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Clinical Trials

February 16 2011
Clinical Trials & Patents
Lorus Therapeutics Inc. (Toronto, ON) announces the enrollment of the first cancer patient in a Phase 1 clinical study evaluating its small molecule anticancer drug candidate LOR-253.
Allon Therapeutics Inc. (Vancouver, BC) has initiated a Phase 2/3 clinical trial to evaluate the company’s lead neuroprotective drug candidate davunetide as a potential treatment for progressive supranuclear palsy (PSP), a rapidly-progressing and fatal degenerative brain disease. On January 4, 2011,

September 27 2010
AFMC supports CIHR recommendation regarding clinical trials on liberation procedure for MS
The Association of Faculties of Medicine of Canada (AFMC), along with other organizations in Canada including the Multiple Sclerosis Society of Canada and the Canadian Institutes for Health Research, is in strong support of rigorous scientific research to determine the possible link between blood vessel anomalies and multiple sclerosis and the potential benefits of surgical intervention to relieve its symptoms.

April 20 2010
Clinical Trials & Patents
Stem Cell Therapeutics Corp. (Calgary, AB) has received a No Objection Letter from Health Canada.
The U.S. FDA has advised YM BioSciences Inc. (Mississauga, ON) that it may begin enrolling patients.

April 20 2010
Æterna Zentaris reports positive opinion for orphan medicinal product designation for Perifosine
Æterna Zentaris Inc. announces it has received a positive opinion for orphan medicinal product designation for its compound perifosine from the Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency.

April 20 2010
Diagnocure’s PCA3 prostate cancer marker can help guide repeat prostate biopsy decisions
DiagnoCure, Inc., a Québec-based life sciences company commercializing cancer diagnostic tests and delivering laboratory services, announced the clinical utility of the PROGENSA® PCA3 test, developed by its partner Gen-Probe, was confirmed in two large worldwide studies, conducted in patients in GlaxoSmithKline’s REDUCE trial of dutasteride.

February 16 2010
Two highest doses removed from AD251 Phase II trial, lowest dose continues as planned
Elan Corporation, plc and Transition Therapeutics, Inc. have notified clinical investigators of modifications to the Phase II study AD201 and open label extension study AD251 for ELND005, a compound being developed for the potential treatment of Alzheimer’s disease.

February 16 2010
Medicago reports positive Phase I results for its Avian Flu pandemic vaccine
Medicago Inc. reports positive interim results from a Phase I human clinical trial with its H5N1 Avian Influenza vaccine candidate.

January 26 2010
Clinical Trials & Patents
The Data Safety Monitoring Board has advised Stem Cell Therapeutics Corp. (SCT) (Calgary, AB) that a regularly scheduled safety analysis has been completed
Lorus Therapeutics Inc. (Toronto, ON) announces that its Phase II clinical trial
Æterna Zentaris Inc. (Québec City, QC) announces positive efficacy data from a Phase 2 study

January 08 2010
Resverlogix commences Phase 2 Atherosclerosis clinical trial
Resverlogix Corp. has begun dosing patients in its US Phase 2 clinical trial lead by Cleveland Clinic. This trial will examine RVX-208, Resverlogix's oral small molecule therapy for the treatment of atherosclerosis, in patients with stable coronary artery disease (CAD).

December 18 2009
Æterna Zentaris terminates agreement with Sanofi-aventis U.S.
Æterna Zentaris Inc. announces the termination of its agreement with Sanofi-aventis U.S. dated March 5, 2009 for the development, commercialization and licensing of cetrorelix in benign prostatic hyperplasia (BPH) for the U.S. market, following the company's announcement of the results for its European Phase 3 study for cetrorelix in BPH.

December 03 2009
Clinical Trials & Patents
Medicago Inc. has initiated a Phase I human clinical trial
Oncolytics Biotech Inc. announces that the Cancer Therapy & Research Center at the University of Texas Health Science Center (CTRC) has started patient enrolment
GeneNews Limited has been granted a U.S. patent for its core platform technology

December 03 2009
Oncolytics Biotech Inc. reaches special protocol assessment agreement with FDA on design of phase 3 trial for Reolysin(R) in head and neck cancers
Oncolytics Biotech Inc. has reached an agreement with the U.S. Food and Drug Administration (FDA) under the Special Protocol Assessment (SPA) process for the design of a Phase 3 trial examining Reolysin in combination with paclitaxel and carboplatin in patients with platinum-refractory head and neck cancers.

December 03 2009
Pharma Notes
Dalton Pharma Services(Toronto, ON) announces the expansion of its pharmaceutical manufacturing services by adding formulation development to its list of integrated capabilities.

October 23 2009
Æterna Zentaris to complete Phase 3 clinical trial
Æterna Zentaris Inc. has initiated activities intended to complete the clinical development of the growth hormone secretagogue ghrelin agonist compound macimorelin (AEZS-130). The product could be the first oral diagnostic test approved for growth hormone deficiency (GHD).

October 19 2009
MethylGene Inc. (Montréal, QC) has initiated its Phase II program
MethylGene Inc. (Montréal, QC) has initiated its Phase II program for the development of MGCD265.

October 19 2009
Vaccine manufacturer Medicago Inc. (Québec City, QC) has received Health Canada approval
Vaccine manufacturer Medicago Inc. (Québec City, QC) has received Health Canada approval to start Phase I clinical trials for their H5N1 vaccine.

October 19 2009
Resverlogix Corps (Calgary, AB) lead drug RVX-208 has met its primary end point
Resverlogix Corps (Calgary, AB) lead drug RVX-208 has met its primary end point of increasing plasma ApoA-I significantly.

October 19 2009
Angiotech Pharmaceuticals (Vancouver, BC) has announced that using their Taxus® Express®
Angiotech Pharmaceuticals (Vancouver, BC) has announced that using their Taxus® Express® stents combined with bypass surgery show comparable safety outcomes.

September 10 2009
Amgen publishes two Phase III studies for their drug Denosumab
Amgen announces the publication of two Phase III studies evaluating the safety and effectiveness of their drug Denosumab.

September 10 2009
BioMS stock falls after news of clinical candidate failing Phase III trial
Shares of BioMS Medical Corp. plunged in August after the Alberta-based biotech said Phase III trial results of a two- year study - MAESTRO-01 - showed the drug, Dirucotide failed to meet its primary endpoint of delaying disease progression in patients with secondary progressive multiple sclerosis.

September 10 2009
Stem Cell Therapeutics Corp.
(Calgary, AB) has published the results of a new study designed to compare the blood and cerebrospinal fluid pharmacokinetic characteristics of the drugs Pregnyl® and Ovitrelle®.

September 03 2009
Resverlogix Phase 1b/2a study meets primary endpoint
The Phase 1b/2a study testing RVX-208 for 28 days in three different doses has met its primary endpoint of increasing plasma ApoA-I significantly. This data, in combination with the drug showing favourable safety and tolerance characteristics, is expected to see RVX-208 progress into Phase 2 studies in cardiovascular disease patients.

July 14 2009
MethylGene Inc. (Montreal, QC) reports preliminary Phase I data for MGCD265
MethylGene Inc. (Montreal, QC) reports preliminary Phase I data for MGCD265, an oral, multi-targeted kinase inhibitor for cancer that targets the c-Met, VEGF, Ron and Tie-2 receptor tyrosine kinases.

July 14 2009
Angiotech Pharmaceuticals Inc. announces that the FDA have granted clearance for the Option™ Inferior Vena Cava
Angiotech Pharmaceuticals Inc. (Vancouver, BC) announces that the U.S. Food and Drug Administration (FDA) have granted 510(k) clearance for the Option™ Inferior Vena Cava (IVC) Filter in the United States.

June 26 2009
Amorfix Life Sciences test for vCJD achieves 100 per cent specificity on 20,000 blood donations in France
Amorfix Life Science announces it has tested 20,000 blood donations in France using its EP-vCJD blood screening test as part of a large-scale study to show the viability of routine testing of blood donations for vCJD.

May 04 2009
Isotechnika announces Phase III essence data meets primary endpoint
Isotechnika Inc. announces that its ESSENCE Phase III trial of voclosporin in moderate to severe psoriasis patients successfully met the primary endpoint of superiority to placebo in the proportion of patients achieving a score of "clear" or "almost clear" in the Static Physician's Global Assessment (SPGA) at 12 weeks of treatment.

April 14 2009
Meducure (Winnipeg, MB) has been approved by Health Canada to launch its Phase II clinical study of Avastrem
Meducure (Winnipeg, MB) has been approved by Health Canada to launch its Phase II clinical study of Avastrem for the treatment of tardive dykinsesia (TD).

April 14 2009
BioMS Medical Corp. (Edmonton, AB) announces results from MINDSET-01
BioMS Medical Corp. (Edmonton, AB) announces results from MINDSET-01, an exploratory Phase II clinical trial evaluating dirucotide in patients with relapsing-remitting MS.

March 16 2009
Clinical Trials & Patents
YM BioSciences Inc. (Mississauga, ON) receives clearance from Canadian regulatory authorities.
Protox Therapeutics Inc. (Vancouver, BC) announces the initiation of a double-blinded placebo.
Cytochroma (Markham, ON) has initiated a Phase I trial of CTAP201 Injection in hemodialysis patients.
Oncolytics Biotech Inc. (Calgary, AB) has been granted its 31st U.S. Patent, No. 7,476,382.

March 13 2009
Oncolytics Biotech announces start enrolment in U.S. phase II clinical trial
Oncolytics Biotech Inc. announces that it has started patient enrolment in a Phase II clinical trial using intravenous administration of REOLYSIN(R) in combination with paclitaxel and carboplatin in patients with non-small cell lung cancer (NSCLC) with K-RAS or EGFR-activated tumours.

March 06 2009
Enobia completes target enrollment in clinical trial for infantile hypophosphatasia
Enobia Pharma completes target enrollment in its pilot clinical trial in infants suffering from a severe form of hypophosphatasia. Enobia is investigating Enzyme Replacement Therapy (ERT) with ENB-0040 for the treatment of this rare and often crippling genetic bone disorder for which there is no approved treatment.

February 18 2009
Clinical Trials & Patents
Oncolytics Biotech Inc. (Calgary, AB) has been granted its 31st U.S. Patent, No. 7,476,382.
Protox Therapeutics Inc. (Vancouver, BC) announces the initiation of a double-blinded placebo.
Cytochroma (Markham, ON) initiates a Phase I trial of CTAP201 Injection in hemodialysis patients.
YM BioSciences Inc. (Mississauga, ON) receives clearance from Canadian regulatory authorities.

February 18 2009
InNexus primate study clears way for human trials
InNexus Biotechnology Inc. completes a primate study it says confirms the effectiveness and safety of its treatment for non-Hodgkins lymphoma tumours.

January 30 2009
Enrolment completed in CINATRATM voclosporin study
Isotechnika Inc. announces that its partner Atrium Medical Corporation has completed patient enrollment for its CONFIRM 1, First-in-Man (FIM) drug coated coronary stent clinical trial evaluating Atrium's CINATRATM voclosporin coated coronary stent system.

January 15 2009
Clinical Trials & Patents
Protox Therapeutics Inc. (Vancouver, BC) announces positive data from its Phase II study.
Allon Therapeutics Inc. (Vancouver, BC) completes patient enrolment in a Phase II clinical trial.
SemBioSys Genetics Inc. (Calgary, AB) initiates a Phase I/II clinical trial of its plant-produced insulin.
Oncolytics Biotech Inc. (Calgary, AB) has exceeded the primary statistical endpoint in its multi-centre Phase II clinical trial.

December 16 2008
Theratechnologies reports 52-week results
Theratechnologies reports the 52-week results of its confirmatory Phase III clinical trial, evaluating the long-term safety profile of the company’s lead compound, tesamorelin, in patients with HIV-associated lipodystrophy.

December 11 2008
Clinical Trials & Patents
Theratechnologies (Montreal, QC) announces that the last patient has completed 52 weeks of treatment.
Cytochroma (Markham, ON) releases positive comparative data on a novel vitamin D analog.
Æterna Zentaris Inc. (Quebec City, QC) enters the second stage of patient recruitment for its Phase II trial in endometrial cancer with AEZS- 108.

December 08 2008
Patient enrolment completed in Phase II clinical trial evaluating Allon’s AL-108
Allon Therapeutics Inc. announces that patient enrolment is complete in a Phase II clinical trial evaluating the safety and efficacy of the company’s proprietary drug candidate AL-108 in patients with schizophrenia-related cognitive impairment.

October 27 2008
Resverlogix advances to second arm of Phase 1b/2a clinical trial
Resverlogix Corp. announces that the ongoing double blind placebo controlled Phase 1b/2a study in subjects with normal and low HDL is progressing as planned.

October 27 2008
MethylGene presents preclinical data
MethylGene Inc. discloses preclinical data for MGCD290, a fungal Hos2 inhibitor to be used in combination with azoles for the treatment of fungal infections. MethylGene is currently evaluating MGCD290 in a Phase I clinical trial.

October 15 2008
Clinical Trials & Patents
Stem Cell Therapeutics Corp. (Calgary, AB) receives a letter from Health Canada.
Transition Therapeutics (Toronto, ON) announces that the first patient has been dosed.
Allon Therapeutics (Vancouver, BC) announces that in a Phase IIa clinical trial evaluating the potential of its drug AL-208 to prevent or reduce mild cognitive impairment (MCI).
Bioniche Life Sciences Inc. (Belleville, ON) releases its first Phase III clinical trial.

September 17 2008
Clinical Trials & Patents
BioMS Medical Corp.(Edmonton, AB)announces that the independent Drug Safety Monitoring Board (DSMB) for its Phase II/III Canadian and European study of dirucotide.
Oncolytics Biotech Inc. (Calgary, AB) completes patient enrolment in the dose escalation portion of its U.K. clinical trial.
Generex Biotechnology Corporation (Toronto, ON) enrolls over 150 patients in its Phase III clinical trial of Generex Oral-lyn™.
Cardiome Pharma Corp. (Vancouver, BC) and its co-development partner Astellas Pharma US, Inc. (Toyko, JA) announce that it has received an action letter dated Aug. 8, 2008 from the U.S. Food and Drug Administration (FDA) for KYNAPID™.

September 15 2008
Transition Therapeutics dose first patient in Phase II clinical study of TT-223 in type 2 diabetes
Transition Therapeutics Inc. announces that the first patient has been dosed in a Phase II clinical study of gastrin analogue, TT-223, in patients with type 2 diabetes.

August 26 2008
Generex Biotechnology Corporation (Worcester, MA)
Generex Biotechnology Corporation (Worcester, MA) initiates dosing of over 100 patients in the company’s Phase III clinical trial.

August 22 2008
MethylGene Inc. (Montreal, QC)
MethylGene Inc. (Montreal, QC) announces the initiation of a Phase II clinical trial (Trial 013) evaluating MGCD0103.

August 22 2008
Theratechnologies (Montreal, QC)
Theratechnologies (Montreal, QC) announces positive 26-week results for its confirmatory Phase III clinical trial.

August 12 2008
Clinical Trials & Patents
Oncolytics Biotech Inc. announces that patient enrolment has started in a Phase I/II clinical trial for patients with metastatic ovarian, peritoneal and fallopian tube cancers.

August 01 2008
BioMS Medical completes patient recruitment in Phase III U.S. Multiple Sclerosis trial
BioMS Medical Corp. completes patient recruitment in its phase III clinical trial of MBP8298 (dirucotide) for the treatment of secondary progressive MS (SPMS). The trial, named MAESTRO-03, includes approximately 510 patients, and is being conducted at 68 trial sites in the U.S.

July 14 2008
Full enrollment achieved in Luminate trial program for Voclosporin
Lux Biosciences has completed enrollment in its Luminate pivotal clinical trial program investigating the use of voclosporin as a corticosteroid-sparing agent for the treatment of patients with non-infectious uveitis.

July 11 2008
Lorus Therapeutics making progress in its Virulizin development program
Lorus Therapeutics Inc. announces progress is being made in its Virulizin® development program, including the publication of two research studies on the Virulizin® mode of action and the issuance of a new patent in Mexico.

July 07 2008
ProMetic Life Sciences Inc.
ProMetic Life Sciences Inc. (Montreal, QC) announces that oral PBI-1402 demonstrates significant activity in patients with chemotherapy-induced anemia CIA, and reduces the need for red blood cell (“RBC”) transfusion.

July 07 2008
MethylGene Inc.
MethylGene Inc. (Montreal, QC) announces the dosing of the first patient in a Phase I clinical trial of MGCD265 in patients with solid tumour cancers.

July 07 2008
WEX Pharmaceuticals Inc.
WEX Pharmaceuticals Inc. (Vancouver, BC) announces the enrolment and dosing of the first patient in a Phase III clinical trial of Tectin™, the company’s lead product candidate for cancer pain.

May 20 2008
Protox Therapeutics Inc. (Vancouver, BC)
Protox Therapeutics Inc. (Vancouver, BC) receives Institutional Review Board (IRB) and Health Canada approvals to proceed with its Phase II clinical trial evaluating PRX302 for the treatment of benign prostatic hyperplasia (BPH).

May 20 2008
YM BioSciences Inc. (Mississauga, ON)
YM BioSciences Inc. (Mississauga, ON) announces that its wholly-owned US subsidiary.

May 20 2008
MethylGene Inc. (Montreal, QC)
MethylGene Inc. (Montreal, QC) announces that the European Medicines Agency (EMEA) and the European Commission (EC) designated MGCD0103, a histone deacetylase (HDAC) inhibitor, as an Orphan Medicinal Product for the treatment of acute myelogenous leukemia in the European Union (EU).

May 12 2008
Study confirms SUPPRELIN(R) LA implant maintains profound suppression of hormones in children with premature onset puberty
Indevus Pharmaceuticals, Inc. announces positive results of the ongoing Phase III extension study of SUPPRELIN(R) LA, the only once-yearly subcutaneous implant for the treatment of central precocious puberty or early onset puberty.

May 12 2008
Omigard(TM) Phase III pivotal registration study enrollment completed
MIGENIX Inc. has been notified by their partner for Omigard(TM), Cadence Pharmaceuticals, Inc., that full enrollment of the pivotal Phase III confirmatory study for preventing catheter-related infections has been reached.

April 11 2008
WEX starts Phase III trial of Tectin™ for cancer pain
WEX Pharmaceuticals Inc. announces the enrolment and dosing of the first patient in a Phase III clinical trial of Tectin(TM), the company's lead product candidate, for cancer pain.

March 25 2008
Medicure Inc. (Winnipeg, MB) announces the results of the company's pivotal Phase III MEND-CABG II trial
Medicure Inc. (Winnipeg, MB) announces the results of the company’s pivotal Phase III MEND-CABG II trial have been accepted for presentation as a late breaking clinical trial at the American College of Cardiology 57th Annual Scientific Session.

March 25 2008
Oncolytics Biotech Inc. (Calgary, AB) has met the initial criteria to proceed to full enrolment
Oncolytics Biotech Inc. (Calgary, AB) has met the initial criteria to proceed to full enrolment in its U.S. Phase II trial to evaluate the intravenous administration of REOLYSIN®

March 25 2008
Allon Therapeutics Inc. (Vancouver, BC) has commenced dosing in a Phase I clinical trial
Allon Therapeutics Inc. (Vancouver, BC) has commenced dosing in a Phase I clinical trial to evaluate the pharmacokinetics of AL-108 (intranasal administration) or AL-208 (intravenous administration) in the blood and cerebrospinal fluid (CSF) of healthy adult subjects.

February 22 2008
Oncolytics Biotech Inc. (Calgary, AB) announces that the U.S. National Cancer Institute (NCI) has filed a protocol with the U.S.
Oncolytics Biotech Inc. (Calgary, AB) announces that the U.S. National Cancer Institute (NCI) has filed a protocol with the U.S. Food and Drug Administration (FDA) for a Phase I/II clinical trial for patients with metastatic ovarian, peritoneal or fallopian tube cancers using concurrent systemic and intraperitoneal administration of REOLYSIN®, Oncolytics’ proprietary formulation of the human reovirus.

February 22 2008
BioMS Medical Corp. (Edmonton, AB) a developer in the treatment of multiple sclerosis (MS)
BioMS Medical Corp. (Edmonton, AB) a developer in the treatment of multiple sclerosis (MS), announces that the independent Data Safety Monitoring Board (DSMB) has reviewed data from the company’s on-going MAESTRO-03 U.S.

February 22 2008
CardioMetabolics Inc. (Edmonton, AB) enrolls its 40th patient
CardioMetabolics Inc. (Edmonton, AB) enrolls its 40th patient, the enrolment midpoint, in its Phase II clinical trial.

February 22 2008
Cytochroma Inc. (Markham, ON) commences dosing in a Phase I/II clinical trial of CTAP101 Capsules
Cytochroma Inc. (Markham, ON) commences dosing in a Phase I/II clinical trial of CTAP101 Capsules, the company’s product candidate for the treatment of vitamin D insufficiency in chronic kidney disease (CKD).

February 07 2008
Insception Biosciences begins human clinical trials of stem cell treatment
Insception Biosciences Inc. receives approval from the Food and Drug Administration (FDA) to begin human clinical studies of a new stem cell treatment, which offers an alternative to bone marrow transplants.

January 30 2008
Clinical Trials & Patents
Æterna Zentaris (Quebec City, QC) announces the completion of patient recruitment for its multi-center Phase II trial in non-small cell lung cancer (NSCLC) testing its transduction inhibitor, perifosine.

December 07 2007
Clinical Trials & Patents
Neuromed Pharmaceuticals Ltd. (Vancouver, BC) doses its first patient in a pivotal Phase III clinical trial of NMED-1077 for the treatment of chronic moderate-to-severe pain. The trial is designed as a randomized withdrawal, placebo-controlled, double-blind trial, which is being conducted at multiple centres in the U.S.

November 20 2007
Clinical Trials & Patents
Urodynamix Technologies Ltd. (Vancouver, BC) announces that enrollment has commenced in a new clinical study evaluating the safety and efficacy of its NIRS IAP Monitor investigational device.

November 01 2007
Clinical trials conducted in Canada versus emerging countries
Biotechnology Focus recently spoke with Sébastien Dupuis, B.Sc., MBA, director of corporate affairs, JSS Medical Research about clinical trials conducted in Canada versus the emerging countries of Central/Western Europe, India and Asia. In his Q&A session, Dupuis had the following to say.

October 22 2007
Clinical Trials & Patents
Medicure Inc. (Winnipeg, MB), a cardiovascular focused biopharmaceutical company, announces that following the second and final planned meeting of the independent Data Safety Monitoring Board (DSMB), the company has received another recommendation to continue its Phase III MEND-CABG II trial as planned.

September 19 2007
Clinical Trials & Patents
ProMetic Life Sciences Inc. (Montreal, QC) announces preliminary data from a Phase Ib/II trial with its orally active drug PBI-1402 for the treatment of chemotherapy-induced anemia (CIA).

September 19 2007
Landmark Cimzia data in Crohn's disease published in New England Journal of Medicine
Two pivotal Phase III clinical trials demonstrating the safety and sustained efficacy of CIMZIATM (certolizumab pegol) in moderate to severe Crohn's disease (CD) have been published in the New England Journal of Medicine (NEJM).

August 30 2007
Neurochem announces results from Tramiprosate Phase III clinical trial
Neurochem Inc. releases top-line results from the North American Phase III clinical trial designed to assess the safety, efficacy and disease modification effect of tramiprosate (ALZHEMED) for the treatment of Alzheimer's disease (AD).

August 14 2007
Study presented at ECVS shows ARCAD Instillate decreases surgical adhesions
ARC Pharmaceuticals Inc. has announced efficacy data from a preclinical study of ARCAD(TM) Instillate in the prevention of surgical adhesions.

August 14 2007
Clinical Trials & Patents
Isotechnika Inc. (Edmonton, AB) the enrolment of the last patient in its Phase 2b trial assessing ISA247 for the prevention of kidney graft rejection following transplantation.

July 03 2007
ViRexx licensing partner presents OvaRex(R) MAb Phase II trial results
ViRexx Medical Corp. announce the results from a Phase II trial of OvaRex(R) MAb conducted by ViRexx's licensing partner, Unither Pharmaceuticals, Inc. (Unither), a subsidiary of United Therapeutics Corporation.

June 21 2007
Clinical Trials & Patents
AEterna Zentaris (Quebec City, QC) reports dosing has commenced with its flagship product candidate, cetrorelix, the company's lead luteinizing hormone-releasing hormone (LHRH) antagonist compound, in the first study of its Phase III program in benign prostatic hyperplasia (BPH).

June 01 2007
Oncolytics begins patient enrolment in clinical trial
Oncolytics Biotech Inc. has commenced patient enrolment in its U.K. clinical trial to evaluate the anti-tumour effects of REOLYSIN(R) in combination with paclitaxel and carboplatin in patients with advanced cancers including head and neck, melanoma, lung and ovarian. It is one of three trials expected to begin in 2007 that will examine the role of REOLYSIN(R) in combination with standard chemotherapeutics.

May 14 2007
Generex Biotechnology Enters Into Agreement
Generex Biotechnology Corporation announces that it has entered into an agreement with the Lebanese-Canadian Hospital in Beirut, Lebanon to conduct a human clinical trial of the Antigen Express synthetic avian influenza vaccine

May 14 2007
Cytochroma Inc. announces clinical trial enrollment
Cytochroma Inc. announces that it has completed the enrollment of patients in a Phase II clinical trial of CTA018 Cream.

May 14 2007
Exelixis delays new enrolment clinical trial
Exelixis says it will delay new enrolment for a clinical trial of the cardiovascular drug XL999 for up to three months.

May 14 2007
Favrille announces Trial Results
Favrille announces results from a Phase II trial of 103 patients treated with FavId following Rituxan showed an increase in overall clinical response rate to 64% versus 49% following Rituxan alone.

May 11 2007
Protox doses first patient in benign prostatic hyperplasia trial using PRX302
Protox Therapeutics Inc. enjoys successful dosing of the first patient in a Phase I clinical study evaluating PRX302 to treat benign prostatic hyperplasia (BPH), commonly called enlarged prostate, a disease that affects one million Canadian men.

April 25 2007
Viventia Biotech initiates patient treatment for Vicinium(TM) Phase II bladder cancer trial
Viventia Biotech Inc. has initiated patient treatment in its open-label Phase II clinical trial for Vicinium(TM), administered using intravesical instillation for the treatment of locally persistent non-invasive bladder cancer.

April 13 2007
Migenix Inc. demonstrates Phase II study benefit
Migenix Inc. demonstrated proof-of-concept and evidence of clinical benefit in a Phase II study using oral alpha-glucosidase inhibitor.

April 13 2007
Vasogen Inc. announces new technology at trial session
Vasogen Inc. announces that its Celacade technology in chronic heart failure was presented at the late breaking clinical trial session of the 2006 Canadian Cardiovascular Congress in Vancouver, BC.

April 13 2007
Isotechnika Inc. reports final data
Isotechnika Inc. reports final safety and efficacy data subsequent to 60 weeks of continuous treatment with ISA247.

April 13 2007
Liponex Inc. clinical protocol
Liponex Inc. announces that it will modify the clinical protocol for its ongoing Phase I/II clinical trails for its lead product, CRD5.

April 13 2007
Allon Therapeutics announces IND filing
Allon Therapeutics Inc. announces that it has filed an Investigational New Drug application (IND) with the United States Food and Drug Administration (FDA), seeking approval to begin human clinical trials evaluating the company's product AL-108 as a treatment for Schizophrenia related cognitive impairment.

April 05 2007
Liponex Inc. Reports Phase I/II Clinical Trial Data for CRD5
Liponex Inc. announces results of the Phase I/II Clinical Trial of its lead product, CRD5. CRD5 is being developed for the treatment of dyslipidemia and heart disease. Results showed, to date, that CRD5 was safe and that the drug formulation was stable throughout the trial.

April 05 2007
Ondine demonstrates high Periowave(TM) efficacy in key tissue-invasive pathogen
Ondine Biopharma Corporation recently performed a presentation of a late-breaking abstract at the prestigious International Association of Dental Research (IADR) annual meeting in New Orleans. This publication showed that the Periowave(TM) photodisinfection system is capable of eradicating one of the most elusive and difficult to kill periopathogens, Actinobacillus actinomycetemcomitans (Aa).

April 04 2007
FDA grants fast track designation to Alzheimer's disease drug candidate
Transition Therapeutics Inc. announces that the United States Food and Drug Administration has granted fast track designation to investigational drug candidate AZD-103/ELND005.

March 12 2007
Ondine announces positive clinical results
Ondine Biopharma Corporation announces that the publication of three Periowave clinical trial abstracts will be presented at the combined meetings of the International Association for Dental research (IADR) and the American Association for Dental Research (AADR) in New Orleans this month.

March 12 2007
Neptune Releases Final ADHD Study Results Showing Significant Benefits
Neptune Technologies & Bioressources Inc. announces very positive final results of the effect of Neptune Krill Oil (NKO) on adult Attention Deficit Hyperactivity Disorder (ADHD).

March 12 2007
Pacific Therapeutics Ltd. Teams Up with UBC for Study
Pacific Therapeutics Ltd. enters into an eight-month contract with UBC to perform animal studies with the companys lead candidate, PTL-101.

March 09 2007
ProMetic announces approval program expansion
ProMetic Life Sciences Inc. announces the receipt of regulatory approval from Health Canada for the expansion of its lead compound PBI-1402's clinical program

March 09 2007
Allon Therapeutics progresses into clinical trial
Allon Therapeutics Inc. progressed into the randomized portion of its Phase II human clinical trial.

March 09 2007
Vanda Pharmaceuticals buoyed by latest data
Vanda Pharmaceuticals was buoyed by the latest data from a late-stage clinical trial of its experimental insomnia therapy.

March 09 2007
Isotechnika Inc. announces kidney transplant trial results
Isotechnika Inc. announces results from initial data for its Phase IIb kidney transplant trial.

February 23 2007
Allon files IND for approval of Schizophrenia Phase II clinical trials
Allon Therapeutics Inc. announces that it has filed an Investigational New Drug application (IND) with the United State Food and Drug Administration (FDA) seeking approval to begin human clinical trials evaluating the companys product AL-108 as a treatment for Schizophrenia related cognitive impairment.

February 05 2007
Allon confirms progress in AL-208 Phase II clinical trial
Allon Therapeutics Inc. announces that it has progressed into the randomized portion of its Phase II human clinical trial evaluating the Company's product AL-208 as a treatment for the mild cognitive impairment (MCI) that commonly occurs following coronary artery bypass graft (CABG) surgery. The Company also announced the selection of the 300 mg dose, the highest one tested, in the randomized portion of the trial.

February 01 2007
Liponex Inc. Suspends Patient Treatment
Liponex Inc. has suspended patient treatment at the highest dose level of 5 grams per day in a Phase I/II clinical trial for its lead product, CRD5.

February 01 2007
Biomira Inc. begins patient enrolment
Biomira Inc. has begun patient enrolment in a global Phase III clinical trial to assess the efficacy and safety of Stimuvax® as a potential treatment for patients with unresectable stage III non-small cell lung cancer (NSCLC).

February 01 2007
Abraxis BioScience Inc. plans to initiate a worldwide head-to-head Phase III Trial
Abraxis BioScience Inc. plans to initiate a worldwide head-to-head Phase III registration trial comparing weekly Abraxanetm to every three week Taxotere® (docetaxel) for the treatment of first-line metastatic breast cancer.

February 01 2007
BioMS Medical Corp. continues clinical trial
BioMS Medical Corp. will continue its Phase II/III clinical trial for MBP8298 for the treatment of secondary progressive multiple sclerosis following clearance from the independent Data Safety Monitoring Board (DSMB).

February 01 2007
Allon Therapeutics Inc. Receives Enrolment Approval
Allon Therapeutics Inc. has received Institutional Review Board approval to begin enrolment.

January 30 2007
Allon confirms progress in AL-208 Phase II clinical trial
Allon Therapeutics Inc., The Neuro Protection CompanyTM, announces that it has progressed into the randomized portion of its Phase II human clinical trial evaluating the Companys product AL-208 as a treatment for the mild cognitive impairment (MCI) that commonly occurs following coronary artery bypass graft (CABG) surgery.

January 30 2007
Ondine announces positive clinical results from its Periowave(TM) trial of maintenance therapy
Ondine Biopharma Corporation announces that the publication of three Periowave(TM) clinical trial abstracts will be presented at the combined meetings of the International Association for Dental Research (IADR) and the American Association for Dental Research (AADR) meeting in New Orleans, March 21-24, 2007.

January 15 2007
ProMetic Life Sciences Inc.  PBI-1402 enters clinical trial for anemia associated with chronic kidney disease
ProMetic Life Sciences Inc. announces that it has received regulatory approval from Health Canada for the expansion of its lead compound PBI-1402s clinical program to include the treatment of anemic patients with Chronic Kidney Disease (CKD).

January 11 2007
Generex Reports Positive Findings
Generex Oral-lyn, an oral insulin spray from Generex Biotechnology Corp. could be more effective than mealtime injections.

January 11 2007
Resverlogix Corp. Concludes RVX-208 Study
A recent study has concluded that Resverlogix Corp.'s clinical candidate, RVX-208, can rapidly increase plasma levels of ApoA-I up to 150% relative to control animals in the first 24 hours.

January 11 2007
Isotechnika Inc. Hopes To Begin New Phase In Drug Trial
Pending clearance of an investigational new drug application by the U.S. Food and Drug Administration, Isotechnika Inc. hopes to begin a Phase II/ III human clinical trial of its lead immunosuppressive drug, ISA247.

January 11 2007
Medicure Inc. begins enrolment in single confirmatory Phase III study
Medicure Inc. has begun enrolment in a single confirmatory Phase III study to evaluate the cardioprotective effects of its FDA fast tracked product, MC-1.

January 11 2007
Helix BioPharma Completes Phase II clinical study
Helix BioPharma Corp. has completed enrolment and treatment in its Phase II clinical study of Topical Interferon Alpha-2b.

January 11 2007
Cytochroma Inc. Recruits For Psoriasis Phase II Clinical Trial
Cytochroma Inc. has begun recruitment of patients with chronic plaque psoriasis for a Phase II clinical trial.

January 10 2007
A Practical Guide To Post-Marketing Observational Studies (PMOS)
What To Do And What To Avoid

In the spectrum of designs available for the evaluation of medical and, specifically, pharmaceutical interventions, the Post-Marketing Phase IV or Observational Study has been considered as the black sheep of the family.

January 09 2007
Liponex Inc. modifies CRD5 Phase I/II clinical trial protocol
Liponex Inc., a biopharmaceutical company specializing in developing advanced products related to High Density Lipoprotein (HDL), often called good cholesterol, announces that it will modify the clinical protocol for its ongoing Phase I/II clinical trial for its lead product, CRD5.

December 18 2006
Allon Therapeutics presents at IBCs EuroTIDES conference
Allon Therapeutics Inc., The Neuro Protection Company, presents a case study during IBC's EuroTIDES 2006 conference: Oligonucleotide, RNAi and Peptides for the Drug Development and Manufacturing Industry in Hamburg, Germany, providing an update on the understanding of how NAP, the core element of Allon's Phase II drug, reaches its target within the central nervous system

November 27 2006
Isotechnika Inc. Meets Safety And Efficacy Endpoints
Isotechnika Inc. has met all safety and efficacy endpoints in a Phase III trial of ISA247 for psoriasis. The SPIRIT trial was extended beyond its initial 24 weeks to give patients the opportunity to continue ISA247 therapy at a 0.3 mg/kg twice daily oral dose for an additional 36 weeks. The extension verified long term safety data while demonstrating continued therapeutic benefit.

November 27 2006
Allon Therapeutics Inc. Completes Dosing
Allon Therapeutics Inc. has completed dosing in a Phase Ib human clinical trial evaluating AL-108 as a treatment for Alzheimer's disease.

November 27 2006
Theratechnologies completes efficacy phase
Theratechnologies has completed the efficacy phase - 26 weeks of treatment - of its first Phase III clinical trial testing TH9507 in HIV-associated lipodystrophy.

November 27 2006
Finnish National Agency for Medicines Gives Approval To BioMS Medical Corp.
The Finnish National Agency for Medicines has given BioMS Medical Corp. approval to begin enrolling patients in Finland into a phase II/III trial of MBP8298, a synthetic peptide for the treatment of secondary progressive multiple sclerosis (SPMS).


November 27 2006
Top ranked cancer centre joins Protox clinical trial
The University of Texas's world renown M. D. Anderson Cancer Center began treatment of its first patients in an ongoing Phase I clinical trial for Vancouver, B.C.-based Protox Therapeutics Inc.'s PRX302 for localized recurrent prostate cancer.

November 21 2006
Neuromedix poised to realize next stage of business plan through
NeuroMedix Inc. announces that based on the positive pre-clinical development data received to date for its lead product, Minozac, it will now explore licensing or acquisition transactions with a view to maximizing shareholder value.

November 07 2006
Allon Therapeutics launches $8 million financing
Allon Therapeutics Inc. (TSX:NPC), The Neuro Protection CompanyTM, today announced that it has engaged a syndicate of agents co-led by Blackmont Capital and Clarus Securities and including Sprott Securities to raise approximately $8 million through a private placement of units priced at $0.80 per unit.

November 07 2006
Optimum Communications Services, Inc. and TRLabs successfully complete interoperability testing and performance validation
Optimum Communications Services, Inc. (OCS) and TRLabs have successfully completed interoperability testing and performance validation for OCS patent-pending, self-optimizing Adaptive-Mesh network architecture implemented by OCS Intelligent Transport Network (trademark) (ITN) technology.

November 02 2006
Resverlogix Corp. intends to begin human trials
Resverlogix Corp. intends to begin human trials in early 2007 after its atherosclerosis and cardiovascular disease candidate RVX-208 illustrated the ability to raise ApoA-I levels.

November 02 2006
Protox Therapeutics Inc. hopes to begin Phase I clinical trial
Protox Therapeutics Inc. hopes to begin a Phase I clinical trial of the lead candidate in its PORxinTM technology platform.

November 02 2006
TOPIGEN Pharmaceuticals Inc. Selects Inhibitor
TOPIGEN Pharmaceuticals Inc. (Montreal, QC) has selected TPI-1100, a potent RNA-targeting inhibitor.

November 02 2006
Bioxel Pharma Inc. Manufactures First cGMP Batch
Bioxel Pharma Inc. has manufactured the first industrial scale cGMP batch.

November 01 2006
Cancer therapy candidate starts clinical trial
in partnership with Pharmion Corporation (Boulder, CO), is launching a Phase I/II clinical trial of a product for use with Gemzar®, an approved chemotherapy for use in a number of different types of cancer.

October 24 2006
Logistically Speaking - A Guide to Global Clinical Trial Coordination
In order to cope with the risky, expensive business of bringing a new drug onto the market, Canadian manufacturers are turning to overseas market to test these new products. The challenges are many, but the savings can be significant, and with the right attention to detail, the results can make such international ventures very appealing.

October 17 2006
Health Canada approves prostate treatment test
Protox Therapeutics Inc. has received federal government permission to carry out a Phase I human clinical trial

September 29 2006
Isotechnika Inc. Completes Phase I Clinical Trial of TAFA93
Edmonton-based Isotechnika Inc. has successfully completed a Phase I clinical trial of TAFA93, a pro-drug of rapamycin that is a small molecule mTOR inhibitor currently used in the prevention of organ rejection in transplantation.

September 29 2006
BioSyntech Inc. Gets Approval to Start Clinical Trial
The Therapeutic Products Directorate of Health Canada has granted BioSyntech Inc. (Laval, QC) approval to begin enrolling subjects in a clinical trial for BST-DermOn.

September 29 2006
Theratechnologies Inc. Received A Special Protocol Assessment
In a move the company hopes will guard against regulatory risks, Theratechnologies Inc. (Montreal, QC) has received a special protocol assessment from the U.S. Food and Drug Administration for the design of a second Phase III trial evaluating TH9507 for the treatment of HIV-associated lipodystrophy.

September 29 2006
MethylGene Inc. Has Begun Enrolment In A Single Agent Phase II Clinical Trial
MethylGene Inc. (Montreal, QC) has begun enrolment in a single-agent Phase II clinical trial of MGCD0103, an oral, isotype-specific HDAC inhibitor in patients with relapsed or refractory Hodgkin's lymphoma.

September 29 2006
Institutes Agree To Lead A Coronary Artery Bypass Graft Study
The Duke Clinical Research Institute (Durham, NC) and the Montreal Heart Institute (Montreal, QC) have agreed to lead a Phase III coronary artery bypass graft study with MC-1, a compound from Winnipeg-based Medicure Inc. The study will involve up to 3,000 patients at more than 120 sites throughout North America and Europe.

September 08 2006
Results from a preclinical study of Allon Therapeutics Inc.
Results from a preclinical study of Allon Therapeutics Inc's proprietary compound NAP show that NAP may help protect against and aid newborn infants recover from brain injury caused by respiratory interruption.

September 08 2006
Liponex Inc. Completes Testing and Analysis On CRD5
In preparing for a Phase I/II clinical trial of its lead compound CRD5, Ottawa-based Liponex Inc. has received the bulk active pharmaceutical ingredient from its contract manufacturer and has successfully completed quality testing and analysis.

September 08 2006
Biomira Inc.'s Stimuvax® Could Slow Rising Prostate Specific Antigen Levels
Results from a recently published study show that Edmonton-based Biomira Inc.'s Stimuvax®, formerly known as BLP25 Liposome Vaccine or L-BLP25, could slow rising prostate specific antigen (PSA) levels.

September 08 2006
Preliminary Data From Topigen Pharmaceuticals Inc.s First Phase II Clinical Trial Of Inhaled TPI-ASM8
Preliminary data from Topigen Pharmaceuticals Inc.s first Phase II clinical trial of inhaled TPI-ASM8 as a single agent in patients with allergic asthma indicate that inhaled TPI-ASM8 demonstrated protection in early- and late-stage allergic responses in patients with asthma.

September 08 2006
Oncolytic Biotech Inc. Receives Approval to Begin Phase II
Oncolytics Biotech Inc. has received approval from the U.K. Medicines and Healthcare products Regulatory Agency (London, U.K.) to begin a Phase II clinical trial to evaluate the anti-tumour effects of intratumoural administration of Reolysin® in combination with low-dose radiation in patients with advanced cancers.

August 09 2006
YM BioSciences Inc.
Phase III trial of tesmilifene in metastatic and recurrent breast cancer can procced as planned following an interim safety and efficacy analysis by the independent Data Safety Monitoring Board (DSMB).

August 09 2006
BioMS Medical Corp.
BioMS Medical Corp. has received approval to start patient enrolment in the Netherlands for its Phase II/III clinical trial of MBP8298, a synthetic peptide for the treatment of secondary progressive multiple sclerosis.

August 09 2006
ViRexx Medical Corp.
ViRexx Medical Corp. has completed enrolment for two Phase III trials for OvaRex® MAb in patients with stage III/IV advanced ovarian cancer who have successfully completed front-line therapy.

August 09 2006
AEterna Zentaris Inc.
AEterna Zentaris Inc. plans to initiate a Phase III program for cetrorelix, a luteinizing hormone-releasing hormone antagonist product candidate intended for the treatment of benign prostatic hyperplasia.

July 05 2006
Migenix Inc. Receives Notice Of Authorization
Vancouver-based Migenix Inc. has received a Notice of Authorization from Health Canada to begin a Phase II viral kinetics study of MX-3253 (celgosivir), an alpha-glucosidase I inhibitor, in hepatitis C virus-infected, treatment-naive patients.

July 05 2006
Topigen Pharmaceuticals Inc. Initiates Phase II Clinical Trial Of TPI-1020
Topigen Pharmaceuticals Inc. (Montreal, QC) has initiated a Phase II clinical trial of TPI-1020, an inhaled NO-donating derivative of budesonide intended to treat chronic obstructive pulmonary disease.

July 05 2006
Pre-Clinical Cancer Study At McGill University
A pre-clinical cancer study at McGill University (Montreal, QC) has shown that CVT-E002 could serve as a potential cancer therapy.

May 10 2005
IMI to Initiate Pivotal Trial for Breast Cancer Test
Toronto, Ont.-based IMI International Medical Innovations Inc., in collaboration with the University of Louisville (Louisville, KY), has launched a pivotal clinical study for its non-invasive breast cancer test.


April 25 2005
Isotechnika Releases Preliminary Psoriasis Trial Results
Edmonton, Alta.-based Isotechnika Inc. has announced preliminary results of its Phase III clinical psoriasis trial for ISA247, the companys lead immunosuppressive compound.


April 12 2005
Bextra Withdrawn From North American Market
Pfizer Inc. (New York, NY), makers of the recently maligned arthritis drug Bextra®, has agreed to pull the product off the market in Canada and the United States.


February 21 2005
Retinal Microchip Trial Expanded
An expanded clinical trial of a retina microchip is providing more patients with the opportunity to have access to this new device, which may slow the progression of retinitis pigmentosa.


January 17 2005
Going Into the Clinic
By Dr. David G. Barnes and Jerry Calver, PhD
Do You Know What You Need to Know?

Product innovators in Canada are an increasingly savvy lot. Today's scientists attend bio-medical conferences where basic science and clinical research are presented side-by-side with patent law and venture capital.

October 23 2004
Transition Therapeutics to Initiate Clinical Trial for Diabetes Candidate
Biopharma firm Transition Therapeutics Inc. (Toronto, ON) has received U.S. Food and Drug Administration clearance to initiate a clinical trial for its lead product, E1-I.N.T.(tm), in Type I diabetes patients.


June 28 2004
Oxytrol Receives Canadian and European Approvals
Watson Pharmaceuticals Inc.'s (Corona, CA) Oxytrol® - an oxybutynin patch for the treatment of urge urinary incontinence - has been approved by Health Canada and has also received marketing authorization from the European Union's Commission of the European Communities.


May 25 2004
ART to Participate in FDA Pilot Program
A producer of optical molecular imaging products, ART Advanced Research Technologies Inc. (ART) (St-Laurent, QC), has announced that it will take part in the U.S. Food and Drug Administrations (FDA) STED Pilot Program.