Hyperion Therapeutics Receives Orphan Drug Designation for HPN-100 for the Treatment of Urea Cycle Disorders
... of patients with the most prevalent urea cycle
deficiencies including those related to ... designation for HPN-100 in the treatment of urea cycle
disorders is an important milestone and provides ... as an orphan drug for the treatment of urea cycle
disorders recognizes the unmet need that remains ...
Hyperion Therapeutics Announces Results for Phase II Study in Urea Cycle Disorders
... II study of HPN-100 for the treatment of urea cycle
disorders. The data was presented on March 27th ... Ammonia Scavenging Agent In Adults With Urea cycle
Disorders (UCDs) ."
(Logo: ... potential of HPN-100 for the treatment of urea cycle
Multi-Pronged Therapeutic Cancer Vaccine Regimen to be Studied in Melanoma Patients
... regimen to induce an immune response.
The first cycle
of vaccine treatment is conducted for a period ... vaccine treatment is extended to a second 16 week cycle
treatment. In the study, patients in Group 2 ... disease has progressed
during the first treatment cycle
may be offered the vaccine regimen as ...
Agile Therapeutics Achieves Phase 2 Study Endpoints in Key Clinical Trials with New, Innovative Low-Dose Contraceptive Patch
primary endpoint of ovulation suppression, cycle
control and safety. The
pharmacokinetic (PK) ... (as demonstrated by ovulation suppression), cycle
tolerability at the lowest hormonal ... the greatest ovulation suppression with the
control of the three regimens studied.
Hyperion Therapeutics Completes Enrollment in Phase 1/2 Clinical Trial in Patients With Urea Cycle Disorders
... (sodium phenylbutyrate) in patients with urea cycle
(UCD). The company plans to announce ... to improve care for these patients."
About Urea cycle
UCDs are inherited, inborn errors of ... of
patients with the most prevalent urea cycle
disorders -- carbamylphosphate
synthetase (CPS), ...
Early Data Presented at ASCO Show Potential of RAD001 to Enhance Efficacy of, and Overcome Resistance to, Breast Cancer Treatments
... ABSTRACT #530 - "Improved clinical and cell cycle
response with an mTOR
inhibitor, daily oral ... 10 mg increased both the clinical
and the cell cycle
efficacy of letrozole tablets 2.5 mg in the ... P=0.035, respectively). In addition, cell cycle
the RAD001/letrozole treatment arm, ...
Interim Safety Analysis Supports Continuation of Allos Therapeutics' Pivotal Phase 2 PROPEL Trial of PDX in Patients with Peripheral T-cell Lymphoma
... in the study who completed at least one cycle
of treatment with
PDX. The Company currently ... for six weeks followed by one week of rest per cycle
treatment. The primary efficacy endpoint of ... to the study who completed at least one cycle
of treatment with
PDX, and recommended that the ...
Hyperion Therapeutics Announces Enrollment of First Patient in Phase 1/2 Clinical Trial of GT4P in Patients With Urea Cycle Disorders
... (4-Phenylbutyrate) (GT4P) in
patients with urea cycle
disorders (UCDs). (Logo: ... of GT4P focused on the chronic
management of urea cycle
disorders," said Marvin Garovoy, Senior ... in the chronic
management of patients with urea cycle
disorders involving deficiencies ...
Studies Suggest Key Correlation Between Lung Cancer Subtype and Treatment Outcomes
... ALIMTA. Patients should not begin a new cycle
of treatment unless the ANC is
greater than or ... Dose adjustments at the start of a subsequent cycle
should be based on
nadir hematologic counts or maximum nonhematologic toxicity from the
of therapy. Modify or suspend therapy according ...
Lilly Files for European Approval of ALIMTA(R) (pemetrexed for injection) for First-Line Treatment of Non-Small Cell Lung Cancer
... and/or cisplatin at the start of a subsequent cycle
based on nadir haematological counts or ... by a one week rest period. This four week cycle
then repeated. Pancreatic Cancer The ... be given on days 1, 8, and 15 of each 28
in combination with cisplatin. Cisplatin is given ...
Injection Reverses Heart-Attack Damage
... birth, heart-muscle cells (cardiomyocytes) normally withdraw from the cell cycle
- meaning they stop dividing and proliferating. But the researchers, led ... the Department of Cardiology at Children's, were able to restart the cell cycle
with NRG1, stimulating cardiomyocytes to divide and make copies of ...
Pixantrone Produces High Rates of Complete and Partial Remissions Even Among Aggressive NHL Patients With Extensive Prior Doxorubicin Treatment or Prior Rituximab Treatment
... (CHF). The total cumulative doxorubicin equivalent exposure per treatment cycle
for all 68 patients treated with pixantrone is noted in the table below:
No. of Patients Pixantrone Lifetime
Proteolix Presents Positive Clinical Data for Carfilzomib in Multiple Myeloma at the 2009 ASCO Annual Meeting
... twice a week over a 28-day cycle, followed by doses of 27mg/m(2) for every cycle
thereafter for up to twelve cycles. The primary endpoint for the Phase 2 ... good partial responses. Notably, responses occurred in the first 28-day cycle
of treatment and initial responses have improved with continued therapy. ...
RAD001 Shows Potential to Reverse Resistance to Herceptin(R)* in Metastatic Breast Cancer Patients, Leading to Phase III Trial
... disease. The critical dose-
limiting toxicities occurring in the first cycle
of treatment included febrile
neutropenia, oral mucositis and confusion ... The critical dose-limiting toxicities
(i.e., dose-limiting toxicities in cycle
1) occurring in the 5 mg daily
treatment group included grade 3/4 ...
Bionovo Presents Positive Results from Phase 1B Trial of BZL101 for Metastatic Breast Cancer at the Society for Integrative Oncology
... cells healthy and intact. Normal cells depend primarily on the
citric acid cycle
(>85%) and very little on glycolysis (<7%) for energy
production. ... on glycolysis (>85%) for energy
production. BZL101 stops the production cycle
of energy in cancer cells by
inhibiting glycolysis. This leads to DNA ...
Bionovo Advances BZL101 to Phase 2 Clinical Trials After Positive Phase 1 Results for Metastatic Breast Cancer
... cells healthy and intact. Normal cells depend
primarily on the citric acid cycle
(>85%) and very little on glycolysis
(<7%) for energy production. Cancer ... on glycolysis
(>85%) for energy production. BZL101 stops the production cycle
in cancer cells by inhibiting glycolysis. This leads to DNA ...
Resurgent Health and Medical Announces That Children's Hospitals and Clinics of Minnesota has Ordered 25 CleanTech Automated Handwashing Systems
... proprietary Chlorhexidine
Gluconate (CHG) sanitizing solution, the single cycle
removes over 99.9% of
pathogens and continues to kill germs for up to six ... using high-pressure water jets that perform a consistent
every time the machines are used.
About Children's Hospitals and Clinics ...
Exelixis Presents Clinical Data Supporting the Safety and Initial Clinical Activity of XL228 in Chronic and Acute Leukemia
... have received at least one dose of XL228, of whom 16
had completed cycle
1 as of May 15, 2008. The trial is evaluating a
consisting of 4 weekly 1-hour IV infusions of XL228 at
doses ranging from ...
Node-Negative Early Stage Breast Cancer Patients Benefit from Taxotere(R)-Based Chemotherapy
during enrollment mandated the use of G-CSF with the first cycle
of TAC, in
order to reduce the incidence and severity of hematological ... febrile neutropenia
decreased to 6.5% with the use of G-CSF from the first cycle
of TAC. The
incidence of febrile neutropenia among patients treated with ...
Medarex Reports Interim Data from Ongoing Ipilimumab Combination Phase 1 Studies in Prostate Cancer at American Association for Cancer Research Meeting
... clinical trial, 26 patients with HRPC received treatment with a 28-day cycle
of daily doses of 250 mg/m2 of GM-CSF for 14 days in combination with ipilimumab administered on the first day of the 28-day cycle
for up to four cycles. Ipilimumab dosing initially ranged from 0.5 ...
Sunesis Pharmaceuticals to Present Non-Clinical Data at the Annual Meeting of the American Association for Cancer Research
... focused on novel
pathways and targets, including inhibition of the cell cycle
Data from non-clinical studies of SNS-595, ... lymphoma cell lines Session: Histone Deacetylase Inhibitors and Cell cycle
Inhibitors Abstract #756 8:00 a.m. - 12:00 p.m. Exhibit Hall B-F, ...
EntreMed Commences Continuous Dosing Clinical Trial For MKC-1
... a Phase 1, open-label, continuous dosing
study with its oral cell cycle
inhibitor, MKC-1, in patients with advanced
or metastatic solid tumors. ... longer effective will be enrolled.
MKC-1 is a novel, orally-active cell cycle
inhibitor with in vitro and
in vivo efficacy against a broad range of ...
Fludarabine, Mitoxantrone and Zevalin(R) Produces 96% Complete Remission Rate in First-Line Treatment of Patients with Follicular Non-Hodgkin's Lymphoma
... of less
than 25 percent four to six weeks after completion of the sixth cycle
chemotherapy were deemed eligible for consolidation treatment six to ten
weeks after the sixth cycle
with one course of Zevalin. Primary endpoints
were complete response and ...
Access Pharmaceuticals Announces Two Poster Presentations Reporting Significant Preclinical Data on ProLindac(TM) at the AACR-NCI-EORTC 'Molecular Targets and Cancer Therapeutics' Conference
... to lower pH conditions. Exposure to ProLindac also
resulted in tumor cell cycle
arrest at a phase of the cycle
where the tumor
cell is more susceptible to damage. These effects can lead ...
EntreMed Shows Increased Survival With MKC-1 in Preclinical Renal Cell Cancer Model
... diseases, today
announced the presentation of results for its cell cycle
in preclinical renal cell carcinoma (RCC) models. The ... treatment of renal cell
carcinoma. MKC-1 is a novel, orally-active cell cycle
inhibitor with in vitro and
in vivo efficacy against a broad range of ...
Kosan Presents Phase 1 Data Showing Antitumor Activity and Safety Profile of Epothilone KOS-1584 at AACR/NCI/EORTC Meeting
... -- 1 patient with breast cancer (3 prior regimens, active on study at cycle
5) experienced a 40% reduction in tumor marker CA-15.3, 42.5% ... cancer had 94% reduction in PSA and improved nodal disease after cycle
2 and was on study for 6 months (6 cycles); -- 1 patient with ...
EntreMed Presents Data for Phase 2 Study of MKC-1 in Metastatic Breast Cancer
... patient population. MKC-1 is a novel, orally-active, small molecule cell cycle
with a unique mechanism of action, which involves inhibition of the
Akt-mTOR pathway, binding importin-b and tubulin, cell cycle
apoptosis. MKC-1 arrests mitosis by inhibiting an ...
GNC Unveils Study Results for First and Only Nitric Oxide Product Clinically Proven to Improve Physical Performance at NSCA Conference in Las Vegas
... (PWC(FT)). The PWC(FT) test estimates the highest power output that can be maintained without neuromuscular evidence of fatigue.
Using a cycle
ergometer (stationary bicycle), all subjects performed an incremental test to exhaustion prior to supplementation and after four weeks of ...
FDA Accepts sNDA for Alternative Dosing Regimen for Dacogen(R) (decitabine for injection) to Treat Patients with Myelodysplastic Syndromes (MDS)
... administered at a dose of 15 mg/m2 via continuous IV infusion over three hours repeated every eight hours for three consecutive days per cycle. The cycle
is repeated every six weeks. The alternative five-day dosing regimen of Dacogen(R) submitted to the U.S. FDA is a single daily dose with a ...
Micromet Presents Update on Blinatumomab's Response Rate and Duration in a Phase 1 Study in Non-Hodgkin's Lymphoma Patients
... single agent blinatumomab(2). The data show that 11 out of 12 patients having received a dose of 0.06 mg/m(2) per day during the first treatment cycle
have responded according to standard Cheson criteria. Remissions appear to be durable without further treatment with a median relapse free interval ...
CuraGen Updates CR011-vcMMAE Data at ASCO
... events included fatigue, diarrhea, anorexia and nausea. Grade 3 or 4 neutropenia was observed in 5 patients. The absence of rash in the first cycle
of treatment predicted a worse PFS. Additionally, in a subset of patients with tumor biopsies, high levels of tumor expression of GPNMB appeared to ...
Kinex Pharmaceuticals To Present at ASCO 2009 Annual Meeting
... platform technologies to identify highly selective inhibitors of therapeutically relevant targets that are involved in signal transduction and cell cycle
CONTACT: Lyn Dyster, Vice President, Research Operations of Kinex Pharmaceuticals, +1-716-881-8984
Strativa Pharmaceuticals Provides Product Pipeline Update
... companies that can sell-in and manage product sales and marketing. For existing and future partners, PharmFilm(R) formulations represent revenue-life cycle
extensions for products with patent lives that have expired or are approaching expiration. PharmFilm(R) is also a tool to help sales and marketing ...
Pharmaxis Announces Milestone in Phase III Trial for Cystic Fibrosis
... is designed to hydrate the airway surface of the lungs, and
promote normal lung mucus clearance in order to improve lung function, break
of repeated respiratory infections and blockages, and improve
quality of life for patients with CF. Approximately 75,000 people in the
Cephalon Announces Positive Results From a Phase Two Study of NUVIGIL in Bipolar Depression
... bipolar I disorder, which is characterized by fluctuations between extreme highs (manic) and lows (depressed) in mood. People with bipolar disorders cycle
between periods of manic or depressive mood and typically spend more time in the depressed phase of the illness.
The eight-week, double-blind, ...
Hana Biosciences Announces Successful Planned Independent Safety Analysis Supports Ability to Complete Pivotal rALLy Clinical Trial of Marqibo, Its Lead Novel Anti-Cancer Compound
... data. This interim assessment
was based upon a planned evaluation of safety data from the first 29 patients in
the study who received at least one cycle
of weekly Marqibo treatment. Safety
was assessed in the context of efficacy defined as the achievement of a complete
response with or without full ...
Ascenta Therapeutics Announces Positive Preliminary Results with AT-101 in Docetaxel Refractory Prostate Cancer
... intervals, with radiological assessments performed at 6-week intervals for patients with soft tissue disease and bone scans performed after cycle
6 and at completion of therapy. Ten of the 37 patients remain on study.
Thirty-eight percent (14/37) of patients treated had at least a 30 ...
CVS Caremark Study Finds Non-Adherent Heart Failure Patients Almost Twice as Likely to be Re-Hospitalized Within a Year
... best-in-class results by changing patient behavior to encourage medication adherence and involves clinical interventions throughout the treatment cycle
with the right tactics to engage each patient. The Adherence to Drug Therapy solution is a mail and retail based program designed to impact patient ...
Oncolytics Biotech Inc. Announces Start of Patient Enrolment in Translational Clinical Trial Investigating REOLYSIN(R) in Patients with Metastatic Colorectal Cancer
... histologically proven colorectal cancer, planned for potentially curative surgical resection of liver metastases. Up to 20 patients will receive one cycle
of treatment in this trial, with approximately 10 in each of the early and late virus groups.
The University of Leeds is covering all costs of the ...
Jennerex Treats First Patients in Phase 2 JX-594 Trial for Liver Cancer
... created copies of JX-594 are
then released and are able to infect and eradicate other tumor cells both
locally and in distant sites in the body. This cycle
of JX-594 replication,
cancer cell destruction, release and spread is then repeated. Normal cells are
not affected by JX-594 resulting in safety and ...