Non-U.S. Clinical Trials, Regulatory Submissions, Recommendations And Approvals: May 2005
Company* | Product | Description | Indication | Status |
AUTOIMMUNE | ||||
Serono SA | Raptiva (FDA-approved) | Efalizumab; humanized antibody designed to block T cells implicated in psoriasis | Psoriasis | 73% of patients who remained on therapy for 36 months achieved a 75% or greater improvement of PASI 75; also, the CLEAR trial demonstrated that high-need patients benefit from treatment (5/23) |
CANCER | ||||
Adherex | Exherin (ADH-1) | Cadherin antagonist; small peptide, tumor/ vascular-targeting agent of repeated doses (5/11) | Various tumor types | Began Phase II trial in up to 60 patients in Canada to evaluate the antitumor activity and tolerability |
Alizyme plc | ATL-104 | Recombinant plant protein designed to stimulate growth of cells that line the gastrointestinal tract | Mucositis in cancer patients | Stage one of a Phase IIa trial demonstrated safety in 27 patients (5/26) |
Antisoma plc | AS1404 | Vascular-targeting agent designed to disrupt tumor blood vessels | Cancer | Phase I trial in New Zealand demonstrated tolerability and effects on tumor blood vessels (ASCO) |
Antisoma plc | AS1405 (formerly AngioMab) | Radiolabeled antibody that binds to a protein found around new tumor blood vessels | Brain cancer | The company dropped the drug and suspended trials (5/5) |
Astex | AT7519 | Cell-cycle inhibitor | Refractory solid tumors | The company is starting a Phase I trial in patients (5/23) |
Ardana plc | Teverelix LA | Gonadotropin-releasing hormone antagonist | Advanced prostate cancer | Phase II trial in 14 patients showed drug can attain and maintain suppression of testosterone to castration levels (5/12) |
Biomira Inc. | BLP25 | Therapeutic vaccine encapsulating a sequence of the MUC1 cancer mucin in a liposomal delivery system | Non-small-cell lung cancer (Stage IIIb) | Phase IIb data showed the median survival of best supportive care patients was 13.3 months; at two years, median survival had not been reached in vaccine patients (ASCO) |
Cyclacel Group | Seliciclib (CYC202) | Small-molecule inhibitor of multiple CDK cell- cycle targets | Non-small-cell lung cancer | Initial data from Phase IIa trial in Europe showed the feasibility of drug with gemcitabine and cisplatin, and showed activity (ASCO) |
Immuno- | Uvidem | Vaccine consisting of mature dendritic cells loaded with lysates of tumor cell lines | Melanoma | Phase II trial in 60 Stage IV patients in France and Australia demonstrated tolerability and immune responses (ASCO) |
Lorus | Virulizin | Immunotherapy agent | Pancreatic cancer | Phase III data showed how Virulizin induced production of IL-17E to enhance antitumor activity (ASCO) |
Lorus | GTI-2040 | Antisense oligonucleotide complementary to the R2 component of ribonucleo- tide reductase | Non-small-cell lung cancer | Clinical data showed GTI-2040 in combination with docetaxel had no dose-limiting toxicities (ASCO) |
Meditech | HyDox and HyFive | Products containing hyaluronic acid with doxorubicin and 5-FU, respectively | Cancers | Phase I trials demonstrated safety of the drugs; antitumor responses were noted in several patients (5/19) |
MethylGene Inc. | MGCD0103 | Isotypic-selective small- molecule inhibitor of histone deacetylase | Non-Hodgkin's lymphoma and advanced solid tumors | Phase I data demonstrated safety, tolerability and pharmacokinetics (ASCO) |
Novagali | -- | Oral formulation of paclitaxel | Advanced cancers | Began Phase I trial in the Netherlands to assess tolerability and pharmacokinetics (5/31) |
Onyvax | Onyvax-P | Cell vaccine; an immunotherapy | Metastatic, hormone- resistant prostate cancer | Second cohort of 20 patients in Phase II trial demonstrated benefits on progression-free survival and PSA velocity (ASCO) |
Oxford | TroVax | Vaccine that delivers an antigen (5T4) using a pox- virus vector | Colorectal cancer | Phase II data show that maximum antibody levels targeted against the 5T4 tumor antigen are significantly higher than in the Phase I/II trial (ASCO) |
PharmaMar SA | Yondelis | Trabectedin; ET-743; derived from the sea squirt Ecteinascidia turbinata | Advanced prostate cancer | Clinical data suggest the compound is effective in reducing PSA and alleviating pain in about 12% of men with advanced prostate cancer (ASCO) |
PharmaMar SA | Kahalalide F | Peptides isolated from the Hawaiian mollusk, Elysia rufescens | Solid tumors | Phase I data showed a complete response in a patient with melanoma, and stable disease lasting more than three months in lung, colon and unknown-origin adenocarcinoma patients (ASCO) |
Pharmexa A/S(Denmark; CSE:PHARMX) | GV1001 | Peptide vaccine | Non-small-cell lung cancer | Phase I/II data showed no serious side effects and an immune response in 13 out of 24 patients completing four weeks of treatment (ASCO) |
Progen | PI-88 | Anti-angiogenesis drug also designed to inhibit tumor-promoting factors | Melanoma | Pilot Phase II trial demonstrated acceptable safety; of 37 patients, one had a partial response and 10 had stable disease (ASCO) |
Santaris | SPC2996 | LNA-based RNA antagonist designed to reduce levels of the Bcl-2 protein | Chronic lymphocytic leukemia | Began Phase I/II trial in Europe in patients who don't respond to chemotherapy (5/19) |
Viventia Biotech | Proxinium | Antibody fragment conjugated with a cancer- killing payload | Refractory head and neck cancer | Clinical data showed the compound has a good safety profile and can produce encouraging efficacy results (ASCO) |
Wilex | Rencarex (WX-G250) | Chimeric monoclonal IgG1 antibody that binds to the MN cell-surface antigen | Metastatic renal-cell cancer | Patients who responded to treatment in a Phase II trial showed a survival benefit following extended treatment (ASCO) |
YM | TheraCIM h-R3 | Humanized anti-epidermal growth factor receptor monoclonal antibody | High-grade malignant glioma | 21 of 24 patients in a Phase I/II trial in Cuba achieved disease stabilization or an objective response (ASCO) |
CARDIOVASCULAR | ||||
Myogen Inc. | Ambrisentan | Type-A selective endothelin receptor antagonist | Pulmonary arterial hypertension | The product was granted orphan designation in Europe for PAH and chronic thromboembolic pulmonary hypertension (5/2) |
Pharming | rhC1INH | Recombinant human C1 inhibitor | Hereditary angioedema | Phase II/III trials in Europe demonstrated rapid time to beginning of relief and time to resolution of HAE attacks(5/2) |
CENTRAL NERVOUS SYSTEM | ||||
Corcept | Corlux (mifepristone) | Oral GR-II antagonist with potential mitigating effects on cortisol | Psychotic major depression | Began third Phase III trial, a study in Europe (Corcept 09) to evaluate the safety and efficacy in up to 280 patients (5/4) |
Cortex | CX717 | Ampakine analogue | Sleep deprivation | Trial in the UK in 16 people showed increased wakefulness and improved performance vs. placebo (5/2) |
Cytos | CAD106 | Immunotherapeutic designed to induce antibodies against the beta-amyloid protein | Alzheimer's disease | Partner Novartis Pharma AG is starting a Phase I trial in Sweden that will assess safety, tolerability and antibody responses in 60 patients (5/18) |
Cytos | CYT002-NicQb | Therapeutic vaccine that induces nicotine-specific antibodies that bind nicotine | Smoking cessation | Phase II trial in 341 smokers in Switzerland showed a clear correlation between antibody levels and abstinence rates (ASCO) |
Enkam Pharmaceuticals | FGLL | Synthetic peptide that mimics the neural cell-adhesion molecule | Alzheimer's disease | Phase I trial in 24 healthy volunteers demonstrated safety and tolerability (5/18) |
Myriad | Flurizan | Selective amyloid beta 42 lowering agent | Alzheimer's disease | Phase II trial in 189 patients in the UK and Canada failed to demonstrate statistical significance, but positive trends were seen (5/2) |
DIABETES | ||||
Generex | Orallyn | Oral insulin spray formulation | Type I and II diabetes | The product was approved in Ecuador; PharmaBrand SA will market the product there (5/3) |
Actelion Ltd. | Palosuran | Urotensin-II receptor antagonist | Diabetic nephropathy | Efficacy data from proof-of-concept study did not support initiation of a full clinical development program (5/23) |
INFECTION | ||||
BioAlliance | Miconazole Lauriad | Oral, bioadhesive buccal tablet containing the antifungal miconazole | Oropharyngeal candidiasis | Phase III trial in France and North Africa demonstrated efficacy in head and neck cancer patients with 10 times less drug than the miconazole oral gel comparator (ASCO) |
BioInvent | BI-201 | Human antibody that binds to the TAT protein | HIV | Starting a Phase I/II trial in the UK to evaluate safety, tolerability and pharmacokinetics in 36 previously untreated patients (5/18) |
Immtech | DB289 | Oral, dicationic antiviral agent | Malaria | Began Phase IIb trial in 120 patients in Thailand that will test the drug alone and with artesunate (5/11) |
Nabi Bio-pharmaceuticals | StaphVAX | Staphylococcus aureus polysaccharide conjugate vaccine | To prevent S. aureus infections | Began Phase II trial in the UK to evaluate safety and antibody levels in 200 patients undergoing orthopedic surgery with a prosthetic device (5/17) |
MISCELLANEOUS | ||||
Aastrom | Tissue Repair Cells | Autologous bone marrow-derived adult stem and progenitor cells | Severe long bone non- union fractures | Feasibility trial in Spain showed clinical and functional healing in all six patients treated (5/17) |
Acologix Inc.* | AC-100 (Dentonin) | Synthetic peptide derived from a protein produced by bone and dental cells | For use in dental procedures | Began a Phase II periodontal trial in Serbia-Montenegro (5/25) |
Allergy | -- | Ragweed allergy vaccine | Ragweed allergy | Began a Phase II trial in Canada to assess safety and efficacy in 240 patients (5/10) |
Ardana plc | Teverelix LA | Gonadotropin-releasing hormone antagonist | Benign prostatic hyperplasia | Phase II trial in 81 patients showed a statistically significant decrease in prostatic symptoms (5/26) |
Cytos | CYT009-GhrQb | Therapeutic vaccine designed to produce a specific anti-ghrelin response | Obesity | Began a Phase I/II trial in 112 obese subjects to evaluate safety, tolerability and exploratory efficacy (5/11) |
DeCode | -- | Compound that targets a gene implicated in development of asthma | Asthma | Began a Phase II trial in 160 patients with the at-risk variants of the gene (5/18) |
Eyetech | Macugen (FDA-approved) | Pegaptanib sodium injection; pegylated anti-VEGF aptamer | Wet age-related macular degeneration | The product was approved in Canada for treating subfoveal choroidal neovascularization secondary to neovascular AMD (5/5) |
Insense Ltd.* | Oxyzyme | System designed to clean a wound, produce oxygen and release small amounts of iodine | Chronic wounds | Data from clinical trials showed improvement and healing in a number of wounds in four weeks (5/23) |
Insmed Inc. | SomatoKine | Composition of insulin- | Growth hormone- insensitivity syndrome | Pivotal Phase III trial in 29 patients met its primary endpoint of change in height velocity after six months (5/31) |
InterMune | Pirfenidone | Small molecule believed to inhibit collagen synthesis, down-regulate profibrotic cytokines and decrease fibroblast proliferation | Idiopathic pulmonary fibrosis | 12-month Phase II trial in 107 patients was stopped at nine months after interim analysis suggested favorable effects of pirfenidone on acute exacerbations and other efficacy parameters; Shionogi & Co. Ltd. ran the trial (5/2) |
Karo Bio | KB2115 | Compound that stimulates the thyroid hormone receptor | Obesity and related conditions | Got approval for clinical studies of the product; details were not disclosed (5/11) |
Manhattan | Oleoylestrone | Oral therapeutic for weight loss | Obesity | Completed Phase Ia trial in Switzerland and began Phase Ib trial there to evaluate safety and tolerability of defined doses (5/4) |
NexMed Inc. | Femprox | Alprostadil cream | Female sexual arousal disorder | 400-patient trial in China demonstrated statistically significant arousal success rate vs. placebo (5/23) |
Threshold | TH-070 | lonidamine; an indazole-3-carboxylic acid | Benign prostatic hyperplasia | Follow-up data from Phase II trial in Italy showed BPH symptoms remained significantly improved six months following treatment (5/19) |
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Notes: | ||||
* Privately held. | ||||
ASCO = Data were presented at the American Society of Clinical Oncology meeting May 14-17. | ||||
MAA = Marketing authorization application; EMEA = European Medicines Agency. | ||||
Unless otherwise noted, the stock symbols listed for public companies are on the Nasdaq market. | ||||
AIM = Alternative Investment Market; AMEX = American Stock Exchange; ASX = Australian Stock Exchange; CSE = Copenhagen Stock Exchange; LSE = London Stock Exchange; NYSE = New York Stock Exchange; OTC BB = Over-the-Counter Bulletin Board; SSE = Stockholm Stock Exchange; SWX = Swiss Stock Exchange; TSE = Toronto Stock Exchange. | ||||