Dosing Study of Amino Acids in Seriously Ill Patients

Inclusion Criteria:

- Have Stages II to IVB head and neck cancer receiving radiation and may also be
receiving chemotherapy.

* Subjects are eligible for inclusion in the study regardless of primary Stages II to
IVB head and neck cancer treatment modality (eg, surgery, chemotherapy).

- Have voluntarily signed and dated a written informed consent form (ICF) after the
nature of the study was explained to them.

- Female subjects must be of non childbearing potential (defined as postmenopausal for
at least 1 year or surgically sterile [bilateral tubal ligation, bilateral
oophorectomy or hysterectomy]) or;

- Female subjects of childbearing potential must be using adequate contraception
(practicing 1 of the following methods of birth control):

- total abstinence from sexual intercourse (minimum of 1 complete menstrual cycle
before study entry),

- a vasectomized partner,

- contraceptives (oral, parenteral, or transdermal) for 3 consecutive months prior
to study drug administration,

- intrauterine device (IUD), or

- double barrier method (condoms, sponge, diaphragm, or vaginal ring with
spermicidal jellies or cream).

- Female subjects must have a negative serum or urinary pregnancy test result at
screening (serum specimen must be obtained within 14 days prior to baseline).

Exclusion Criteria:

- Had a loss of > 10% of body weight within the 3 month period prior to the study as
noted in the subjects medical history chart.

- Have renal disease as determined by an estimated glomerular filtration rate (eGFR) <
30 mL/min/1.73m2.

- Have a hemoglobin level of < 9 g/dl.

- Have Stage 0, I, or IVC metastatic cancer.

- Have diabetes.

- Have any reason which, in the opinion of the Investigator, would prevent the subject
from safely participating in the study.

- Have, in the opinion of the Investigator, a dependence on alcohol.

- Have, in the opinion of the Investigator, a dependence on illicit drugs.