Cytokinetics ($CYTK) announces CK-2017357 receives fast track designation from the FDA for the potential treatment of amyotrophic lateral sclerosis

Cytokinetics (NASDAQ: CYTK) announced that CK-2017357, its fast skeletal muscle troponin activator, has received Fast Track designation from the FDA for the potential treatment of amyotrophic lateral sclerosis (ALS), also commonly known as Lou Gehrig's Disease.

• Cytokinetics anticipates that results from two recently completed Phase II clinical trials, designed to assess the safety and tolerability of CK-2017357 in patients with ALS, will be presented at the American Academy of Neurology 64th Annual Meeting in New Orleans, LA on April 25, 2012.
• Cytokinetics has met with the FDA's Division of Neurology Products and with the European Medicines Agency to discuss its progress in the development of CK-2017357 as a potential treatment for patients with ALS and the company's plans for its further development, including potential registration strategies.
• Cytokinetics is assessing options that may enable the initiation of a registration program for CK-2017357.
• Cytokinetics anticipates having additional interactions with U.S. and European regulatory authorities during 2012 to discuss the development of CK-2017357 as a potential treatment for patients with ALS, including potential registration strategies.

Daily Dose Conclusion: New treatments for ALS and competition could pressure cell therapy company Neuralstem (CUR).

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Abbott ($ABT) Positive results from interferon-free phase 2 "Co-Pilot" study for the treatment of hepatitis presented by Abbott

Abbott Labs (NYSE: ABT) says data from 'Co-Pilot,' found that more than 90% of patients new to HCV treatment achieved sustained viral response through 12 weeks.

• In a three-arm study known as 'Co-Pilot,' different doses of ABT-450/r, plus ABT-333 and ribavirin administered for 12 weeks showed sustained virological response at 12-weeks post treatment (SVR12) in 95% and 93% of treatment-naive genotype 1 (GT1) patients, with no post-treatment relapses. In these patients, response was independent of HCV subtype, host IL28B genotype or dose of ABT-450/r.
• In addition, SVR12 was achieved in 47% of patients who were previous non-responders to past HCV treatment.
• Safety info – Arm 1 in Treatment-Naive Patients
  • There were no post-treatment relapses in these patients
  • One patient discontinued due to asymptomatic isolated ALT/AST elevations at week 2
• Safety info – Arm 2, Treatment-Naive Patients
  • There were no post-treatment relapses in these patients
  • One patient discontinued due to noncompliance in week 1

Gilead ($GILD) announces early sustained Virologic response rates for GS-7977 plus Ribavirin in genotype 1 Treatment-Navee hepatitis C patients

Gilead Sciences, Inc. (NASDAQ: GILD) announced interim data from the Phase 2 ELECTRON study examining the investigational once-daily oral agent GS-7977 plus ribavirin (RBV) in treatment-naïve patients with genotype 1 chronic hepatitis C virus (HCV) infection.

• Of the 25 patients who completed 12 weeks of treatment with the GS-7977-based regimen, 88 percent of patients (n=22/25) remained HCV RNA undetectable four weeks after completion of treatment.
• Three patients experienced viral relapse.
• These findings are being presented this week during a poster session (Poster #1113) at the 47th Annual Meeting of the European Association for the Study of the Liver (International Liver Congress 2012) in Barcelona, Spain.
• Overall, GS-7977 was well tolerated and exhibited a favorable safety profile. No patients experienced viral rebound during treatment. No patients discontinued therapy due to an adverse event. The most common adverse events were fatigue, dizziness and headache, and two grade 3/4 laboratory abnormalities were reported.
• Results from three additional arms of the ELECTRON study examining GS-7977-based therapy in various patient populations are also being presented this week at the International Liver Congress. These include null responder genotype 1 patients, and genotype 2 and genotype 3 patients, both treatment-naïve and prior non-responders.

Gilead today also announced interim results from a second Phase 2 trial (QUANTUM) examining a 12- and 24-week duration of GS-7977 plus RBV in treatment-naïve patients. Twenty-five patients were randomized to the 12-week treatment arm: 19 genotype 1 patients; four genotype 3 patients; and two genotype 2 patients.

• Two genotype 1 patients discontinued therapy prematurely during the 12-week treatment period. At the four-week post-treatment time period, data were available for 17 genotype 1 patients.
• Of these, 10/17 (59%) remained HCV RNA undetectable.
• Seven patients (41%) experienced viral relapse.
  • The seven patients who relapsed in the QUANTUM study either had IL28B C/T (n=4) or IL28B T/T (n=3) genetic polymorphisms.
• Additionally, seven of the patients who have reached the eight week post-treatment time period, and who achieved SVR4, remain HCV RNA undetectable.
• The overall safety and efficacy profile of GS-7977 was consistent with that seen in ELECTRON. No patients experienced viral rebound while on treatment and no patients discontinued therapy due to an adverse event.

Eleven of the 25 patients (44%) in ELECTRON and three of 19 patients (16%) in QUANTUM had the IL28B C/C genetic polymorphism.

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Idenix Pharmaceuticals ($IDIX) announces initial data from phase I clinical trial of IDX719

Idenix Pharmaceuticals NASDAQ: IDIX) is engaged in the discovery and development of drugs for the treatment of human viral and other infectious diseases.

• IDX719 is an an NS5A inhibitor for the treatment of hepatitis C virus (HCV) infection
• In the first part of the study, eight healthy volunteers received 100 mg of IDX719 daily for seven days. All doses were well tolerated and pharmacokinetic data supports once-daily dosing in future studies.
• In the second part of the study, single-ascending doses of IDX719 achieved substantial viral load reductions in the following cohorts of HCV-infected patients:
  • A cohort of 12 HCV genotype 1-infected patients received single IDX719 doses of 1, 5, 10, 25, 50 or 100 mg (2 patients per dose). Mean maximal viral load reductions were 1.9 log10, 2.6 log10, 3.3 log10, 3.7 log10, 2.8 log10 and 3.5 log10, respectively;
  • A cohort of three HCV genotype 2-infected patients received single IDX719 doses of 25, 50 or 100 mg (1 patient per dose). Maximal viral load reductions were 0.4 log10, 3.2 log10 and 3.5 log10, respectively; and
  • A cohort of three HCV genotype 3-infected patients received single IDX719 doses of 25, 50 or 100 mg (1 patient per dose). Maximal viral load reductions were 2.2 log10, 3.7 log10 and 3.3 log10, respectively.
• A three-day proof-of-concept study has initiated dosing and is designed to evaluate 64 treatment-naïve genotype 1, 2, 3 or 4 HCV-infected patients.
• Additionally, Idenix has completed enrollment of the second cohort of 30 patients in the ongoing 12-week phase IIb study of IDX184. IDX184 continues to be safe and well tolerated with no treatment-emergent serious adverse events reported and a side effect profile similar to that of PegIFN/RBV. Further data from the ongoing clinical trial will be available in H2.

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AtheroNova ($AHRO) C.E.O. Thomas W. Gardner on atherosclerosis market size (video)

AtheroNova (OTCBB: AHRO) is an early stage biotech company focused on discovery, research, development and licensing of novel compounds to reduce or regress atherosclerotic plaque deposits.

In this film, AtheroNova C.E.O. Thomas W. Gardner speaks about the market size for atherosclerosis:

Watch more on Film Annex

NeoStem to Present at BioCentury Future Leaders in the Biotech Industry Conference - $NBS

NeoStem, Inc. (NYSE Amex:NBS) announced that Company management will present an overview of the Company at the Future Leaders in the Biotech Industry Conference in New York City.

Location: Millennium Broadway Hotel & Conference Center, NYC

Presentation date: Friday, April 20, 2012

Presentation time: 2:00 p.m. ET
 
A live webcast of this presentation will be available and archived for 90 days at: http://www.media-server.com/m/p/3o8w4i2

Mesoblast Intervertebral Disc Repair Phase II Trial Update ($MSB)

Mesoblast Limited (ASX: MSB; OTC ADR: MBLTY) is the world’s leading developer of innovative biological products for the broad field of regenerative medicine.  Mesoblast’s commercial strategy is based on its unique proprietary adult mesenchymal precursor cells.  The company’s lead products will target cardiovascular conditions, diabetes, inflammatory conditions of lungs and joints, eye diseases, bone marrow cancers, bone fractures, cartilage degeneration and musculoskeletal conditions. Mesoblast and Teva Pharmaceutical Industries Ltd. have established a strategic alliance to commercialize adult stem cell products for degenerative conditions of the cardiovascular and central nervous systems. The alliance also extends to products for augmenting bone marrow transplantation in cancer patients.

Mesoblast announced that its Phase 2 clinical trial of allogeneic (off-the-shelf) Mesenchymal Precursor Cells has now enrolled 50% of the total study patients.  This trial will investigate non-surgical treatment of lower back pain due to degenerated intervertebral discs.  The rapid enrollment of this study indicated the Phase 2 trail will reach full capcity for its study by the third quarter.  The pace in which this study has enrolled participants bespeaks of the great need back patients have for non-surgical treatments.   

The Company commented,

"Up to 15 per cent of people in industrialized countries have chronic low back pain lasting more than six months. For those with progressive, severe and debilitating pain due to degenerating intervertebral discs, the only current option is major back surgery involving spinal fusion, artificial disc replacement, or other surgical procedures. Avoidance of surgery and its complications is a major objective of any new treatment for degenerative disease of the spine."

Mesoblast published the results of its previous successful study in the March 2012 issue of the Journal of Neurosurgery. 

Read the full press release here.  

Cytomedix Providing Treatment for Diabetic Foot Ulcers (CMXI)

Cytomedix is well positioned to achieve a leadership position in the field of advanced tissue regeneration technologies, with the continuing development and marketing of biologically active products to treat patients with debilitating and life-threatening conditions. Its synergistic Angel® and AutoloGel products place Cytomedix as a leader in PRP technology with FDA indications in the areas of orthopedics and wound care. Both product lines have proven clinical benefits and significant growth potential.

Recently, GBI Research released its Diabetes Therapeutics Market to 2017 report favorably reviewing the global diabetes therapeutic industry and offering that companies like  Cytomedix, Inc. are poised for rapid growth.    

BiotechStockTrader.com then expounded upond these findings with their own in depth analysis of Cytomedix.  Pointing out that diabetic foot ulcers effect 15 percent of patients with diabetes, BiotechStockTrader predicts strong growth for the company, commenting,

"This is where Cytomedix, a leader in the commercialization of innovative autologous therapies that promote healing by harnessing the innate regenerative capacity of platelets and adult stem cells, offers a revolutionary technology that outstrips current wound care therapies and provides a convenient and cost-effective new approach."

See the full presentation from BiotechStockTrader.com below:  

Biotech stock trader april 2012

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