NIDA seeks SBIR/STTR apps on Spice, bath salts

C&EN senior business editor Melody Bomgardner dropped me a note yesterday about a new request for applications from NIH’s National Institute on Drug Abuse (NIDA) for small business grants. Read the text below but here’s what I find interesting as a pharmacologist who plays well with chemists: the call for applications is not for analytical methods for designer drugs. Rather the announcement solicits novel methods for detecting some biochemical or pharmacological endpoint of these agents (a bioassay, in old-speak) that doesn’t require new method development every time a new structural analogue pops onto the market. Other areas of substance abuse are also fair game but Melody thought the Spice and bath salts angle would be of greatest interest to our readers here at Terra Sig. Here’s the text directly from NIDA – I can’t find an exact RFA to link to, however: (see update below) NIDA seeks innovative solutions from small businesses, including developing new tests for designer drugs such as Spice, Bath Salts The National Institute on Drug Abuse (NIDA) is seeking new ways of detecting “designer drug” use (e.g., “K2/Spice” or “Bath Salts”) by promoting the development of biofluid drug screens based on pharmacological activity (how the drug works in the body) rather than chemical structure. Because these “designer drugs” are constantly evolving, they frequently evade currently available structure-based drug screens. NIDA is also seeking solutions to a variety of other drug abuse issues. Specific topics of interest could include, but are not limited to: Human Brain Neurochemical and Molecular Imaging Discovery of New Chemical Probes Nanoscience-based Design of Therapies for Substance Abuse Treatment Drug Discovery – Chemistry and Pharmaceutics Preclinical Drug Development Clinical Drug Development High priority will be given to research that seeks to (1) develop innovative technologies, methods or tools or (2) apply emerging and existing methods to develop medications to treat addiction. Grant application deadlines are April 5, August 5, or December 5, 2012. For more information, see the Omnibus Solicitation, issued by the U.S. Department of Health and Human Services: http://grants.nih.gov/grants/funding/sbirsttr1/2012-2_SBIR-STTR-topics.pdf. For more information on NIDA’s SBIR/STTR Program, including tips to improve a grant application, go to: www.drugabuse.gov/funding/funding-opportunities/science-education-grants-contracts/sbirsttr/about-national-institute-drug-abuse-sbirsttr-progra. Here’s an update I received from NIDA Deputy Press Officer Sheri Grabus: Hi, David. We read your post (http://cenblog.org/terra-sigillata/2012/03/15/nida-seeks-sbirsttr-apps-on-spice-bath-salts/), and we greatly appreciate your getting the word out to your readers. You mentioned in your post that you could not find the RFA. This was part of a large “omnibus” solicitation – one that covered various agencies at HHS. The link to the Omnibus Solicitation can be found at http://grants.nih.gov/grants/funding/sbirsttr1/2012-2_SBIR-STTR-topics.pdf. NIDA’s portion starts on page 53. The part specific to developing assays for “designer” drugs of abuse...

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Bad news for Bionovo and herbal drug development
Mar11

Bad news for Bionovo and herbal drug development

A pharmacognosy colleague contacted me on Friday morning with word that the botanical drug development company Bionovo was closing its chemistry group. Well, the news is actually worse as judging from this 8 pm Friday press release: Bionovo, Inc. (OTC Link Platform: BNVI.PK) today announced that it will need to obtain substantial additional funding to achieve its objectives of internally developing drugs. The Company reduced its workforce by over 90%. The remaining management of the Company will receive reduced cash compensation until either adequate financing can be obtained or the Company is sold.  The Company can not make any assurances about either of these events.  As previously announced, management and the board of directors are continuing to explore strategic options for the Company.  Management is currently reviewing the status of the ongoing clinical trial for Menerba. The Company does not currently have adequate internal liquidity to meet its cash needs.  If sufficient additional funds are not received in the near term, the Company may not be able to execute its business plan and may need to further curtail or cease operations. Bionovo has been the rare superb example of a company that’s been trying to develop FDA-approvable drugs based on Chinese traditional medicine. Led by Isaac Cohen, a UCSF guest scientist and Doctoral of Oriental Medicine, and chief medical officer, Mary Tagliaferri, Bionovo took a hard, science-based approach to identifying herbal extracts for cancer and women’s health issues. Cohen and colleagues at UCSF and elsewhere examined Chinese herbal medicines for their biochemical and cellular effects based upon their traditional use. Some of their early work was with a molecular endocrinology physician-scientist Dale Leitman, then at UCSF. Leitman has a solid track record in the transcriptional regulation of estrogen receptor-beta (ERβ), particularly by natural products such as soy isoflavones. Leitman led the group that reported in 2007 that a 22-herb extract, Bionovo’s MF101 (Menerba), had selective ERβ agonist activity with the potential for treating menopausal symptoms without increased risk of breast cancer. This extract advanced to Phase III trials last October. Even more interesting to me was Bionovo’s extract of Scutellaria barbata (BZL101, Bezielle). Given the recent enthusiasm in searching for drugs that targeted the aerobic glycolysis phenotype of many cancers, BZL101 was exciting because it had these effects in cell culture and was formulated into an oral preparation with good bioavailability. (I should make the disclaimer here that my wife, a former Duke University breast oncologist, enrolled patients in a Phase I trial of BZL101 and was co-author of a 2008 ASCO abstract on the results. However, she received no personal compensation for this work and we have never...

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How Do You Like Your Caffeine?
Mar08

How Do You Like Your Caffeine?

Inhaled or oral? Natural or synthetic? Two interesting reports came across the interwebs over the last couple of days. Earlier this week, the US Food and Drug Administration issued a warning letter (press release) to makers of Aeroshot brand of inhaled caffeine. No, it’s not an asthma medicine (although oral theophylline is). It’s billed as a non-caloric caffeine delivery system, 100 mg per hit. That’s roughly the amount in two 12 fl oz/355 mL cans of Mountain Dew or one gulp more than a 8.4 fl oz/250 mL can of Red Bull energy drink. However, the company claims that only 15-25 mg are delivered – perhaps half the amount in a Coca-Cola. The FDA has concerns about the dual promotion of the product for swallowing and inhalation, the relative safety of inhaled caffeine, and the potential for children and adolescents to use the product in combination with alcohol. The company’s FAQ specifically notes that the product is not marketed for use in children. Readers will recall that Four Loko caffeinated alcohol drinks were withdrawn from the market in late 2010 and replaced with alcohol-only versions. On another front, Analytical Chemistry published a paper by a group led by Maik Jochmann at Essen, Germany on an isotopic ratio method for determining whether caffeine in a consumer product is derived from plants or synthetically. While public demand for naturally-caffeinated products doesn’t seem to be especially a big deal in the US, the FDA only requires listing of caffeine content for products with added synthetic caffeine. (Note: I only just found out this afternoon that C&EN Online had covered this paper back on February 29th. My apologies to all for not linking to it. That report is here.) The authors show here that 13C ratios can indeed be used to determine the source of caffeine. In general, 13C represents 1.11% of Earth’s carbon. However, plants incorporate less 13C in making caffeine via C3 carbon fixation from atmospheric carbon dioxide. I’m still a bit unclear as to whether the method can determine the difference between naturally-occurring caffeine from products spiked with purified, plant-derived caffeine (I don’t think so). In the paper, I learned something new and of relevance to the American South (where I live): the international standard for 13C/12C ratios is Vienna Pee Dee Belemnite (VPDB). In 1957, the late Scripps Institution of Oceanography geochemist Harmon Craig, defined terrestrial carbon isotope ratios from a fossilized cephalopod in the Pee Dee limestone formation of South Carolina. Although none of the original specimen remains, secondary standards are now used for calculations. To complete our history lesson, you should know that the Pee Dee River...

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Legislation to protect men from PDE5 inhibitors
Mar04

Legislation to protect men from PDE5 inhibitors

I’ve been rather quiet here as of late, Dear Reader. Between my new day job and trying to finish my book chapter on natural toxins while fighting an overall bout of writer’s block, these pages have been devoid of pixels. But I couldn’t resist posting this news that came across my screen from various sources: State Senator Nina Turner (D-Cleveland) announced legislation today that would protect men in Ohio from the risks of PDE-5 inhibitors, drugs commonly used to treat symptoms of impotence.  Turner’s legislation would include provisions to document that the symptoms are not psychological in nature, and would guide men to make the right decision for their bodies. Physicians would be required to obtain a second opinion from a psychological professional to verify that a patient has a true medical malady before the medication could be prescribed. “The men in our lives, including members of the General Assembly, generously devote time to fundamental female reproductive issues—the least we can do is return the favor,” Senator Turner said. “It is crucial that we take the appropriate steps to shelter vulnerable men from the potential side effects of these drugs.” No, this is not from The Onion. This is a press release from State Senator Turner’s website. And the closer: “We must advocate for the traditional family, protect the sanctity of procreation, and ensure that all men using PDE-5 inhibitors are healthy, stable, and educated about their options—including celibacy as a viable life choice. This legislation will do just that.”   The State Senator is my new hero....

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