Keep a close eye on Biodel Inc. (BIOD). After the closing bell on Wednesday, the company reported positive preliminary results from Study 3-151, which demonstrate that its proprietary, concentrated insulin formulation BIOD-531 provides superior post-meal glucose control compared to Humalog(R) Mix 75/25 and Humulin(R) R U-500
Many type 2, and some type 1, diabetes patients in clinical practice are treated with pre-mixed insulins, such as Humalog(R) Mix 75/25, in order to receive both basal and prandial insulin in single injections. Humulin(R) R U-500, currently the only concentrated insulin available in the U.S., is used most commonly to treat type 2 diabetes patients with severe insulin resistance who require very high doses of insulin -- typically greater than 150 units per day.
According to BIOD, the results of this recently completed Phase 2a Study 3-151 show that its BIOD-531 may confer similar clinically meaningful benefits of superior mealtime coverage and adequate basal duration for diabetes patients with higher degrees of insulin resistance and insulin dose requirements.
BIOD's concentrated insulin BIOD-531 contains 400 units per milliliter (U-400) of recombinant human insulin formulated with EDTA, citrate and magnesium sulfate. Based on its unique combination of ultra-rapid absorption with a basal duration profile, BIOD-531 may provide superior meal-time glucose control for patients using Humulin(R) R U-500 and pre-mixed insulins such as Humalog(R) Mix 75/25.
BIOD is a specialty biopharmaceutical company focused on the development and commercialization of innovative treatments for diabetes that may be safer, more effective and more convenient for patients.
More about Biodel Inc. (BIOD) at www.biodel.com
**
BIND Therapeutics, Inc. (BIND) said that the first patient expressing a KRAS mutation was enrolled in a global, multicenter two-tiered phase 2 trial with BIND-014 in non-small cell lung cancer (NSCLC) patients with KRAS mutant tumors (mutated Kirsten ras oncogene homolog) or squamous histology.
According to BIND, phase 2 data for BIND-014 demonstrate that its Accurin technology is providing on-target anti-tumor activity with meaningful reductions in the incidence and severity of side-effects expected from conventional drugs
BIND also reported topline data from its ongoing phase 2 trial with BIND-014 in metastatic castration resistant prostate cancer (mCRPC), providing further validation for the differentiated Accurin platform
In December 2014, BIND achieved a development milestone as part of its global collaboration agreement with Pfizer Inc. to develop and commercialize Accurins utilizing select small molecule targeted therapies. BIND has the potential to receive payments up to $89.5 million upon the achievement of specified development and regulatory events. BIND may also receive additional payments up to $110 million for specified commercial events as well as royalties in the low-single to high-single digit percentages on potential future sales of each Accurin commercialized, if any.
BIND ended 2014 with approximately $41 million (unaudited) in cash, cash equivalents and short-term investments. the company expects that one of its collaboration partners will file an IND application with the U.S. FDA for an Accurin therapeutic by mid-2015.
BIND is a clinical-stage nanomedicine platform company developing Accurins, its novel targeted therapeutics.
More about BIND Therapeutics, Inc. (BIND) at www.bindtherapeutics.com.
**
NephroGenex, Inc. (NRX) reported that it has received positive Scientific Advice from the European Medicines Agency (EMA) regarding their Phase 3 program with Pyridorin(R) in diabetic nephropathy that has been accepted by the U.S. Food and Drug Administration under a Special Protocol Assessment.
The EMA indicated that the current Phase 3 program could be adequate to support a Marketing Authorization Application for full market approval in Europe.
Pyridorin inhibits pathogenic oxidative chemistries, which are collectively elevated in diabetic patients and induce pathological changes implicated in the development of diabetic nephropathy.
NRX is a clinical-stage pharmaceutical company focused on developing therapeutics to treat kidney diseases caused by pathogenic oxidative chemistries. Its product pipeline includes an oral formulation of Pyridorin, which is being developed as a chronic, therapeutic agent to slow the progression of diabetic nephropathy, as well as an intravenous formulation of Pyridorin to treat specific types of acute kidney injury.
More about NephroGenex, Inc. (NRX) at www.nephrogenex.com
**
Crown Equity Holdings Inc. (CRWE) is currently developing its CRWE Network ( www.CRWE-PR.com ), a growing network of community targeted sites.
It has recently included Oxnard ( www.oxnard.crwe-pr.com ), the largest city in Ventura County, California to the CRWE Network.
The City of Oxnard is located along the coast of Southern California, about 60 miles northwest of Los Angeles and 35 miles south of Santa Barbara. It boasts some of the richest agricultural land in California. Its economy is driven by international trade, agriculture, manufacturing, defense, and tourism.
Oxnard had an estimated population in 2013 (U.S. Census Bureau) of 203,007, and represents an important marketplace for the CRWE Network, which business model is based on selling advertising to businesses targeting both locally and nationally
The CRWE Network has reached the 1487th community website in the U.S., associated with 3456 ZIP Codes, and includes coverage in the states of California, Mississippi, Michigan, Florida, Nevada and New York, as well as across 10 provinces in Canada.
CRWE provides marketing solutions that boost customer awareness and merchant visibility on the Internet
More about Crown Equity Holdings Inc. (CRWE) at www.crownequityholdings.com
**
Disclaimer: This material is for informational purposes only and should not be construed as an offer or solicitation of an offer to buy or sell securities. Investors should always conduct their own due diligence with any potential investment, with independent research and other professional advice. Read Full Disclaimer at CRWE-PR Finance www.finance.crwe-pr.com/disclaimer
Many type 2, and some type 1, diabetes patients in clinical practice are treated with pre-mixed insulins, such as Humalog(R) Mix 75/25, in order to receive both basal and prandial insulin in single injections. Humulin(R) R U-500, currently the only concentrated insulin available in the U.S., is used most commonly to treat type 2 diabetes patients with severe insulin resistance who require very high doses of insulin -- typically greater than 150 units per day.
According to BIOD, the results of this recently completed Phase 2a Study 3-151 show that its BIOD-531 may confer similar clinically meaningful benefits of superior mealtime coverage and adequate basal duration for diabetes patients with higher degrees of insulin resistance and insulin dose requirements.
BIOD's concentrated insulin BIOD-531 contains 400 units per milliliter (U-400) of recombinant human insulin formulated with EDTA, citrate and magnesium sulfate. Based on its unique combination of ultra-rapid absorption with a basal duration profile, BIOD-531 may provide superior meal-time glucose control for patients using Humulin(R) R U-500 and pre-mixed insulins such as Humalog(R) Mix 75/25.
BIOD is a specialty biopharmaceutical company focused on the development and commercialization of innovative treatments for diabetes that may be safer, more effective and more convenient for patients.
More about Biodel Inc. (BIOD) at www.biodel.com
**
BIND Therapeutics, Inc. (BIND) said that the first patient expressing a KRAS mutation was enrolled in a global, multicenter two-tiered phase 2 trial with BIND-014 in non-small cell lung cancer (NSCLC) patients with KRAS mutant tumors (mutated Kirsten ras oncogene homolog) or squamous histology.
According to BIND, phase 2 data for BIND-014 demonstrate that its Accurin technology is providing on-target anti-tumor activity with meaningful reductions in the incidence and severity of side-effects expected from conventional drugs
BIND also reported topline data from its ongoing phase 2 trial with BIND-014 in metastatic castration resistant prostate cancer (mCRPC), providing further validation for the differentiated Accurin platform
In December 2014, BIND achieved a development milestone as part of its global collaboration agreement with Pfizer Inc. to develop and commercialize Accurins utilizing select small molecule targeted therapies. BIND has the potential to receive payments up to $89.5 million upon the achievement of specified development and regulatory events. BIND may also receive additional payments up to $110 million for specified commercial events as well as royalties in the low-single to high-single digit percentages on potential future sales of each Accurin commercialized, if any.
BIND ended 2014 with approximately $41 million (unaudited) in cash, cash equivalents and short-term investments. the company expects that one of its collaboration partners will file an IND application with the U.S. FDA for an Accurin therapeutic by mid-2015.
BIND is a clinical-stage nanomedicine platform company developing Accurins, its novel targeted therapeutics.
More about BIND Therapeutics, Inc. (BIND) at www.bindtherapeutics.com.
**
NephroGenex, Inc. (NRX) reported that it has received positive Scientific Advice from the European Medicines Agency (EMA) regarding their Phase 3 program with Pyridorin(R) in diabetic nephropathy that has been accepted by the U.S. Food and Drug Administration under a Special Protocol Assessment.
The EMA indicated that the current Phase 3 program could be adequate to support a Marketing Authorization Application for full market approval in Europe.
Pyridorin inhibits pathogenic oxidative chemistries, which are collectively elevated in diabetic patients and induce pathological changes implicated in the development of diabetic nephropathy.
NRX is a clinical-stage pharmaceutical company focused on developing therapeutics to treat kidney diseases caused by pathogenic oxidative chemistries. Its product pipeline includes an oral formulation of Pyridorin, which is being developed as a chronic, therapeutic agent to slow the progression of diabetic nephropathy, as well as an intravenous formulation of Pyridorin to treat specific types of acute kidney injury.
More about NephroGenex, Inc. (NRX) at www.nephrogenex.com
**
Crown Equity Holdings Inc. (CRWE) is currently developing its CRWE Network ( www.CRWE-PR.com ), a growing network of community targeted sites.
It has recently included Oxnard ( www.oxnard.crwe-pr.com ), the largest city in Ventura County, California to the CRWE Network.
The City of Oxnard is located along the coast of Southern California, about 60 miles northwest of Los Angeles and 35 miles south of Santa Barbara. It boasts some of the richest agricultural land in California. Its economy is driven by international trade, agriculture, manufacturing, defense, and tourism.
Oxnard had an estimated population in 2013 (U.S. Census Bureau) of 203,007, and represents an important marketplace for the CRWE Network, which business model is based on selling advertising to businesses targeting both locally and nationally
The CRWE Network has reached the 1487th community website in the U.S., associated with 3456 ZIP Codes, and includes coverage in the states of California, Mississippi, Michigan, Florida, Nevada and New York, as well as across 10 provinces in Canada.
CRWE provides marketing solutions that boost customer awareness and merchant visibility on the Internet
More about Crown Equity Holdings Inc. (CRWE) at www.crownequityholdings.com
**
Disclaimer: This material is for informational purposes only and should not be construed as an offer or solicitation of an offer to buy or sell securities. Investors should always conduct their own due diligence with any potential investment, with independent research and other professional advice. Read Full Disclaimer at CRWE-PR Finance www.finance.crwe-pr.com/disclaimer
