Aeterna Zentaris reaches SPA agreement with FDA for AEZS-108 Phase 3 trial in endometrial cancer

Aeterna Zentaris Inc. announced that it has reached an agreement with FDA  on a Special Protocol Assessment ("SPA") for an upcoming Phase 3 registration trial in endometrial cancer with its doxorubicin peptide conjugate, AEZS-108. The SPA agreement states that the proposed trial protocol design, clinical endpoints and planned analyses are acceptable to the FDA to support a regulatory submission. 

About AEZA-108 : AEZS-108: AEZS-108 (AN-152, or zoptarelin doxorubicin) is a targeted cytotoxic peptide conjugate which is a hybrid molecule composed of a synthetic peptide carrier and a well-known cytotoxic agent, doxorubicin. The design of this product allows for the specific binding and selective uptake of the cytotoxic conjugate by the LHRH receptor-positive tumors. The binding of conjugate molecule AEZS-108 to cancerous cells that express these receptors results in its accumulation in the malignant tissue. This binding is followed by internalization and retention of the cytotoxic drug, doxorubicin, in the cells. Therefore, since they target specific cells, cytotoxic conjugates are postulated to be more effective and have less side-effects than the respective non-conjugated/non-linked cytotoxic agents in inhibiting tumor growth. AEZS-108 is the first drug in a clinical study that targets the cytotoxic activity of doxorubicin specifically to LHRH-receptor expressing tumors. 

"We are pleased with the agreement with the FDA which provides us with a clearly defined development and regulatory pathway for AEZS-108 in endometrial cancer", stated Juergen Engel , PhD, President and CEO at Aeterna Zentaris. "AEZS-108's innovative targeted approach could offer a new treatment option for women with endometrial cancer and provide the Company with a significant market opportunity."

Aeterna Zentaris reaches SPA agreement with FDA for AEZS-108 Phase 3 trial in endometrial cancer

Drug May Help Women Who Quit Smoking Avoid Weight Gain - Drugs.com MedNews

In continuation of my update on Naltrexone

We know that, Naltrexone is an opioid receptor antagonist used primarily in the management of alcohol dependence and opioid dependence. It is marketed in generic form as its hydrochloridesalt, naltrexone hydrochloride, and marketed under the trade names Revia andDepade. In some countries including the United States, a once-monthly extended-release injectable formulation is marketed under the trade name Vivitrol. Also in the US, Methylnaltrexone Bromide, a closely related drug, is marketed as Relistor, for the treatment of opioid induced constipation.

Naltrexone should not be confused with naloxone (which is used in emergency cases of overdose rather than for longer-term dependence control) nor nalorphine. Using naloxone in place of naltrexone can cause far worse withdrawal symptoms; conversely, using naltrexone in place of naloxone in an overdose can lead to insufficient opiate antagonism and fail to reverse the overdose.

Drug May Help Women Who Quit Smoking Avoid Weight Gain - Drugs.com MedNews

FDA Approves Juxtapid - New Orphan Drug for Rare Cholesterol Disorder

In continuation of my update on Juxtapid (lomitapide) 

We know that, Lomitapide (INN) is an investigational drug for the treatment of familial hypercholesterolemia, developed by Aegerion Pharmaceuticals.  It has been tested in several Phase II clinical trials as single treatment and in combinations with atorvastatin, ezetimibe and fenofibrate. 

The US Food and Drug Administration approved lomitapide on December 21, 2012 as anorphan drug to reduce LDL cholesterol, total cholesterol, apolipoprotein B, and non-high-density lipoprotein (non-HDL) cholesterol in patients with homozygous familial hypercholesterolemia (HoFH).

FDA Approves Juxtapid - New Orphan Drug for Rare Cholesterol Disorder

Ability to metabolize tamoxifen affects breast cancer outcomes

In continuation of my update on tamoxifen

Ability to metabolize tamoxifen affects breast cancer outcomes

Continuous vancomycin optimizes neonate therapy

In continuation of my update on vancomycin...

Continuous vancomycin optimizes neonate therapy

Scientists design small molecules that recognize myotonic dystrophy-associated RNAs

In continuation of my update on RNAs

Scientists design small molecules that recognize myotonic dystrophy-associated RNAs

Killing the message: An approach to direct the cleavage of RNA targets with small molecules in living cells is described (see scheme). A bifunctional small molecule (purple) that recognizes a specific three nucleotide repeat sequence and cleaves that sequence in response to light was shown to be effective at degrading the myotonic dystrophy type 1 (DM1) extended repeat RNAs, affecting biological functions.

Ref : http://onlinelibrary.wiley.com/doi/10.1002/anie.201206888/abstract

Chinese medicine yields secrets: Atomic mechanism of two-headed molecule derived from Chang Shan, a traditional chinese herb

The mysterious inner workings of Chang Shan  a Chinese herbal medicine used for thousands of years to treat fevers associated with malaria  have been uncovered thanks to a high-resolution structure solved at The Scripps Research Institute (TSRI). Described in the journal Nature this week, the structure shows in atomic detail how a two-headed compound derived from the active ingredient in Chang Shan works. Scientists have known that this compound, called halofuginone (a derivative of the febrifugine), can suppress parts of the immune system  but nobody knew exactly how.

The new structure shows that, like a wrench in the works, halofuginone jams the gears of a molecular machine that carries out "aminoacylation," a crucial biological process that allows organisms to synthesize the proteins they need to live. Chang Shan, also known asDichroa febrifuga Lour, probably helps with malarial fevers because traces of a halofuginone-like chemical in the herb interfere with this same process in malaria parasites, killing them in an infected person's bloodstream.

"Our new results solved a mystery that has puzzled people about the mechanism of action of a medicine that has been used to treat fever from a malaria infection going back probably 2,000 years or more," said Paul Schimmel, PhD, the Ernest and Jean Hahn Professor and Chair of Molecular Biology and Chemistry and member of The Skaggs Institute for Chemical Biology at TSRI. Schimmel led the research with TSRI postdoctoral fellow Huihao Zhou, PhD.

Halofuginone (see structure, below) has been in clinical trials for cancer, but the high-resolution picture of the molecule suggests it has a modularity that would make it useful as a template to create new drugs for numerous other diseases.

 Ref : http://www.nature.com/nature/journal/vaop/ncurrent/full/nature11774.html

Chinese medicine yields secrets: Atomic mechanism of two-headed molecule derived from Chang Shan, a traditional chinese herb

Gattex Approved for Short Bowel Syndrome - Drugs.com MedNews

We know that, Gattex (teduglutide) is a recombinant analog of human glucagon-like peptide 2 for the treatment of adults with short bowel syndrome....

Gattex Approved for Short Bowel Syndrome - Drugs.com MedNews

FDA Approves Adasuve (loxapine) Inhalation Powder for the Acute Treatment of Agitation Associated with Schizophrenia or Bipolar I Disorder in Adults

We know that, Loxapine (Loxapac, Loxitane) is a typical antipsychotic medication, used primarily in the treatment of schizophrenia. It is a member of the dibenzoxazepine class and structurally related to clozapine (which belongs to the chemically akin class of dibenzodiazepines). Several researchers have argued that Loxapine may behave as an atypical antipsychotic.  Loxapine may be metabolized by N-demethylation to amoxapine, a tetracyclic antidepressant. ........

FDA Approves Adasuve (loxapine) Inhalation Powder for the Acute Treatment of Agitation Associated with Schizophrenia or Bipolar I Disorder in Adults

Penn Team Mimicking a Natural Defense Against Malaria to Develop New Treatments

Penn Team Mimicking a Natural Defense Against Malaria to Develop New Treatments

Dantrolene shows promise for treating DMD

 

We know that, Dantrolene sodium is a muscle relaxant that acts by abolishing excitation-contraction coupling in muscle cells, probably by action on the ryanodine receptor. It is the only specific and effective treatment for malignant hyperthermia, a rare, life-threatening disorder triggered by general anesthesia. It is also used in the management of neuroleptic malignant syndrome, muscle spasticity (e.g. after strokes, in paraplegia, cerebral palsy, or patients with multiple sclerosis), 3,4-methylenedioxymethamphetamine ("ecstasy") intoxication, serotonin syndrome, and 2,4-dinitrophenol poisoning. It is marketed by JHP Pharmaceuticals LLC as Dantrium (in North America) and Dantrolen (Europe).

  

Dantrolene shows promise for treating DMD

Dantrolene shows promise for treating DMD

 

We know that, Dantrolene sodium is a muscle relaxant that acts by abolishing excitation-contraction coupling in muscle cells, probably by action on the ryanodine receptor. It is the only specific and effective treatment for malignant hyperthermia, a rare, life-threatening disorder triggered by general anesthesia. It is also used in the management of neuroleptic malignant syndrome, muscle spasticity (e.g. after strokes, in paraplegia, cerebral palsy, or patients with multiple sclerosis), 3,4-methylenedioxymethamphetamine   ("ecstasy") intoxication, serotonin syndrome, and 2,4-dinitrophenol poisoning. It is marketed by JHP Pharmaceuticals LLC as Dantrium (in North America) and Dantrolen (Europe).

  

Dantrolene shows promise for treating DMD

Lapatinib benefits found for HER2-positive early-stage patients

In continuation of my update on Lapatinib

Lapatinib benefits found for HER2-positive early-stage patients

FDA Approves Varizig for Reducing Chickenpox Symptoms

FDA Approves Varizig for Reducing Chickenpox Symptoms :

Varizag : http://www.cangene.com/VariZIG

Abiraterone improves outcomes for prostate cancer prior to chemo

In continuation of my update on abiraterone

Abiraterone improves outcomes for prostate cancer prior to chemo