Navigation Links
AACR: Positive data supports advancing BIND-014 to phase 2 clinical trials for solid tumors
Date:4/9/2013

Cambridge, MA, April 9, 2013 BIND Therapeutics, a clinical-stage biopharmaceutical company developing a new class of highly selective targeted and programmable therapeutics called AccurinsTM, announced today that positive Phase 1 clinical data for BIND-014, the company's lead drug candidate, were presented today in an oral presentation at the American Association for Cancer Research (AACR) 2013 Annual Meeting.

Clinical investigators presented the Phase 1 results with BIND-014, its targeted docetaxel Accurin, in 28 heavily-pretreated patients with advanced or metastatic solid tumors. In the study, BIND-014 was shown to be generally safe and well-tolerated at the established maximum tolerated dose of 60 mg/m2 and showed encouraging signs of anti-tumor activity including one complete response, three partial responses and five patients with stable disease lasting at least four cycles (> 12 weeks). In addition, the pharmacokinetic (PK) profile of BIND-014 was substantially different from the published PK of conventional docetaxel.

"This Phase 1 trial has successfully established the safety and tolerability profile and maximum tolerated dose of BIND-014 in patients with advanced or metastatic solid tumor cancers," commented Daniel D. Von Hoff, M.D., F.A.C.P., Principal Investigator for the study and Physician-in-Chief and Distinguished Professor at the Translational Genomics Research Institute (TGen) and the Scottsdale Clinical Research Institute. "There is a critical need for targeted treatment options for patients with difficult to treat solid tumors and we look forward to further evaluating the potential of BIND-014 in patients with specific solid tumor types in the near future."

"In addition to confirming the safety, tolerability and maximum tolerated dose of BIND-014, these data also provide encouraging signs of anti-tumor activity in a variety of solid tumors," said Gregory Berk, M.D., Chief Medical Officer of BIND Therapeutics. "Based on these data, BIND is moving expeditiously to advance BIND-014 into multiple Phase 2 clinical trials in 2013 including non-small cell lung cancer, prostate cancer and bladder cancer."

BIND-014 represents the first targeted and programmable Accurin nanomedicine to reach the clinic from BIND's proprietary drug development platform that creates targeted therapeutics designed to accumulate at the site of disease for high drug concentration and maximum therapeutic effect. BIND- 014 employs a combination of a targeted biodegradable nanoparticle and docetaxel, a well-established chemotherapy agent.

In an oral presentation entitled "A Phase 1 Study of BIND-014, a PSMA-targeted Nanoparticle Containing Docetaxel, in Patients with Refractory Solid Tumors," Dr. Von Hoff presented complete Phase 1 clinical data of BIND-014 consistent with previously reported preliminary observations in which safety, tolerability and efficacy in multiple tumor types was demonstrated.

  • BIND-014 was generally safe and well-tolerated with transient and manageable neutropenia as the dose limiting toxicity. Minimal neuropathy, mucositis, fluid retention, rash, and nail changes were observed.

  • Established the maximum tolerated dose of 60 mg/m2 when administering BIND-014 on a once every 3 week (Q3W ) schedule.

  • Evidence of anti-tumor activity was shown with BIND-014 at 60mg/m2 in nine out of the 28 patients treated, ranging from one complete response (cervical cancer), three partial responses (non-small cell lung cancer, prostate and ampullary) and five patients with stabilization of disease lasting at least four cycles (> 12 weeks; pancreatic, colorectal, gall bladder, tonsillar and anal cancer).

  • The PK profile of BIND-014, characterized by prolonged and elevated encapsulated docetaxel levels, was highly differentiated from published PK of conventional docetaxel.


'/>"/>

Contact: Kathryn Morris
kathryn@theyatesnetwork.com
845-635-9828
The Yates Network
Source:Eurekalert

Related medicine news :

1. Positive stress helps protect eye from glaucoma
2. False-Positive Mammogram Results May Turn Out Not to Be: Study
3. The bright side of death: Awareness of mortality can result in positive behaviors
4. Decision support system translates into high percentage of positive chest CT examinations
5. Breast cancer patients with positive ultrasound guided axillary node biopsy need dissection
6. Automated insulin dosage titration system demonstrates positive clinical study results
7. Lung changes are present in nearly half of ACPA positive RA patients at disease onset
8. NIH study finds HIV-positive young men at risk of low bone mass
9. Surgeons Seek Repeal of Transplant Ban Between HIV-Positive People
10. Higher levels of public reimbursement positively influence national birth rates and reduce unmet needs in subfertile populations
11. HPV testing in HIV-positive women may help reduce frequent cervical cancer screening
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/26/2016)... ... June 26, 2016 , ... Many women ... diagnosed with endometriosis. These women need a treatment plan to not only alleviate ... that can help for preservation of fertility and ultimately achieving a pregnancy. The ...
(Date:6/25/2016)... ... 25, 2016 , ... Austin residents seeking Mohs surgery services, can now turn ... to Dr. Russell Peckham for medical and surgical dermatology. , Dr. Dorsey brings specialization ... selective fellowship in Mohs Micrographic Surgery completed by Dr. Dorsey was under the direction ...
(Date:6/25/2016)... ... , ... "With 30 hand-drawn hand gesture animations, FCPX users can easily customize ... Pixel Film Studios. , ProHand Cartoon’s package transforms over 1,300 hand-drawn pictures into ... Simply select a ProHand generator and drag it above media or text in the ...
(Date:6/25/2016)... ... June 25, 2016 , ... As a lifelong Southern Californian, Dr. Omkar ... M.D from the David Geffen School of Medicine at UCLA. He trained in Internal ... complete his fellowship in hematology/oncology at the UCLA-Olive View-Cedars Sinai program where he had ...
(Date:6/25/2016)... ... , ... On Friday, June 10, Van Mitchell, Secretary of the Maryland Department ... in recognition of their exemplary accomplishments in worksite health promotion. , The Wellness at ... Wellness Symposium at the BWI Marriott in Linthicum Heights. iHire was one of 42 ...
Breaking Medicine News(10 mins):
(Date:6/23/2016)... Research and Markets has announced ... Type (Organic Chemical (Sugar, Petrochemical, Glycerin), Inorganic Chemical), Functionality ... - Global Forecast to 2021" report to their ... global pharmaceutical excipients market is projected to reach USD ... in the forecast period 2016 to 2021. ...
(Date:6/23/2016)... LOS ANGELES , June 23, 2016 /PRNewswire/ ... (NASDAQ: CAPR ), a biotechnology company ... first-in-class therapeutics, today announced that patient enrollment in ... progrEssion in Duchenne) has exceeded 50% of its ... its enrollment in the third quarter of 2016, ...
(Date:6/23/2016)... and INDIANAPOLIS , June ... receiving a Lilly Diabetes Tomorrow,s Leaders Scholarship is any ... scholarship winners, announced today online at www.diabetesscholars.org ... type 1 diabetes stand in the way of academic ... supported the Foundation,s scholarship program since 2012, and continues ...
Breaking Medicine Technology: