Company* |
Product |
Description |
Indication |
Status |
| | ||||
AUTOIMMUNE | ||||
Applied Molecular Evolution Inc. (AMEV) |
AME-527 |
Humanized monoclonal antibody that recognizes TNF-alpha with high |
Rheumatoid |
AME filed an IND for a Phase I/II trial to assess safety, biological effects and pharmacokinetics in 24 to 30 RA patients (11/18) |
|
||||
Celltech Group |
CDP 870 |
Pegylated |
Rheumatoid |
Celltech partner Pfizer Inc. is delaying study of the drug as it waits for data from ongoing Phase III trials, setting development back at least one year; Pfizer also wants to renegotiate terms (11/13) |
|
||||
Merrimack Pharmaceuticals |
MM-093 |
Recombinant version of human alpha-fetoprotein |
Autoimmune diseases |
Company completed dosing in a Phase I safety trial and is planning a pilot study in rheumatoid arthritis (11/19) |
|
||||
Repligen |
CTLA4-Ig |
Soluble form of T-cell regulatory protein |
Rheumatoid |
Published study showed drug in combination with methotrexate produced statistically significant improvements on ARC 20 scores vs. methotrexate alone; study included 339 patients and came from Bristol-Myers Squibb Co. (11/13) |
|
||||
Vertex |
Pralnacasan |
Oral inhibitor of |
Rheumatoid |
Companies discontinued a Phase IIb trial based on animal data showing liver abnormalities after nine months of high-dose treatment; two shorter-term Phase I trials continued (11/10) |
|
||||
CANCER | ||||
Allos |
PDX |
Antifolate compound |
Non-small-cell |
Phase I results in 10 patients showed drug in combination with docetaxel was active and well tolerated (11/18) |
|
||||
Allos |
RSR13 |
Efaproxiral; small |
Brain |
Results of a Phase III trial showed patients receiving whole-brain radiation therapy with RSR13 experienced a 17.6% increase in median survival vs. those getting WBRT without RSR13; Allos is planning an NDA (11/17) |
|
||||
American |
Abraxane |
Paclitaxel delivered via |
Metastatic |
Results from clinical trials showed the product allowed administration by 30-minute infusion vs. three hours with Taxol (11/18) |
|
||||
AnorMED Inc. |
AMD3100 |
Drug designed to block receptor-triggering movement of stem cells |
Stem cell |
AnorMED began its third Phase II trial of the product, a study in 10 non-Hodgkin's lymphoma patients who will get AMD3100 and G-CSF or G-CSF alone (11/21) |
|
||||
Antisoma plc |
R1549 |
Pemtumomab; |
Gastric cancer |
Company and partner F. Hoffmann-La Roche Ltd. released pilot Phase II data showing a broadened tolerability profile (11/6) |
|
||||
Ariad |
AP23573 |
Small molecule |
Glioblastoma |
Study showed low doses of drug resulted in a 40% reduction in the growth of brain tumor cell (11/14) |
|
||||
Aton Pharma |
SAHA |
Oral histone |
Refractory |
Aton presented Phase I data that showed evidence of antitumor activity (11/20) |
|
||||
Atrix |
Eligard 45mg |
Leuprolide acetate for injectable suspension; sustained-release |
Prostate cancer |
Atrix said it completed the pivotal study and found results consistent with other Eligard products; it is putting an NDA together (11/11) |
|
||||
Celgene |
Thalomid (FDA-approved) |
Thalidomide |
Various cancers |
Data presented on Thalomid as part of regimen for solid tumors showed positive results in prostate, renal-cell and neuroendocrine cancers (11/13) |
|
||||
Celgene |
Revimid (CC-5013) |
Immunomodulatory |
Myelodysplastic |
Results from 33 evaluable patients in Phase II trial showed 21 patients experienced an erythroid response (11/12) |
|
||||
Cell |
CT-2106 |
20S-camptothecin |
Cancers |
A Phase I trial of escalating doses in 19 patients showed no bladder toxicity; some evidence of activity was seen (11/20) |
|
||||
Dendreon |
Provenge |
Immunotherapy |
Androgen- |
Overview results from previously survival of 26.3 months in drug group vs. 19.3 months in placebo; Provenge is in a pivotal Phase III study (11/10) |
|
||||
Genentech Inc. (NYSE:DNA) |
Avastin |
Therapeutic antibody designed to inhibit |
Metastatic |
Phase II trial comparing Avastin and chemotherapy regimen vs. regimen alone showed survival benefit for Avastin, but not in a statistically significant manner; Genentech said it expected no delay in its already-filed BLA with the results (11/25) |
|
||||
Genentech Inc. (NYSE:DNA) |
Rituxan (FDA-approved) |
Rituximab; antibody |
Indolent non- |
Phase III study evaluating drug as maintenance therapy was ended after interim analysis showed trial met prespecified efficacy endpoint (11/13) |
|
||||
Genentech Inc. (NYSE:DNA) |
Rituxan (FDA-approved) |
Rituximab; antibody |
Large B-cell |
An abstract with initial Phase II data of study in combination with CHOP regimen showed prolongation in time to treatment failure (11/5) |
|
||||
GenVec |
TNFerade |
Contains TNF-alpha |
Cancers |
Presentation of results from various studies showing safety and activity against cancers (11/19) |
|
||||
Hybridon |
IMOxine (HYB2055) |
Immunomodulatory oligonucleotide |
Cancers |
Preliminary Phase I data showed the drug was well tolerated and produced clinical activity (11/20) |
|
||||
Introgen |
Advexin |
p53-based gene |
Head and neck |
Company started Phase II trial that will enroll 60 patients with squamous-cell carcinoma of the oral cavity and oropharynx who are undergoing surgery; patients also will get chemotherapy and radiotherapy (11/24) |
|
||||
Introgen |
Advexin |
Oral-rinse formulation |
Oral |
Company began a Phase I/II trial in which premalignant lesions will be treated for six months (11/19) |
|
||||
Medarex |
MDX-214 |
Recombinant human epidermal growth factor linked to a fully human antibody fragment |
Cancers that |
Medarex got OK for a Phase I/II study in up to 48 patients with relapsed or refractory cancers (11/24) |
|
||||
MGI Pharma |
Irofulven (MGI 114) |
Compound from family |
Cancers |
Data from two Phase I studies showed the agent in combination with chemotherapy drugs demonstrated clinical activity in a variety of cancers (11/18) |
|
||||
NeoPharm Inc. (NEOL) |
LE-SN38 |
Liposomal formulation |
Cancers |
Preliminary Phase I data showed the drug was safe and resulted in disease stabilization in some patients (11/20) |
|
||||
NeoPharm |
IL13-PE38QQR |
Tumor-targeting agent designed to deliver |
Malignant |
Results from Phase I/II studies in more than 75 patients showed evidence of the killing of cancer cells and encouraging survival results (11/17) |
|
||||
Novuspharma |
Pixantrone (BBR 2778) |
Anthracycline agent |
Aggressive |
Preliminary results of Phase I trial of Pixantrone in a variant of the CHOP regimen showed an overall response rate of 80% (11/10) |
|
||||
Onyx |
BAY 43-9006 |
Signal transduction |
Advanced |
Updated Phase II data showed 34 patients (68%) did not have tumor progression at 12 weeks (11/20) |
|
||||
OSI |
Tarceva |
Erlotinib; small-molecule HER1/EGFR inhibitor |
Advanced non- small-cell lung cancer |
OSI initiated dose-escalation Phase II study in patients who failed prior chemotherapy (11/10) |
|
||||
Oxigene |
Combretastatin A4 Prodrug |
Vascular-targeting drug designed to block flow of blood to tumor |
Anaplastic carcinoma |
The drug will be tested in combination with chemotherapy and radiation in about 33 newly diagnosed patients (11/3) |
|
||||
Pharmacyclics |
Xcytrin |
Motexafin gadolinium; small-molecule texaphyrin |
Advanced head |
Phase I data from a chemoradiation regimen showed 8 of 9 patients demonstrated complete response (11/13) |
|
||||
Pharmacyclics |
Xcytrin |
Motexafin gadolinium; small-molecule texaphyrin |
Relapsed |
Company initiated trial to gauge safety and efficacy of increasing doses of drug in combination with Rituxan and Zevalin, two approved drugs (11/6) |
|
||||
Sonus |
Tocosol Paclitaxel |
Formulation of paclitaxel using Sonus' delivery |
Various cancers |
An update of Phase IIa results in three cancers showed the drug was safe and well tolerated, and demonstrated antitumor activity (11/19) |
|
||||
SuperGen |
Dacogen |
Decitabine for injection |
Chronic myelogenous leukemia |
Preliminary results from 27 patients who failed Gleevec treatment showed drug appeared active against the disease (11/14) |
|
||||
SuperGen |
Nipent (FDA-approved) |
Pentostatin for injection |
B-chronic lymphocytic leukemia |
Preliminary results from study of Nipent in combination therapy showed all 15 patients eligible for analysis experienced a response, with four of them showing complete response (11/14) |
|
||||
Telik |
Telcyta (TLK286) |
Small-molecule prodrug activated by the enzyme GST P1-1 |
Cancer |
Data presented from three Phase I/IIa studies showed evidence of efficacy of the drug in combination with other cancer drugs (11/19) |
|
||||
Therion |
Prostvac-VF |
Immunotherapy that |
Prostate cancer |
Therion began a Phase II trial designed to enroll 120 patients with metastatic disease; progression-free survival is the primary endpoint (11/19) |
|
||||
YM |
Tesmilifene |
Small-molecule chemopotentiator |
Metastatic |
Company got FDA OK to start pivotal Phase III trial comparing combination regimens with an endpoint of survival (11/4) |
|
||||
CARDIOVASCULAR | ||||
Aderis |
Selodenoson |
Selective adenosine A1 agonist |
Control of heart |
Phase II data presented by investigator showed all six doses in 63-patient study demonstrated statistically significant decrease in ventrical rate compared to placebo (11/10) |
|
||||
Alexion |
Pexelizumab |
Terminal complement inhibitor |
Reduction of infarction |
Final Phase III results in patients undergoing coronary artery by- pass graft surgery did not demonstrate statistical significance in the primary endpoint, but did show reduction in secondary analyses (11/10) |
|
||||
Avant Immunotherapeutics Inc. (AVAN) |
TP10 |
Soluble complement |
Inhibiting complement- mediated inflammation |
Data from 564 high-risk patients in Phase II trial in men undergoing cardiac surgery involving cardiopulmonary bypass showed drug reduced in a statistically significant manner death, heart attack and other endpoints (11/11) |
|
||||
Biogen |
Adentri |
Adenosine receptor antagonist |
Heart failure |
Phase II data showed no safety concerns; the study showed increases in sodium excretion without reduction in kidney function (11/10) |
|
||||
Esperion |
ETC-216 |
ApoA-I |
Atherosclerosis |
Phase II results in 47 patients showed a statistically significant reduction in plaque volume compared to baseline volumes (11/4) |
|
||||
Genentech Inc. (NYSE:DNA) and Boehringer Ingelheim GmbH (Germany) |
TNKase/ Metalyse (FDA-approved) |
Tenecteplase; |
Acute myocardial |
Companies will begin 4,000-patient Assent 4 PCI trial of drug in combination with percutaneous coronary intervention; the primary endpoint is death, cardiogenic shock or congestive heart failure within 90 days (11/11) |
|
||||
Genentech |
TNKase (FDA-approved) |
Tenecteplace; |
Sudden cardiac arrest |
University researcher presented results of a pilot study in 50 patients showing agent has promise in that indication (11/9) |
|
||||
GenVec |
-- |
Myoblast-cell |
Myocardial infarction/ congestive heart failure |
Data from 27 patients in Phase I study demonstrated the safety and feasibility of the treatment (11/12) |
|
||||
Genzyme |
Ad2/HIF-1 alpha/VP16 |
Gene therapy using |
Critical limb ischemia |
Phase I trial in which 21 patients were treated showed therapy appeared safe and suggested bioactivity (11/11) |
|
||||
Hollis-Eden Pharmaceuticals |
HE2200 |
Immune-regulating |
Significant dyslipidemia |
Phase II results showed the drug did not have a statistically significant effect on lipids (11/4) |
|
||||
The Medicines |
Angiomax (FDA-approved) |
Bivalirudin; direct |
Coronary angioplasty |
One-year data from REPLACE-2 trial comparing GPIIb/IIIa inhibitors plus Angiomax or heparin showed mortality advantage in Angiomax arm (11/11) |
|
||||
Medicure |
MC-1 |
Cardioprotective agent |
Coronary artery bypass |
Company got approval in the U.S. and Canada for 900-patient MEND- CAPG study to assess ischemic reperfusion and neuroprotective effects (11/20) |
|
||||
Nuvelo |
Alfimeprase |
Modified fibrolase |
Chronic peripheral |
Phase I trial showed drug was safe and well tolerated with no drug-related adverse events (11/18) |
|
||||
The |
Aliskiren |
Renin inhibitor |
Hypertension |
Partner Novartis AG presented results showing drug was as good or better as an angiotensin blocker in 650-patient study; Phase III is being planned (11/19) |
|
||||
Synthetic Blood International |
Oxycyte |
Perfluorocarbon-based blood substitute |
For use in stroke, heart attack, cancer and as |
Company began a double-blind Phase I trial that was expected to be completed by the end of the year (11/3) |
|
||||
Telik |
Telintra (TLK199) |
Small-molecule drug |
Myelodysplastic |
Interim results from Phase I/IIa trial showed nine of 16 patients had improvements in at least one of the three blood lineages (11/19) |
|
||||
United |
Remodulin (FDA-approved) |
Treprostinil sodium for injection |
Pulmonary |
Long-term improvements and survival benefit were shown in 39 patients treated for up to 54 months (11/10) |
|
||||
V.I. Technologies |
Inactine |
Pathogen reduction |
Blood substitute |
Data safety monitoring comittee recommended the halting of enrollment in a Phase III trial due to concern over antibody responses (11/17) |
|
||||
CENTRAL NERVOUS SYSTEM | ||||
Avigen |
AV201 |
Delivers gene for |
Advanced Parkinson's |
Avigen filed an IND seeking clearance to enter clinical testing; it next would present the protocol to a review board at the University of California at San Francisco (11/5) |
|
||||
Guilford Pharmaceuticals |
Aquavan Injection |
Water-soluble prodrug |
Sedation/ |
Results from two Phase II trials showed the product provided rapid onset and recovery without serious adverse events; gastroenterolists in a 77-patient study reported 94% of patients were adequately sedated (11/6) |
|
||||
Neurochem Inc. (Canada; NRMX) |
Alzhemed |
Small molecule designed |
Alzheimer's |
Company said open-label Phase II extension study showed drug improved cognitive function; results are from first 10 of 33 patients in study (11/4) |
|
||||
Neurocrine |
Indiplon |
Immediate-release formulation of non- |
Insomnia |
Phase I trial in elderly patients showed they did not experience next-morning residual effects compared to placebo (11/10) |
|
||||
Repligen |
RG1068 |
Synthetic human |
CNS disorders |
Repligen began a study in human volunteers to assess safety an tolerability when administered via intravenous injection (11/3) |
|
||||
XenoPort Inc.* |
XP13512 |
Prodrug of the |
CNS disorders |
XenoPort began a Phase I study to demonstrate safety and pharma- cokinetic properties of drug, whichis designed to improve properties of gadapentin (11/10) |
|
||||
DIABETES | ||||
Amylin |
Exenatide |
Synthetic exendin-4 |
Type II diabetes |
Second of three Phase III trials showed statistically significant reductions in the glucose-control endpoint (11/10); third study also hit glucose-control endpoint; submission for approval expected in mid-2004 (11/25) |
|
||||
Emisphere |
Oral insulin tablet |
Prototype of product prepared with an |
Type II diabetes |
Phase I results showed the oral insulin tablets exhibited a rapid onset of action and reduced post-prandial glucose excursion (11/10) |
|
||||
Generex |
Oralin |
Bucal delivery system for insulin |
Type II diabetes |
Company presented data from study of 22 patients showing Oralin increased serum insulin levels and improved glucose control when compared to oral agents (11/6) |
|
||||
Generex |
Oralin |
Bucal delivery system for insulin |
Type II diabetes |
Company said it was beginning studies of Oralin in adolescents (11/5) |
|
||||
INFECTION | ||||
Acambis plc (UK;ACAM) |
ChimeriVax West Nile |
Vaccine for West Nile |
West Nile virus |
Acambis started a Phase I trial in 60 healthy volunteers to test safety, tolerability and immun-ogenicity (11/6) |
|
||||
Advanced Viral Research Corp. |
AVR118 (Product R) |
Peptide-nucleic acid immunomodulator |
Cachexia from AIDS wasting |
Results from 15 patients in Phase I/II trial showed positive results in appetite, weight gain and quality of life (11/10) |
|
||||
Enzo Biochem Inc. (NYSE:ENZ) |
HGTV43 vector |
Gene construct using |
HIV |
The firm's Enzo Therapeutics subsidiary go the final approval to start a Phase I/II study at the New York Presbyterian Hospital Cornell Medical College (11/6) |
|
||||
Gilead Sciences |
Emtricitabine |
Nucleoside analogue |
Hepatitis B |
Preliminary results from 48-week Phase III trial (Study FTCB-301) showed improvement in liver histology vs. placebo (11/25) |
|
||||
Immtech |
DB289 |
Oral antiviral agent |
Malaria |
Immtech said initial results from a Phase IIa trial in Thailand showed the drug was safe and effective; full results are due this month (11/18) |
|
||||
Rigel |
R803 |
Small-molecule non- nucleoside HCV |
Hepatitis C |
Rigel began an escalating single-dose safety study of the drug (11/12) |
|
||||
Stressgen Biotechnologies |
HspE7 |
Fusion product consisting |
Recurrent respiratory papillomatosis |
Interim Phase II data from 50% of children in study showed statistically significant improvement in length of interval between surgeries needed (11/3) |
|
||||
Tanox |
TNX-355 |
Humanized anti-CD4 monoclonal antibody |
HIV |
Preliminary analysis of 22 patients in Phase Ib trial showed continuing evidence of tolerability and antiretroviral activity (11/11) |
|
||||
VaxGen |
AIDS/Vax B/E |
Vaccine made of recombinant |
HIV |
Phase III trial in 2,546 injecting drug users in Thailand failed to demonstrate efficacy for the primary or secondary endpoints, a result seen in earlier Phase III trial (11/12) |
|
||||
MISCELLANEOUS | ||||
Advanced |
Ferumoxytol |
Intravenous iron- replacement therapeutic |
Anemia in chronic |
Data presented from early studies showed the drug has promise as a therapy and could have dosing advantages (11/17) |
|
||||
Amgen |
Aranesp (FDA-approved) |
Darbepoetin alfa; a recombinant |
Anemia in chronic |
Results of a 98-patient study suggested the drug could be dosed once per month (11/16) |
|
||||
Amgen |
Cincalcet |
Oral calcimimetic that modulates activity of the calcium-sensing receptor |
Secondary hyperpara- thyroidism |
Amgen presented Phase III results in patients with HPT associated with kidney disease; positive results were seen relative to parathyroid hormone levels and other endpoints; Amgen already filed an NDA (11/15) |
|
||||
Avanir Pharmaceuticals Inc. (AMEX:AVN) |
AVP 13358 |
Molecule designed to |
Asthma/allergy |
Phase I data showed the product was well tolerated at four oral dose levels (11/21) |
|
||||
BCY LifeSciences Inc. (Canada; TSE:BCY) |
DCF 987 |
An inhaled low-molecular- weight dextran |
Cystic fibrosis |
Phase II results showed the drug was well tolerated and showed positive signs on disease markers, thus warranting further development (11/20) |
|
||||
BioMarin Pharmaceutical Inc. (BMRN) |
Aryplase |
Enzyme replacement |
Mucopoly- saccharidosis-VI |
BioMarin said long-term data from Phase I and II trials indicated the drug generally was well tolerated and that patients continued to benefit (11/6) |
|
||||
Discovery Laboratories Inc. (DSCO) |
Surfaxin |
Engineered version of |
Respiratory |
Company reported that Surfaxin met both primary endpoints vs. a cow-derived surfactant in a pivotal Phase III trial in premature infants; an NDA is expected in Q1:04 (11/25) |
|
||||
Encysive Pharmaceuticals Inc. (ENCY) and GlaxoSmithKline plc (UK) |
Argatroban (FDA-approved) |
A direct thrombin |
End-stage renal disease |
An open-label study involving 13 patients on hemodialysis showed no serious adverse or bleeding events (11/17) |
|
||||
GenVec |
AdPEDF |
Product that produces |
Wet age-related |
Update on progress of 18 patients enrolled to date in Phase I trial showed it was well tolerated with no dose-limiting toxicities (11/17) |
|
||||
Genzyme Corp. (GENZ) |
Synvisc (FDA-approved) |
Hylan G-F20; an elastoviscous hylan therapeutic |
Pain due to osteoarthritis of |
Genzyme began a 300-patient pivotal study comparing Synvisc to an alternative treatment in that indication (11/24) |
|
||||
GTx Inc.* |
Acapodene |
Toremifene citrate; a |
To reduce incidence |
Company began a pivotal Phase III trial in men with advanced prostate cancer; the 24-month, placebo-controlled trial is expec- ted to include 1,200 patients (11/10) |
|
||||
Guilford Pharmaceuticals |
GPI 1485 |
Neuroimmunophilin |
Post-prostatectomy erectile dysfunction |
Guilford began a Phase II trial designed to enroll 240 prostate cancer patients and last one year (11/18) |
|
||||
Micrologix Biotech Inc. (Canada; TSE:MBI) |
MBI 594AN |
Antimicrobial cationic peptide delivered |
Acne |
Company achieved statistically significant results vs. vehicle in reducing lesion parameters in a Phase IIb trial (11/17) |
|
||||
Miravant Medical Technologies Inc. (MRVT) |
SnET2 |
Photodynamic therapy |
Wet age-related macular degeneration |
Analyses from two Phase III trials showed therapy was safe and well tolerated; company is preparing an NDA (11/17) |
|
||||
Nabi Biopharmaceuticals (NABI) |
PhosLo |
Calcium acetate |
Control of serum and calcium phosphorous |
A study in 100 patients on hemo- dialysis with end-stage renal disease showed the product was more efficacious than Renagel (11/14) |
|
||||
Nastech Pharmaceutical Co. Inc. (NSTK) |
PYY 3-36 |
Nasal delivery of high- affinity Y2 receptor |
Obesity |
Phase I study in 15 patients showed successful nasal delivery and that the product was well tolerated (11/13) |
|
||||
Pain Therapeutics Inc. (PTIE) |
PTI-901 |
Low-dose naltrexone, designed to restore the balance of opioid activity |
Irritable bowel syndrome |
Company started a Phase III program that includes two trials, one with 600 men and one with 600 women (11/25) |
|
||||
Pain Therapeutics Inc. (PTIE) |
Remoxy (formerly PTI-821) |
Long-acting oxycodone capsule |
Oxycodone abuse |
Company said it planned to initiate a Phase I/II pharmacokinetics study in the first quarter of 2004 (11/5) |
|
||||
Palatin Technologies Inc. (AMEX:PTN) |
PT-141 |
Intranasally delivered melanocortin agonist |
Male sexual dysfunction |
Phase IIb trial met primary and secondary endpoints in area of erectile dysfunction, and established dosing (11/1) |
|
||||
|
Progenics Pharmaceuticals
|
MNTX |
Methylnaltrexone; |
Post-operative |
Company began Phase I trial of oral formulation of drug in 35 healthy volunteers (11/21) |
|
||||
Transkaryotic Therapies Inc. (TKTX) |
Iduronate-2- sulfatase |
Enzyme replacement |
Hunter syndrome |
TKT said long-term data from Phase I/II trial showed I2S treatment was clinically active; TKT is advancing drug into pivotal study (11/6) |
|
||||
| | ||||
Notes: | ||||
* Privately held | ||||
Unless otherwise noted, the stock symbols listed for public companies are on the Nasdaq market. | ||||
AMEX = American Stock Exchange; LSE = London Stock Exchange; NYSE = New York Stock Exchange; OTC BB = Over-the-Counter Bulletin Board; TSE = Toronto Stock Exchange. | ||||
