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Carbylan Therapeutics, Inc. (CBYL)

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Last Post: 10/1/2016 5:06:09 AM - Followers: 19 - Board type: Free - Posts Today: 1
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Technology


Our research and development efforts have focused on developing a proprietary versatile methodology to cross-link hyaluronic acid to form hydrogels. This methodology is versatile because slight alterations in the formula allow us to prepare hydrogels that can be pre-formed or prepared on site and can range in texture from soft to hard gels. The chemistry used to cross-link the hyaluronic acid does not produce harmful reaction by-products that must be removed from the hydrogel during the manufacturing process. This enables the direct incorporation of biologically-active agents into the hydrogel without the need for further purification. Thus, these prepared hydrogels can be used directly without further processing. Additionally, biologically-active agents such as small molecule drugs, certain proteins and cells can be incorporated into the hydrogel. Such hydrogel formulations can be applied topically or parenterally.








Carbylan Therapeutics, Inc., a specialty pharmaceutical company, focuses on the development and commercialization of novel and proprietary combination therapies. Its product candidate is Hydros-TA, which has completed Phase IIb clinical trial designed to provide rapid and sustained relief from pain associated with osteoarthritis. The company was formerly known as Carbylan Biosurgery, Inc. and changed its name to Carbylan Therapeutics, Inc. in March 2014. Carbylan BioSurgery, Inc. was founded in 2004 and is headquartered in Palo Alto, California.

Clinical Studies


Clinical Studies

Our Phase 2b clinical trial of Hydros-TA, known as COR1.0, was a prospective, multicenter, randomized, double-blind feasibility study to evaluate the safety and performance of Hydros-TA in subjects with OA of the knee. Eight clinical centers in Canada, Europe and the Caribbean participated in the COR1.0 trial. A total of 98 subjects were enrolled, treated and followed for six months post-treatment. Subjects were randomized 1:1:1 to receive a single 6mL intra-articular injection of one of three study treatments: Hydros- TA, Hydros (the viscosupplement without steroid) and Synvisc-One (the U.S. market leading HA viscosupplement).
 
Key Observations from COR1.0: The results from COR1.0 suggest that a single injection of Hydros-TA was well-tolerated and could relieve pain associated with symptomatic OA of the knee over 26 weeks. Although not statistically significant, Hydros-TA demonstrated a numerically higher pain relief at all time points after injection when compared with Synvisc-One and the percentage of subjects who responded favorably to the product as measured by the OMERACT-OARSI responder rate was higher in the Hydros and Hydros-TA groups when compared to Synvisc-One.
 
To our knowledge, this is the first clinical study to report on the safety and effectiveness of a single-injection viscosupplement that combines HA and corticosteroid for the treatment of knee OA. Reductions in WOMAC pain scores observed in this study suggest that this combination may have a faster onset of pain relief compared to non-steroid containing products and may provide improved pain relief over the full 26 weeks post injection. These results reflect a synergistic effect of combining HA with a corticosteroid.
 
Phase 3 Clinical Trial Program
The first of our two pivotal Phase 3 trials began enrollment in mid-January 2014. We are actively enrolling up to 510 subjects at 30 to 40 sites in Australia, Canada, New Zealand, Europe and the Caribbean.
 


2015 News Releases


Date Title  
04/14/15 Carbylan Therapeutics, Inc. Announces Closing of Initial Public Offering and Full Exercise of Underwriters' Option to Purchase Additional Shares Printer Friendly Version
04/08/15 Carbylan Therapeutics, Inc. Announces Pricing of Initial Public Offering Printer Friendly Version



 
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CBYL News: Proxy Soliciting Materials (revised) (prer14a) 09/30/2016 04:59:47 PM
CBYL News: Current Report Filing (8-k) 09/30/2016 04:10:22 PM
CBYL News: Carbylan Shareholder (CBYL) Alert: Shareholder Rights Law Firm Johnson & Weaver, LLP Continues its Investigation of Carbylan... 09/23/2016 07:53:00 AM
CBYL News: Amended Statement of Ownership (sc 13g/a) 09/12/2016 01:38:46 PM
CBYL News: Proxy Statement - Merger or Acquistion (preliminary) (prem14a) 08/24/2016 06:02:54 AM
News News Alert: Proxy Soliciting Materials (revised) (prer14a) 09/30/2016 04:59:47 PM
PostSubject
#336  Sticky Note Problem is, they've giving that cash away for Toxic Avenger 10/01/16 05:06:09 AM
#313  Sticky Note CBYL is on fire today and it just Value_Investor 08/23/16 10:46:12 AM
#336   Problem is, they've giving that cash away for Toxic Avenger 10/01/16 05:06:09 AM
#335   CBYL is the only Nasdaq Bio-Tech stock whose Value_Investor 09/28/16 10:28:32 AM
#334   CBYL was Up 1.83% in AH session of Value_Investor 09/24/16 05:31:00 PM
#333   Yes, CBYL is on fire today! It just Value_Investor 09/23/16 02:32:02 PM
#332   Here we go!!!!! harmsen 09/23/16 01:27:57 PM
#331   Nice! CBYL is the Unique Cheapest Bio-Tech Nasdaq Value_Investor 09/16/16 03:24:26 PM
#330   In with 10000 shares 0,48 harmsen 09/16/16 03:00:09 PM
#329   Good news today! One Big Institution just filed Value_Investor 09/12/16 03:30:57 PM
#328   Insiders buying and not reporting is illegal. You Toxic Avenger 09/12/16 08:47:28 AM
#327   I'm not sure but I think this is MrSparex 09/12/16 07:36:18 AM
#326   CBYL has Zero-Debt now which is a Sought-After Value_Investor 09/11/16 06:42:47 PM
#325   That was about as vague and worthless a Toxic Avenger 09/11/16 12:27:04 AM
#324   Among all the Debt-Free Bio-tech peers CBYL is Value_Investor 09/10/16 11:47:04 PM
#323   Read the very important conference call from the Value_Investor 09/09/16 04:41:19 PM
#322   CBYL is the cheapest Nasdaq stock in terms Value_Investor 09/02/16 11:55:10 AM
#321   LOL, it was earlier today you called the Toxic Avenger 08/26/16 05:51:12 PM
#320   CBYL hit another New bottom support $0.495 today! Value_Investor 08/26/16 04:58:33 PM
#319   Broke below $.5 now. That proxy appears to Toxic Avenger 08/26/16 02:36:55 PM
#317   Once the merger goes through, it will be Toxic Avenger 08/26/16 11:41:28 AM
#316   Yesterday's low $0.5101 seems the New bottom support Value_Investor 08/26/16 11:28:32 AM
#315   They just sent out the proxy which again Toxic Avenger 08/26/16 08:15:37 AM
#314   Disagreed! The next day CBYL actually bounced to Value_Investor 08/25/16 07:55:25 PM
#313   CBYL is on fire today and it just Value_Investor 08/23/16 10:46:12 AM
#312   Yeah, it was a paint at the end Toxic Avenger 08/20/16 07:29:46 PM
#311   4,800 shares Slapped at 0.58 ~ 0.5488 and Value_Investor 08/20/16 06:50:54 PM
#310   The $.58 was on 2 trades of 400 Toxic Avenger 08/19/16 06:05:48 PM
#309   Wow, CBYL hit the New daily high $0.58 Value_Investor 08/19/16 04:20:26 PM
#308   CBYL crashed to $0.5503 today from yesterday's high Value_Investor 08/18/16 04:26:54 PM
#307   Ref: Value_Investor chrislal 08/17/16 03:20:44 PM
#306   Still trying to figure out why they would Toxic Avenger 08/17/16 12:22:07 PM
#305   Yes. CBYL hit $0.65 so far! It was Value_Investor 08/17/16 12:07:51 PM
#304   CBYL going to fly. chrislal 08/17/16 10:38:31 AM
#303   Paying-off over $4M debts is a great news Value_Investor 08/14/16 03:00:51 PM
#302   It would be great if they hadn't agreed Toxic Avenger 08/13/16 07:52:48 PM
#301   Great news for CBYL --- the 10-Q just Value_Investor 08/13/16 06:10:30 PM
#300   CBYL is the cheapest Nasdaq stock among Thousands Value_Investor 08/12/16 04:20:08 PM
#299   CBYL Chart SsbTwentyTwo 08/12/16 07:09:07 AM
#298   Is it possible for the company to cancel Value_Investor 08/05/16 04:59:03 PM
#297   Glad to see CBYL hit another new low Value_Investor 07/29/16 11:20:04 AM
#296   CBYL hit another New low $0.5701 today! So Value_Investor 07/28/16 03:19:02 PM
#295   Very true. When will the company file the Value_Investor 07/27/16 02:36:07 PM
#294   $0.5712 seems the New bottom support besides the Value_Investor 07/27/16 02:07:17 PM
#293   It seems nothing to do with that R/S Value_Investor 07/26/16 10:54:18 AM
#292   Today CBYL hit $0.5712 again! I wish it Value_Investor 07/26/16 09:56:09 AM
#291   No, the reverse split so they could uplist Toxic Avenger 07/26/16 06:43:12 AM
#290   I suspect its because the planed Toxic R/S bigbux1 07/25/16 10:39:06 PM
#289   I'm not a biotech expert, but it seems Toxic Avenger 07/25/16 04:42:17 PM
#288   Unless the New drug from that private company Value_Investor 07/25/16 04:23:42 PM
#287   I agree. I'm holding shares just for that Toxic Avenger 07/25/16 04:19:20 PM
#286   What is the good part of that merger Value_Investor 07/25/16 04:18:09 PM
PostSubject