Pfizer aims to become industry leader in gene therapy with acquisition of Bamboo Therapeutics, Inc.

Pfizer Inc. (NYSE:PFE) has acquired Bamboo Therapeutics, Inc., a privately held biotechnology company based in Chapel Hill, N.C., focused on developing gene therapies for the potential treatment of patients with certain rare diseases related to neuromuscular conditions and those affecting the central nervous system. This acquisition significantly expands Pfizer's expertise in gene therapy by providing Pfizer with a clinical and several pre-clinical assets that complement the company's rare disease portfolio, an advanced recombinant Adeno-Associated Virus (rAAV) vector design and production technology, and a fully functional Phase I/II gene therapy manufacturing facility that Bamboo acquired from the University of North Carolina earlier this year.

Gene therapy is an emerging area of medical research focused on highly specialized, one-time, transformative treatments addressing the root cause of diseases caused by genetic mutation. Gene therapy is a promising investigational technology, especially for patients with rare diseases, many of which are caused by a single genetic mutation. The technology involves introducing genetic material into the body to deliver a corrected copy of a gene to a patient's cells to compensate for a defective one. The genetic material can be delivered to the cells by a variety of means, most frequently using a viral vector such as rAAV. There have been no gene therapy products approved in the U.S. to date.

"The field of gene therapy research has made tremendous strides in recent years, and we are pleased to be able to further enhance our leadership position in this area through this transaction with Bamboo," said Mikael Dolsten, President, Pfizer Worldwide Research & Development. "We believe that gene therapy may hold the promise of bringing true disease modification for patients suffering from devastating diseases, and we hope to see this promise come to fruition - through new and existing in-house capabilities and potential partnership opportunities - in the years to come."

Bamboo's portfolio includes potential best-in-class rAAV-based gene therapies that will complement Pfizer's rare disease and gene therapy portfolios in two priority areas: neuromuscular, with a pre-clinical asset for Duchenne Muscular Dystrophy (DMD); and central nervous system, with pre-clinical assets for Friedreich's Ataxia and Canavan disease, and a Phase I asset for Giant Axonal Neuropathy.

Bamboo's approximately 11,000-square foot, fully staffed and operational manufacturing facility has experience producing Phase I/II materials using a superior suspension, cell-based production platform that increases scalability, efficiency and purity. This helps enable the DMD program and other projects requiring large amounts of rAAV. The facility, previously known as the University of North Carolina Vector Core facility, has served as a qualified supplier of rAAV vectors for several healthcare companies and academic institutions.

Bristol-Myers Squibb reports second quarter financial results

Bristol-Myers Squibb Company (NYSE:BMY) today reported results for the second quarter of 2016, which were highlighted by strong sales, key regulatory and clinical milestones in Immuno-Oncology and business development transactions that strengthened the company's Immuno-Oncology pipeline.

"During the second quarter we delivered strong sales and earnings growth, achieved important regulatory milestones with Opdivo across multiple types of cancer, and further advanced our leadership in Immuno-Oncology through the breadth of the clinical data we presented at ASCO," said Giovanni Caforio, M.D., chief executive officer, Bristol-Myers Squibb. "I am confident strong performance of our in-line products, progress with our diversified pipeline and our focused approach to business development position us well for continued success."

Second quarter financial results

• Bristol-Myers Squibb posted second quarter 2016 revenues of $4.9 billion, an increase of 17% compared to the same period a year ago. Global revenues increased 18% adjusted for foreign exchange impact. Excluding Abilify and Erbitux , global revenues increased 24% or 26% adjusted for foreign exchange impact.
• U.S. revenues increased 46% to $2.7 billion in the quarter compared to the same period a year ago. International revenues decreased 6% primarily from lower Hepatitis C Franchise sales in Japan and France. When adjusted for foreign exchange impact, international revenues decreased 4%.
• Gross margin as a percentage of revenues was 75.2% in the quarter compared to 75.7% in the same period a year ago.
• Marketing, selling and administrative expenses increased 9% to $1.2 billion in the quarter.
• Research and development expenses decreased 32% to $1.3 billion in the quarter. Research and development expenses in the second quarter of 2015 include an $800 million charge resulting from the Flexus acquisition.
• The effective tax rate was 26.4% in the quarter, compared to 311.5% in the second quarter last year. The second quarter 2015 Flexus acquisition was non-deductible for tax purposes.
• The company reported net earnings attributable to Bristol-Myers Squibb of $1.2 billion, or $0.69 per share, in the quarter compared to a net loss of $130 million, or $0.08 per share, a year ago. The results in the second quarter of 2015 include a $0.48 per share charge from the Flexus acquisition.
• The company reported non-GAAP net earnings attributable to Bristol-Myers Squibb of $1.2 billion, or $0.69 per share, in the second quarter, compared to $890 million, or $0.53 per share, for the same period in 2015. An overview of specified items is discussed under the "Use of Non-GAAP Financial Information" section.
• Cash, cash equivalents and marketable securities were $7.9 billion, with a net cash position of $1.2 billion, as of June 30, 2016.

Losing weight lowered levels of proteins associated with tumor growth

Overweight or obese women who lost weight through diet or a combination of diet and exercise also significantly lowered levels of proteins in the blood that help certain tumors grow, according to a Fred Hutchinson Cancer Research Center study published July 14 in Cancer Research, a journal of the American Association for Cancer Research.

Two study leaders - Dr. Catherine Duggan, principal staff scientist in the Public Health Sciences Division, and Dr. Anne McTiernan, cancer prevention researcher in the Public Health Sciences Division and the article's senior author - are available to provide details on the study and its implications.

The study:

• Measured three proteins that are known to enhance tumor-related angiogenesis - the formation of blood vessels that feed tumors and enable them to grow.
• Was intended to see how cancer-promoting proteins changed when overweight, sedentary, postmenopausal women lost weight through diet or diet and exercise over the course of a year.
• Enrolled 439 healthy women (they did not have cancer), placing each participant in one of four study arms:
  • Calorie- and fat-restricted diet.
  • Aerobic exercise five days a week.
  • Combined diet and exercise.
  • Control (no intervention).
• Found that women in the diet arm and the diet and exercise arm lost more weight and had significantly lower levels of angiogenesis-related proteins, compared with women in the exercise-only arm and the control arm.

The authors said that it is known that being overweight and having a sedentary lifestyle are associated with increased risk for developing certain cancers, but the reasons for this relationship are not clear.

Over 750 biomarkers identified as potentials for early cancer screening test

Researchers have identified 788 biomarkers in blood that could be used to develop an early stage cancer screening test for the general population. The study, led by the University of Sheffield, is the first to create a comprehensive list of relevant cancer blood biomarkers that have been researched in the last five years. The study also groups them by molecular function and records the technologies that can be used to detect them.

The team - from the Universities of Sheffield, Coventry and Warwick - started with over 19,000 scientific studies published over the last five years that investigated blood based biomarkers. Systematic review methods - including ruling out studies in fewer than 50 patients - reduced this to 4,000 studies from which the final biomarker list was compiled.

Lead researcher, Dr Lesley Uttley, from the University of Sheffield's School of Health and Related Research, said: "Because of the sheer number of publications in this field, previous reviews have only been able to look at one biomarker or a small group of biomarkers. Our data mining approach allowed us to take in all relevant research findings from the five-year period, which meant we could map the full range of potential blood-based biomarkers that are particularly relevant for early detection of cancer."

The work was carried out on behalf of the Early Cancer Detection Consortium, a group of nearly 40 organisations, including universities, hospitals and commercial companies. The Consortium was funded by Cancer Research UK to investigate whether a cost-effective screening test can be used in the general population to identify people with early stage cancers.

The next step will be to look in detail at the research behind each biomarker, to check that it is robust and that the biomarker could feasibly be used as part of a screening test. Biomarkers will also be grouped by cancer type at this stage. The validated biomarkers will then be put through a clinical study, using samples from cancer patients and healthy controls, to check how effectively they identify the presence of cancer.

Finally, those biomarkers which work successfully in the study will be taken forward into a clinical trial, to see if the screening test works in practice and is cost-effective.

ECDC Director and Molecular Pathologist at University Hospitals Coventry and Warwickshire NHS Trust, Professor Ian Cree, said: "Our expectation is that, once the validation and clinical studies are completed, we will have a suite of around 50 biomarkers, identified using four different tests, that can go into the clinical trial. To complete the validation and the trials will take six to eight years, but in theory, we could have a test ready within three years for use in high risk groups".

SwastiChmex - Product list

Expertise in manufacturing of API Intermediates

                 Intermediate name                        CAS NO’S                    API name

1.       4-BromoPhenyl acetic acid                                CASNO: [1878-65-5]                Bilastin

2.       4-Bromo benzyl cyanide                                     CASNO: [16532-79-9]             Bromo phenaramine  Maleate

3.        4-Methoxy-3-sulfamoylPhenyl acetone         CASNO:[116091-63-5]            Tamsulosin

4.       1-(2-Bromoethoxy)-2-methoxybenzene         CASNO: [4463-59-6]                Tamsulosin

5.       Cyclopropyl isonitrile                                          CASNO: [58644-53-4]             Telaprevir                

6.        3,5-Bis-(Di bromo methyl ) toluene                CASNO:[19294-04-3]               Anastrazole                    

7.        6-Nitro Veratric acid                                          CASNO: [4998-07-6]                Doxazocin

8.        4-Nitro Pyridine N-Oxide                                  CAS NO:[1124-33-0] 

9.       3,5 Dimethyl -4-Nitro Pyridine-N-Oxide          CAS NO:[14248-66-9]             Omeprazole

10.   2, 3- Dimethyl-4- Nitro Pyridine- N-Oxide  CAS NO:[37699-43-7 ]            Lansaprazole

Reagents Class

11.   Tertiary butyl nitrite (> 80% )                            CASNO:[540-80-7 ]

12.   Iso amyl nitrite           (>80% )                            CASNO: [110-46-3 ]

13.   Morpholine Hydrochloride                                CASNO: [10024-89-2]

Fine Chemicals

14.   4-Nitro-3-Picoline-N-oxide                                      CASNO:[1074-98-2 ]

15.   2-Picoline-N-Oxide                                                   CASNO: [931-19-1]

16.   2-Chloropyridine-N-Oxide                                       CASNO:[2402-95-1 ]

17.   5-Nitro Barbuturic acid                                            CASNO: [480-68-2  ]

18.   2,4,6-TrichloroPyrimidine                                       CASNO: [3764-01-0]

19.   4-Bromo Guaiacol                                                    CASNO: [7368-78-7]

Contact : swasti.chemx@gmail.com 

Cyclopropyl isonitrile

Synonyms: Cyclopropylisocyanide;Cyclopropyl isonitrile;Isocyanocyclopropane;

• Name: Cyclopropane, isocyano-
• Molecular Formula: C₄H₅N
• Molecular Structure:
• Usage:
• Analytical:
• Analytical:
• CAS: 58644-53-4
• Chemical Properties:
• Molecular Weight: 68.10
• InChI: InChI=1/C4H5N/c1-5-4-2-3-4/h4H,2-3H2
• Specification: The cas register number of Cyclopropyl isocyanide is 58644-53-4. It also can be called as Cyclopropane, isocyano- and the Systematic name about this chemical is cyclopropyl isocyanide.
  Physical properties about Cyclopropyl isocyanide are: (1)#H bond acceptors: 1; (2)#H bond donors: 0; (3)#Freely Rotating Bonds: 0; (4)Polar Surface Area: 4.36Ų.
  
  More Details : Contact  :swasti.chemex@gmail.com
  
  

Oncurious begins phase I/IIa study with TB-403 to treat medulloblastoma

Oncurious NV, an emerging oncology company focused on the development of innovative orphan drugs for the treatment of pediatric cancers, has initiated a phase I/IIa study that will evaluate the safety and tolerability and explore the preliminary efficacy of TB-403 for the treatment of relapsed or refractory medulloblastoma, a rare, life-threatening brain tumor that mainly affects children.

Today's study initiation follows the earlier announced partnership between Oncurious, its TB-403 project partner BioInvent, and the Neuroblastoma and Medulloblastoma Translational Research Consortium (NMTRC) in the US. NMTRC is a collaboration of 25 US academic medical centers, teaching hospitals and other entities, with the purpose of facilitating and conducting collaborative research activities and investigations of new treatments for neuroblastoma, medulloblastoma and other pediatric cancers.

Headquartered at the Helen DeVos Children's Hospital in Grand Rapids, MI, USA, NMTRC is the key clinical trial partner for this Phase I/IIa study. The study aims at recruiting a minimum of 27 patients, with first results expected to be reported in 2017.

TB-403 is a humanized monoclonal antibody against placental growth factor (PlGF) which is expressed in several types of cancer, including medulloblastoma. A paper in Cell in February 2013 (Cell, 152, 1065-76, 2013), highlighted for the first time that PlGF plays a role in the growth of medulloblastoma. The paper was based on pre-clinical research conducted by Prof Rakesh Jain from the Massachusetts General Hospital at Harvard (Boston) and the team of Prof Peter Carmeliet from the VIB/ KU Leuven.