG-858 |
Vaccine; a |
Chronic myelogenous leukemia |
Seven of eight patients evaluated in a pilot study demonstrated responses (6/2)# |
|
||||
Antigenics Inc. |
Oncophage |
Vaccine; uses heat- |
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 |
SAHA |
Suberoylanilide |
Solid tumors, lymphomas myeloma and leukemias |
Phase I data showed SAHA can induce antitumor responses of substantial durability (6/3)# |
|
||||
AVI BioPharma |
AVI-4126 |
Neugene antisense |
Breast and prostate cancer |
Phase Ib data demonstrated the effectiveness of systemic drug delivery into solid tumor tissues (6/19) |
|
||||
Bioenvision |
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 |
Metastatic |
A Phase III trial failed to reach its two primary endpoints of time to disease progression and overall survival (6/17) |
|
||||
BioNumerik |
Karenitecin BNP1350 |
A member of a new class of lipophilic camptothecins; a silicon-containing |
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 |
OncoVEX GM-CSF |
Oncolytic virus that |
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. |
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 |
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 |
BMS-275291 |
A selective matrix metalloproteinas |
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 |
CT-2106 |
PG-CPT |
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 |
Xyotax |
Links paclitaxel, the |
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. |
-- |
A HER-2/neu |
Breast cancer |
Companies started a Phase I trial (6/3) |
|
||||
Corixa Corp. |
Bexxar (FDA- |
Tositumomab and |
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. |
Provenge |
Therapeutic vaccine |
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. |
APC8024 |
Vaccine designed to |
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- |
Oxy- |
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. |
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* |
-- |
5-fluorouracil |
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. |
XL119 |
DEAE- |
Bile duct |
Phase II data showed encouraging results relative to overall and progression-free survival (6/2)# |
|
||||
Exelixis Inc. |
XL784 |
Small-molecule |
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. |
Squalamine |
Angiogenesis inhibitor |
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. |
Avastin |
Bevacizumab; an |
Metastatic colorectal |
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- |
Rituxan (FDA- |
Rituximab; |
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. |
Herceptin (FDA- |
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), |
Tarceva |
Epidermal growth |
Bronchiolo- alveolar cell carcinoma |
Phase I/II data showed a 26% response rate in 50 patients (6/2)# |
|
||||
Genentech Inc. (NYSE:DNA), |
Tarceva |
Epidermal growth |
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. |
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. |
Genasense |
Oblimersen sodium |
Advanced |
Company initiated a clinical |
|
||||
GenVec Inc. |
TNFerade |
Delivers the human |
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 |
Satraplatin |
Member of the |
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 |
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 |
Zevalin |
Ibritumomab tiuxetan; monoclonal antibody |
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* |
IGN101 |
An antibody-based product; vaccine |
Epithelial |
Phase II data showed that the vaccine retained an immune response despite concomitant chemotherapies (6/3)# |
|
||||
ILEX Oncology |
Clofarabine |
A second-generation nucleoside analogue |
Acute |
Phase II data showed the overall response rate was 28% (6/2)# |
|
||||
ILEX Oncology |
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- |
Onco TCS |
Liposomal version of |
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 |
Advexin |
p53 gene therapy |
Bronchoalveolar lung carcinoma |
Phase I data showed the drug is safe and had evidence of therapeutic activity (6/3)# |
|
||||
Introgen |
INGN 241 |
Mda-7 therapeutic; a modified adenoviral |
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 |
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- |
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- |
Ontak (FDA- |
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- |
Ceplene |
Histamine |
Advanced metastatic melanoma |
Phase III data showed survival was achieved without adversely affecting quality of life (6/12) |
|
||||
Medarex Inc. |
MDX-010 |
A fully human |
Melanoma |
Phase II data showed an objective response rate of 21%, which included two complete tumor responses (6/25) |
|
||||
MethylGene Inc.* |
MG98 |
A second-generation antisense compound designed to inhibit the expression of DNA methyltransferase, an enzyme implicated in |
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 |
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- |
Velcade (FDA- |
Blocks the proteasome, |
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. |
Skeletal |
Designed to deliver |
Multiple myeloma |
Phase I/II data demonstrated an overall response rate of 64%, including a complete response rate of 35% (6/2)# |
|
||||
Onyx Pharma- |
BAY 43-9006 |
A RAF kinase |
Tumors |
Phase I data showed safety and antitumor activity (6/2)# |
|
||||
Pharmacyclics |
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* |
ES-285 |
Derived from the edible Arctic clam, Mactromeris polynyma |
Solid tumors |
Company entered Phase I trials (6/19) |
|
||||
Protein Design |
-- |
Anti-a5B1 integrin antibody |
Solid tumors |
Company initiated a Phase I trial (6/2) |
|
||||
Seattle Genentics |
SGN-30 |
Monoclonal antibody |
Hematologic malignancies |
Phase I data showed SGN-30 was safe with a favorable pharmacokinetic profile (6/2)# |
|
|
|||
Seattle Genetics |
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 |
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. |
Dacogen |
Decitabine for injection |
Dacogen |
Company began a Phase II trial of Dacogen in combination with Gleevec (6/13) |
|
||||
SuperGen Inc. |
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. |
Orathecin |
Rubitecan capsules; |
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. |
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- |
Pivanex |
Acts by inhibiting enzymes called histone deacetylases |
Non-small-cell lung cancer |
Company initiated a Phase IIb trial (6/30) |
|
||||
Transgene |
Ad-IFN |
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- |
VNP- |
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- |
VNP- |
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 |
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. |
Thrombo- |
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, |
Respiratory distress |
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. |
Liprostin |
A vasodilator and stimulator for new |
Peripheral artery occlusive disease |
Phase II data showed the first angioplasty case using Liprostin was successfully performed (6/16) |
|
||||
Esperion |
ETC-216 |
ApoA-1 Milano |
Acute coronary syndromes |
Phase II data showed the study met its primary efficacy objective of demonstrating statistically significant regression of atherosclerosis (6/26) |
|
||||
Esperion |
ETC-642 |
RLT peptide |
Cardiovascular disease |
Company began a Phase I trial (6/30) |
|
||||
Hemosol Inc. |
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. |
Alfimeprase |
A modified fibrolase that directly degrades fibrin when delivered through a catheter at the site of a blood clot |
Catheter |
Company initiated dosing in a Phase II trial (6/5) |
|
||||
Sunol Molecular Corp.* |
Sunol-cH36 |
A chimeric recombinant antibody |
Coronary |
Company began a Phase I trial (6/18) |
|
||||
Valentis Inc. |
Del-1 |
Angiogenesis product |
Peripheral |
Phase I data showed there were no observed severe adverse events from the drug and Del-1 was well tolerated (6/9) |
|
||||
XOMA Ltd. |
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 |
ATI022 |
A hydromorphone skin patch designed to deliver an opiate |
Severe pain |
Company began a Phase I trial (6/3) |
|
||||
Axonyx Inc. |
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 |
Altropane |
Radioimaging agent |
Parkinson's disease |
Company plans to conduct an additional Phase III trial (6/17) |
|
||||
Durect Corp. |
-- |
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- |
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; |
ABT-202 |
Ion channel |
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 |
Parkinson's disease |
Companies initiated a Phase II trial (6/16) |
|
||||
NicOx SA |
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 |
Xyrem (FDA- |
Sodium oxybate oral solution |
Excessive daytime sleepiness associated with narcolepsy |
Patient enrollment began for a second Phase IIIb trial (6/3) |
|
||||
Pain Therapeutics |
Oxytrex |
A combination of immediate-release oxycodone and low-dose naltrexone |
Chronic pain |
Company began a pivotal Phase III trial (6/30) |
|
||||
Pozen Inc. |
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 |
Depo- |
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) |
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DIABETES | ||||
Amylin Pharma- |
Exenatide |
Synthetic exendin-4 |
Type II |
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) |
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Auxilium |
Testim |
Testosterone gel |
Hypogonadism |
Clinical data showed men had significant improvements in sexual performance and lean body mass, as well as a decline in glucose levels (6/23) |
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Avanir Pharma- |
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) |
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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 |
Phase I/II data showed the compound was well tolerated with no serious adverse events and no injection-site irritation (6/11) |
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Emisphere Technologies Inc. (EMIS) |
-- |
Orally delivered eligen technology |
Type II |
Clinical data showed the technology induced clinically relevant activity in Type II diabetes (6/16) |
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Generex Biotechnology Corp. (Canada; GNBT) |
Oralin |
Oral insulin spray |
Type I and |
Company will begin Phase IIb studies (6/2) |
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Nektar |
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) |
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Thera- |
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) |
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INFECTION | ||||
Cubist Pharma- |
CAB-175 |
Parenteral cephalosporin |
Gram-positive and Gram-negative bacterial infections |
Company began a Phase I trial (6/24) |
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DepoMed Inc. (AMEX:DMI) |
Ciprofloxacin |
Newer formulation of Cipro using |
Urinary tract infection |
Company started a Phase III trial (6/3) |
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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) |
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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) |
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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) |
|
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Medarex Inc. (MEDX) |
MDX-010 |
A fully human anti-CTLA-4 antibody |
HIV |
Company began a Phase I trial (6/11) |
|
||||
NeuTec Pharma |
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)** |
|
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Pharmasset Inc.* |
Reverset |
A nucleoside analogue that retains activity against 3TC- and AZT-resistant HIV-1 |
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) |
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MISCELLANEOUS | ||||
Adolor Corp. (ADLR) |
Alvimopan |
Small-molecule opioid receptor antagonist |
Postoperative ileus |
Company completed enrollment in a Phase III trial (6/5) |
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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) |
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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) |
|
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Arriva Pharma- |
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 |
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. |
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 |
Periostat (FDA- |
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. |
rhIGF- |
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 |
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 |
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 |
-- |
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 |
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- |
Probuphine |
Delivers buprenorphine |
Opiate |
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) |
|
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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. | ||||
AMEX = American Stock Exchange; ASX = Australian Stock Exchange; CSE = Copenhagen Stock Exchange; FSE = Frankfurt Stock Exchange; LSE = London Stock Exchange; NYSE = New York Stock Exchange; OTC BB = Over-the-Counter Bulletin Board; SSE = Stockholm Stock Exchange; TSE = Toronto Stock Exchange. |