$IDRA Follow Mr. Julian and Felix Baker a Long Journey !!!FEW YEARS AGO !!

The following poem is for Mr Julian Baker

He has been blessed  God gifted eyes and mind few years ago

INCY was 2 few years ago

GEVA was under 10 few years ago

PCYC was .57c few years ago

SLXP was teens few years ago

AVNR was pennies few years ago

VPHM was teens few years ago

RCPT was under 25 few months ago

ITMN was teen few years ago

and story goes on forever

Is there Guarantee IDRA will be one of this kind ?

NO ONe knows for now BUT

I will be singing in few years

WOOW IDRA was 4 FEW years AGO

I cann’t remmebr those names which were bpought out few years ago

What is common in all these few years ago

THEY were blessed by Mr. Julian and Feix Baker’s hand few years ago.

$KIPS Super High Risk Entry under .20 Cents in my Roth IRA HUGE Upside / vs. 20c risk

Almost 1 year Ago The news came as follows
“We are very early in the process and still have a lot to learn, but, if this product performs like many in the clinical world think it will, it could be the biggest game-changer heart surgery has seen in decades,” says Dr. Wolfe. “We’re talking about improving a basic principle of the way bypass surgery has been performed since the late 1960’s.”

Heart bypass surgery is typically performed when one or more of a patient’s coronary arteries are blocked, which makes it difficult for the heart to pump blood to the rest of the body. The surgeon will take healthy arteries or veins from other parts of the patient’s body and attach them to the blocked artery in a way that allows blood flow to “bypass” the blockage.

Saphenous veins are most commonly used to bypass blockages, because they are readily available in most patients, but using them presents two key issues:

1) Saphenous veins are also more likely to degenerate following surgery because they have thinner, less rigid walls than arteries
2) Veins have a normal blood pressure of 10, which is significantly less than the blood pressure of 120 in arteries.

That’s where the eSVS Mesh comes in. It’s an extremely thin, flexible tube of knitted mesh metal (nitinol) that is placed around the saphenous vein, like a sheath, to make the vein stronger and prevent enlargement. Medical research suggests that the sudden enlargement of the vein bypass graft often results in a buildup of plaque within the graft that ultimately causes it to narrow and stop working.

“Recent studies confirm that as many as 30 – 40 percent of saphenous vein grafts are closed within one year after surgery, which means patients may have to come back for a second surgery down the road and are put at risk for future heart attacks,” says Dr. Wolfe. “As a clinician, our goal is to devise a way to make the vein perform more like an artery. If the eSVS Mesh proves to help accomplish that goal, it may help spare patients the pain and expense of future heart problems.”

Dr. Wolfe says the first eSVS patient treated at NGMC is doing well and recovering normally at home. Although NGMC is currently the only hospital in the United States participating in the clinical trial, several other preeminent cardiac surgery centers from across the nation – including Cleveland Clinic, Mayo Clinic and Emory University – are expected to join the clinical trial.

https://www.accessnorthga.com/detail.php?n=258462

Milano said he was approached about the CEO job from an Idera board member who was also a ViroPharma investor

“They have really interesting science,” Milano said. “The company has been around for a while and the science has evovled. We are at a place now where we are looking to advance the science into clinical development.”
http://www.bizjournals.com/philadelphia/blog/health-care/2014/12/former-viropharma-chairman-and-ceo-gets-a-new-job.html

MRTX $15.00 very high risk upcoming catalysts But they might do Secondary offering before data

“We are excited to report that each of our clinical oncology programs are advancing and are positioned to deliver proof of concept data in the coming months,” said Charles M. Baum, M.D., Ph.D., president and CEO of Mirati. “We have opened the expansion cohorts for MGCD265 in selected patients with MET and Axl mutations at a dose we are confident is fully inhibiting MET and Axl and should result in clinical responses. In addition, Phase 2 studies of mocetinostat are underway in patient populations selected for CREBBP and EP300 genetic mutations in Bladder Cancer and Diffuse Large B-cell Lymphoma. We look forward to delivering multiple data readouts in early 2015 that could result in the launch of registration studies in 2015.”

Pipeline Highlights

MGCD265

  • We have reached MTD and selected a dose for the expansion cohorts that we believe will fully inhibit MET and Axl
  • Expansion cohorts are open to enroll selected patients with Non-Small Cell Lung Cancer and other solid tumors that have MET driver mutations, MET amplifications, and Axl gene fusions
  • Initial proof of concept data expected in early 2015

Mocetinostat in Bladder Cancer

  • Initiated a multi-center registration-enabling study in patients with bladder cancer who have mutations of CREBBP or EP300 genes
  • Mirati is partnering with Foundation Medicine to use their comprehensive genomic profile to screen patients for genomic alterations of CREBBP and EP300 genes prior to clinical trial enrollment
  • Initial proof of concept data expected in early 2015

Mocetinostat in Diffuse Large B-cell Lymphoma (DLBCL)

  • Memorial-Sloan Kettering has initiated a Phase 2 study enrolling patients with relapsed/refractory DLBCL whose tumors harbor CREBBP or EP300 gene mutations
  • Initial proof of concept data is anticipated in early 2015

MGCD516

  • Phase 1 safety dose escalation study is ongoing and on track to identify a Phase 2 dose and initiate expansion cohorts in selected patients in the first half of 2015

AUPH a $3.90 hidden Gem with Potential gain of 200% to 400 % but HIgh risk

The Company has cash, cash equivalents and short term investments of $35.5 million at September 30, 2014. Aurinia believes its cash position will be sufficient to finance its operational needs until at least December 31, 2016. However, future cash requirements could vary materially from current estimations due to a number of factors including the costs associated with its clinical trial and strategic opportunities.

On July 29, 2014, Mr. Charles A. Rowland, Jr. was appointed to the Board of Directors and has assumed the role of Audit Committee Chair. Mr. Rowland, a CPA, has over 32 years of diversified financial experience and most recently was Vice-President and CFO of ViroPharma Inc., which was acquired in January of 2014 by Shire PLC for over $4.2 billion.

The Company is also pleased to announce the appointment of Benjamin (Beni) Rovinski, PhD, Managing Director of Lumira Capital, as a member of its Board of Directors, effective immediately. Dr. Rovinski joined Lumira Capital in 2001 with an investment focus on mid- to late-stage private and public life sciences companies. Prior to joining Lumira Capital, he held several senior management positions in the biotechnology sector, including 13 years at Sanofi Pasteur where he was a senior scientist and director of molecular virology. Dr. Rovinski received a PhD in biochemistry from McGill University in Montréal with post-doctoral studies in molecular oncology and retrovirology at the Ontario Cancer Institute in Toronto. –

Many members of Aurinia’s current leadership team are former senior managers of Aspreva Pharmaceuticals (“Aspreva”), which Galenica acquired for C$915 million in 2008. While at Aspreva, this management team executed one of the largest and most important lupus nephritis studies ever conducted, called the Aspreva Lupus Management Study (“ALMS”), which resulted in the emergence of mycophenolate mofetil as a new standard treatment for patients suffering from this devastating and potentially fatal disease. Aurina holds global rights to all indications for voclosporin and has development and commercialization partners in Canada, Israel, South Africa and Greater China. Aurinia also has a development and commercialization partner for ophthalmologic indications. In addition, Aurinia holds certain rights to exploit the ALMS database.
November 2014 Presentation

$XOMA Bakers bros. own 20% should we, I know it’s too late now that’s why I risked less and got March 10 calls .70c risking $350 on 5 calls

XOMA’s flagship candidate, gevokizumab, is being studied in a global Phase 3 clinical program, termed EYEGUARD, which is being conducted by SERVIER and XOMA. This program is designed to determine gevokizumab’s ability to treat acute non-infectious uveitis (“NIU”) in EYEGUARD-A, to prevent disease flares in patients with Behçet’s uveitis in EYEGUARD-B, and to prevent disease flares in NIU patients who are controlled with steroids and immunosuppressants in EYEGUARD-C.

Gevokizumab Proof-of-Concept Program

XOMA has a Proof-of-Concept (POC) program underway in which the Company is exploring the efficacy and safety of gevokizumab in multiple indications.  The Company reported promising data in January 2013 from the interim analysis of a Phase 2 study in moderate to severe inflammatory acne.  Data from the National Eye Institute’s study of gevokizumab in patients with active non-infectious anterior scleritis is expected in 2014.  XOMA anticipates full results from its two POC studies in patients with erosive osteoarthritis of the hand (EOA) in the first quarter of 2014.  Separately, SERVIER initiated a Phase 2 study to determine gevokizumab’s ability to reduce arterial wall inflammation in patients with marked atherosclerotic plaque inflammation and who have experienced an acute coronary syndrome in the previous twelve months, as well as POC studies in polymyositis/dermatomyositis, giant cell arteritis, and Schnitzler syndrome. 

More information on all of XOMA’s clincial programs can be found at  www.clinicaltrials.gov orwww.clinicaltrialsregister.eu.

.http://www.xoma.com/content/pipeline/overview.htm

ONCS I like .30c and under

OncoSec plans to present long term PFS data from its Phase I melanoma program. Please note that the date for this milestone is tentative and subject to change.

August 15, 2013 — December 31, 2013
Present interim response data on Phase II Merkel cell carcinoma program

OncoSec plans to present interim response data on Phase II Merkel cell carcinoma program. Please note that the date for this milestone is tentative and subject to change.

October 31, 2013 — December 31, 2013
Present top line interim data for Phase II melanoma program

OncoSec plans to present top line interim data for Phase II melanoma study. Please note that the date for this milestone is tentative and subject to change
http://oncosec.com/?p=3697

LJPC MArch 2014 Phase 2 is catalyst

A Phase 2a Study of Weekly Doses of GCS-100 in Patients With Chronic Kidney Disease
This study is currently recruiting participants.
Verified July 2013 by La Jolla Pharmaceutical Company
Sponsor:
La Jolla Pharmaceutical Company
Information provided by (Responsible Party):
La Jolla Pharmaceutical Company
ClinicalTrials.gov Identifier:
NCT01843790
First received: April 25, 2013
Last updated: July 25, 2013
Last verified: July 2013
History of Changes
Full Text View Tabular ViewNo Study Results PostedDisclaimerHow to Read a Study Record
Purpose
The primary objective of this study is to compare the change in estimated glomerular filtration rate (eGFR) from baseline to Week 8 between placebo and GCS-100 treatment. The secondary objective is to determine the safety and tolerability of GCS-100 administered for 8 weeks relative to placebo. In addition, the study will measure the effect of GCS-100 on circulating galectin-3 and other markers of disease activity.

Condition Intervention Phase
Chronic Kidney Disease
Drug: GCS-100
Drug: Placebo, Saline
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: A Phase 2a, Placebo-Controlled, Randomized, Single-Blind Study of Weekly Doses of GCS-100 in Patients With Chronic Kidney Disease

Resource links provided by NLM:

MedlinePlus related topics: Chronic Kidney Disease
U.S. FDA Resources

Further study details as provided by La Jolla Pharmaceutical Company:

Primary Outcome Measures:
Change in estimated glomerular filtration rate (eGFR) from baseline relative to placebo after administration of GCS-100 for 8 weeks in patients with chronic kidney disease (CKD) and baseline eGFR of 15 – 44 mL/min/1.73m2 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
Number of adverse events as a measure of safety and tolerability of GCS-100 administered for 8 weeks relative to placebo in patients with CKD [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 117
Study Start Date: June 2013
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo, saline
Saline, dosed weekly for 8 weeks
Drug: Placebo, Saline
Experimental: GCS-100 low dose
Low dose of GCS-100 given IV once per week for 8 weeks
Drug: GCS-100
Experimental: GCS-100 high dose
High dose of GCS-100 given IV once per week for 8 weeks
Drug: GCS-100

Eligibility

Ages Eligible for Study: 18 Years to 80 Years
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Criteria
Inclusion Criteria:

Subject is capable of understanding the purpose and risks of the study and is able to provide written informed consent
Subject is ≥18 and ≤75 years of age; patients >75 years old may be included at the request of the investigator and discretion of the Medical Monitor
Subject has an eGFR of 15 – 44 mL/min/1.73m2 determined using the 4-variable Modification of Diet in Renal Disease (MDRD) equation (see Section 10.1)
Patients with CKD diagnosis >12 months and stable, in the opinion of the investigator, within the past 3 months
Subject is willing and able to comply with all protocol requirements
Female subjects of childbearing potential (i.e., women who have not been surgically sterilized or have not been post-menopausal for at least 1 year) and male subjects with partners of childbearing potential must agree to use medically acceptable methods of contraception throughout the study period
Exclusion Criteria:

Treatment with an experimental (unlicensed) drug within 4 weeks or ≤5 half-lives prior to screening
Kidney disease due to systemic lupus erythematosus (regardless of whether active or in remission), any form of vasculitis (regardless of whether active or in remission), IgA nephropathy, multiple myeloma, polycystic kidney disease, untreated obstructed nephropathy or any other causes that, in the opinion of the investigator, may put the subject at an increased risk
Planned renal replacement therapy of any kind within 6 months of randomization
Previous solid organ transplant
Systolic blood pressure ≤90 mmHg and ≥160 mmHg and diastolic blood pressure ≤40 mmHg and ≥100 mmHg at screening
Subject has clinical laboratory values of:
Hemoglobin: ≤9 g/dL
Total bilirubin: >1.5X the upper limit of normal (ULN)
ALT and/or AST: >2.5X ULN
Current treatment with immunosuppressive agents, except for topical agents or inhaled steroids when conditions are chronic and stable
Treatment with any form of IV iron therapy within 4 weeks prior to screening
Known history of cancer (excluding non-melanoma skin cancer that is not being actively treated) within 5 years of screening
Known history of human immunodeficiency virus, active hepatitis C virus (HCV), active hepatitis B virus (HBV), or prior history of infection with HBV (HBcAb positive); if adequate hepatic function has been documented for patients with HCV or prior history of hepatitis B without evidence of cirrhosis, the Medical Monitor may approve their enrollment
Clinically relevant active infection and/or a serious co-morbid medical condition, such as recent myocardial infarction (within the last 6 months), unstable angina, difficult-to-control congestive heart failure, uncontrolled hypertension, difficult-to-control cardiac arrhythmias, severe or uncontrolled chronic obstructive or chronic restrictive pulmonary disease, and/or cirrhosis.
Subject had major surgery within 4 weeks of randomization
If female, subject is pregnant or breastfeeding
Subject has a concomitant disease or condition, including laboratory abnormalities, which, in the opinion of the investigator, could interfere with the conduct of the study or put the subject at unacceptable risk
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01843790

Contacts
Contact: George Tidmarsh, MD, PhD 650-208-3191 gtidmarsh@ljpc.com

Locations
United States, Arizona
Southwest Clinical Research Institute, LLC Recruiting
Tempe, Arizona, United States, 85284
Contact: Bhupinder Singh, MD 480-610-6120
Principal Investigator: Bhupinder Singh, MD
United States, California
California Institute of Renal Research Recruiting
La Mesa, California, United States, 91942
Contact: George Fadda, MD gfadda@bnmg.org
Principal Investigator: George Fadda, MD
United States, Colorado
Denver Nephrology Recruiting
Denver, Colorado, United States, 80230
Contact: Geoffrey Block, MD 303-364-4775
Principal Investigator: Geoffrey Block, MD
United States, Texas
Clinical Advancement Center, PLLC Recruiting
San Antonio, Texas, United States, 78215
Contact: Pablo Pergola, MD
Principal Investigator: Pablo Pergola, MD
Sponsors and Collaborators
La Jolla Pharmaceutical Company
More Information

http://clinicaltrial.gov/ct2/show/NCT01843790?term=gcs-100&rank=3
Responsible Party: La Jolla Pharmaceutical Company
ClinicalTrials.gov Identifier: NCT01843790 History of Changes
Other Study ID Numbers: GCS-100-CS-4002
Study First Received: April 25, 2013
Last Updated: July 25, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency

ClinicalTrials.gov processed this record on October 09, 2013

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