Nektar Issues Data from NKTR-181; CryoLife Receives Conditional IDE Approval Print E-mail
By Staff and Wire Reports   
Wednesday, 19 June 2013 18:45
Below is a look at some of the headlines for companies that made news in the healthcare sector on June 19, 2013.

Nektar Therapeutics (Nasdaq: NKTR)
announced positive top-line results from a human abuse liability (HAL) study for NKTR-181, a first-in-class, opioid analgesic molecule with a slow rate of entry into the brain.  This slow rate of entry is designed to reduce the euphoria that can lead to the abuse of and addiction to current opioid analgesics.1 In the study data being presented today, NKTR-181 was rated similar to placebo in "drug liking" and "feeling high" scores and had highly statistically significant lower "drug liking" scores and reduced "feeling high" scores as compared to oxycodone at all doses tested (p<0.0001).  

Prescription opioids are critical in the management of moderate-to-severe chronic pain.  However, the abuse and misuse of these opioids have led to a serious public health crisis.   HAL studies are clinical studies that assess the relative abuse potential of a medicine.  These studies are conducted in a non-dependent, recreational drug abuser population and are designed to predict how probable it is that a particular medicine will be attractive to abusers (i.e., "liked").  The primary endpoint for the NKTR-181 HAL study was drug-liking measured on a bi-polar visual analogue scale (VAS).  This endpoint is known to correlate most directly with a drug's potential for abuse.^2

"It is clear that there is a pressing societal need for better and safer analgesics," said Dr. Lynn Webster, President of the American Academy of Pain Medicine and lead investigator for the study at CRI Lifetree. "We know that speed of entry into the brain is important in abuse.  When we look at the critical period following dosing when the commonly abused drug oxycodone reaches maximum liking, NKTR-181 was not distinguished from placebo with respect to both drug-liking and feeling high.  These are two of the most important metrics that help us understand the abuse potential of a medicine.  Importantly, NKTR-181 was dosed as an oral liquid, which underscores that its less rewarding properties are inherent to this NCE and independent of any abuse-deterrent formulation.  These data, along with previous efficacy data, suggest NKTR-181 may be a major advance towards safer opioid therapy for the treatment of moderate to severe chronic pain."

The HAL study compared drug liking between each treatment group (oxycodone 40 mg, Placebo, and NKTR-181 100 mg, 200 mg, and 400 mg).  On the bipolar VAS scale (0-100), a score of 50 indicates that the subject "neither likes nor dislikes" the drug.  In the study, 40 mg of oxycodone oral solution resulted in a maximum mean drug liking score of 85, indicating a "strong liking" for the effects of oxycodone.  The oxycodone liking score was significantly different from placebo as early as 15 minutes after dosing and peaked at 60 minutes. In the placebo arm, the maximum mean drug liking score was 50, indicating that the subjects neither liked nor disliked the effects.  NKTR-181 dosing was similar to placebo with maximum mean drug liking VAS scores of 58, 58 and 63 for 100 mg, 200 mg and 400 mg, respectively.

"The data from this study are remarkable and clearly demonstrate that drug abusers could not discriminate NKTR-181 from placebo at doses that we know produced analgesia in the validated pain models from our Phase 1 studies," said Robert Medve MD, SVP and Chief Medical Officer of Nektar Therapeutics. "These data suggest that NKTR-181 could change the way we think about opioids and how we treat patients with chronic pain."


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CryoLife (NYSE: CRY)
, a leading tissue processing and medical device Company focused on cardiac and vascular surgery, announced it has received conditional approval of its Investigational Device Exemption (IDE) for PerClot from the United States Food and Drug Administration (FDA).

PerClot is a unique hemostat composed of absorbable polysaccharide granules and is intended for use in surgical procedures as an adjunctive hemostatic device when control of capillary, venular, and arteriolar bleeding by pressure, ligature, and other conventional means is ineffective or impractical. PerClot has CE Mark designation and CryoLife began distributing PerClot in several international markets in the fourth quarter of 2010. PerClot international sales were up 34 percent in the first quarter of 2013 compared to the first quarter of 2012.

"We're pleased to reach this initial milestone toward the commercialization of PerClot in the U.S.," stated Steven G. Anderson, CryoLife president and chief executive officer. "Subject to satisfaction of the FDA's conditions, we plan to begin enrollment in the pivotal trial in the third quarter of 2013, and hope to have pre-market approval in 2015."

The U.S. hemostatic market is estimated to be $889 million in 2012 growing to approximately $1.1 billion in 2014, while the European market is estimated to be $361 million in 2012 growing to approximately $430 million in 2014.[1]

The PerClot IDE is a prospective, multicenter, multidisciplinary, controlled clinical investigation. The primary objective of this investigation will be to collect clinical data concerning the safety and efficacy of PerClot versus a similar marketed hemostatic device in multiple surgical disciplines when used as an adjunct to conventional means of achieving hemostasis such as pressure or ligature. The primary efficacy endpoint of this investigation will be achievement of hemostasis at the site of application at 5 minutes following application of the prescribed hemostatic agent. The secondary efficacy endpoint for this investigation will be hemostasis at the site of application evaluated at 2 minutes. Safety endpoints will include, but are not limited to, the incidence of reoperation due to bleeding, total hospitalization and procedure time, and the incidence of procedure complications and/or adverse events through final patient follow-up.

As part of the conditional approval for the PerClot IDE, CryoLife must make certain revisions to the investigational study protocol, clinical product labeling and Patient Informed Consent forms. The Company anticipates refiling the IDE submission in July. The Company expects to begin enrollment in the general and urological surgical cohorts during the third quarter. The Company will have further discussions with the FDA to clarify the requirements prior to enrollment in the cardiac and orthopedic indications.



Also Wednesday:



Align Technology, Inc. (NASDAQ: ALGN)
today announced awards totaling $220,000 in new funding to five universities in North America and seven international universities for projects seeking to better understand orthodontic treatment with clear aligners and use of orthodontic scanners.

Amarantus BioScience Holdings, Inc. (OTCQB: AMBS)
, a biotechnology company discovering and developing treatments and diagnostics for diseases associated with neurodegeneration and apoptosis, announces that positive neuroprotective properties for the Company’s MANF therapeutic were reported in a preclinical research study conducted by the Department of Orthopaedics at Qilu Hospital of Shandong University, in Jinan, China.

Biodel Inc. (Nasdaq:BIOD)
today announced the pricing of an underwritten public offering of 4,482,760 shares of its common stock at a public offering price of $4.35 per share.

Biotechnology industry pioneer Amgen (NASDAQ: AMGN), is teaming up with financial software provider BlackLine Systems  and enterprise application software leader SAP AG (NYSE: SAP) for a webinar next week entitled "No Account Left Behind! Learn How Amgen Uses Solutions from BlackLine and SAP to Help Keep Its Account Reconciliations in Good Shape."  

ChemoCentryx, Inc. (Nasdaq:CCXI)
announced that it has completed the target enrollment of 270 patients in a Phase II clinical trial in diabetic nephropathy with CCX140, an inhibitor of the chemokine receptor known as CCR2 and the Company's lead wholly owned drug candidate.

Competitive Technologies, Inc. (OTCQX:CTTC)
announced today its financial results for the first quarter 2013. Revenues for the quarter were $0.06 million and expenses were $0.8 million producing a net loss for the quarter of $0.8 million.

Fibrocell Science, Inc. (NYSE MKT:FCSC)
, an autologous cell therapy company focused on the development of innovative products for aesthetic, medical and scientific applications, announced today that it will be included in the Russell Global, the Russell 3000®, and the Russell Microcap Indexes when Russell Investments reconstitutes its comprehensive set of U.S. and global equity indexes on June 28, according to a preliminary list of additions posted June 14 on www.russell.com/indexes.

HASCO Medical, Inc. (OTCQB: HASC)
, www.HascoMed.com, today announced its intent to purchase privately held Auto Mobility Sales, Inc. of Lake Worth, Florida, a leader in wheelchair accessible vehicle sales, service and rentals in southeastern Florida.

Life Technologies Corporation (NASDAQ: LIFE)
today announces a licensing agreement granting Suzhou Ribo Life Sciences (Ribo) the exclusive rights to develop and manufacture siRNA therapeutics in China using Life's Invivofectamine® Rx delivery technology.  

Raptor Pharmaceutical Corp. (Nasdaq:RPTP)
today announced that PROCYSBI™ (cysteamine bitartrate) delayed-release capsules are now available in the U.S. for shipment to cystinosis patients. The U.S. Food and Drug Administration (FDA) approved PROCYSBI on April 30, 2013 for the management of nephropathic cystinosis in adults and children ages 6 years and older.

OTC Markets Group Inc. (OTCQX: OTCM)
, operator of Open, Transparent and Connected financial marketplaces, today announced that RXi Pharmaceuticals Corporation (OTCQX: RXII), a biotechnology company focused on discovering, developing, and commercializing innovative therapies based on its proprietary, next-generation RNAi platform, has upgraded to OTCQX®, the best marketplace with qualified companies.

Senesco Technologies, Inc. (OTC QB: SNTI)
reported results of cohort 2 in its Phase 1b/2a clinical study of SNS01-T.

SpectraScience, Inc. (OTCQB: SCIE)
announced today that its WavSTAT4 Optical Biopsy System is being demonstrated at the 31st annual Gastroenterology and Endotherapy European Workshop (GEEW) that is taking place from Monday, June 17, through Wednesday, June 19, 2013 at the Brussels Exhibition Centre Hall 10 and Auditorium 2000 in Brussels, Belgium.

Sunshine Biopharma Inc. (OTCQB: SBFM)
, a pharmaceutical company focused on the research, development and commercialization of drugs for the treatment of various forms of cancer, today announces that its operations are unaffected by the recent Supreme Court ruling on patentability of Human Genes.

Takeda Pharmaceutical Company Limited (TSE:4502) and Seattle Genetics, Inc. (NASDAQ: SGEN) today announced data from a post-hoc analysis examining progression-free survival (PFS) following treatment with ADCETRIS® (brentuximab vedotin) versus last prior therapy in patients diagnosed with relapsed or refractory Hodgkin lymphoma (HL) post-autologous stem cell transplant (ASCT) or relapsed or refractory systemic anaplastic large cell lymphoma (sALCL).

VIVUS, Inc. (Nasdaq:VVUS)
, a pharmaceutical company commercializing and developing innovative, next-generation therapies to address unmet needs in obesity and sexual health, today announced that it has posted an investor presentation to the Company's website.

VIVUS, Inc. (Nasdaq:VVUS)
today announced positive results from a multicenter, placebo-controlled study, TA-501, designed to assess the efficacy of STENDRA™ (avanafil) in approximately 15 minutes. In the study, STENDRA patients achieved statistically significant improvement over placebo, in the mean proportion of attempts that resulted in erections sufficient for successful intercourse, as early as 10 minutes for the 200 mg dose and 12 minutes for the 100 mg dose after being taken.



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