Tag Archives: PK

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Emergent BioSolutions Announces Positive Preclinical Efficacy and PK Data for Its New Bispecific Ada

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By Business Wirevia The Motley Fool

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Emergent BioSolutions Announces Positive Preclinical Efficacy and PK Data for Its New Bispecific Adaptir Protein Therapeutic ES414 at AACR

ROCKVILLE, Md.–(BUSINESS WIRE)– Emergent BioSolutions Inc. (NYS: EBS) today announced that two posters on the development of its lead bispecific ADAPTIRTM (Modular Protein Technology) molecule, ES414, were presented earlier this week at the American Association for Cancer Research annual meeting in Washington, D.C.

The ES414 molecule was constructed using Emergent’s ADAPTIR technology platform and selectively binds to the T cell receptor on cytotoxic T cells and Prostate Specific Membrane Antigen (PSMA), an antigen commonly found on prostate cancer cells. In preclinical studies, ES414 has been shown to redirect T-cell cytotoxicity (RTCC) towards prostate cancer cells expressing PSMA. ES414 is being developed as a potential therapeutic for castrate-resistant prostate cancer.

In the first poster, Emergent scientists described the efficacy of ES414 to prevent growth of human prostate cancer cells in vivo that express the PSMA protein on their surface:

  • “Anti-PSMA x anti-CD3 ADAPTIR molecule inhibits tumor growth in vivo”

    • Treatment with ES414 showed statistically significant inhibition of subcutaneous tumor outgrowth in the presence of human T cells in two independent mouse xenograft models of prostate cancer (C4-2B, MDA-PCa-2b). In both models, all treatment groups also showed a statistically significant decrease in serum PSA compared to negative controls.

The second poster described initial PK and tolerability:

  • “Pharmacokinetic evaluation and tolerability assessment of anti-PSMA x anti-CD3 ADAPTIR molecule”

    • These non-clinical studies showed that ES414 is pharmacologically active, has an extended serum half-life compared to antibody fragments, is well tolerated at levels well above the expected human dose, and possesses suitable characteristics for further in vivo toxicology studies.

“We were excited to present the results of these studies and were very pleased with the interest these data received at the meeting,” said Jane Gross, Ph. D., vice president of applied research at Emergent BioSolutions. “ES414 is a promising molecule. Non-clinical efficacy studies have shown that it is well tolerated. It can also be manufactured using standard methodologies. These findings certainly support further development of this molecule and have generated significant partnering interest in our product candidate.”

From: http://www.dailyfinance.com/2013/04/11/emergent-biosolutions-announces-positive-preclinic/

Business, Finance, Occupation & Industry

USCorp Announces Share Distribution Record Date

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By Business Wirevia The Motley Fool

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USCorp Announces Share Distribution Record Date

LAS VEGAS–(BUSINESS WIRE)– USCorp (OTCMarkets: USCS.PK) today announced that the record date for distribution of shares of its subsidiaries, USMetals, Inc. (“USMetals”) and Southwest Resource Development, Inc. (“Southwest”), will be market close on April 15, 2013. All holders of USCorp shares as of the April 15, 2013 record date will be entitled to receive one common share each of USMetals and Southwest for each 10 common shares (or shares convertible into common shares) held in USCorp.

The Company plans to file the forms necessary in order for USMetals and Southwest to commence trading in the United States. Shareholders will receive their shares from our transfer agent regarding the distribution of shares in USMetals and Southwest. European shareholders will be contacted by their respective stock brokers or receive their shares from the Company’s transfer agent. More details will be announced as they become available.

Robert Dultz, USCorp Chairman and CEO said, “We are pleased to make this announcement. It has been a long time coming and the result will be well worth the wait. The finalization of the spinoffs of our subsidiaries will allow our shareholders to more fully participate in the growth of each company separately. Although this process has taken more time than anticipated, when the spinoffs are completed it is our intention that our shareholders will own shares in three publicly trading companies, each with its own properties, and each able to develop independently of the other.”

USCorp is an exploration stage company with gold and silver projects in Arizona and California. Information about USCorp can be found at the company’s website: http://uscorpgold.com.

SAFE HARBOR STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995: The statements contained in this release which are not historical facts are forward-looking statements that are subject to risks and uncertainties that could cause actual results to differ materially from those set forth in or implied by forward-looking statements. These risks and uncertainties include the Company’s entry into new commercial businesses, the risk of obtaining financing, recruiting and retaining qualified personnel, and other risks described in the Company’s Securities and Exchange Commission filings. The forward-looking statements in this press release speak only as of the date hereof, and the Company disclaims any obligation to provide updates, revisions or amendments to any forward-looking statement to reflect changes in the Company’s expectations or future results.

USCorp
Robert Dultz, Chairman …read more

Source: FULL ARTICLE at DailyFinance

News, Politics, Government

A Skeptic's Take on Nuvilex After Speaking With Management; Patience Should be Rewarded

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By Jordan S. Terry, Contributor Since my first article on (NVLX.PK) went more into the science, technology, etc, the company has/is developing (as well as detailed risk factors), and my second article, here for Forbes mentioned Nuvilex more as an example of how to approach investing/trading in penny stocks, I want to take some time to share a few additional thoughts and insights gleaned subsequently. …read more

Source: FULL ARTICLE at Forbes Latest

Business, Finance, Occupation & Industry

ABMC Reports Fourth Quarter and Year End 2012 Results

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By Business Wirevia The Motley Fool

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ABMC Reports Fourth Quarter and Year End 2012 Results

KINDERHOOK, N.Y.–(BUSINESS WIRE)– American Bio Medica Corporation (ABMC.PK) today announced financial results for the fourth quarter and the year ended December 31, 2012.

Net sales in the fourth quarter of 2012 were $2,302,000 compared to $2,374,000 in the fourth quarter of 2011, a decrease of 3%. Operating loss for the fourth quarter of 2012 was $501,000, compared to operating income of $27,000 in the fourth quarter of 2011. Net loss in the fourth quarter of 2012 was $564,000, or $0.03 per share, compared to a net loss of $15,000, or $0.00 per share, in the fourth quarter of 2011.

Net sales for the year ended December 31, 2012 were $9,343,000, compared to net sales of $9,272,000 for the year ended December 31, 2011; representing an increase of 1.0%. Operating loss for 2012 was $929,000, compared to an operating loss of $146,000 in 2011. Net loss for 2012 was $1,111,000, or $0.05 per share, compared to $345,000, or $0.02 per share, in 2011.

ABMC Chief Executive Officer, Stan Cipkowski stated, “Sales were relatively flat in 2012; although the very modest increase in sales is a welcome change from the declines in the previous three years. In 2012, we incurred increased legal fees and other costs associated with regulatory compliance, as well as increased inventory disposals. Expense reductions in other areas of the company did mitigate the impact these increased costs had on financial results by minimizing the loss.”

Cipkowski continued, “Our new financing package, for up to $3 million, with Imperium Commercial Finance, will provide us with the necessary capital to diversify our markets through investments in new products and position the Company for profitable sales growth in 2013. I have three primary objectives in our core drug test business this year; offering a full line of cost effective, foreign manufactured drug tests for price conscious markets, the marketing clearance and commercialization of a new product for both clinical and consumer markets, and the submission of our FDA 510(k) marketing application for our oral fluid drugs of abuse test.”

For more information on ABMC or its drug testing products, please visit www.abmc.com.

About American Bio Medica Corporation

American Bio Medica Corporation develops, manufactures and markets accurate, cost-effective immunoassay test kits, primarily point of collection tests for drugs of abuse. The Company and its worldwide distribution network target the workplace, …read more
Source: FULL ARTICLE at DailyFinance

Business, Finance, Occupation & Industry

NovaDel Reports Unaudited Financial Results for the Twelve Months Ended December 31, 2012

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By Business Wirevia The Motley Fool

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NovaDel Reports Unaudited Financial Results for the Twelve Months Ended December 31, 2012

BRIDGEWATER, N.J.–(BUSINESS WIRE)– NovaDel Pharma Inc. (NVDL.PK) reported unaudited financial results for the twelve months ended December 31, 2012.

As previously reported, the Company has entered into negotiations for the sale of its intellectual property and certain other assets to SUDA LTD, an Australian company listed on the ASX. An agreement has not as yet been reached. In addition, we are seeking a purchaser for our NitroMist® and ZolpiMist™ licenses together with the related NDA‘s. We are currently appealing the FDA fees levied on these products and they continue to be an impediment to the sale of the licenses.

The Company, at the end of March 2012, deregistered its common stock and exited the Securities and Exchange Commission reporting system.

The Company recorded a loss of $1,200,000 or $(0.01) per share for the twelve months ended December 31, 2012, compared to a net loss of $5,341,000 or $(0.04) per share in the twelve months ended December 31, 2011.

During the twelve months of 2012, the Company earned royalties from the license of NitroMist and ZolpiMist in the amount of $471,000. The Company also received $200,000 from the sale of NitroMist rights outside the US, Canada and Mexico. Also included in revenue is the recognition of previously received payments under various license agreements. In January, 2013, we terminated our ZolpiMist license agreement with Rechon Life Science AB. Rechon breached the initial performance clause of the license and under the terms of the agreement the license was terminated.

Expenses for the twelve months ended December 31, 2012, were $2,572,000 as compared to $4,700,000 and include amounts to maintain and expand our intellectual property base, as well as an expense accrual under a severance agreement with a former officer of the Company. The Company continues to closely manage its expenses as well as actively negotiate with its creditors to reduce its outstanding debts.

As of December 31, 2012, the Company has approximately $30,000 in cash and cash equivalents.

The current liabilities of the Company, at December 31, 2012, of $4,365,000 include fees due to the FDA approximating $2,800,000. The imposition of these fees is an impediment to our ability to raise capital to continue to develop our product opportunities or find a strategic partner. The Company has filed an appeal with the FDA for relief of the fees currently imposed and future fees relating to our licensed and marketed products. There is …read more
Source: FULL ARTICLE at DailyFinance