Chromosomal Crossover News and Research

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Scientists to present preclinical pharmacology data on TRV120027 at Heart Failure Society of America Meeting

Trevena Inc., the leader in the discovery and development of G-protein coupled receptor biased ligands, today announced that its scientists are presenting two posters featuring compelling preclinical pharmacology data on TRV120027 at the 14th Annual Heart Failure Society of America Meeting being held September 12-15, 2010 in San Diego.

13 Sep 2010

Incyte Corporation enters SPA agreement with FDA for INCB18424 inhibitor

Incyte Corporation announced today that it has reached agreement with the U.S. Food and Drug Administration (FDA) regarding a Special Protocol Assessment (SPA) for the design of a pivotal Phase III trial for its JAK1 and JAK2 inhibitor, INCB18424 in patients with polycythemia vera (PV), a blood cancer that belongs to a group of diseases known as myeloproliferative neoplasms (MPNs).

13 Sep 2010

MAP Pharmaceuticals completes 12 months of treatment in LEVADEX open-label safety trial

MAP Pharmaceuticals, Inc. today announced that all non-asthmatic patients and a subset of asthmatic patients have completed 12 months of treatment in the open-label safety trial of LEVADEX™. In addition, the Company has completed patient treatment in a thorough QT trial, the last trial necessary to support a New Drug Application (NDA) for LEVADEX.

8 Sep 2010

MAP Pharmaceuticals reports results from PD trial that compares effects of LEVADEX, IV DHE

MAP Pharmaceuticals, Inc. today reported results from a pharmacodynamics trial comparing the acute effects on pulmonary artery pressure of LEVADEX, dihydroergotamine mesylate administered intravenously and placebo. In the trial, there was no statistically significant difference between the LEVADEX and placebo groups in the primary endpoint of pulmonary artery pressure over two hours after administration.

8 Sep 2010

Halozyme initiates Ultrafast Insulin combination Phase 2 studies with rHuPH20

Halozyme Therapeutics, Inc. today announced the initiation of two Phase 2 Ultrafast Insulin treatment studies that utilize its rHuPH20 hyaluronidase enzyme (PH20) in combination with the two leading commercially available mealtime analogs: insulin aspart, the active ingredient in NovoLog®, and insulin lispro, the active ingredient in Humalog®.

2 Sep 2010

Dietary supplement combining zinc, phytase enhances effectiveness of BTX injections: Study

Taking a dietary supplement of organic zinc and the enzyme phytase four days before receiving botulinum toxin injections made the toxin more effective in 93 percent of patients tested in a recent study at The Methodist Hospital in Houston.

2 Sep 2010

Raptor Pharmaceutical updates on cysteamine bitartrate Phase 3 clinical trial in cystinosis patients

Raptor Pharmaceutical Corp.,provides updates on timelines related to its clinical programs including the pivotal Phase 3 clinical trial of its proprietary delayed-release oral formulation of cysteamine bitartrate ("DR Cysteamine") in patients with nephropathic cystinosis ("cystinosis").

24 Aug 2010

Palatin reports positive results from bremelanotide Phase 1 trial for sexual dysfunction

Palatin Technologies, Inc. today announced positive results of a Phase 1 clinical trial of subcutaneously administered bremelanotide, its melanocortin agonist drug candidate for treatment of male erectile dysfunction (ED) and female sexual dysfunction (FSD). The results demonstrate that with subcutaneous administration consistent therapeutic blood plasma levels can be obtained without sustained clinically significant blood pressure effects and support the continued development of bremelanotide.

17 Aug 2010

CRF announces additional featured trials to be presented at Transcatheter Cardiovascular Therapeutics 2010

The Cardiovascular Research Foundation has announced that in addition to the previously announced late breaking clinical trials and first reports, a series of additional featured trials will be presented at the Transcatheter Cardiovascular Therapeutics (TCT) 2010 scientific symposium. These trials will focus on a wide range of significant topics in interventional cardiovascular medicine. TCT 2010 will take place September 21 - 25 in Washington, DC.

13 Aug 2010

ViroPharma announces data on safety, efficacy of Cinryze to treat acute angioedema attacks

ViroPharma Incorporated today announced that data from Phase 3 studies of Cinryze (C1 esterase inhibitor [human]) have been published in the August 5, 2010 issue of the New England Journal of Medicine. The paper entitled Nanofiltered C1 Inhibitor Concentrate for Treatment of Hereditary Angioedema by Dr. Bruce L. Zuraw et al. describes the safety and efficacy of Cinryze in treating and preventing attacks of hereditary angioedema. Cinryze is the first and only FDA-approved C1 esterase inhibitor therapy indicated for routine prophylaxis against angioedema attacks in adolescent and adult patients with hereditary angioedema (HAE), a rare, debilitating and potentially fatal disease; it is not approved by the FDA to treat acute angioedema attacks.

6 Aug 2010

V-101 shows safety profile in treating erythema of rosacea: Clinical study

Vicept Therapeutics, Inc., a privately held specialty biopharmaceutical company, announced positive results from a pharmacodynamic and pharmacokinetic clinical trial of the Company's lead product V-101, a topical cream under investigation for the treatment of erythema in patients with rosacea.

6 Aug 2010

MAP Pharmaceuticals reports net loss of $12.5M for second-quarter 2010

MAP Pharmaceuticals, Inc. today announced financial results for the second quarter ended June 30, 2010.

3 Aug 2010

Researchers develop techniques to identify evolution of drug resistance strains of malaria

Researchers at Case Western Reserve University developed techniques to quickly identify evolution of drug resistance in strains of malaria. Their goal is to enable the medical community to react quickly to inevitable resistance and thereby save lives while increasing the lifespan of drugs used against the disease.Currently, disease monitoring requires months of clinical trials. The new methods can provide more information in just days, and far cheaper.

3 Aug 2010

ZIOPHARM Oncology commences palifosfamide Phase III clinical trial for metastatic soft tissue sarcoma

ZIOPHARM Oncology, Inc. today announced the initiation of the pivotal Phase III clinical trial for palifosfamide in patients with front-line metastatic soft tissue sarcoma. The study, called PICASSO 3, is an international, randomized, double-blinded, placebo-controlled trial designed to enroll approximately 424 patients with metastatic soft tissue sarcoma who have never been treated with chemotherapy for metastatic disease.

20 Jul 2010

MAP Pharmaceuticals reports results from LEVADEX PK and safety clinical trial in smokers, non-smokers

MAP Pharmaceuticals, Inc. today announced results from a clinical trial comparing the pharmacokinetics (PK) and safety of LEVADEX™ orally inhaled migraine therapy with intravenous dihydroergotamine mesylate (DHE) in smokers and non-smokers. The trial was designed to measure whether systemic absorption and exposure in smokers is greater than in non-smokers. In the trial, the systemic absorption of LEVADEX was not higher and systemic exposure to DHE was not greater in smokers than in non-smokers.

13 Jul 2010

Biogen Idec, Swedish Orphan Biovitrum present results from rFIXFc Phase 1/2a study in hemophilia B

Biogen Idec and Swedish Orphan Biovitrum AB today announced results from a Phase 1/2a open-label, dose-escalation, safety and pharmacokinetic study of the companies' long-lasting, fully-recombinant factor IX Fc fusion protein (rFIXFc) in hemophilia B patients. The data, which were presented at the World Federation of Hemophilia Congress in Buenos Aires, Argentina, on July 11, 2010, showed that rFIXFc was well tolerated and demonstrated an approximately three-fold increase in half-life compared to historical data for existing therapies.

12 Jul 2010

bitop's Ectoin allergy nasal spray reduces symptoms of acute allergic rhinitis in two-week crossover study

bitop AG, a biotech company specializing in the development of Ectoin®-containing medical devices, reports that Ectoin allergy nasal spray has been shown to significantly reduce symptoms of acute allergic rhinitis in a two-week observational, randomized, comparative crossover study with 50 patients suffering from acute allergic rhinitis. Based on this study, bitop performed a clinical trial on eyes drops and nasal spray in humans using an environmental exposure chamber (EEC) model.

12 Jul 2010

Biogen Idec, Swedish Orphan Biovitrum announce advancement of rFVIIIFc into registrational study

Biogen Idec and Swedish Orphan Biovitrum today announced that they plan to advance the companies' long-lasting, fully-recombinant factor VIII Fc fusion protein (rFVIIIFc) into a registrational clinical trial in people with hemophilia A. The decision to advance the program is based on promising data from a Phase 1/2a open-label, cross-over, multi-center, dose-escalation study that evaluated the safety and pharmacokinetics of an intravenous injection of rFVIIIFc in 16 previously-treated patients with severe hemophilia A.

12 Jul 2010

Threshold Pharmaceuticals initiates Phase 2 clinical trial of TH-302 in patients with first line pancreatic cancer

Threshold Pharmaceuticals, Inc. today announced that it has initiated a multi-center, randomized, controlled, crossover Phase 2 clinical trial of TH-302 in combination with gemcitabine in patients with first line pancreatic cancer. TH-302 is a proprietary tumor selective Hypoxia-Activated Prodrug that specifically targets tumor hypoxia.

1 Jul 2010

BioSante reports positive results from Phase II study of Pill-Plus "triple hormone" oral contraceptive

BioSante Pharmaceuticals, Inc. announced today positive results in a Phase II study of the Pill-Plus "triple hormone" oral contraceptive (OC). Results showed an increase in the frequency of sexual activity (p< 0.05) and reduced frequency of rejection of initiation of sexual activity by partner (p< 0.05).

30 Jun 2010

Chromosomal Crossover News and Research

Scientists to present preclinical pharmacology data on TRV120027 at Heart Failure Society of America Meeting

Incyte Corporation enters SPA agreement with FDA for INCB18424 inhibitor

MAP Pharmaceuticals completes 12 months of treatment in LEVADEX open-label safety trial

MAP Pharmaceuticals reports results from PD trial that compares effects of LEVADEX, IV DHE

Halozyme initiates Ultrafast Insulin combination Phase 2 studies with rHuPH20

Dietary supplement combining zinc, phytase enhances effectiveness of BTX injections: Study

Raptor Pharmaceutical updates on cysteamine bitartrate Phase 3 clinical trial in cystinosis patients

Palatin reports positive results from bremelanotide Phase 1 trial for sexual dysfunction

CRF announces additional featured trials to be presented at Transcatheter Cardiovascular Therapeutics 2010

ViroPharma announces data on safety, efficacy of Cinryze to treat acute angioedema attacks

V-101 shows safety profile in treating erythema of rosacea: Clinical study

MAP Pharmaceuticals reports net loss of $12.5M for second-quarter 2010

Researchers develop techniques to identify evolution of drug resistance strains of malaria

ZIOPHARM Oncology commences palifosfamide Phase III clinical trial for metastatic soft tissue sarcoma

MAP Pharmaceuticals reports results from LEVADEX PK and safety clinical trial in smokers, non-smokers

Biogen Idec, Swedish Orphan Biovitrum present results from rFIXFc Phase 1/2a study in hemophilia B

bitop's Ectoin allergy nasal spray reduces symptoms of acute allergic rhinitis in two-week crossover study

Biogen Idec, Swedish Orphan Biovitrum announce advancement of rFVIIIFc into registrational study

Threshold Pharmaceuticals initiates Phase 2 clinical trial of TH-302 in patients with first line pancreatic cancer

BioSante reports positive results from Phase II study of Pill-Plus "triple hormone" oral contraceptive

Achieving and maintaining ISO/IEC 27001 and BS 10012 certifications

Expanding research and clinical options for children with cancer

Examining how pain could play a direct protective role in the gut

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