Print 18 Апреля 2011
San Diego, California — April 18, 2011 — CoDa Therapeutics, Inc. announced today that it has raised $19.2 million in a Series B financing. Current investors Domain Associates, GBS Venture Partners and BioPacificVentures participated in the round. The company expects further Series B financing with participation from additional investors in a second closing, scheduled for a future date.
«The financing will allow us to take essential steps for the development of CoDa; in particular, we will now conduct a large Phase 2 multicenter venous leg ulcer trial in the United States, New Zealand and Australia with Nexagon®, our lead product for chronic wound patients. In addition, we will continue the preclinical development of our product portfolio in our research laboratories,» said Bradford Duft, CEO of CoDa.
CoDa is a clinical-stage biopharmaceutical company working to develop a new drug therapy for wounds that do not heal properly, including venous leg and diabetic foot ulcers. CoDa’s lead drug candidate, Nexagon® — a first-in-class compound being tested for its ability to speed healing and reduce inflammation — would be applied topically to stop over-production of a protein known as «connexin43.» CoDa discovered that chronic, poorly healing wounds are characterized by too much continuing connexin43 expression, and that suppression by Nexagon® can improve wound healing. The company is now working under an FDA-approved IND to generate clinical data in support of eventual regulatory approval for marketing.
CoDa completed a first Phase 2 trial with Nexagon® in 98 patients with venous leg ulcers. In the drug arm almost one third of patients were completely healed after four weeks following just three application of Nexagon® compared to only 6% complete healing in the placebo arm (p<0.02).
According to Dr. Thomas Serena, a Nexagon® study investigator and Founder and Medical Director of the Penn North Centers for Advanced Wound Care, «The data from CoDa’s Nexagon® trial are not only therapeutically very impressive, but tell us that we have a real opportunity to alleviate the difficult burdens of chronic wounds that are faced by patients and insurers alike. Nexagon® appears to be an important step forward, and a possible ‘game changer’ in the treatment of chronic wounds.»
«We see CoDa as a good example of today’s preferred biotech enterprise, bringing together excellent science, an experienced management team, a solid value proposition, a clear execution path and addressing a global unmet medical need,» added Dr. James Blair, a Domain Associates Partner with over 40 years’ experience with venture and emerging growth companies.
«CoDa is developing a unique technology with the potential to change the treatment paradigm of patients with impaired healing wounds and other inflammatory conditions. We look forward to further supporting the developments of the company on a global basis,» said Dr. Geoff Brooke, Co-Founder and Managing Partner of GBS Venture Partners, Australia’s leading life science specialist venture capital investor.
«This round of financing is an important validation of the potential of CoDa’ approach to develop a new generation of innovative products to better serve the growing wound and inflammation markets,» explained Andrew Kelly, Executive Director of BioPacificVentures, a leading life science company investor in New Zealand.
About CoDa Therapeutics Inc. — CoDa Therapeutics is a clinical stage biotechnology company focused on developing novel targeted therapies that address major unmet medical needs in inflammation, wound-healing and tissue repair. The company is pioneering a new field of science: gap junction modulation using a new class of therapeutics that can modulate wound responses and reduce inflammation. CoDa has two open INDs and has completed two Phase 1 clinical trials in skin and eye, where Nexagon® was shown to be safe and tolerable following administration to over 250 wounds on more than 60 subjects. CoDa’s technology, which can be applied topically, been shown to work across a wide variety of wound and inflammatory settings and conditions. CoDa presently has issued patents in the US, Europe and elsewhere, and pending applications in more than a dozen other patent families directed to methods and compositions for the treatment of acute wounds, chronic wounds, scarring, abnormal scarring, inflammation and pain, fibrosis, surgical adhesions, and orthopedic procedures, as well as combination therapies and improved medical devices.
About NEXAGON® — The active ingredient in NEXAGON®, which has been shown to work across a wide variety of tissues and conditions, is CODA001, a natural, unmodified antisense oligonucleotide that down-regulates the key gap junction protein connexin43 to dampen inflammatory responses and enhance healing. Data shows that for optimal healing connexin43 is normally dialed-down at the edges of acute wounds (i.e., wounds that will heal normally).
Conversely, other data demonstrate that connexin43 is wrongly up-regulated at the edge of chronic wounds (i.e., wounds that are difficult to heal such as venous and diabetic ulcers). CoDa believes that one can better target available medical options and design more effective woundhealing alternatives by devising a therapeutic approach based on biological mechanisms naturally at work or conversely, at fault, in a given situation. The answer is thought to lie in connexin43, which can be seen as a «master switch» in wound healing that is temporarily turned «off» for superior healing of acute wounds, and when left «on» can lead to the unwanted inflammation and/or stalled healing characteristic of chronic wounds.
Российская фармацевтическая компания «НоваМедика», портфельная компания Роснано, объявляет о старте строительства завода по производству стерильных инъекционных препаратов в рамках своей долгосрочной стратегии по локализации в России инновационных лекарственных препаратов и технологий их разработки и производства. Завод будет построен на территории индустриального парка «Ворсино» в Калужской области.
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